Last updated October 21, 2026. Approval line checked October 21, 2026. No compounding source date is assigned.
FDA status
Approved
Approved. Tesamorelin is the active ingredient in Egrifta, FDA-approved to reduce excess abdominal fat in HIV-associated lipodystrophy. Approval is specific to that product and indication.
Drugs@FDA: Egrifta (NDA 022505)By signing up you agree to get PeptideX update emails. Unsubscribe anytime. Educational only, not medical advice.
Evidence tier
Human RCT. The tier is the highest indexed study type. It is not a safety rating and it is not an FDA approval. Confidence score 5/5. 620 PubMed citations indexed.
Stabilized GHRH analog with trans-2,3-diaminopropionic acid modification extending half-life; stimulates GH release with documented effects on visceral adipose tissue.
What the literature studies
HIV Lipodystrophy & GH Stimulation
Evidence tier
Human RCT
Compounding record
Status not verified
Status not verified. No product-specific FDA primary source is recorded for this entry. FDA approval and compounding eligibility are not verified. Research information is not evidence of FDA approval. Approval, where applicable, is specific to a drug product, indication and route. Research information is not evidence of FDA approval. Approval, where applicable, is specific to a drug product, indication and route.
Regulatory source not verified; no checked date is assigned.
Regulatory context and verification limits are documented below.
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Tesamorelin is an FDA-approved GHRH analog for reducing excess abdominal fat in people with HIV-associated lipodystrophy; off-label "fat loss" use outside that population is not supported by trials.
Growth-hormone-releasing factor analog (Egrifta, Theratechnologies) [R2].
Approved Nov 10 2010 for HIV lipodystrophy abdominal fat [R1]; reformulation Egrifta WR approved Mar 25 2025 [R2]. Prescription only. The label states it is not indicated for weight-loss management [R2].
Phase 3 RCT in HIV patients with abdominal fat accumulation: visceral fat fell 15.2% with tesamorelin vs a 5.0% rise with placebo; triglycerides improved; IGF-1 rose 81% [R3].
Not central; human RCTs exist.
Label warnings: neoplasm risk with active malignancy, elevated IGF-1 (long-term effects unknown), fluid retention, glucose intolerance, hypersensitivity; contraindicated in pregnancy; long-term CV safety not established [R2].
No pending FDA action identified for new indications.
Last checked 2026-10-27
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