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Tesamorelin

A GHRH analogue and the one FDA-approved compound in this atlas, cleared for a specific HIV-related use. Evidence outside that use is thin.

The basics

Human protocol on record2 figures
Animal or laboratory figures1
Published records retrieved15
Registered trials20
Certificate of analysisPublished by the partner
Regulatory statusHas an approved label for one specific indication, which is not approval for any other purpose

1. The protocol on record

Hard disclaimer. Figures below are transcribed from a published study or an approved label exactly as the source states them. They record what researchers administered in a trial population, not instructions for any person, and none of it is adjusted to you. Most compounds here have no approved human use. Do not act on any of it without a licensed prescriber who knows your history.

Amounts and schedules, human record

Phase or modelAmountFrequencyTimingRouteDurationSource
Phase 2 randomized open-label trial, neurocognitive impairment in virally suppressed people with HIV and abdominal obesity2 mgdailynot statedsubcutaneous6 monthssource
Two 26-week phase 3 trials and their extension phases, HIV-associated central fat accumulationnot statednot statednot statedsubcutaneous26 weeks per trial; reduction in visceral adipose tissue maintained in patients who continued treatment until week 52 in the extension phasessource

Animal and laboratory models (not human figures)

Phase or modelAmountFrequencyTimingRouteDurationSource
Intravenous administration in rats (one GHRH compound per test animal), carried out to validate a plasma detection assay for anti-doping analysisnot statednot statednot statedintravenousblood samples collected 2, 4, and 8 hours after administrationsource

Half-life and why the schedule looks like that

No half-life, clearance figure, or duration of action is stated in the cited record. The record does state a dosing frequency: 2 mg subcutaneously daily in a 6-month phase 2 randomized open-label trial in virally suppressed people with HIV and abdominal obesity (PMID: 39813152). The only time-course statement in the record comes from an anti-doping assay validation study, not a pharmacokinetic description: after intravenous administration of GHRH compounds to rats, all intact substances, including tesamorelin, were detected in plasma for at least 4 hours (PMID: 26879649). That is a detection window in a rat model, not a stated half-life.

Handling and storage

- Lyophilised storage: Not stated in the cited record. - Storage after reconstitution: Not stated in the cited record. - Temperature: Not stated in the cited record. - Light: Not stated in the cited record. - Stability duration: Not stated in the cited record for tesamorelin as a drug product. The only stability-related statement in the record concerns analytical detection, not storage or handling: a validation study examined the stability and metabolism of GHRH analytes, including tesamorelin, in plasma samples using in vitro and in vivo approaches (PMID: 26879649).
These figures summarise what published research and approved labels describe. They are educational, not a recommendation or a personal protocol. Any dose, schedule, or decision to use a compound belongs with a licensed prescriber.

Open the interactive builder for reconstitution maths and a calendar →

2. Safety and harm reduction

Reported adverse effects

EffectHow often reportedPopulationSource
Treatment-emergent serious adverse events<4% of patients during 26 weeks of therapytwo 26-week phase 3 trials, adults with HIV-associated central fat accumulationPMID: 21668043
Injection-site reactionsdescribed as most of the serious events abovetwo 26-week phase 3 trials, adults with HIV-associated central fat accumulationPMID: 21668043
Arthralgiafrequency not stated; described as an event known to be associated with growth hormone therapytwo 26-week phase 3 trials, adults with HIV-associated central fat accumulationPMID: 21668043
Headachefrequency not stated; described as an event known to be associated with growth hormone therapytwo 26-week phase 3 trials, adults with HIV-associated central fat accumulationPMID: 21668043
Peripheral oedemafrequency not stated; described as an event known to be associated with growth hormone therapytwo 26-week phase 3 trials, adults with HIV-associated central fat accumulationPMID: 21668043

Cautions stated in the literature

  • Growth hormone-releasing hormone and its synthetic analogs, tesamorelin among them, are prohibited in sports by the World Anti-Doping Agency (PMID: 34665524; PMID: 26879649).
  • Lack of long-term safety and adherence data is named as a potential limitation of tesamorelin use, and long-term clinical experience is described as needed to further assess the benefits and risks of therapy (PMID: 22298602; PMID: 21668043).
  • A phase 2 trial in people with HIV excluded participants with malignancy, active substance use disorder, and conditions other than HIV causing neurocognitive impairment; these are the exclusion criteria the cited record states (PMID: 39813152).
  • Reviews of unapproved peptide markets state that rigorous human safety data are scarce for many marketed peptides and that there is potential for serious harm; tesamorelin is discussed in these reviews as an approved drug, and this caution is stated for the broader peptide market rather than for tesamorelin itself (PMID: 41966639; PMID: 42123471).

Stop and get help

  • Any severe or worsening reaction after administration.
  • Signs of an allergic reaction, such as rash, itching, swelling of the face or throat, or difficulty breathing.
  • Signs of injection-site infection, such as spreading redness, warmth, swelling, pus, or fever.
  • Anything unexpected that persists, recurs, or causes concern.
Tesamorelin at Peptara Labs

Read the third-party certificate of analysis before anything else. Research-grade material, research use only.

Open the Tesamorelin page