Tesamorelin dosage in published studies and labels

These are the doses used for Tesamorelin in FDA labelling and published clinical studies, reported as each source states them, one row per regimen. They describe what was studied or approved for a specific population. They are not a recommendation, and none of them is a dose for any individual.

Research and educational reference only. This is not medical advice, and no figure on this page is a dosing recommendation.

Last checked against primary sources:

Studied regimens and sources

Tesamorelin has an FDA-approved human dosage: 1.4 mg reconstituted and injected subcutaneously into the abdomen once daily, approved only for the reduction of excess abdominal fat in adults with HIV-associated lipodystrophy. It is not approved for general growth-hormone or body-composition use, and the phase 3 evidence behind the label was generated in that HIV population.

FDA Approved
Dosage evidence summary for Tesamorelin
Human dosing establishedYes
Studied dose range1.4 mg once daily (2 mg once daily in earlier phase 3 formulation)
RouteSubcutaneous
FrequencyOnce daily
Duration studiedContinuous; the label sets no fixed course length
TitrationNone. The approved dose is fixed, with no escalation schedule.
Evidence levelFDA Approved
Last reviewed2026-09-05

Research-reported dosing

Doses as studied, one row per regimen. Different trials used different regimens; they are listed separately rather than averaged.

Research-reported dosing for Tesamorelin, one row per studied regimen
Study / contextPopulationDoseRouteFrequencyDurationOutcome studiedSource
FDA label — EGRIFTA SV, HIV-associated lipodystrophyFDA-approved label · FDA prescribing informationAdults with HIV-associated lipodystrophy and excess abdominal fat1.4 mg (0.35 mL of the reconstituted solution)Subcutaneous, into the abdomen with site rotationOnce dailyNot fixed by the labelReduction of excess abdominal fatEGRIFTA SV (tesamorelin) for injection — FDA prescribing information, DailyMed
NCT00123253 — phase 3, HIV-associated lipodystrophyClinical trial · Phase 3 randomised placebo-controlled trialPatients with HIV-associated lipodystrophy (n=412)2 mg (TH9507)SubcutaneousOnce daily26 weeksVisceral adipose tissueNCT00123253 — TH9507 in Patients With HIV-Associated Lipodystrophy
NCT00608023 — phase 3 extensionClinical trial · Phase 3 extension trial with posted resultsPatients with HIV-associated lipodystrophy (n=263)2 mg (TH9507)SubcutaneousOnce dailyExtension beyond the initial 26 weeksDurability of visceral fat reduction and safetyNCT00608023 — TH9507 Extension Study in Patients With HIV-Associated Lipodystrophy
NCT02572323 — phase 2, cognition in ageing HIVClinical trial · Phase 2 trial with posted resultsAgeing adults with HIV (n=73)Per trial protocolSubcutaneousOnce dailyPer trial protocolCognitionNCT02572323 — Phase II Trial of Tesamorelin for Cognition in Aging HIV-Infected Persons

Where sources disagree

  • The approved 1.4 mg dose applies to the EGRIFTA SV formulation. The earlier phase 3 programme used 2 mg daily of the original TH9507 formulation; the two are not interchangeable, because the reformulation changed the delivered amount rather than the regimen.
  • Every approved and trialled use of tesamorelin is in HIV-associated lipodystrophy. Dosing quoted for general growth-hormone, anti-ageing or body-composition purposes has no approved indication and no phase 3 evidence in that population behind it.