FDA Approved Growth Hormone Axis

Tesamorelin

also known as: Egrifta, Egrifta SV, TH9507

An FDA-approved GHRH analog for reducing excess visceral fat in HIV-associated lipodystrophy.

A 44-amino-acid synthetic GHRH analog with a trans-3-hexenoyl modification at the N-terminus that resists DPP-4 degradation, extending half-life compared with native GHRH.

Mechanism of action

Binds GHRH receptors on pituitary somatotrophs, stimulating pulsatile release of endogenous growth hormone. The resulting GH increase raises IGF-1 and drives lipolysis, preferentially in visceral adipose tissue. Because GH release remains pulsatile and pituitary-mediated, tesamorelin preserves feedback regulation in a way that exogenous GH does not.

Primary uses

  • HIV-associated lipodystrophy (FDA-approved indication)
  • Visceral fat reduction (off-label in non-HIV populations)
  • NAFLD/NASH (investigational)

Typical dosing

1–2 mg once daily (subcutaneous)

FDA-labeled dose is 2 mg daily. Community off-label dosing sometimes uses 1 mg. Administered in the abdomen.

Regulatory status

FDA-approved as Egrifta (2010) and Egrifta SV (2019) for reduction of excess abdominal fat in HIV-infected patients with lipodystrophy. Manufactured by Theratechnologies.

References

  1. [fda-pi] Egrifta SV (tesamorelin) Prescribing Information. Theratechnologies.
  2. [clinical-trial] Falutz J, et al. "Effects of tesamorelin on visceral fat and liver fat in HIV-infected patients with abdominal fat accumulation." JAMA, 2014;312:380-389.
  3. [clinical-trial] Stanley TL, et al. "Effects of tesamorelin on non-alcoholic fatty liver disease in HIV." Lancet HIV, 2019;6:e821-e830.

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Disclaimer

This entry is for educational purposes only and does not constitute medical advice. Dosing information reflects published regulatory or research data and is not a recommendation. Many compounds described here are not approved for human use in the United States. Consult a licensed medical professional before considering any peptide therapy.