RECORD · 03 / DOSE CONTEXT
The doses of tesamorelin studied in the research record
What was administered to whom, by which route, at which dose — logged from the trial protocols and the FDA-approved regimen, as research context, not as instructions.
The short version
When researchers studied tesamorelin, almost everyone used the same regimen: 2 mg injected under the skin (subcutaneous) of the abdomen, once a day. That is the dose in both big HIV trials and the FDA-approved label. A lower 1 mg dose showed up in a couple of studies. This page describes those studied doses as a record of what the trials did — not as a recommendation. There is no human dosing instruction here, because research-grade tesamorelin is not the approved medicine and these pages are an editorial digest, not a clinic.
Doses studied in the research literature
The tesamorelin dosage that dominates the literature is 2 mg subcutaneously once daily. That was the dose in both pivotal Phase 3 trials — the 26-week NEJM trial [5] and the 52-week program [6] — and it is the FDA-approved regimen under NDA 022505 [4]. The JAMA hepatic-fat RCT [7], the healthy-men mechanistic study [8], and the drug-interaction crossover study [3] all used 2 mg/day as well.
A lower dose of 1 mg subcutaneously once daily appears in the dose-ranging literature: the 12-week study compared 1 mg and 2 mg and found dose-related IGF-1 increases (+48% at 1 mg, +65% at 2 mg) with trunk-fat reduction at both [9], and 1 mg was a lower arm in the type-2-diabetes safety trial [2]. The dose-response is real but modest across that range. These are descriptions of doses studied in the literature, not a protocol — the approved product is a prescription drug for one indication, and no general-population dosing exists.
Route, half-life, and the once-daily rationale
Every clinical trial used the same route: subcutaneous injection at an abdominal site — the only route studied and the only FDA-approved route [4]. There is no oral or other route in the human record.
The pharmacokinetics explain the once-daily schedule. The parent peptide clears rapidly — an apparent elimination half-life of ~21-45 minutes in dogs in non-clinical work [10], and a terminal half-life on the order of ~26-38 minutes cited by secondary sources [1], with apparent plasma clearance near 1,060 L/h [1]. Yet the GH/IGF-1 response it triggers persists across the day, which is why a once-daily injection sustains the downstream effect despite minutes-long plasma residence [1]; the research page details half-life and pharmacokinetics in full. The visceral-fat benefit is contingent on continued dosing: it reaccumulated within weeks of discontinuation in the long-term program [6].
Stability and handling in the studied product
The N-terminal trans-3-hexenoic acid modification is a stability device first: it blocks the DPP-IV cleavage that rapidly inactivates native GHRH, which is what gives tesamorelin a usable duration of action at all [10]. In the studied finished product, the compound is supplied as a lyophilized powder requiring reconstitution; the FDA label specifies refrigerated storage and use of the reconstituted solution within a defined window [1].
These handling notes describe the characterized clinical product. Research-grade material sold for laboratory use lacks the purity and potency oversight of the approved product, so its stability behavior should not be assumed equivalent. Storage, reconstitution, and assay conditions are properties a laboratory establishes for its own material — not a dosing instruction.