P Palthera
Hormone Analogues

Tesamorelin

TH9507 / Egrifta / Egrifta SV

Tesamorelin is a synthetic 44- of human (with an N-terminal trans-3-hexenoyl modification for ). It is FDA-approved as Egrifta / Egrifta SV for the reduction of excess abdominal fat in patients with HIV-associated lipodystrophy. Approval is indication-specific; use outside that indication is investigational.

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Hormone Analogues
Classification
Synthetic GHRH(1–44) analogue · FDA-approved (Egrifta)
Research stage
Phase III clinical evidence; FDA-approved for HIV-associated lipodystrophy
Sequence
Trans-3-hexenoyl-Tyr-Ala-Asp-Ala-Ile-Phe-Thr-Asn-Ser-Tyr-Arg-Lys-Val-Leu-Gly-Gln-Leu-Ser-Ala-Arg-Lys-Leu-Leu-Gln-Asp-Ile-Met-Ser-Arg-Gln-Gln-Gly-Glu-Ser-Asn-Gln-Glu-Arg-Gly-Ala-Arg-Ala-Arg-Leu-NH2
Molecular weight
5135.8 Da

Snapshot

Key takeaways

A three-bullet snapshot before reading the full dossier.

  1. 01

    Stabilised (1–44) with an N-terminal trans-3-hexenoyl group.

  2. 02

    FDA-approved for a single specific indication: HIV-associated lipodystrophy.

  3. 03

    Subsequent peer-reviewed work has investigated effects on hepatic steatosis (NAFLD) in people with HIV.

Dossier overview

4

research areas

3

references

3

handling notes

01

Mechanism of action

Tesamorelin binds the at the pituitary, restoring pulsatile growth hormone secretion and downstream IGF-1 signalling. The lipid-modification on the increases plasma versus native GHRH(1–44).

02

Research applications

  • Endocrine pathway and - pharmacology research
  • HIV-associated lipodystrophy clinical research
  • Hepatic steatosis and NAFLD trial research in people with HIV
  • Comparative research

Evidence at a glance

What's behind this profile

3 citations · 2011–2024

Human
2

Studies in human volunteers or patients (incl. early-phase trials).

Review
1

Narrative or systematic reviews; no primary data.

Publication years

  1. 11
  2. 12
  3. 13
  4. 14
  5. 15
  6. 16
  7. 17
  8. 18
  9. 19
  10. 20
  11. 21
  12. 22
  13. 23
  14. 24
20112024

Counts are derived from the cited studies below. A study covering both in vivo and in vitro work is counted by its primary model. Sample size is reported in 2 of 3 citations. Findings remain model-specific and are not extrapolated to therapeutic use.

03

Study references

Each profile cites a minimum of two peer-reviewed sources, with model type and reported sample size where the source provides it. Findings are model-specific and must not be extrapolated to therapeutic use.

Tesamorelin (drug approval review)

2011

Grunfeld C et al. · Nature Reviews Drug Discovery

Model
Drug approval review
Sample
N/A (review)

Reviewed the regulatory and clinical evidence supporting FDA approval of tesamorelin for reducing excess abdominal fat in patients with HIV-associated lipodystrophy.

PMID 21283099 DOI 10.1038/nrd3362

Effects of tesamorelin on hepatic transcriptomic signatures in HIV-associated NAFLD

2020

Fourman LT et al. · JCI Insight

Model
Randomised placebo-controlled trial with paired liver biopsies (people with HIV and NAFLD)
Sample
Paired specimens from the parent clinical trial cohort

Tesamorelin was associated with increased hepatic oxidative phosphorylation and decreased inflammatory and fibrosis-related signatures in paired liver biopsies.

PMID 32701508 DOI 10.1172/jci.insight.140134

Efficacy and safety of tesamorelin in people with HIV on integrase inhibitors

2024

Russo SC et al. · AIDS

Model
Randomised double-blind trial in people with HIV on integrase-inhibitor regimens
Sample
n=38 randomised; 31 completed 12-month study

Tesamorelin reduced visceral and hepatic fat and trunk-to-appendicular fat ratio versus placebo without significantly worsening glycaemic control over 12 months.

PMID 38905488 DOI 10.1097/QAD.0000000000003965

Evidence caveats

  • FDA approval is specific to HIV-associated lipodystrophy. Use outside that indication is investigational and is not endorsed here.
  • Clinical decisions involving tesamorelin must be made with a qualified healthcare professional. Palthera does not provide dosage or administration guidance.

04

Storage and handling

Approved product follows manufacturer cold-chain instructions. Research-grade material must be stored under controlled laboratory conditions per protocol.

  • Approved-product handling follows the manufacturer label; research-grade material is separate and must be documented per protocol.
  • Maintain cold-chain records per supplier guidance.
  • Record conditions and dates for each batch.

Common questions

Tesamorelin FAQ

Plain-English answers backed by the citations on this profile — what it is, what's been studied, regulatory status, evidence limits.

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