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Growth hormone axis

Tesamorelin

An approved medicine for one specific indication, routinely marketed for a much broader one.

L4Strong humanApproved — narrow indicationApprovedModerate confidenceLast reviewed 2026-08-23
SC injection

Also known as: Egrifta, TH9507, GHRH analogue

Evidence passport

Last reviewed 2026-08-23

Evidence level
L4Strong human
Confidence
Moderate confidence
Human efficacy
70/100
Human safety
65/100
Regulatory status
Approved — narrow indication
Development
Approved
Routes
SC injection
Evidence base
Includes human data
Furthest stage
Approved
Source curation
Sources fully curated
Clinical maturity
Approved for a defined indication with Phase 3 support

Overview

Human evidence70/100
Preclinical evidence70/100
Human safety evidence65/100

Clinical maturity: Approved for a defined indication with Phase 3 support

Routes & formulations

Studied / approved routes

SC injection

The approved product is a subcutaneous injection studied in the labelled HIV-associated lipodystrophy population.

Route availability is not evidence of efficacy, and evidence from one route does not transfer to another. The Registry never provides dosing or sourcing information.

Peptide lifecycle

  1. Discovery

  2. Preclinical

  3. Phase I

  4. Phase II

  5. Phase III

  6. Approved

Approved

Approved for HIV-associated lipodystrophy; broader uses remain unapproved.

What it is

A stabilised analogue of growth-hormone-releasing hormone that stimulates the pituitary to release growth hormone in a relatively physiological pattern.

What people claim

  • Reduces visceral fat
  • Improves body composition in healthy adults
  • Anti-ageing and cognitive benefits

What the evidence actually says

Within its approved indication, tesamorelin has real randomised evidence for reducing visceral adipose tissue. Outside it, the evidence thins quickly: studies in healthy or general populations are limited, and the anti-ageing framing runs well past the data. Visceral fat reduction is also a surrogate endpoint, not a guaranteed health outcome.

Human evidence

  • Randomised placebo-controlled trials in HIV-associated lipodystrophy showing visceral fat reduction.
  • Smaller exploratory studies in other populations, including cognition-related work, that are not practice-changing.

Preclinical evidence

  • Established GHRH-receptor pharmacology and growth-hormone axis physiology.

Animal and cell findings are Level 1–2 evidence.

Mechanism and pathways

  • GHRH receptor agonism at the pituitary increases pulsatile growth hormone release.
  • Downstream IGF-1 elevation drives lipolysis in visceral fat.

Safety and unknowns

  • Common: injection-site reactions, joint pain, fluid retention, paraesthesia.
  • Raises IGF-1, requiring monitoring; effects on glucose metabolism can be unfavourable in some people.
  • Benefits reverse after stopping.

Cancer relevance

Monitored in trials; not demonstrated in humans

Elevating growth hormone and IGF-1 is a mechanistically meaningful concern because IGF-1 signalling supports cell proliferation, and epidemiology links higher IGF-1 with some cancer risks. Trials in the approved indication have not demonstrated increased cancer incidence, but this is a monitored consideration rather than a settled question.

Regulatory status

Approved in the US (Egrifta WR) for reduction of excess abdominal fat in HIV-infected adult patients with lipodystrophy. The label states it is not indicated for weight-loss management and that long-term cardiovascular safety has not been established. General body-recomposition or anti-ageing use is off-label.

  • Baseline · United States

    Approved for excess visceral abdominal fat in HIV-associated lipodystrophy only.

Evidence grade

L4Strong humanModerate confidence

Solid controlled human trials, though not yet definitive or fully replicated.

What would change our rating?

  • Long-term outcome data beyond surrogate imaging endpoints.
  • Controlled trials in non-HIV populations.

References and sources

Sources fully curated

Source hierarchy: regulatory documents and trial registries first, peer-reviewed work next, sponsor material flagged as non-independent. We never use supplier or clinic marketing as evidence, and where a verified source has not yet been curated we say so rather than inventing one.

Evidence change history

No recorded changes yet. Baseline position set on 2026-08-23.