P/OSPeptideOS evidence & status map
OPEN SOURCE MEDICINE FOUNDATIONLast reviewed 2026-10-10No dosing · no vendors · no advicesource file

← All compounds · evidence tier first, by design

Evidence tier for each claimed use · ← established · unknown →
UseE1E2E3E4E5E6E7E8
E1 Excess abdominal (visceral) fat in adults with HIV-associated lipodystrophyE1
E3 Fatty liver (NAFLD) in people with HIVE3
E3 Visceral fat and cardiometabolic markers in people without HIV (abdominal obesity)E3
E3 Cognition in older adults and mild cognitive impairmentE3
Class A · Approved

Tesamorelin

The full 44-residue sequence of human growth hormone-releasing factor (GHRH 1-44) with a trans-3-hexenoyl group attached to the N-terminal tyrosine (US label, section 11). Left null because of the N-terminal acylation.

Non-standard residues or modifications: no plain one-letter sequence

Also: Tesamorelin acetate · Codes: TH9507 · Brands: Egrifta, Egrifta SV, Egrifta WR

A synthetic, chemically stabilised version of human growth hormone-releasing hormone (GHRH). It is approved in the US only for reducing excess abdominal fat in adults with HIV and lipodystrophy; the US label states it is not indicated for weight loss. An EU marketing application was withdrawn in 2012, and its Canadian product listing was cancelled in 2022. It is also offered outside its label for fat loss, body composition, cognition and "anti-ageing".

  • US A approved
  • EU C gray market
  • UK ? not verified
  • CA C gray market
  • AU ? not verified
  • JP ? not verified
  • CN ? not verified

01Regulatory status, by jurisdiction

Standing notice. Approved in United States only. In European Union, Canada it is not an approved medicine: material sold there under this name is of unverified origin and is not manufactured or tested to pharmaceutical standards there.
JurisdictionStatusDetail and primary source
USApprovedApproved 10 Nov 2010 (Theratechnologies; originally NDA 022505, deemed a BLA on 23 March 2020). Current formulations are Egrifta SV and Egrifta WR, which the label states are not substitutable. Indication limited to reduction of excess abdominal fat in HIV-infected adults with lipodystrophy. Not on any 503A bulk-substance category list (FDA list updated 14 May 2026).
“EGRIFTA WR is a growth hormone-releasing factor (GHRF) analog indicated for the reduction of excess abdominal fat in HIV”
EGRIFTA WR (tesamorelin) for injection Prescribing Information, revised 3/2025 · retrieved 2026-10-10
EUNot approvedNot authorised. The marketing application (Ferrer Internacional) was withdrawn on 21 June 2012; at that point the CHMP's provisional opinion was that it could not have been approved, citing doubts about clinical meaningfulness of the fat reduction, applicability to European patients and IGF-1 elevation.
“the CHMP had some concerns and was of the provisional opinion that Egrifta could not have been approved for the treatment of excess abdominal fat in HIV patients with lipodystrophy.”
Egrifta: withdrawn application | European Medicines Agency (EMA) · retrieved 2026-10-10
CAWithdrawn / discontinuedHealth Canada's Drug Product Database lists EGRIFTA (DIN 02438712, first marketed 23 June 2015) as Cancelled Post Market since 30 Sept 2022; a second EGRIFTA listing (DIN 02423677) is Cancelled Pre Market. No other tesamorelin product was found in the database.
“Current status: Cancelled Post Market Current status date: 2022-09-30”
Drug Product Database: EGRIFTA (DIN 02438712) · retrieved 2026-10-10
UK AU JP CNNot yet verified from a primary source. No status is shown rather than an unsourced one.

Sport (WADA): Prohibited · class S2.2.4. “growth hormone-releasing hormone (GHRH) and its analogues (e.g. CJC-1293, CJC-1295, sermorelin and tesamorelin)” WADA source

02What the human evidence shows

E1

Excess abdominal (visceral) fat in adults with HIV-associated lipodystrophy

2published human RCTs
n/cpublished human trials
24registered studies
10with posted results

n/c: not counted here; see the cited review.

Two randomised placebo-controlled trials (412 and 404 participants) found that tesamorelin reduced CT-measured visceral fat over 26 weeks (about 15% and 11% versus small changes on placebo), with improvements in some lipid measures and raised IGF-1. In the extension phase, visceral fat returned toward baseline after switching to placebo. Neither trial measured cardiovascular events; the US label states long-term cardiovascular safety is not established, and the EMA's committee questioned whether the fat reduction was clinically meaningful.

  • [1] Visceral adipose tissue fell 15.2% with tesamorelin versus a 5.0% rise with placebo over 26 weeks in 412 adults with HIV
  • [2] Visceral fat fell 10.9% versus 0.6% on placebo at 6 months; gains were lost after switching to placebo
  • [3] 26-week re-randomised extension of the first Phase 3 trial reporting longer-term safety and visceral fat effects in adults with HIV

Registered-study counts: ClinicalTrials.gov intervention search “tesamorelin”, fetched 2026-10-10. Registered studies include trials of other uses; the gap between registered and reported is itself a finding.

E3

Fatty liver (NAFLD) in people with HIV

No randomised controlled trial in humans has been published for this use.

0published human RCTs
2published human trials
4registered studies
2with posted results

Two small randomised placebo-controlled trials in people with HIV (50 and 61 participants) found reductions in liver fat; the larger trial's primary endpoint was a 4.1 percentage-point absolute reduction in hepatic fat fraction over 12 months. Neither was powered for liver-related clinical outcomes, and the authors called for further studies of long-term histological effects. Not an approved indication.

  • [4] Greater reduction in hepatic fat fraction than placebo over 12 months in 61 adults with HIV and NAFLD
  • [5] Reduced visceral fat and modestly reduced liver fat over 6 months versus placebo in 50 adults with HIV

Registered-study counts: ClinicalTrials.gov intervention search “tesamorelin AND fatty liver”, fetched 2026-10-10. Registered studies include trials of other uses; the gap between registered and reported is itself a finding.

E3

Visceral fat and cardiometabolic markers in people without HIV (abdominal obesity)

No randomised controlled trial in humans has been published for this use.

0published human RCTs
1published human trials
4registered studies
3with posted results

One randomised placebo-controlled trial of 60 abdominally obese adults selected for reduced growth hormone secretion found lower visceral fat, triglycerides, C-reactive protein and carotid intima-media thickness after 12 months, with no change in subcutaneous fat. No trial has tested it in obesity without that selection, and none measured clinical outcomes. The US label states it is not indicated for weight loss and has a weight-neutral effect.

  • [6] Reduced visceral adipose tissue versus placebo over 12 months in 60 abdominally obese adults with reduced GH secretion

Registered-study counts: ClinicalTrials.gov intervention search “tesamorelin AND obesity”, fetched 2026-10-10. Registered studies include trials of other uses; the gap between registered and reported is itself a finding.

E3

Cognition in older adults and mild cognitive impairment

No randomised controlled trial in humans has been published for this use.

0published human RCTs
1published human trials
3registered studies
1with posted results

One randomised placebo-controlled trial of 152 adults aged 55 to 87 (66 with mild cognitive impairment) reported a favourable effect on a cognitive composite after 20 weeks, driven mainly by executive function. Adverse events were reported by 68% on tesamorelin versus 36% on placebo. The result has not been replicated in a larger or longer trial, and no dementia or functional outcomes were assessed.

  • [7] Favourable effect on a cognitive composite versus placebo over 20 weeks in older adults with and without mild cognitive impairment

Registered-study counts: ClinicalTrials.gov intervention search “tesamorelin AND cognition”, fetched 2026-10-10. Registered studies include trials of other uses; the gap between registered and reported is itself a finding.

Key registered trials

NCTTitle (as registered)PhaseStatus
NCT00123253TH9507 in Patients With HIV-Associated Lipodystrophy3Completed
NCT00608023TH9507 Extension Study in Patients With HIV-Associated Lipodystrophy3Completed
NCT02196831Tesamorelin Effects on Liver Fat and Histology in HIVNACompleted
NCT00675506Effectiveness of Growth Hormone Releasing Hormone in Reducing Abdominal Fat in People Who Are Obese2Completed
NCT00257712SMART: Somatotrophics, Memory, and Aging Research Trial2Completed

03Safety signals

S2Substantial controlled-trial safety data
  • Glucose intolerance or diabetes, fluid retention (oedema, arthralgia, carpal tunnel syndrome), hypersensitivity reactions, raised IGF-1 [8]
    Listed in Warnings and Precautions of the current US label, which also contraindicates use with active malignancy and states the effects of prolonged IGF-1 elevation are unknown.
  • Anti-drug antibodies [8]
    The US label reports anti-tesamorelin IgG antibodies in about half of trial patients at 26 and 52 weeks, with cross-reactivity to endogenous GHRH in about 60% of antibody-positive patients.

04What is unknown

  • Long-term cardiovascular safety has not been established (US label limitation of use)
  • Whether visceral fat reduction translates into fewer cardiovascular, liver or metabolic clinical events has not been tested
  • The effects of prolonged IGF-1 elevation are unknown (US label)
  • No randomised trial in people without HIV beyond a single 60-person trial in obese adults with reduced GH secretion
  • A long-term post-marketing observational study (NCT01579695) was terminated; no results were identified
  • Regulatory status in the UK, Australia, Japan and China was not verified from regulator sources for this record

05Product quality

No independent purity results have been published for this compound yet. The purity programme will publish full methods and vendor-named results, passes and failures, once its protocol has had legal review.

06Citations

  1. Metabolic Effects of a Growth Hormone–Releasing Factor in Patients with HIV (2007). doi:10.1056/NEJMoa072375
  2. Effects of Tesamorelin, a Growth Hormone–Releasing Factor, in HIV-Infected Patients With Abdominal Fat Accumulation: A Randomized Placebo-Controlled Trial With a Safety Extension (2010). doi:10.1097/QAI.0b013e3181cbdaff
  3. Long-term safety and effects of tesamorelin, a growth hormone-releasing factor analogue, in HIV patients with abdominal fat accumulation (2008). doi:10.1097/QAD.0b013e32830a5058
  4. Effects of tesamorelin on non-alcoholic fatty liver disease in HIV: a randomised, double-blind, multicentre trial (2019). doi:10.1016/S2352-3018(19)30338-8
  5. Effect of Tesamorelin on Visceral Fat and Liver Fat in HIV-Infected Patients With Abdominal Fat Accumulation (2014). doi:10.1001/jama.2014.8334
  6. Metabolic Effects of a Growth Hormone-Releasing Factor in Obese Subjects with Reduced Growth Hormone Secretion: A Randomized Controlled Trial (2012). doi:10.1210/jc.2012-2794
  7. Effects of Growth Hormone–Releasing Hormone on Cognitive Function in Adults With Mild Cognitive Impairment and Healthy Older Adults (2012). doi:10.1001/archneurol.2012.1970
  8. EGRIFTA WR (tesamorelin) for injection Prescribing Information. https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/022505s020lbl.pdf

Every DOI is resolved against Crossref and every NCT number against ClinicalTrials.gov, title for title, before publication. Regulatory sources are cited inline above with a verbatim quote and retrieval date.

07Mechanism

Tesamorelin binds pituitary GHRH receptors; in clinical trials it increased growth hormone and IGF-1 concentrations and reduced CT-measured visceral fat.

Mechanism is placed last on purpose: a plausible mechanism is not evidence that a compound works in people.

Reviewed by OSMF research team (AI-assisted, source-verified) on 2026-10-10. Found an error? It goes in the corrections log: report it.