Research digest / studied doses
The tesamorelin doses, routes, and stability studied in the trials.
What was administered, to whom, by which route, for how long — the research-context record, with no human-dosing guidance.
In plain English
This page lists the tesamorelin doses used in the research, not a regimen to follow. In the main HIV trials, people received 2 mg injected under the skin (subcutaneously) once a day [1][2]. A lower 1 mg dose was tested in a safety study and a memory study [7]. The drug comes as a freeze-dried powder that has to be mixed before use, and it is injected into the belly. Because the molecule clears the blood within minutes but its growth signal lasts all day, once-daily dosing was enough [10]. Nothing here is medical advice or a recommendation — it is a record of what the studies did.
The Studied Research Doses
The dose that carries almost the entire efficacy record is 2 mg subcutaneously once daily. It was the regimen in both pivotal Phase 3 trials and the dose used in the JAMA hepatic-fat study [1][2][6]. A 1 mg subcutaneous once-daily dose appears as a lower arm in the type-2-diabetes safety trial and in a cognition trial in older adults [7].
The early dose-ranging work established the dose-response. In a 12-week randomized, double-blind, placebo-controlled trial of 61 HIV-infected adults with central fat accumulation, subcutaneous tesamorelin at 1 or 2 mg once daily produced dose-related IGF-1 increases (+48% at 1 mg, +65% at 2 mg) and reduced trunk fat, while being generally well tolerated with no change in glucose [8]. That graded IGF-1 response is the clearest read on the dose-response curve: more drug produced more downstream signal, and 2 mg became the carried-forward dose into the pivotal program.
These are doses administered in studies to defined populations, stated as research context. This page gives no human-dosing instruction, and the doses above should not be read as a regimen — they are a record of what investigators administered, to whom, and for how long.
Route, Reconstitution, and Stability
Subcutaneous injection at an abdominal site is the only route studied in the clinical trials and the only approved route [5]. There is no oral, transdermal, or intranasal tesamorelin in the trial record — a peptide of this size would not survive oral digestion intact, which is why the studied delivery is injection. Tesamorelin is supplied as a lyophilized (freeze-dried) powder requiring reconstitution before injection; the labeling specifies refrigerated storage and use of the reconstituted solution within a defined window.
The molecule's stability is engineered, not incidental. Native GHRH is inactivated almost immediately by DPP-IV; tesamorelin's N-terminal trans-3-hexenoic acid modification blocks that cleavage, which is what gives it enough plasma activity to produce a usable GH pulse [4]. That same design is what differentiates it from a truncated GHRH analogue, a contrast covered on the tesamorelin vs sermorelin page. Research-grade tesamorelin sold for laboratory use is not the approved finished drug product and does not carry its purity, potency, or storage oversight.
Half-Life and Why Once-Daily Dosing Was Studied
Plasma exposure is brief but the downstream effect is durable, and that gap explains the once-daily schedule. Population PK modeling reported an apparent clearance of about 1,060 L/h, with a roughly 13% increase in absorbed fraction by day 14 versus day 1 [10]. Secondary sources (the FDA label, Mayo Clinic) describe a terminal half-life on the order of 26-38 minutes.
Despite that rapid clearance, the IGF-1 elevation the GH pulse produces persists across the dosing interval, which is why a single daily injection was the studied paradigm rather than multiple doses. The population PK-PD model formalized this exposure-response link, connecting the brief subcutaneous exposure to the episodic GH secretion and the longer-lived IGF-1 response [10]. In plain terms, the dosing schedule is built around the downstream signal, not the parent molecule. For the full pharmacokinetic picture see pharmacokinetics and half-life. The 2 mg once-daily regimen is the extensively studied one; later reformulations use a different concentration but keep the once-daily subcutaneous frame, so the once-daily structure is the constant across the program.