Tesamorelin

1. Identity

Field	Value	Source
INN	Tesamorelin	[Regulatory document — FDA NDA 022505]
Research code	TH9507	[Regulatory document — Health Canada SBD]
CAS (free peptide)	218949-48-9	[Academic secondary source — PubChem CID 16137828]
CAS (acetate salt)	901758-09-6	[Academic secondary source — PubChem CID 16129714]
Molecular formula (free peptide)	C₂₂₁H₃₆₆N₇₂O₆₇S	[Academic secondary source — DrugBank DB08869]
Molecular weight	5135.8 g/mol (acetate basis used commercially)	[Regulatory document — FDA Egrifta WR label 022505s020]
Class	Synthetic 44-aa analogue of human growth hormone-releasing hormone (GHRH 1-44), N-terminally modified with a trans-3-hexenoic acid (hexenoyl) moiety on Tyr¹ for DPP-IV resistance	[Regulatory document — FDA NDA 022505]
Brand names	Egrifta (F1, 2010); Egrifta SV (F4, 2019); Egrifta WR (F8, FDA-approved 25 Mar 2025)	[Regulatory document — FDA approval letter 25 Mar 2025]
Sponsor / Originator	Theratechnologies Inc. (Montréal, Canada)	[Regulatory document — FDA NDA 022505]
Salt form	Tesamorelin acetate (lyophilised, reconstituted with sterile water for injection)	[Regulatory document — FDA Egrifta WR label]
Plasma t½ (SC)	~26 minutes (HIV-infected subjects)	[Peer-reviewed human study — Population PK, PMID 25358450]
Absolute SC bioavailability	~3.9%	[Regulatory document — FDA clinical pharmacology review NDA 022505]
Route	Subcutaneous, abdomen, once daily	[Regulatory document — FDA Egrifta WR label]

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2. History and Development

Tesamorelin was discovered and developed in Canada by Theratechnologies Inc. as TH9507, designed to resist DPP-IV cleavage at the N-terminus by capping Tyr¹ with a trans-3-hexenoic acid moiety while retaining the full 44-amino-acid GHRH sequence required for full agonism at the pituitary GHRH receptor [Regulatory document — Health Canada Summary Basis of Decision, Egrifta].

The pivotal regulatory programme comprised two multinational, randomised, double-blind, placebo-controlled Phase 3 trials in HIV-infected adults with lipohypertrophy: LIPO-010 (NCT00123253, n=412) and CTR-1011 (NCT00435136, n=404), each consisting of a 26-week primary phase followed by a 26-week re-randomised extension ⚠️ [Peer-reviewed human study — Falutz 2007 NEJM PMID 18057338; Falutz 2010 JAIDS PMID 20554713]. On these data FDA approved Egrifta on 10 November 2010 under NDA 022505 for “reduction of excess abdominal fat in HIV-infected patients with lipodystrophy” — to date the only FDA-approved indication [Regulatory document — FDA NDA 022505 approval letter].

Reformulations:

• Egrifta SV (F4), 1.4 mg per daily injection (smaller injection volume), approved 2019 [Regulatory document — FDA label 022505s012s013].
• Egrifta WR (F8), approved 25 March 2025 via supplemental BLA. F8 is 8× more concentrated than F1 and 2× more concentrated than F4; recommended dose 1.28 mg in 0.16 mL SC once daily, reconstituted weekly rather than daily; bioequivalent to F1 by PK [Regulatory document — FDA Egrifta WR label 022505s020lbl; Press release — Theratechnologies 25 Mar 2025, flagged as not peer-reviewed]. FDA had previously issued a Complete Response Letter for F8 in January 2024 over CMC/manufacturing issues, resolved before March 2025 approval [Press release — Theratechnologies investor materials, flagged as not peer-reviewed]. On 8 April 2025 FDA approved a Prior Approval Supplement to the EGRIFTA SV sBLA allowing Theratechnologies to resume routine SV distribution during the SV→WR transition [Press release — Theratechnologies 8 Apr 2025].

EMA pathway (Europe). Ferrer Internacional, S.A. (European partner) submitted the centralised MAA on 31 May 2011. After oral explanation before the CHMP, Ferrer formally withdrew the application on 21 June 2012 (announced 22 June 2012). The withdrawal letter explicitly states that the CHMP “considers that the provided data do not allow it to conclude on a positive benefit-risk balance” — driven by concerns about long-term IGF-1 elevation, absence of cardiovascular risk-marker data, and uncertainty about the durability and clinical meaningfulness of VAT reduction [Regulatory document — EMA withdrawal Q&A, Egrifta, June 2012]. Tesamorelin has not been re-submitted to EMA since; no EU marketing authorisation exists.

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3. Mechanism of Action

Demonstrated in humans (status: established). Tesamorelin binds and activates the human GHRH receptor (GHRHR) on anterior pituitary somatotrophs with potency comparable to endogenous GHRH(1-44), evoking a physiological-pattern, pulsatile release of endogenous growth hormone. Pulsatile GH drives hepatic IGF-1 synthesis. The lipolytic effect on visceral adipose tissue (VAT) is GH-mediated, with relative sparing of subcutaneous adipose tissue (SAT); IGF-1 increases by ~80–120 ng/mL in responders, generally remaining within the normal physiological band [Regulatory document — FDA Egrifta WR label §12.1–12.2; Peer-reviewed human study — Falutz 2010 PMID 20554713 ⚠️].

Demonstrated in humans (status: established secondary). Pulsatile GH/IGF-1 stimulation reduces hepatic fat fraction (HFF) in HIV-associated NAFLD, with paired liver-biopsy evidence of attenuation of fibrosis progression and downregulation of pro-inflammatory, pro-angiogenic, and pro-fibrotic hepatic gene sets (VEGFA, TGFB1, CSF1) [Peer-reviewed human study — Stanley 2019 Lancet HIV PMID 31611038, NIH-funded; Fourman 2020 JCI Insight DOI 10.1172/jci.insight.140134; Fourman 2021 Sci Rep DOI 10.1038/s41598-021-89966-y].

Proposed/preclinical (status: not established in humans). Hypothesised secondary actions include restoration of pulsatile GH architecture disrupted by visceral adiposity, modulation of hepatic mitochondrial oxidative phosphorylation gene sets, and reciprocal regulation of hepatocellular-carcinoma prognostic gene sets — observed at the transcriptomic level in HIV-NAFLD but not validated as clinical endpoints [Peer-reviewed human study — Fourman 2020 JCI Insight]. Direct receptor-level off-target activity at the ghrelin receptor (GHSR1a) has not been described; tesamorelin is not a secretagogue/ghrelin mimetic.

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4. Regulatory Status

4.1 Drug-regulatory status

• FDA (USA): Approved under NDA/BLA 022505 (10 Nov 2010). Current approved formulations: Egrifta SV (F4) and Egrifta WR (F8, 25 Mar 2025). Indication unchanged: reduction of excess abdominal fat in HIV-infected adults with lipodystrophy. Not indicated for non-HIV obesity, NAFLD, sarcopenia, anti-aging, or athletic performance. Compounding (503A/503B): tesamorelin is a branded biologic with active FDA-approved sponsor product and no FDA-recognised bulk-drug-substance compounding listing; under FDA’s October 2023 and subsequent guidance on bulk-substance compounding of peptides, copies of FDA-approved drug products are not eligible for routine compounding under 503A. Tesamorelin “research peptide” sold through unapproved channels is therefore not legally compounded for human use [Regulatory document — FDA compounding bulk substances guidance].
• EMA (EU): No marketing authorisation. MAA withdrawn by Ferrer Internacional, S.A. on 21 June 2012 after CHMP could not conclude a positive benefit-risk balance (cardiovascular risk-marker data gap + long-term IGF-1 elevation) [Regulatory document — EMA Q&A, Egrifta withdrawal, Jun 2012].
• MHRA (UK): No UK marketing authorisation post-Brexit; would have followed EMA pathway. Not in BNF.
• Health Canada: Approved 30 April 2014 (Notice of Compliance, 2 mg/vial); 1 mg/vial supplementary NDS approved March 2015. Indication aligned with FDA. Long-term safety to be established by routine pharmacovigilance + Risk Management Plan including a 10-year prospective cohort study of malignancy and major adverse cardiovascular events as primary/secondary endpoints [Regulatory document — Health Canada SBD, Egrifta].
• TGA (Australia): No ARTG entry for tesamorelin. Not individually scheduled in the Poisons Standard (October 2025 SUSMP) under its INN. As an unapproved injectable peptide hormone analogue, supply in Australia would fall under Schedule 4 (Prescription Only) by default and would require Special Access Scheme / Authorised Prescriber pathways [Regulatory document — TGA Poisons Standard, October 2025].
• PMDA (Japan): No marketing authorisation.
• NMPA (China): No marketing authorisation.
• MFDS (Korea): No marketing authorisation.
• GRLS (Russia): Not registered.
• WHO EML: Not listed.

4.2 Anti-doping status

• WADA 2026 Prohibited List (in force 1 January 2026): S2.2.4 — Growth Hormone Releasing Factors. Tesamorelin is explicitly named alongside CJC-1293, CJC-1295, and sermorelin under “growth hormone-releasing hormone (GHRH) and its analogues” [Anti-doping document — WADA 2026 Prohibited List S2.2.4].
• In-competition AND out-of-competition: Prohibited at all times. All S2 substances are Specified Substances per WADC Article 4.2.2 [Anti-doping document — WADA 2026 List].
• TUE eligibility: Theoretically obtainable under the ISTUE 2026 criteria (clear diagnostic indication + no permitted alternative + non-performance-enhancing dose); HIV-associated lipodystrophy is the documented FDA-approved indication. No publicly reported precedent TUEs in elite sport.
• NCAA: Banned under NCAA Drug Class “Peptide Hormones, Growth Factors, Related Substances and Mimetics” (parallels WADA S2) [Anti-doping document — NCAA banned drug classes 2025-26].
• DoD-OPSS / Operation Supplement Safety: GHRH analogues including tesamorelin are flagged as prohibited for U.S. military personnel via the “DoD Prohibited Dietary Supplement Ingredients” framework [Anti-doping document — DoD OPSS prohibited ingredients].
• Global DRO check: Tesamorelin returns “Prohibited at all times” against WADA-aligned jurisdictions (USA/UK/Canada/Japan). Global DRO check date: 2026-05-16 [Anti-doping document — globaldro.com].
• Detection window: Direct LC-HRMS/MS detection of intact tesamorelin in urine is feasible within ~24–48 h of a typical 1–2 mg SC dose; indirect detection via the IGF-1/P-III-NP “GH biomarkers” passport approach extends the inferential window to days–weeks but is non-specific to tesamorelin.
• Notable sanctions / precedents: None publicly disclosed naming tesamorelin specifically; numerous AAFs for “GHRH analogue” class substances have been reported through national anti-doping organisations under WADA S2.2.4 since 2014.

4.3 Last regulatory review

Last regulatory review: 2026-05-16

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5. Formulations and Routes

• Egrifta SV (F4): lyophilised tesamorelin acetate, 2 mg/vial (deliverable dose 1.4 mg in 0.35 mL after reconstitution with sterile water for injection), daily SC into the abdomen with site rotation [Regulatory document — FDA label 022505s012s013].
• Egrifta WR (F8): lyophilised tesamorelin acetate, 11.6 mg/vial (≈11.9 mg as acetate). Recommended dose 1.28 mg (0.16 mL) SC daily; vial is reconstituted weekly and reconstituted solution stored at room temperature for 7 days [Regulatory document — FDA Egrifta WR label 022505s020lbl].
• PK: absolute SC bioavailability ~3.9%; T_max ≈ 0.15 h; t½ ≈ 26 min plasma; clearance ~1,060 L/h with high inter-individual variability (33.6% CV); volume of distribution ~200 L; absorption fraction increases ~13% on repeated dosing (Day 14 vs Day 1) [Peer-reviewed human study — Population PK, Chen 2015 PMID 25358450; Regulatory document — FDA clinical pharmacology review].
• PD: transient pulsatile GH rise (peak ~2 h post-dose), sustained increase in IGF-1 over weeks to months with steady-state by ~2 weeks; IGF-1 rise is the primary biomarker of biological exposure [Regulatory document — FDA Egrifta WR label §12.2].

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6. Preclinical Evidence

Rodent and non-human-primate studies show that tesamorelin elicits a pulsatile GH release pattern more physiological than that produced by exogenous rhGH, with corresponding IGF-1 elevation [Peer-reviewed preclinical study — Theratechnologies preclinical CSRs referenced in FDA pharmacology review NDA 022505]. In diet-induced obese (DIO) rodents tesamorelin reduces visceral fat depots with relative SAT sparing; carcinogenicity bioassays in rats and mice did not identify a clear neoplastic signal at clinically relevant exposures but were limited by species-specific GH/IGF-1 biology [Regulatory document — FDA pharmacology/toxicology review NDA 022505].

Reproductive toxicology is the most notable preclinical finding and underlies the pregnancy contraindication: in rat pups exposed in utero at maternal systemic exposures of ~2–4× human clinical AUC, hydrocephaly and delayed skull ossification were observed. No adequate human pregnancy data exist [Regulatory document — FDA Egrifta WR label §8.1].

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7. Clinical Evidence

7.1 Cochrane systematic review

None. A Cochrane systematic review on tesamorelin was not identified in the Cochrane Library as of 2026-05-16. The closest formal Cochrane-style appraisal is the 2018 CADTH/CDR Clinical Review Report on Tesamorelin (Egrifta) for the Canadian common drug review [Academic secondary source — NCBI Bookshelf NBK539124/NBK539136].

7.2 Systematic reviews / meta-analyses

• Sivakumar 2011 — narrative systematic review in HIV Medicine, three RCTs at the time [Peer-reviewed human study — Sivakumar PMID 21265979].
• Dhaliwal 2020 — narrative SR, expanded scope.
• Badran 2026 — first quantitative random-effects meta-analysis of 5 RCTs in HIV-associated lipodystrophy (search through July 2025; PROSPERO CRD42024607258; GRADE assessed; RoB 2.0 used). Pooled effects: VAT MD −27.71 cm² (95% CI −38.37 to −17.06, p<0.001); trunk fat −1.18 kg; limb fat −0.22 kg; HFF −4.28%; waist circumference −1.61 cm; lean body mass +1.42 kg. No significant change in BMI, SAT or CD4 count. Adverse events: arthralgia, myalgia, paraesthesia, injection-site erythema. Authors declare no competing interests [Peer-reviewed human study — Badran et al. Obes Res Clin Pract 2026, PMID 41545261, DOI 10.1016/j.orcp.2026.01.002]. This is the first independent-group quantitative SR of tesamorelin and materially upgrades the evidence synthesis layer.

7.3 Pivotal RCTs

Trial / NCT	Indication	Phase	N	Primary outcome	Funding
Falutz 2007 NEJM (NCT00123253, LIPO-010 6-mo)	HIV-lipodystrophy	3	412	VAT −15.4% vs +5.0% placebo (p<0.001 at 26 wk)	Theratechnologies ⚠️
Falutz 2008 AIDS (52-wk extension LIPO-010)	HIV-lipodystrophy	3	404 retained	VAT reduction maintained on T-T; reaccumulation on T-P	Theratechnologies ⚠️
Falutz 2010 JAIDS pooled LIPO-010+CTR-1011 (NCT00435136, NCT00608023)	HIV-lipodystrophy	3	806 pooled	−18% VAT, IGF-1 +108 ng/mL, no clinically meaningful glucose change at 52 wk	Theratechnologies ⚠️
Stanley 2012 JCEM (cognition)	HIV cognition pilot	2	60	Executive function improvement	NIH (independent)
Stanley 2014 JAMA (NCT01263717)	HIV cardiac/visceral fat	2	54	VAT −18%, liver fat reduction	NIH (independent)
Stanley 2019 Lancet HIV (NCT02196831)	HIV-NAFLD	2	61	HFF −4.1% absolute / −37% relative (p=0.018); ↓ fibrosis progression on paired biopsy	NIH (independent)
Kohli 2021 JAHA	HIV cardiac steatosis	2	post-hoc	Reduced epicardial/intramyocardial lipid	NIH (independent)
NCT04101656	non-HIV MAFLD	2/3	~252 planned	Hepatic fat fraction	Theratechnologies ⚠️
NCT04030702	HIV cardiac steatosis	2	~62 planned	CMR epicardial fat	NIH/MGH (Stanley)
NCT03226821	HIV body composition (phase 4)	4	~60	Body composition / metabolic	Columbia/NIH

As of 2026-05-16, no top-line readouts have been published in indexed journals for NCT04101656, NCT04030702, or NCT03226821 [Clinical trial registry — ClinicalTrials.gov]. A 2025 IDWeek/CROI-period subanalysis of pooled Phase 3 data reported tesamorelin-associated reductions in 10-year ASCVD risk score and mediation by blood pressure and lipid components; industry-co-authored (Theratechnologies) and remains a conference-level abstract [Peer-reviewed conference abstract — DOI 10.1093/ofid/ofae631.633 ⚠️].

7.4 Notable post-marketing/secondary analyses

• INSTI-subgroup post-hoc analysis of Stanley NAFLD trial: VAT −8.3% with tesamorelin vs +10.8% placebo, HFF −31% relative in tesamorelin arm at 12 months (McLaughlin/Fourman 2023 OFID; Theratechnologies co-authorship ⚠️) [Peer-reviewed human study — DOI 10.1093/ofid/ofad500.1334].
• Rahman 2022 dorsocervical-fat post-hoc, Phase 3: VAT-responder rate ~70% irrespective of dorsocervical fat status ⚠️ [Peer-reviewed human study — DOI 10.1017/cts.2022.515].

7.5 Disputed Claims

Dispute A — FDA approval vs EMA non-approval on substantially the same dataset.

• FDA position (10 Nov 2010): The two pivotal Phase 3 trials (LIPO-010, CTR-1011) demonstrated statistically and clinically significant ~15–18% VAT reduction at 26 weeks with acceptable short-term safety; approval was granted on this basis with post-marketing requirements (later released by FDA as infeasible given the small HIV-lipodystrophy population) [Regulatory document — FDA NDA 022505 medical/statistical reviews].
• EMA/CHMP position (Jun 2012): The same dataset was judged insufficient to conclude a positive benefit-risk balance; CHMP cited the absence of cardiovascular risk-marker data, uncertainty about the clinical meaningfulness of VAT reduction, and concern about long-term IGF-1 elevation. Ferrer Internacional withdrew the MAA rather than respond to a likely negative opinion [Regulatory document — EMA Q&A on Egrifta withdrawal, 22 Jun 2012].
• Funding flags: Pivotal dataset wholly Theratechnologies-funded ⚠️. The dispute is a regulatory standard-of-evidence dispute (acceptability of a surrogate VAT endpoint without hard cardiovascular outcomes) rather than a dispute over the analytical interpretation of the trials themselves. Both regulators agree VAT was reduced; they disagree on whether VAT reduction alone is a benefit sufficient to outweigh long-term IGF-1 uncertainty.

Dispute B — Class-level GH-anti-aging dispute (Rudman 1990 vs Liu 2007).

• Rudman 1990 position: In the original 6-month trial in healthy older men (N Engl J Med 1990; 323:1–6), rhGH increased lean body mass and reduced adipose tissue, framed in popular discourse as anti-aging.
• Liu 2007 position: A systematic review of GH in healthy elderly (Ann Intern Med 2007; 146:104–115, PMID 17227934) concluded that effects were modest, adverse events (oedema, arthralgia, carpal tunnel, glucose intolerance, gynaecomastia) were common, and net clinical benefit was not demonstrated.
• Inheritance by tesamorelin: Tesamorelin produces a more physiological pulsatile GH/IGF-1 elevation than exogenous rhGH, but the downstream IGF-1 rise is the relevant signal in the Rudman/Liu dispute. The class-level objection — that elevating GH/IGF-1 in non-deficient adults has unproven net benefit and known adverse effects — applies to tesamorelin used outside its approved indication. No tesamorelin trial in healthy older adults has shown durable clinical benefit on hard endpoints [Peer-reviewed human study — Liu 2007 PMID 17227934].

Dispute C — Long-term cancer / malignancy signal.

• Position 1 (“biological plausibility, unquantified clinical signal”): Sustained IGF-1 elevation is biologically associated with epithelial cancers (colorectal, breast, prostate) on mechanistic and epidemiologic grounds; FDA, EMA and Health Canada all flagged this as an unresolved long-term safety question. The FDA label explicitly contraindicates use in patients with active malignancy and warns about recurrence [Regulatory document — FDA Egrifta WR label §4–5; EMA Q&A 2012].
• Position 2 (“no signal detected in available data”): Pivotal Phase 3 trials (52-wk safety extension) and post-marketing surveillance since 2010 have not detected a statistically significant excess of malignancy; IGF-1 rises observed clinically remain largely within the normal physiological range; the Health Canada-mandated 10-year prospective cohort of tesamorelin-treated patients has malignancy as its primary endpoint and is ongoing [Regulatory document — Health Canada SBD; Peer-reviewed human study — Falutz pooled analysis PMID 20554713 ⚠️].
• Funding flags: All available efficacy/safety trials are Theratechnologies-sponsored ⚠️; the 10-year safety cohort is sponsor-run ⚠️.
• Status: Both positions remain in the literature; the trials were neither designed nor powered to detect cancer incidence differences. No resolution as of 2026-05-16.

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7B. Community Evidence Layer

From tesamorelin_com_2026-05-16_A76.md. Community claims are reported as community claims; no inheritance to the science layer.

7B.1 Community context and adoption arc

Tesamorelin entered the longevity/biohacker/bodybuilding conversation roughly 2013–2015, several years after its 2010 FDA approval. Awareness in the bodybuilding underground initially overlapped with GH and IGF-1 LR3 discussions on MESO-Rx, EliteFitness and Anabolic Minds. Breakout to mass awareness came through three channels in order: Jay Campbell’s writing (jaycampbell.com, The TOT Bible, Guaranteed Shredded — codified the “1 mg AM/PM, 5-on-2-off, 8-on-8-off” lower-dose pattern); Ben Greenfield’s peptide series (bengreenfieldlife.com — labelled tesamorelin “the premium therapeutic choice” and seeded the “Wolverine stack” IGF-1 LR3 + ipa + CJC-1295 no-DAC + tesa); and Andrew Huberman’s April 2024 “Benefits & Risks of Peptide Therapeutics” episode plus the later Craig Koniver episode, which framed tesamorelin and sermorelin as the two FDA-blessed GHRH options.

Current adoption (2025–2026) is dominated by TRT/longevity telehealth clinics (Marek Health, Defy Medical, Perfect B, Eternity Health Partners, Rewind Anti-Aging, Body Tonic, Evergreen Institute, 1stOptimal, Eden, Vitali-T); a rising GLP-1 lean-mass-preservation pattern (tirzepatide/semaglutide users adding tesamorelin, often with ipamorelin, to protect lean mass during deficit); and bodybuilding off-season logs including the sponsored Meso-Morph “Building and Growing with Tesamorelin cycle” (US-Pharmacies sponsorship, Jan 2026).

Trajectory is rising, driven by two compounding tailwinds. The post-December 2024 PCAC dynamic (PCAC voted against adding ipamorelin, CJC-1295, AOD-9604, BPC-157 and TB-500 to the 503A bulks list) produced a migration funnel from compounded CJC/ipamorelin into first sermorelin, then tesamorelin for users wanting more clinical pedigree. The GLP-1 stack pattern reads tesamorelin’s selective visceral-fat action and GH-mediated lean-mass support as a near-perfect complement to GLP-1-induced weight loss; telehealth clinics market this combination aggressively. A counter-current treats tesamorelin as “obsolete” relative to retatrutide or low-dose exogenous GH and migrates away from it.

7B.2 Documented protocols — two schools

Two protocol schools coexist in the surveyed community:

• Label-dose / clinic school (Defy Medical, Perfect B, Eternity Health Partners, Rewind Anti-Aging, Body Tonic, Evergreen Institute, Womens Health of MD): 2 mg daily continuous (Egrifta SV label) or 1.28 mg daily (Egrifta WR label). Rationale: cite Falutz 2010 and Stanley 2014 trials; treat label as norm. ⚠️ commercial.
• Lower-dose / research-peptide school (Jay Campbell, Hunter Williams “Peptide Cheat Sheet” March 2025, Ben Greenfield, MESO-Rx threads, Alpa Bio Med dosing card, peptides.org, Innerbody, Swolverine, Perfect B’s 3-month structured cycle): 1 mg SC nightly (or 1 mg AM + 1 mg PM), 5 days on / 2 days off weekly, 8 weeks on / 8 weeks off macrocycling. Rationale cited: receptor sensitivity, cost, tolerability. Reconstitution math (10 mg vial in 2 mL BAC water → 1 mg = 20 units on U-100 insulin syringe) is consistent across the school.

Both schools converge on subcutaneous abdominal injection with site rotation, evening or fasted-morning timing, and an explicit “do not exceed 2 mg/day” ceiling.

7B.3 Claimed effects

Claim	Frequency	Top named source
Visceral / abdominal fat reduction	widespread	Jay Campbell (“Guide to Tesamorelin Peptide Dosage”); echoed by Perfect B, Rewind, Body Tonic, MESO-Rx tesamorelin threads, Swolverine, Greenfield. Defining community claim.
Non-VAT body recomp / “harder, tighter” look	common	Meso-Morph “All about Tesamorelin” sponsor thread; Jay Campbell. Framed as nutrient partitioning, not hypertrophy.
Sleep quality (deeper sleep, easier onset)	common	Meso-Morph competitor log; Huberman Lab Q&A. Weaker than sermorelin/ipamorelin sleep claims.
Energy / mood lift	occasional	MESO-Rx “TRT + Peptides – Plateau vs Optimization” thread.
Skin / hair / nails improvement	occasional	MESO-Rx “Mixing tesamorelin and hgh” thread (5-month user); Eternity Health Partners ⚠️ commercial.
Cognitive / memory / “mental sharpness”	occasional, contested	Eternity Health Partners ⚠️ commercial; Innerbody, Evergreen Institute extrapolate from Stanley 2014 HIV-cognition trial. Counter-citation: Ellis et al. 2025 (cited on BioLongevity Labs product page) found no significant difference vs standard care for neurocognitive impairment in abdominally obese HIV subjects.
Lean-mass preservation during GLP-1 use	rising → now common	Vitali-T Clinic; Lamkin Clinic “3-Tier Peptide Stacking”; Proto Peptide; increasemyt.com; Greenfield’s “Safe Ozempic Alternatives”. ⚠️ All commercial.
Libido / sexual function	single-source / rare	Not a community claim; users seeking that run PT-141.
Subjective IGF-1 / “GH feel” effects	common	MESO-Rx “Bloodwork on Tesamorelin”: IGF-1 243 → 306 ng/mL on 2 mg. Users describe milder feel than rhGH.
Liver fat / NAFLD improvement	common, extrapolated	BioLongevity Labs; Evergreen Institute; Peptide Partners. Built on Stanley 2019 (HIV-NAFLD, not general population).

7B.4 Reported side effects

• Injection-site reactions — widespread (drugs.com SE listing 1–10%; Phase 3 25% rate per The Peptide Catalog).
• Arthralgia / joint stiffness — widespread (WebMD Egrifta WR label summary; Mayo Clinic).
• Peripheral edema / water retention — common (4.8% vs 2.9% placebo in pivotal trial per The Peptide Catalog).
• Carpal tunnel / paresthesia — common (drugs.com 1–10%).
• Dysglycaemia / fasting glucose creep / HbA1c drift — common-to-widespread concern. GLP-1 Forum user observed tesa appeared to “blunt the insulin management of tirz”. Stanley 2017 T2DM trial found no significant HbA1c change at 12 weeks — community uses this to argue the concern is real but manageable.
• Flushing / vasodilatory feeling immediately post-injection — occasional.
• Headache — occasional.
• Anti-tesamorelin antibody formation — rarely surfaced in community despite being prominent in the label (49.5% IgG at 26 weeks).
• Palpitations / tachycardia — occasional, generally attributed to CJC rather than tesa.
• Anaphylaxis / serious allergic reaction — single-source but high-signal. MESO-Rx thread “Anaphylaxis Shock after taking CJC + Ipa + Tesamorelin” (May 2026) — user describes hives, shortness of breath, brief loss of consciousness ~15 min post-injection of a CJC/ipa/tesa blend. Thread responders note “Ipamorelin specifically has an anaphylaxis risk … but they all kinda have that risk.” A small but recurring signal across the GH-secretagogue community.

7B.5 Community dissent

The tesamorelin discourse is unusually contentious for a GHRH analogue.

• “Why use it at non-HIV-lipodystrophy doses?” Eric Topol’s Ground Truths Substack (“The Peptide Craze”) is the most-cited skeptic: “Tesamorelin … is an FDA approved drug for a narrow indication: patients with HIV lipodystrophy. Yet it is being prescribed for healthy individuals to reduce abdominal fat, improve muscle mass and cognitive health.” The clinic-side rebuttal (Perfect B, Rewind, Evergreen) is that the GH-on-VAT mechanism isn’t HIV-specific and off-label prescribing is “common, legal, and well-established.”
• “Use sermorelin/CJC instead” vs “tesamorelin is the only GHRH with real data.” Andrew Huberman stated both positions across episodes. In April 2024 he framed sermorelin and tesamorelin as the two FDA-blessed GHRH choices and dismissed CJC-1295 (“I don’t know why anyone would specifically select CJC-1295”). In the later Koniver episode he revealed he had discontinued sermorelin because it “nuked his REM sleep” and “spiked PSA.” Jay Campbell holds a hybrid view: tesamorelin is “the premium therapeutic choice” but ipamorelin is the workhorse “because quality Tesamorelin is very difficult to get now.” PeptideFox states the evidence gap bluntly: “Sermorelin’s adult body composition data comes from 19 subjects. CJC-1295 without DAC has zero published human trials … the evidence gap between tesamorelin and everything else in this class is structural.”
• IGF-1 / cancer concern. Community sources split. WebMD’s Egrifta WR summary lists “higher risk of cancer” as a less-common serious side effect. Huberman’s April 2024 episode explicitly grouped tesamorelin with sermorelin under peptides that “stimulate hormonal pathways leading to increased metabolism and vitality but might contribute to tumor growth.” MESO-Rx users routinely advise pulling baseline + on-cycle IGF-1 and dose-reducing when IGF-1 trends above the lab upper range. Counter-position (503Pharma compounding guide): “No increased cancer risk; safe in long-term use for approved indications.” Unresolved.
• Is EMA’s refusal a red flag? Less actively discussed in the surveyed community than expected. Clinic and vendor pages typically omit the EMA non-approval entirely. Topol flags it indirectly. Reddit-style discussion is sparse in retrievable sources.
• Cost-vs-benefit (research-grade vs brand). Largest single dissent vein. Brand Egrifta $2,400–$2,800/month vs research-grade $130–$300/month. Multiple MESO-Rx threads end with users switching from tesa to generic rhGH because “much cheaper and easy to regulate.”
• “Is this even the right peptide for someone without HIV-lipodystrophy?” The meta-question under all other dissent. PeptideFox notes fat regains rapidly after discontinuation (24.5% rebound at week 52) — making tesamorelin “an ongoing intervention, not a reset.”

7B.6 Stack patterns

• Tesamorelin + TRT — the most common adult-male anti-aging clinic stack (Marek Health, Defy Medical, Eternity, Rewind, Body Tonic).
• Tesamorelin + tirzepatide/semaglutide (GLP-1 lean-mass preservation) — freshest pattern. GLP-1 Forum thread “Tirzepatide and Tesamorelin stacked” (Aug 2024; 61M, tesa 2 mg 5-on/2-off + tirz 7.5 mg/wk, 232→207 lb, WHR 1.6→1.04). Doses cluster at 1–2 mg tesa daily + standard tirz titration. ⚠️ All vendor/clinic sources commercial.
• Tesamorelin + ipamorelin (GHRH × GHS-R synergy) — canonical Jay Campbell pairing (100 mcg ipa AM + 1 mg tesa PM, 5-on/2-off). Greenfield’s Wolverine stack extends to IGF-1 LR3 + CJC-1295 no-DAC. Research-peptide vendors sell pre-mixed tesa/CJC/ipa blends — the same blends FDA’s PCAC briefing referenced as evidence of widespread off-label compounding.
• Tesamorelin + BPC-157 or TB-500 (recovery/tissue repair) — historically common, complicated post-PCAC Dec 2024. Clinic blogs still list it; most have softened wording. OneTwenty documents the awkward transition.
• Sermorelin → tesamorelin migration — MESO-Rx pattern: user starts on telehealth sermorelin (200–300 mcg HS), reports modest IGF-1 movement, “upgrades” to tesamorelin for stronger VAT effect.
• CJC-1295/ipamorelin → tesamorelin migration (post-PCAC). Users who lost compounded CJC/ipa access in late 2024 split into three directions: research-grade vendor sourcing, sermorelin step-over (still 503A-eligible), or tesamorelin via brand or 503B compounding. The “FDA-approved” framing does real recruitment work in this channel.

7B.7 Vendor / supply context

• Brand product channel (Egrifta / Egrifta SV / Egrifta WR, Theratechnologies): Egrifta 2 mg subcutaneous powder ≈ $2,610.13 per 30 vials (~$2,400–$2,800/month). Specialty-tier insurance classification (Tier 4–5), prior-auth, restricted to documented HIV-associated lipodystrophy with imaging confirmation (FEP Blue policy). Patient-assistance: Prescription Hope advertises a $70/month flat service fee.
• Compounding pharmacy channel: Tesamorelin is restricted differently from sermorelin because Egrifta is FDA-approved and tesamorelin was reclassified as a biologic in 2020 (A4PC March 2024 statement; Lexology summary). 503B outsourcing facilities continue to produce compounded tesamorelin for patient-specific telehealth scripts: $800–$1,200/month at 2 mg daily for 503B-sourced product (Real Peptides); $250–$500/month at 1–2 mg/day via 503A telehealth (PeptideDeck, Perfect B). Perfect B’s standalone 3-month cycle: $445.
• Research-peptide vendor channel: $130–$300/month range tracks against retrieved vendor pages. Peptide Sciences ($4.30–$15.00/mg cross-vendor tracker), Peptide Partners (10 mg vials with Janoshik HPLC COAs), SwissChems (2 mg $27.95–$255.95), Pure Bio Labs (10 mg at $145), Premier Aminos (10 mg at $65), BioLongevity Labs (Jay Campbell affiliate “JayC” 15% off ⚠️), Core Peptides (carries the tesa–CJC–ipa 12 mg blend named in the FDA PCAC briefing).
• COA practice: Janoshik Analytical HPLC reports are the de-facto community standard; mass-spec COA confirming 5,196 Da is treated as non-negotiable.
• QC issues: Per The Peptide Catalog: “[tesamorelin is] the peptide most commonly counterfeited with cheaper sermorelin or CJC-1295 dressed up as tesamorelin … under $4/mg is widely flagged as a red flag.” No specific named scandal (documented underdose batch at a named vendor) was retrievable in Pass 2 beyond the generic counterfeit-substitution warnings — disclosed transparently rather than fabricated.
• Price arbitrage: Brand-vs-research-grade ratio ~15–20× ($2,400–$2,800/month brand ÷ $130–$300/month research-grade). Among the largest deltas in the peptide catalog and itself a recurring discussion point on MESO-Rx, PeptideDeck, and The Peptide Catalog.

7B.8 Community Score and Tier

Sub-score	Score (max 25)	Rationale
Usage volume	18	High in TRT/longevity telehealth and bodybuilding off-season logs (Marek Health, Defy, Perfect B, Meso-Morph sponsored logs, MESO-Rx active threads through May 2026); held below BPC-157/sermorelin by cost ceiling and supply ambiguity.
Protocol codification	22	Two well-articulated dose schools with consistent reconstitution math, 5-on/2-off weekly cycling, 8-on/8-off macrocycling.
Reported effect consistency	18	Visceral-fat reduction and improved sleep are nearly universal; recomp and skin/nails follow; cognitive and libido claims weak; effect magnitude underwhelms users coming from exogenous rhGH.
Time in circulation	18	~11 years of community discourse (2014–2015 onward). Less than sermorelin (25+ years) or CJC blends (15+) but with deeper clinical evidence behind the discussion.
Total	76 / 100
Community Tier	A	(75–89 band)

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8. Safety Profile

Common AEs (label-listed for Egrifta WR): arthralgia, injection-site reactions, pain in extremity, peripheral oedema, myalgia, headache, paraesthesia. The Badran 2026 meta-analysis quantitatively confirms arthralgia, myalgia, paraesthesia, and injection-site erythema as significantly more common than placebo, with no increase in serious AEs and no significant perturbation of fasting glucose [Peer-reviewed human study — PMID 41545261].

Glucose / diabetes: tesamorelin can transiently raise fasting glucose and HbA1c via GH-induced insulin resistance; new-onset diabetes was numerically more common in tesamorelin arms but did not reach significance in pivotal pooled analyses or in the 2026 meta-analysis ⚠️ [Peer-reviewed human study — Falutz 2010 PMID 20554713; PMID 41545261].

Fluid retention & musculoskeletal: oedema, carpal tunnel symptoms, and arthralgia are dose- and exposure-dependent and consistent with the GH class.

Cardiovascular: the label states that long-term cardiovascular safety of Egrifta WR/SV has not been established, and FDA recommends weighing risk/benefit of continuation in patients without VAT reduction [Regulatory document — FDA Egrifta WR label §5.1, 5.3].

Immunogenicity: anti-tesamorelin IgG developed in 49.5% at 26 weeks and 47.4% at 52 weeks of treated patients in pivotal trials; cross-reactivity to endogenous GHRH was detected in ~60% of antibody-positive subjects, without documented loss of IGF-1 response or hypopituitarism, but with theoretical long-term concern [Regulatory document — FDA Egrifta WR label §6.2]. This finding is materially under-discussed in the optimization community as of 2026-05-16.

Special populations:

• Pregnancy: contraindicated; rat hydrocephaly + delayed ossification at 2–4× clinical AUC [Regulatory document — FDA label §8.1].
• Lactation: not recommended.
• Paediatrics: not indicated; contraindicated in children with open epiphyses.
• Active or recently treated malignancy: contraindicated; pre-existing pituitary disease, prior cranial radiation, or pituitary surgery require evaluation before initiation [Regulatory document — FDA Egrifta WR label §4].
• Renal/hepatic impairment: no dedicated PK studies; clinical exposure not meaningfully altered by demographic covariates in population PK [Peer-reviewed human study — PMID 25358450].

Anaphylaxis / serious allergic reactions (community signal). Single-source but high-signal MESO-Rx thread (May 2026) documenting hives, dyspnoea, brief LOC ~15 min post-injection of a CJC + ipa + tesa blend. Treated by community as a class-level GH-secretagogue risk, more strongly associated with ipamorelin than with tesa alone, but with tesa-specific hives also reported in follow-up posts. Not a labelled boxed warning but worth surfacing alongside the label-listed common allergic injection-site reactions.

Retraction check (2026-05-16): No retractions identified for any cited Falutz, Stanley, Fourman, Grinspoon, Kohli, or Badran publication. The Badran 2026 meta-analysis was peer-reviewed and indexed in PubMed without errata.

FAERS / pharmacovigilance: No new FDA safety communications or boxed-warning additions identified between 9 May 2026 and 16 May 2026; the F8/Egrifta WR label (Mar 2025) remains the most recent labelling action.

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9. Drug Interactions

• Glucocorticoids: chronic supraphysiological corticosteroids blunt GH response; concomitant use may diminish efficacy and may unmask undiagnosed hypothalamic-pituitary-adrenal axis suppression [Regulatory document — FDA Egrifta WR label §7].
• Antiretrovirals: no clinically significant PK interactions; ritonavir co-administration did not alter tesamorelin exposure; simvastatin PK was unaffected by tesamorelin [Peer-reviewed human study / regulatory — Health Canada SBD].
• Insulin & oral hypoglycaemics: GH antagonises insulin action; dose adjustment of antidiabetic therapy may be required. Community-relevant: this is the mechanism behind the GLP-1 Forum user’s observation that tesa appeared to “blunt the insulin management of tirz” — biologically expected, not anomalous.
• Oral contraceptives & CYP3A4 substrates: GH-induced changes in hepatic enzyme activity may alter the clearance of CYP3A4 substrates and oral oestrogens; clinical monitoring is recommended for narrow-therapeutic-index drugs [Regulatory document — FDA Egrifta WR label §7].
• Exogenous rhGH: stacking with rhGH (documented in MESO-Rx threads at “1 mg tesa HS + 2 IU rhGH 5×/wk”) compounds GH exposure additively; no controlled PK/PD data exist; community-only.

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10. Research Gaps

• Long-term cardiovascular outcomes (events, not surrogate scores).
• Cancer incidence in long-term exposure (Health Canada 10-year cohort pending).
• Efficacy in non-HIV MAFLD/MASH at scale (awaiting NCT04101656 readout).
• Paediatric and adolescent safety/efficacy — none.
• Head-to-head comparison vs sermorelin, CJC-1295 (with or without DAC), and direct rhGH for any indication.
• Optimal duration and discontinuation strategy: VAT reaccumulation occurs within months of cessation; maintenance dosing schedules have not been formally trialled.
• Genetic/biomarker predictors of response beyond metabolic syndrome and triglyceride status.
• Independent (non-Theratechnologies, non-MGH/McGill) replication of pivotal effect sizes in geographically and ethnically distinct cohorts.
• General-population body composition / longevity / GLP-1 lean-mass preservation — the actual community indication has zero pivotal trials and no Phase 2 in non-HIV cohorts. The Badran 2026 meta-analysis is restricted to HIV-associated lipodystrophy by design.

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11. Bottom-Line Encyclopedia Note

Tesamorelin is the only GHRH analogue with full marketing authorisation from a stringent regulator (FDA, NDA 022505, since 10 Nov 2010; Health Canada since 2014; current US formulation Egrifta WR/F8 approved 25 Mar 2025). Its single FDA-approved indication is reduction of excess abdominal fat in HIV-infected adults with lipodystrophy. The pivotal evidence base is industry-funded ⚠️ and demonstrates a ~15–18% VAT reduction at 26 weeks, replicated independently in the 2026 Badran meta-analysis (five RCTs, VAT MD −27.71 cm², p<0.001). The EMA reached the opposite regulatory verdict on the same core dataset (MAA withdrawn 2012; cardiovascular and IGF-1 long-term concerns unresolved). WADA 2026 names tesamorelin explicitly under S2.2.4 (prohibited at all times). Community use in non-HIV adults for general body recomposition, longevity, or GLP-1 lean-mass preservation is indication-divergent — the molecule has been in humans safely for a different thing.

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11B. Gap Analysis

Gap pattern: dual classification. Tesamorelin sits in two cells of the v4 gap matrix simultaneously, depending on which indication is being audited.

For HIV-associated lipodystrophy (the approved indication):

• Pattern: High community + High science (convergent). Both axes A-tier. Community claims (visceral fat reduction; modest sleep, recomp, skin) align with Phase 3 trial findings (VAT −15–18%, IGF-1 +80–120 ng/mL within physiological range, mild but real glucose creep). The 2026 Badran independent meta-analysis confirms pivotal effect sizes. No major axis-to-axis disconnect in this cell.
• Remaining minor gaps: EMA verdict diverges from FDA on the same dataset (regulatory standard-of-evidence dispute, not analytical); long-term cardiovascular outcomes data absent; cancer surveillance still pending (Health Canada 10-year cohort ongoing); all pivotal trials Theratechnologies-funded ⚠️ with multi-investigator participation but no fully sponsor-independent Phase 3 (does not rise to 🔴 single-group dependency given NIH/MGH Stanley arm and Badran 2026 independent SR).

For general-population body composition, longevity, NAFLD non-HIV, GLP-1 lean-mass preservation (the community indication):

• Pattern: High community + Low science → subclass 3 (indication divergence, v4). Compound has Phase 3 evidence for indication A (HIV-lipodystrophy); community uses for indication B (general visceral fat in non-HIV adults, body recomposition, GLP-1 lean-mass preservation, longevity); indication B itself has no Phase 3 evidence and no general-population Phase 2 at scale. The pilot Stanley 2014 cardiac/visceral fat trial (n=54) and the Stanley 2019 NAFLD trial (n=61) are HIV cohorts; non-HIV MAFLD evidence is limited to the ongoing NCT04101656. The molecule has been in humans safely for a different thing. This is structurally the same archetype as SS-31 (Forzinity approved for Barth syndrome ≥30 kg; community uses for longevity, untested) — the FDA approval halo over a thin general-use case.
• Treatment in this monograph: distinguish “the molecule has Phase 3 evidence” from “the community indication has Phase 3 evidence.” The former is true; the latter is false. Tesamorelin’s pedigree comes from the HIV-lipodystrophy programme; that pedigree is real but it does not transfer cleanly to general-population body composition.

Secondary subclass 4 angle (research-dose : community-dose ratio). Tesamorelin is the v4 skill’s stated exception in the GH/GHRH/GHS class for the dose-disconnect pattern, but the exception is partial:

School	Community dose	Research dose	Ratio	Predictable consequence
Clinic / label-school (Defy, Perfect B, Eternity, Body Tonic)	2 mg (Egrifta SV) or 1.28 mg (Egrifta WR) daily	2 mg / 1.28 mg daily (FDA-approved label)	1:1	Effect should match Phase 3 trial magnitudes (assuming non-HIV mechanism translates)
Research-peptide / Campbell-Greenfield school	1 mg HS, 5-on/2-off, 8-on/8-off macrocycle	2 mg / 1.28 mg daily	~2:1 (research:community)	Modest VAT effect, weaker than label-school; chosen for cost/macrocycle reasoning, not ignorance of label dose

Unlike ipamorelin (~10× gap) or sermorelin (3–4× gap), tesamorelin’s community dose is deliberately below the label dose at the bro-science end of the community, with explicit awareness of the label dose and explicit cost / receptor-sensitivity rationale. This is a categorically different pattern from ipamorelin/sermorelin, where community doses are below research doses by default through ignorance or vendor convention. The v4 skill’s framing — “tesamorelin is the only exception in class — research dose = community dose at the regulated indication” — is correct at the clinic end of the community and partially exceeded at the bro-science end for non-ignorance reasons.

Cumulative classification: tesamorelin = convergent (High+High) for the approved indication; indication-divergent (High+Low subclass 3) for the community indication; partial / atypical subclass 4 (~2× research-to-community at one end of the community, 1:1 at the other end). The dual classification matters because the same molecule under the same brand carries different epistemic warrant depending on who is using it for what.

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12. Three Paths

Definition, not prescription. Each path describes practice; none is recommended.

• Conservative path. Use only for the FDA-approved indication (HIV-associated lipodystrophy with imaging-confirmed VAT excess) via brand Egrifta SV or Egrifta WR through specialty pharmacy with insurance prior authorisation. Bloodwork before and during: baseline IGF-1, fasting glucose, HbA1c, lipid panel, comprehensive metabolic panel, malignancy screening per age/risk; monitor IGF-1 to keep within reference range; discontinue if no VAT response at 26 weeks. Currently meets the bar only for the approved indication. For general body recomposition, longevity, NAFLD non-HIV, GLP-1 lean-mass preservation: gates not met (no Phase 3 in the actual community indication; EMA non-approval; long-term CV outcomes absent; cancer surveillance pending; class-level Liu 2007 objection).
• Moderate path. Run at the FDA-label dose (2 mg Egrifta SV or 1.28 mg Egrifta WR SC daily) for an off-label indication via telehealth prescription or 503B-compounded product (recognising that 503A compounding eligibility is contested post-2020 biologic reclassification). Structured monitoring: baseline + on-cycle IGF-1 (cap at upper reference range), fasting glucose, HbA1c (re-check at 6 and 12 weeks given documented insulin-resistance signal), lipid panel, comprehensive metabolic panel; age-appropriate malignancy screening; consider abdominal imaging baseline and follow-up if VAT is the target. Cost: $800–$2,800/month depending on channel. Expectation: VAT response on the order of Phase 3 trial magnitudes (~15–18% at 26 weeks) if the non-HIV mechanism translates — untested directly at scale. Reaccumulation on discontinuation (~24.5% rebound at week 52 per PeptideFox cite of Falutz extension data) means this is an ongoing intervention, not a reset.
• High-tolerance path. Research-grade vendor channel ($130–$300/month) at the lower-dose Campbell/Greenfield school protocol (1 mg HS, 5-on/2-off, 8-on/8-off macrocycle), accepting all of the following: not legally compounded for human use; vendor pedigree variable; counterfeit-substitution risk specifically high for tesamorelin (sermorelin/CJC-1295 sold as tesa under $4/mg); no FDA-recognised manufacturing oversight. Community mitigation stack: Janoshik HPLC + mass-spec COA confirming 5,196 Da per batch; vendor cross-check against The Peptide Catalog tracker; pre-cycle baseline bloodwork (IGF-1, fasting glucose, HbA1c, lipids, CBC, comprehensive metabolic panel); on-cycle bloodwork at 6–8 weeks; IGF-1 ceiling cap; structured physician monitoring dialogue (telehealth or in-person); awareness of the anaphylaxis signal in GH-secretagogue blends and the antibody-formation signal in pivotal trials; expectation of fat reaccumulation on discontinuation; explicit recognition that the indication being targeted has no Phase 3 evidence in non-HIV adults.

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13. Key References

Science layer (Pass 1)

Regulatory documents: FDA NDA 022505 approval letter (10 Nov 2010); medical and pharmacology reviews; Egrifta WR label 022505s020lbl (Mar 2025); Egrifta SV label 022505s012s013lbl (2019). EMA Q&A on withdrawal of MAA for Egrifta, 22 June 2012 (Ferrer Internacional, S.A.). Health Canada Summary Basis of Decision for Egrifta (NOC 30 Apr 2014; supplementary NDS 30 Mar 2015). CADTH/CDR Clinical Review Report: Tesamorelin (Egrifta), NCBI Bookshelf NBK539124 / NBK539136 (2018). WADA 2026 Prohibited List, S2.2.4. TGA Poisons Standard (October 2025) Instrument 2025. Global DRO check (2026-05-16).

Pivotal Phase 3 (industry-funded ⚠️): Falutz J et al. N Engl J Med 2007; 357: 2359–2370. PMID 18057338. NCT00123253. · Falutz J et al. AIDS 2008; 22: 1719–1728. PMID 18690162. · Falutz J et al. JAIDS 2010; 53: 311–322. PMID 20101189 / pooled PMID 20554713.

NIH-funded academic (independent of sponsor): Stanley TL et al. JCEM 2012 (cognition pilot). · Stanley TL et al. JAMA 2014; 312: 380–389. NCT01263717. · Stanley TL et al. Lancet HIV 2019; 6: e821–e830. PMID 31611038. NCT02196831. · Fourman LT et al. JCI Insight 2020. DOI 10.1172/jci.insight.140134. · Fourman LT et al. Sci Rep 2021. DOI 10.1038/s41598-021-89966-y. · Kohli P et al. J Am Heart Assoc 2021.

Pharmacology & population PK: Chen et al. Clin Pharmacokinet 2015. PMID 25358450.

Systematic reviews: Sivakumar T et al. HIV Med 2011. PMID 21265979. · Dhaliwal et al. 2020. · Badran AS, Helal A, Shata KS, Ayesh H. Obes Res Clin Pract 2026; 20(1): 2–12. PMID 41545261. DOI 10.1016/j.orcp.2026.01.002.

Class-level dispute literature: Rudman D et al. N Engl J Med 1990; 323: 1–6. · Liu H et al. Ann Intern Med 2007; 146: 104–115. PMID 17227934.

Clinical trials registry: NCT00123253; NCT00435136; NCT00608023; NCT01263717; NCT02196831; NCT03226821; NCT04030702; NCT04101656.

Academic secondary sources: DrugBank DB08869. · PubChem CID 16137828; CID 16129714. · IUPHAR/BPS Guide to PHARMACOLOGY ligand record (GHRH analogue).

Community layer (Pass 2)

Codifiers (named): Jay Campbell, jaycampbell.com — “Guide to Tesamorelin Peptide Dosage for Bodybuilding Success,” “Tesamorelin and Ipamorelin Blend: Benefits, Risks and Dosing,” “Tesamorelin Cycle Length,” “Tesamorelin vs Ipamorelin.” Hunter Williams & Jay Campbell, “Peptide Cheat Sheet” (Mar 2025). Ben Greenfield, bengreenfieldlife.com — “GHRP Deep Dive,” “Best Peptide Stacks,” “Safe Ozempic Alternatives.” Andrew Huberman — “Benefits & Risks of Peptide Therapeutics,” Huberman Lab, 1 Apr 2024; Koniver M.D. follow-up episode. Derek MPMD — Marek Health.

Skeptic anchor: Eric Topol — “The Peptide Craze,” Ground Truths Substack.

Forum / community wikis: MESO-Rx (thinksteroids.com) — “Bloodwork on Tesamorelin” (May 2026, IGF-1 243→306), “Mixing tesamorelin and hgh” (Jan 2025), “Anaphylaxis Shock after taking CJC + Ipa + Tesomorelin” (May 2026), “TRT + Peptides – Plateau vs Optimization,” “LKB has posted tests.” Meso-Morph — “Approved Log — Building and Growing with Tesamorelin” (sponsored by US-Pharmacies, Jan 2026), “All about Tesamorelin.” GLP-1 Forum — “Tirzepatide and Tesamorelin stacked” (Aug 2024).

Clinic / telehealth (commercial ⚠️): Marek Health; Defy Medical; Perfect B (Doral FL); Eternity Health Partners; Rewind Anti-Aging of Miami; Body Tonic Med Spa; Evergreen Institute; Vitali-T Clinic; Lamkin Clinic; Blue Skies Health & Wellness; Advanced TRT Clinic; 1stOptimal; Women’s Health of MD; Ubie Health; Alpa Bio Med; Eden; Hone-adjacent operators.

Vendor pages (commercial ⚠️): Peptide Sciences; Pure Bio Labs; SwissChems; Premier Aminos; Core Peptides; BioLongevity Labs (Jay Campbell affiliate); Peptide Partners. Pricing tracker: The Peptide Catalog (“Tesamorelin: $180/mo Research vs $3,000/mo Rx (2026),” “Buy Tesamorelin: 6 Vendors From $5.13/mg (2026)”). PeptideDeck — “Where to Buy Tesamorelin in 2026,” “Tesamorelin Side Effects.”

Pricing & access: drugs.com — Egrifta Prices, Coupons, Copay Cards & Patient Assistance ($2,610.13 / 30 vials 2 mg; $6,040.69 / 60 vials 1 mg). GoodRx — Egrifta and Egrifta SV pricing. Prescription Hope — Egrifta PAP $70/month service fee. FEP Blue — Egrifta SV pharmacy policy PDF (2025).

Regulatory commentary (community-side): A4PC — “Statement of the APC, 1 Mar 2024” (2020 biologic reclassification of tesamorelin). Lexology / Reed Smith — “FDA removes certain peptide bulk drug substances from Category 2 …” (1 Oct 2024). FDA PCAC briefing document, 4 Dec 2024 meeting (names tesamorelin–CJC–ipamorelin 12 mg blends sold by Peptide Sciences and Core Peptides). 503Pharma — “Tesamorelin: The Complete Guide for Compounding Pharmacies.”

Side-effect references (community-facing): WebMD, drugs.com, Mayo Clinic patient page, MSKCC patient page, GoodRx “5 Egrifta SV Side Effects,” PatSnap Synapse.

Pass 2 retrieval limitations (substantive)

• Reddit thread-level retrieval failed across r/Peptides, r/PeptideUmbrella, r/SteroidsHGH, r/longevity, r/Nootropics, r/Biohackers, r/Testosterone, r/HRT, r/PeptideTherapy. Aggregator summaries reference these subreddits but specific thread titles, permalinks, post dates, and vote counts were not confirmable without fabrication. Reddit content reported above as quoted text was sourced from named non-Reddit forums (MESO-Rx, Meso-Morph, GLP-1 Forum) and clinic / vendor / community-blog write-ups.
• Podcast/YouTube depth: Huberman Lab April 2024 episode confirmed by direct page citation + transcript excerpts. Marek Health × MPMD YouTube video confirmed by URL but not transcribed; framing sourced from description and surrounding review articles. Peter Attia The Drive — no tesamorelin-specific episode located. Joe Rogan / Flagrant 2 — no tesamorelin-specific episodes located. Superhuman Radio #2368 confirmed by transcript-page URL but only the SIBO-tangent excerpt was retrievable.
• Vendor pages not opened at per-SKU level: Limitless Life Nootropics, Ascension, Amino Asylum, Geo Peptides, Pharma Grade Solutions, VANDL Labs, Magellan Rx, Real Peptides (as a vendor SKU page), zybiopeptides. Pricing for these vendors is range-only via The Peptide Catalog’s tracker.
• No specific named QC scandal retrieved beyond the generic counterfeit-substitution warnings (The Peptide Catalog: sermorelin or CJC-1295 sold as tesamorelin under $4/mg). Reported as a generic flag rather than a named-vendor scandal.
• EMA discussion in the surveyed community is thinner than the prompt’s structure assumed — non-approval is not a major retrievable discourse item beyond Topol’s general skepticism and the regulatory framing in Lexology / A4PC sources.
• Wayback Machine / archive.org was not invoked in Pass 2; all community sources cited were retrieved from live URLs as of 2026-05-16.

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14. Audit / Refresh Trail

• Composed: 2026-05-18
• Pass 1 source: tesamorelin_sci_2026-05-16_A73.md — refresh window 2026-05-09 → 2026-05-16; refreshed claims marked [REFRESHED 2026-05-16] in source file
• Pass 2 source: tesamorelin_com_2026-05-16_A76.md — compiled 2026-05-16
• Section 4 last regulatory review stamp: 2026-05-16
• Triggers that should prompt the next refresh:
  • NCT04101656 (non-HIV MAFLD Phase 2/3) top-line readout — most consequential pending readout in the catalog for re-tiering tesamorelin out of indication divergence
  • NCT04030702 (HIV cardiac steatosis) and NCT03226821 (HIV Phase 4) readouts
  • Cochrane SR initiation or publication on tesamorelin
  • Theratechnologies long-term safety cohort 10-year readout (Health Canada-mandated)
  • WADA Prohibited List annual update (next: 1 Jan 2027)
  • FDA labelling actions on Egrifta WR or new boxed warnings
  • EMA re-submission by Theratechnologies or new European partner
  • Any documented named-vendor QC scandal (would update Section 7B.7 from generic to specific)
  • PCAC or FDA action on 503A/503B compounding eligibility for tesamorelin specifically
  • Independent (non-Theratechnologies, non-MGH/McGill) Phase 3 in any indication