Tesamorelin
Tesamorelin (Egrifta) — evidence, FDA approval & status

Class: peptide
Synonyms: tesamorelin acetate
Egrifta (brand name)
developer code TH9507
brand Egrifta → Egrifta SV (2019) → Egrifta WR / "F8" (2025)
stabilized GHRH analog. PubChem CID 16137828. INCI: none
Function tags: GHRH analog / GH secretagogue
visceral fat (approved: HIV-lipodystrophy)
(off-label:) body composition / liver fat
Overall evidence grade: A
WADA prohibited: yes
WADA note: Sport: WADA-prohibited — GHRH analogs / GH-releasing factors fall under Section S2.2. Banned even though FDA-approved.
Last updated: 2026-07-13

In brief: Tesamorelin is a stabilized 44-amino-acid GHRH analog and the only GHRH analog with a current FDA approval (as Egrifta, for HIV-associated lipodystrophy since 2010). It carries the strongest evidence in this register — multiple large Phase 3 RCTs showing ~15–18% visceral-fat reduction. Its popular non-HIV / anti-aging use is off-label and not RCT-anchored in those populations. It is banned in sport.

## Identity a synthetic **44-amino-acid** analog of human GHRH (the full-length 44-aa sequence) carrying an **N-terminal *trans*-3-hexenoic acid (hexenoyl) modification** that resists DPP-4/enzymatic degradation. Developed by **Theratechnologies** (Canada) and marketed under the brand name **Egrifta** (later Egrifta SV and Egrifta WR). At **44 aa it sits at the upper boundary of the "peptide" range** (endogenous GHRH is also 44 aa), and the FDA now regulates it as a **biologic** (BLA). (CJC-1295 stabilises the shorter 1-29 fragment instead.) ## Development & history - Theratechnologies developed **TH9507** as a stabilized GHRH that survives systemic proteases long enough to reach the pituitary.
- Pivotal **Phase 3 RCT** — **Falutz et al., N Engl J Med 2007** — established efficacy in HIV-associated lipodystrophy.
- **FDA approval November 2010** as **Egrifta**, for **reduction of excess abdominal (visceral) fat in HIV-infected adults with lipodystrophy** — the first and only drug specifically approved for that condition, and the **only FDA-approved GHRH analog**.
- Reformulated as **Egrifta SV** (2019) and again as **Egrifta WR / F8** (2025) — approvals that keep it a **current, actively-marketed** medicine (unlike Sermorelin's withdrawn Geref). ## Mechanism (as proposed) a **GHRH-receptor agonist** on pituitary somatotrophs → **pulsatile GH** release → hepatic **IGF-1** → GH/IGF-1 drive **lipolysis preferentially in visceral fat** (which expresses more GH receptors than subcutaneous fat), giving the visceral-selective effect documented in the trials. Its **short half-life (~26–38 min)** preserves the body's natural pulsatile GH rhythm — unlike the sustained "GH bleed" of CJC-1295-DAC.

Evidence grades by outcome:
outcome: HIV-associated lipodystrophy — visceral-fat (VAT) reduction (approved indication)
grade: A
base: Phase 3 RCTs — Falutz 2007 NEJM (n=412); pooled n=806 (JCEM 2010); FDA-approved
effect: ~15–18% VAT reduction vs placebo at 26 wk (p<0.001)
caveat: The strongest evidence in the register; the effect reverses on discontinuation
outcome: Liver fat / NAFLD (in HIV)
grade: B
base: RCT — Stanley 2014, JAMA
effect: Reduced liver fat
caveat: Off-label; studied specifically in the HIV population
outcome: Non-HIV visceral fat / general body composition / longevity (popular off-label)
grade: C
base: Mechanism + observational; not RCT-anchored in these groups
effect: Plausible
caveat: Not FDA-approved for these; the approved evidence is HIV-specific
outcome: Cognition (older adults)
grade: C
base: Some GHRH-administration trial data
effect: Suggestive
caveat: Early; not an approved use
outcome: Safety
base: Phase 3 + post-marketing label
effect: Well-characterised
caveat: Raises IGF-1 (monitored); glucose/insulin effects; injection-site reactions, arthralgia; WADA-banned

Legal status:
region: US
status: Approved / prescription
note: Current FDA approval (Egrifta / Egrifta SV / Egrifta WR) for HIV-associated lipodystrophy; the only approved GHRH analog; regulated as a biologic. Compounded tesamorelin also exists and is used off-label (non-HIV visceral fat, NAFLD, body composition). Not part of the gray-market Category-2 situation.
region: EU
status: Not marketed under a general EU authorisation (availability 
note: Not marketed under a general EU authorisation (availability differs from the US) — confirm current EU status before relying on it.
region: INT
status: Status varies
note: Varies.

Cosmetic claims:

Note: Reference entry — not sold here. The apex of the GH-secretagogue set: the only GHRH analog with a current FDA approval, and the compound with the strongest evidence in this register. A prescription biologic, not a wellness peptide. No dosing published here; neutral reference only.

Sources:
Falutz J, et al. Metabolic effects of a growth hormone-releasing factor in patients with HIV. N Engl J Med. 2007. (PMID 17978289)
Pooled Phase 3 analysis (n=806), J Clin Endocrinol Metab. 2010; Falutz J, et al. Long-term safety and effects of tesamorelin. AIDS. 2010. (PMID 20861624)
Stanley TL, et al. Effect of tesamorelin on visceral fat and liver fat in HIV. JAMA. 2014. (PMID 24449321)
FDA prescribing information — Egrifta / Egrifta SV / Egrifta WR (Theratechnologies).