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Research profile · Peptide analogue

Tesamorelin

Also known as TH9507

Clinical — evidence level 4 of 4: Established clinical evidenceUnlicensed — UK regulatory status: Unlicensed medicinal product (UK)

Overview

A stabilised analogue of growth-hormone-releasing hormone. Licensed in the United States; no UK marketing authorisation.

Category
Peptide analogue
Highest evidence level identified
Established clinical evidence
Last scientifically reviewed
22 August 2026
Last regulatory review
22 August 2026

Mechanism under investigation

Tesamorelin is the full 44-amino-acid sequence of human growth-hormone-releasing hormone with a trans-3-hexenoyl group attached to the N-terminus, a modification that protects it from cleavage by DPP-4 and extends its activity. It acts at the pituitary GHRH receptor to stimulate pulsatile growth hormone secretion, which in turn raises IGF-1 — an indirect mechanism that preserves feedback regulation, in contrast to administering growth hormone itself.

Research areas

  • Somatotropic axis research
  • Metabolic research

These are fields in which the compound has been investigated. Listing a field is not a statement that anything was demonstrated within it.

Current evidence

In-vitro evidence

Cells, tissues or biochemical systems outside a living organism.

Receptor pharmacology follows from the parent hormone, which is thoroughly characterised; tesamorelin-specific in-vitro work concerns the stability conferred by the N-terminal modification.

Animal evidence

Studies in living non-human animals.

Preclinical characterisation of GHRH analogues is extensive as a class; the tesamorelin development programme itself moved quickly to human pharmacology.

Human observational evidence

Studies observing people without assigning an intervention.

Post-marketing experience exists in the United States within its licensed indication; independent observational literature is modest.

Clinical-trial evidence

Studies assigning an intervention to human participants.

Good within a narrow question. Two phase-3 trials in HIV-associated central fat accumulation showed reductions in visceral adipose tissue versus placebo over 26 weeks, and a randomised trial reported reduced liver fat in HIV-associated fatty liver disease. Effects reversed after discontinuation, and trials outside the HIV setting are limited.

Study limitations

  • The controlled evidence is confined to HIV-associated lipodystrophy and its liver-fat extension; generalisation beyond that population is unsupported.
  • Visceral fat returned after stopping treatment in the extension studies — the trials establish an effect during administration, not a lasting change.
  • The European assessment that preceded the withdrawn EU application found the clinical benefit insufficiently established and raised IGF-1-related safety questions; those concerns were never resolved by later submission.
  • IGF-1 elevation is intrinsic to the mechanism, and its long-term consequences in otherwise healthy users are unstudied.

UK regulatory context

Unlicensed medicinal product (UK)

A product meeting the definition of a medicinal product but holding no UK marketing authorisation.

Source: The Human Medicines Regulations 2012, regulation 46 — prohibition on sale or supply of an unauthorised medicinal product (opens legislation.gov.uk in a new tab) (legislation.gov.uk)

Regulatory classification is jurisdiction-specific. A compound authorised elsewhere is not thereby authorised in the UK, and a supplier’s description of a substance does not determine how it is classified in law. See safety and regulation for the framework and the authoritative sources.

Safety and interpretation

Tesamorelin has no UK marketing authorisation: the EU application was withdrawn in 2012 after the CHMP concluded the benefits had not been shown to outweigh the risks, citing unproven clinical benefit and IGF-1-related concerns, and no UK application has succeeded since. Supplying it as a medicine in the UK is prohibited by regulation 46 of the Human Medicines Regulations 2012. The American licence attests to a specific benefit–risk judgement inside a monitored HIV population; it says nothing about unsupervised use, and raising growth hormone and IGF-1 without monitoring carries exactly the endocrine risks the European assessors declined to accept.

References