Tesamorelin (Egrifta): benefits, evidence and legal status

Tesamorelin is a synthetic 44-amino-acid analog of human growth hormone-releasing hormone (GHRH), made by Theratechnologies and sold in the US as Egrifta SV and Egrifta WR. It is FDA-approved for one use only: reducing excess abdominal fat in adults with HIV and lipodystrophy. The strongest evidence is two phase 3 randomized trials that enrolled 412 and 404 people (Falutz 2007; Falutz 2010). It is not approved for weight loss, raises IGF-1 above the normal range in many users, can raise blood sugar, and is prohibited in sport at all times.

Item	Status
US FDA status	Approved Rx drug (Egrifta, first approved 2010-11-10); indication limited to HIV-associated abdominal fat
Compounding (503A/503B)	Not on FDA’s Category 2 list; regulated as a biological product since 2020-03-23
WADA 2026	Prohibited at all times, class S2.2.4 (named)
Strongest evidence	Approved label; Human RCTs (n=412 and n=404)
Human trials	14+ registered, e.g. NCT00123253, NCT02196831
Main risks	High IGF-1, glucose intolerance, fluid retention, injection-site reactions
Last checked	2026-10-01

Property	Value
Length and structure	44 amino acids of human GHRH plus an N-terminal trans-3-hexenoyl group (label)
Molecular formula	C221H366N72O67S (free base)
Molecular weight	5,135.9 Da (label); 5,136 (PubChem)
CAS number	218949-48-5
PubChem CID	16137828
Half-life	8 min (Egrifta SV) and 11 min (Egrifta WR) in healthy adults, per the labels
Bioavailability	Under 4% after subcutaneous injection (label)
Route studied	Subcutaneous injection
Class	GHRH analog (growth hormone secretagogue)

What is tesamorelin?

Tesamorelin was developed under the code name TH9507. A 12-week dose-ranging trial in 61 people with HIV was published in 2005 (Falutz 2005), followed by two phase 3 programs. The FDA approved Egrifta on 10 November 2010 under NDA 022505 (FDA approval letter). The application was deemed a biologics license on 23 March 2020. A newer formulation, Egrifta WR, was approved as a supplement on 25 March 2025 (FDA letter, BLA 022505/S-020). The label states it has a weight-neutral effect and is not indicated for weight loss.

How does tesamorelin work?

• Receptor binding: in vitro, tesamorelin binds and activates human GHRH receptors with potency similar to the body’s own GHRH [Lab (in vitro), cited in the Egrifta WR label].
• Pulsatile growth hormone release: in 13 healthy men given tesamorelin for 2 weeks, mean overnight growth hormone, pulse area and basal secretion rose, and IGF-1 increased by 181 µg/L [Human, uncontrolled, n=13] (Stanley 2011).
• IGF-1 as the downstream signal: growth hormone raises IGF-1 and IGFBP-3, and no clinically significant changes in TSH, LH, ACTH or prolactin were seen in trials [Approved label].
• Fat-depot selectivity: visceral fat fell while abdominal subcutaneous fat did not change significantly [Human RCT, n=806 pooled] (Falutz 2010, pooled).

What the research shows

Claim	Evidence level	Best study and result
Reduces visceral fat in HIV lipodystrophy	Human RCT (n=806 pooled); Approved label	Falutz 2010: −24 vs +2 cm² at 26 weeks, treatment effect −15.4%
Effect lasts after stopping	Human RCT (n=404)	Falutz 2010: gains “rapidly lost” after switch to placebo
Lowers triglycerides	Human RCT (n=412)	Falutz 2007: −50 vs +9 mg/dL
Reduces liver fat in HIV with fatty liver	Human RCT (n=61)	Stanley 2019: −37% relative reduction in hepatic fat fraction
Reduces visceral fat in obesity without HIV	Human RCT (n=60)	Makimura 2012: treatment effect −35 cm² at 12 months
Improves cognition in older adults	Human RCT (n=152), single trial	Baker 2012: favorable composite effect, P=.03
Improves cognition in HIV	Human RCT, open-label (n=73)	Ellis 2025: no significant difference vs standard care
Increases trunk muscle area	Human, secondary analysis (n=341)	Adrian 2019: small gains in responders only
General fat loss or anti-aging	No trial evidence	Label: not indicated for weight loss

Visceral fat in HIV

In the first phase 3 trial, 412 people with HIV and excess abdominal fat received tesamorelin or placebo for 26 weeks; visceral fat fell 15.2% versus a 5.0% rise with placebo, and IGF-1 rose 81% [Human RCT, n=412] (Falutz 2007). The second trial (n=404) found −10.9% versus −0.6%, with better scores for belly-appearance distress (Falutz 2010). The reduction held at about 18% over 52 weeks of continued use, and visceral fat returned when the drug was stopped (Falutz 2008). A 2026 meta-analysis of four RCTs (909 patients) confirmed the visceral fat effect and found a trend toward more discontinuations (RR 2.25, P=0.06) (Ditta 2026).

Liver fat

A 6-month trial in 50 people with HIV reported reductions in both visceral fat and liver fat [Human RCT, n=50] (Stanley 2014). A 12-month NIH-funded trial in 61 people with HIV and fatty liver found an absolute −4.1% drop in hepatic fat fraction versus placebo; 35% on tesamorelin versus 4% on placebo fell below the 5% threshold (Stanley 2019). Among people with HIV and raised liver enzymes in the phase 3 data, those whose visceral fat fell at least 8% had larger ALT drops (Fourman 2017). Fatty liver is not an approved indication.

Obesity without HIV, diabetes and cognition

In 60 abdominally obese adults with low growth hormone secretion, 12 months of tesamorelin reduced visceral fat, triglycerides, C-reactive protein and carotid wall thickness without changing glucose (Makimura 2012). In 53 people with type 2 diabetes, 12 weeks did not change insulin response or HbA1c [Human RCT, n=53] (Clemmons 2017). The cognition data are mixed: one 20-week trial in older adults found a favorable effect on executive function, with adverse events in 68% on the drug versus 36% on placebo (Baker 2012), while a 6-month trial in people with HIV found no significant between-group difference (Ellis 2025).

Human studies and trials

ClinicalTrials.gov lists more than 20 studies with tesamorelin as the intervention. The main ones are below; the second phase 3 trial’s own registration (NCT00435136) now redirects to NCT00123253, although the label cites it as a separate study.

Trial	Phase, n, status	Result
NCT00123253 HIV abdominal fat	Phase 3, 412, completed	VAT −15.2% vs +5.0%
NCT00608023 extension	Phase 3, 263, completed	VAT regained after switch to placebo
NCT01263717 liver fat, HIV	54 enrolled, completed	Liver fat −2.9% net (JAMA 2014)
NCT02196831 fatty liver, HIV	61, completed	Hepatic fat −37% relative
NCT00675506 obesity	Phase 2, 60, completed	VAT −35 cm² vs placebo
NCT00257712 aging, MCI	Phase 2, 151, completed	Executive function improved
NCT02572323 cognition, HIV	Phase 2, 73, completed	No significant difference
NCT01264497 type 2 diabetes	Phase 2, 55, completed	No change in glycemic control
NCT03375788 fatty liver, no HIV	Phase 2, 51, completed 2025	Results posted; no journal paper found
NCT01591902 diabetic retinopathy	Phase 4, 129, terminated	Safety study, not completed
NCT01579695 10-year safety cohort	Observational, 391, terminated	Stopped in 2018
NCT01388920 COPD	Phase 2, 3, terminated	Stopped by a non-safety corporate decision
NCT06554717 physical function, HIV	Phase 2, 100 planned, recruiting	Pending
NCT03150511 nerve injury	Phase 2, 36 planned, recruiting	Pending

Two long-term safety studies the manufacturer ran after approval, one on diabetic eye disease and one planned as a 10-year cohort, were both terminated, so long-term safety data, which the European regulator noted were missing in 2012, remain limited (EMA). Recruiting trials test tesamorelin with exercise in older adults with HIV and after surgical repair of peripheral nerve injury.

Doses used in studies

Route and amount	Species	Study
Subcutaneous, 2 mg once daily, 26–52 weeks	Human (HIV)	Falutz 2007; Falutz 2010
Subcutaneous, 1 or 2 mg once daily, 12 weeks	Human (HIV)	Falutz 2005
Subcutaneous, 1 mg once daily, 20 weeks	Human (older adults)	Baker 2012
Subcutaneous, 1 or 2 mg once daily, 12 weeks	Human (type 2 diabetes)	Clemmons 2017
0.1–1.2 mg/kg, developmental toxicity	Rat	Egrifta WR label, section 8.1

No established human dose exists outside approved labels. The approved labels set 1.28 mg once daily for Egrifta WR and 1.4 mg once daily for Egrifta SV, for the approved indication only, and state that the two formulations are not substitutable.

Side effects and safety

The label pools 543 people who received tesamorelin in the 26-week placebo-controlled phases. Injection-site reactions occurred in 17% versus 6% on placebo, arthralgia in 13% versus 11%, and peripheral edema and myalgia in 6% each versus 2% [Approved label] (Egrifta WR label). The label’s main warnings are:

• High IGF-1: after 26 weeks, 47% had IGF-1 above 2 standard deviation scores and 36% above 3; the long-term effects of raised IGF-1 are unknown.
• Glucose intolerance or diabetes: HbA1c reached 6.5% or more in 5% versus 1% on placebo (hazard ratio 3.3). In one trial fasting glucose rose by 7 mg/dL more than placebo at 2 weeks, though not at 6 months (Stanley 2014).
• Cancer risk: growth hormone is a growth factor, so the drug is contraindicated with active malignancy.
• Fluid retention: edema, joint pain and carpal tunnel syndrome.
• Hypersensitivity: rash and urticaria occurred in trials.
• Critical illness: the label advises considering stopping it in critically ill patients, based on higher mortality seen with growth hormone.

The label contraindicates tesamorelin in pregnancy (it caused hydrocephaly in rat offspring), in disruption of the hypothalamic-pituitary axis, in active malignancy and in hypersensitivity to the drug. It is not indicated for children. The European committee called the IGF-1 rise, with its possible link to cancer and worsening diabetic eye disease, “a major safety concern” (EMA).

Products sold as “research use only” are a separate risk. In a warning letter dated 24 August 2026, FDA classed one seller’s “Tesamorelin” as an unapproved new drug (FDA warning letter). Such products have no approved labeling or manufacturing oversight, so their identity, purity and sterility are unverified.

Legal and regulatory status

Jurisdiction	Status
US FDA	Approved Rx (Egrifta SV, Egrifta WR) for HIV-associated abdominal fat; BLA 022505
US compounding	Biological product since 2020; FDA guidance says 503A and 503B do not exempt biologics
WADA 2026 and 2027	S2.2.4, prohibited in and out of competition, non-specified (2027 list)
EU (EMA)	Not authorised; application withdrawn 2012-06-21
Canada	Egrifta listings cancelled (Drug Product Database)

Dated events: FDA approval on 10 November 2010; the European application withdrawn on 21 June 2012 after the committee’s provisional view that it could not be approved, partly because the fat reduction had not been shown to bring actual health benefits (EMA); transition to a biologics license on 23 March 2020 (FDA list); approval of Egrifta WR on 25 March 2025 (FDA letter); and the August 2026 warning letter covering “research use only” tesamorelin (FDA). In sport, tesamorelin is named on the WADA 2026 Prohibited List and on the list that takes effect on 1 January 2027. The wider picture is covered in WADA banned peptides 2027.

Related peptides

Tesamorelin sits in the same WADA class, S2.2.4 growth hormone releasing factors, as sermorelin and CJC-1295 (other GHRH analogs) and the ghrelin-mimetic secretagogues ipamorelin and ibutamoren (MK-677) (WADA 2026 list). Ipamorelin (503B) and ibutamoren (503A and 503B) remain on FDA’s Category 2 compounding list. PeptideWikis entries for these peptides are not yet published.