Tesamorelin

What is Tesamorelin?

Tesamorelin is a synthetic 44-amino-acid analog of growth hormone-releasing hormone, stabilized by a trans-3-hexenoic acid group on the N-terminal tyrosine that resists enzymatic breakdown. It is the only FDA-approved GHRH-class peptide with a current marketed indication, sold as Egrifta (later Egrifta SV, now Egrifta WR) by Theratechnologies for reducing excess visceral abdominal fat in adults with HIV-associated lipodystrophy. It does not supply growth hormone directly; it stimulates the pituitary to release the body's own.

How it’s supplied

Brand / trade names: Egrifta, Egrifta SV, Egrifta WR

Supplied as the FDA-approved prescription product for subcutaneous injection into the abdomen: originally Egrifta (2 mg daily), then Egrifta SV (1.4 mg daily, single-vial formulation approved 2019), and now Egrifta WR (the F8 formulation, 1.28 mg daily, approved March 2025), which replaces Egrifta SV and allows weekly rather than daily reconstitution at less than half the injection volume. Research-grade tesamorelin vials are also sold for off-label study; those are not the FDA-approved product and are not FDA-reviewed for identity, purity, or potency.

Dosage Chart

Potential Benefits and Side Effects

Effects reported in published research. Not a promise of results, and not medical advice.

Reconstitution Steps

How to prepare the lyophilized vial. Confirm specifics with your pharmacist or prescriber.

1. Follow the FDA-approved prescribing information for the specific formulation (Egrifta WR, Egrifta SV, or legacy Egrifta), which supersedes general guidance; reconstitution differs meaningfully between them.
2. Confirm the product and strength (Egrifta WR 1.28 mg daily, Egrifta SV 1.4 mg daily, or legacy Egrifta 2 mg daily) and check the expiration date.
3. Wash your hands and gather supplies: the vial, the supplied diluent (sterile water for injection), an alcohol swab, and a U-100 insulin syringe.
4. Wipe the stopper of the vial and diluent with a fresh alcohol swab and let them dry.
5. Draw up the diluent volume specified in the labeling and inject it slowly down the inside wall of the powder vial.
6. Do not shake. Gently swirl or roll the vial until fully dissolved.
7. Inspect the solution: it should be clear and colorless with no particles. Do not use if cloudy or discolored.
8. Note the resulting concentration for reference, then draw the prescribed dose and inject subcutaneously into the abdomen, rotating sites daily.
9. Store the reconstituted vial per the formulation-specific labeling: Egrifta WR permits weekly reconstitution with refrigerated storage, whereas earlier formulations required daily preparation.

US regulatory status

Classifications are public record but can change. For reference only, not legal advice.

Development: Tesamorelin was developed by Theratechnologies under the code TH9507 and approved by the FDA in November 2010 as Egrifta, the first and still only therapy approved in the US to reduce excess abdominal fat in adults with HIV-associated lipodystrophy. Approval rested on two pivotal Phase III trials reported by Falutz and colleagues: in a pooled analysis of 806 participants, tesamorelin 2 mg daily reduced visceral adipose tissue by approximately 15.4 percent versus placebo at 26 weeks (p less than 0.001), with concurrent reductions in fasting triglycerides. A later randomized trial (Stanley et al., JAMA 2014) found a net visceral fat treatment effect of about -42 cm squared and a net -2.9 percent reduction in liver fat versus placebo. Two important caveats from the literature: the visceral fat effect reverses once treatment stops, and the drug did not meaningfully change subcutaneous fat. The product has been reformulated twice: Egrifta SV (1.4 mg, 2019) and Egrifta WR (the F8 formulation, 1.28 mg), whose supplemental Biologics License Application was approved in March 2025 to replace Egrifta SV with weekly reconstitution and a smaller injection volume; an April 2025 Prior Approval Supplement resolved a period of supply uncertainty for Egrifta SV. Off-label research has explored non-alcoholic fatty liver disease, cognition, and non-HIV visceral adiposity.

Notes: Tesamorelin is FDA-approved and marketed as Egrifta WR (previously Egrifta and Egrifta SV) by Theratechnologies for reducing excess abdominal fat in adults with HIV-associated lipodystrophy; it is the only FDA-approved GHRH-class peptide with a current marketed indication. It is regulated as a biologic under a Biologics License Application, and biologics are not eligible for pharmacy compounding under sections 503A or 503B, so compounded tesamorelin does not have a lawful pathway; only the approved product should be used. Uses outside the approved indication are off-label. Tesamorelin is prohibited at all times in sport (WADA). It is not a controlled substance. (Status current as of mid-2026.)

International status

Pharmacokinetics

Storage and handling

Important Notes

Practical considerations for consistency and safety.

• Tesamorelin is the only FDA-approved GHRH-class peptide with a current marketed indication, and that indication is narrow: HIV-associated lipodystrophy.
• As a biologic under a BLA, it cannot be legally compounded; only the approved product is lawful.
• It reduces visceral fat selectively, without meaningfully changing subcutaneous fat or total body weight; it is not a general weight-loss drug like a GLP-1 agent.
• The visceral fat effect reverses when treatment stops.
• Formulations differ: Egrifta WR (F8, 1.28 mg) replaced Egrifta SV (1.4 mg) in 2025 and allows weekly rather than daily reconstitution; follow the labeling for the specific product.
• It is contraindicated in active malignancy and pregnancy, and is banned in sport.

Lifestyle Factors

• Administered once daily by subcutaneous injection into the abdomen under physician supervision, with site rotation; no dose ramp-up is used, and the full dose starts on day one.
• IGF-1 and glucose monitoring are part of standard management.
• The fat-reducing effect builds over months and reverses if treatment stops.

References

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