Tesamorelin
Also known as TH9507 · developed by Theratechnologies
Licensed by at least one major regulator for a specific indication, on the strength of completed phase 3 trials. Approval is for that indication in that population — it is not a general endorsement of the compound.
What it is
A stabilised analogue of growth hormone releasing hormone, and one of the few growth hormone secretagogues to complete clinical development and reach approval.
How it is thought to work
GHRH receptor agonist, stimulating endogenous pulsatile growth hormone release from the pituitary rather than supplying growth hormone directly.
What the studies found
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Approved for HIV-associated lipodystrophy
Phase 3 trials showed reduction in visceral adipose tissue in people with HIV-associated lipodystrophy, supporting FDA approval in 2010.
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Studied in NAFLD
Later trials examined liver fat in people with HIV, reporting reductions in hepatic fat fraction.
What the evidence does not show
- The licensed indication is narrow and specific to an HIV-associated condition.
- Visceral fat returns after discontinuation.
- Effects in people without that condition have not been established through comparable trials.
Reported risks and adverse effects
- Arthralgia, peripheral oedema and injection site reactions are the common reported effects.
- Raises IGF-1, and the licence requires monitoring; growth hormone axis stimulation carries theoretical concerns around neoplasia.
- Can worsen glucose tolerance.
- Contraindicated in active malignancy.
This is a summary of what has been reported in the literature, not a complete safety profile. For anything concerning your own health, speak to a doctor.
Regulatory status
FDA-approved, prescription-only, for a specific HIV-associated indication.