FDA-approved (different indication)Human evidenceProhibited in sport

Tesamorelin

Also referred to as Egrifta, TH9507

A GHRH analogue with phase 3 randomised evidence in one specific population: adults with HIV-associated abdominal lipodystrophy.

Molecule class: Growth-hormone-releasing factor analogue
Category: GH axis
Last evidence review: 2026-08-23

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Human studies

Animal / in vitro

Graded claims

806

Participants

Derived from qualifying human evidence

Most commonly studied duration: 52 weeks. Most frequently reported duration among 1 qualifying human study with a stated duration.
Longest qualifying human study: 52 weeks. Longest duration among qualifying human studies with a stated duration.

These figures are computed from the study records shown below. Records without a verified source identifier are excluded from the calculation.

Mechanism

What is being studied

Binds the GHRH receptor on pituitary somatotrophs, stimulating endogenous growth hormone release in a manner that preserves pulsatility.

Evidence

Claims, graded individually

Each statement below carries its own evidence level, its own confidence rating, and its own account of what remains unestablished. A compound does not have a single grade.

GH-Axis Research

AStrongHigh confidenceHuman evidence

In adults with HIV-associated abdominal lipodystrophy, tesamorelin 2 mg daily was associated with reduced visceral adipose tissue versus placebo.

What is not established

The population is specific. The effect attenuated after discontinuation. No comparable evidence exists in adults without HIV-associated lipodystrophy.

Supporting sources (1)

Randomised controlled trialHuman Identifier verified

Effects of tesamorelin (TH9507), a growth hormone-releasing factor analog, in HIV-infected patients with excess abdominal fat: a pooled analysis of two multicenter, double-blind placebo-controlled phase 3 trials with safety extension data

Falutz J, Mamputu JC, Potvin D, et al. · Journal of Acquired Immune Deficiency Syndromes · 2010 · n = 806

Population: Adults with HIV infection and excess abdominal adiposity
Endpoint: Change in visceral adipose tissue measured by CT
Route: Subcutaneous
Quantity as reported: 2 mg daily
Frequency: Once daily
Duration: 52 weeks

Result. Reported reduction in visceral adipose tissue versus placebo, with attenuation of the effect after discontinuation.

Adverse events. Injection-site reactions, arthralgia, peripheral oedema; effects on glucose parameters were monitored.

Limitations. Population is specific to HIV-associated lipodystrophy. Findings should not be extrapolated to other populations, and the effect reversed after stopping.

PMID20554713

Last evidence review: 2026-08-23

Metabolic & Body-Composition Research

XInsufficient / conflictingVery low confidenceNo human evidence

Whether the visceral-fat finding extends to adults without HIV-associated lipodystrophy is not established.

What is not established

No adequate trials exist in this population. Extrapolation from the approved population is not supported.

Last evidence review: 2026-08-23

Human evidence

1 human study catalogued

Human and non-human evidence are kept strictly separate. They are never pooled, averaged, or presented as a single body of support.

Randomised controlled trialHuman Identifier verified

Effects of tesamorelin (TH9507), a growth hormone-releasing factor analog, in HIV-infected patients with excess abdominal fat: a pooled analysis of two multicenter, double-blind placebo-controlled phase 3 trials with safety extension data

Falutz J, Mamputu JC, Potvin D, et al. · Journal of Acquired Immune Deficiency Syndromes · 2010 · n = 806

Population: Adults with HIV infection and excess abdominal adiposity
Endpoint: Change in visceral adipose tissue measured by CT
Route: Subcutaneous
Quantity as reported: 2 mg daily
Frequency: Once daily
Duration: 52 weeks

Result. Reported reduction in visceral adipose tissue versus placebo, with attenuation of the effect after discontinuation.

Adverse events. Injection-site reactions, arthralgia, peripheral oedema; effects on glucose parameters were monitored.

Limitations. Population is specific to HIV-associated lipodystrophy. Findings should not be extrapolated to other populations, and the effect reversed after stopping.

PMID20554713

Pharmacology

Reported parameters

Half-life

24 minutes

Short circulating half-life of roughly 20–40 minutes, consistent with daily administration in the trials.

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Routes studied

Subcutaneous

Evidence from one route does not transfer to another. Topical, oral, and injected administration can produce entirely different exposure from the same quantity.

Regulatory status

FDA-approved for reduction of excess abdominal fat in adults with HIV-associated lipodystrophy. Use outside that population is outside the approved indication and outside the evidence base.

Storage as documented

Per approved product labelling; the approved product is supplied lyophilised.

Safety

Signals reported in the literature

This lists what has been reported. It is not a complete safety profile, and for several compounds in this catalogue no systematic safety surveillance exists at all.

Injection-site reactions, arthralgia, peripheral oedema
Effects on glucose parameters warrant monitoring per labelling
Effect reversed after discontinuation in the trials

Interactions

Register entries involving this compound

tesamorelin ↔ insulin

Approved labelling addresses monitoring of glucose parameters.

Limitations. Magnitude varies; monitoring is the labelled approach.

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Limitations

What the evidence cannot tell you

Given as much prominence as the findings, because for most compounds in this category it is the more important half.

The entire efficacy evidence base is a specific HIV-associated lipodystrophy population
Extrapolation to healthy adults is not supported by the trials

Reference

Evidence grading key

AStrong

Multiple high-quality human trials, or strong systematic-review or meta-analytic evidence.

BModerate

Human controlled evidence exists, but replication or sample size is limited.

CPreliminary

Small human studies, observational evidence, or early-phase clinical work.

DPreclinical

Predominantly animal or in-vitro evidence. No adequate human outcome data.

EMechanistic

Biological plausibility or mechanistic reasoning without adequate outcome evidence.

XInsufficient / conflicting

Evidence is absent, irreconcilable, or too weak to support any directional statement.

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