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.
| Human dosing established | Yes |
|---|---|
| Studied dose range | 1.4 mg once daily (2 mg once daily in earlier phase 3 formulation) |
| Route | Subcutaneous |
| Frequency | Once daily |
| Duration studied | Continuous; the label sets no fixed course length |
| Titration | None. The approved dose is fixed, with no escalation schedule. |
| Evidence level | FDA Approved |
| Last reviewed | 2026-09-05 |
Research-reported dosing
Doses as studied, one row per regimen. Different trials used different regimens; they are listed separately rather than averaged.
| Study / context | Population | Dose | Route | Frequency | Duration | Outcome studied | Source |
|---|---|---|---|---|---|---|---|
| FDA label — EGRIFTA SV, HIV-associated lipodystrophyFDA-approved label · FDA prescribing information | Adults with HIV-associated lipodystrophy and excess abdominal fat | 1.4 mg (0.35 mL of the reconstituted solution) | Subcutaneous, into the abdomen with site rotation | Once daily | Not fixed by the label | Reduction of excess abdominal fat | EGRIFTA SV (tesamorelin) for injection — FDA prescribing information, DailyMed |
| NCT00123253 — phase 3, HIV-associated lipodystrophyClinical trial · Phase 3 randomised placebo-controlled trial | Patients with HIV-associated lipodystrophy (n=412) | 2 mg (TH9507) | Subcutaneous | Once daily | 26 weeks | Visceral adipose tissue | NCT00123253 — TH9507 in Patients With HIV-Associated Lipodystrophy |
| NCT00608023 — phase 3 extensionClinical trial · Phase 3 extension trial with posted results | Patients with HIV-associated lipodystrophy (n=263) | 2 mg (TH9507) | Subcutaneous | Once daily | Extension beyond the initial 26 weeks | Durability of visceral fat reduction and safety | NCT00608023 — TH9507 Extension Study in Patients With HIV-Associated Lipodystrophy |
| NCT02572323 — phase 2, cognition in ageing HIVClinical trial · Phase 2 trial with posted results | Ageing adults with HIV (n=73) | Per trial protocol | Subcutaneous | Once daily | Per trial protocol | Cognition | NCT02572323 — 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.