Tesamorelin

Tesamorelin is an FDA-approved GHRH analog sold as finished Egrifta products for reduction of excess abdominal fat in HIV-infected adults with lipodystrophy. Current labelled formulations include EGRIFTA WR (11.6 mg/vial) and EGRIFTA SV (2 mg/vial); the WR label states these products are not substitutable. Pivotal evidence is VAT reduction on CT in two Phase 3 trials, not anti-aging or general obesity use. Long-term cardiovascular safety is not established on the labels. Research-chemical listings are not the approved Egrifta products.

Tesamorelin is a synthetic growth hormone-releasing factor (GHRF/GHRH) analog. Per the Egrifta labels, it binds human GRF receptors and stimulates pituitary synthesis and pulsatile release of endogenous growth hormone, with subsequent rises in IGF-1 and IGFBP-3. The labelled clinical effect of interest is reduction of visceral adipose tissue in HIV-infected adults with lipodystrophy; the products are not indicated for weight-loss management and have a weight-neutral effect on the labels.

Label clinical studies (shared across WR/SV labels, bridging from earlier Egrifta 1 mg/vial data): Study 1 (NCT00123253) randomized 412 adults (273 active / 137 placebo); Study 2 (NCT00435136) randomized 404 (270 / 126). Primary endpoint in both: percent change in VAT by CT at L4–L5 to Week 26. Label Table 2 (ITT, LOCF): Study 1 mean VAT change −27 cm² vs +4 cm² placebo (treatment difference −31 cm²; model-based mean % change −18% vs +2%, difference −20%); Study 2 −21 cm² vs 0 (difference −21 cm²; −14% vs −2%, difference −12%). Weight was essentially unchanged (weight-neutral). Falutz et al., N Engl J Med 2007 (PMID 18057338; ClinicalTrials.gov NCT00123253) is the Study 1 publication: VAT −15.2% with tesamorelin vs +5.0% with placebo over 26 weeks in 412 patients; trial population was 86% male—a baseline demographic fact only, not a sex-class claim for the peptide. IGF-1 rose on treatment in both label studies. Labels limit use: not for weight-loss management; long-term CV safety not established. Evidence outside the labelled HIV-lipodystrophy VAT indication is not the basis for this grade.

FDA-approved finished drug products (Egrifta brand family) for reduction of excess abdominal fat in HIV-infected adults with lipodystrophy. EGRIFTA WR (DailyMed setid 839334d3-8c1d-4c26-9036-2ab524a6ea75; SPL effective ~Jul 2026, label revised Mar 2025) is the 11.6 mg/vial formulation; EGRIFTA SV (setid 3d783378-b02d-4f19-99dd-0fc91a042224) is the 2 mg/vial formulation. The WR label states EGRIFTA WR and EGRIFTA SV are not substitutable (different strengths, reconstitution, and storage). Limitations of use on both labels include: long-term cardiovascular safety not established; not indicated for weight-loss management (weight-neutral effect). Prescription products; grey-market or research-chemical tesamorelin is not approved Egrifta.

Prescription Egrifta (or Egrifta WR) from a specialty pharmacy, for the labeled HIV-lipodystrophy indication, under a clinician who monitors IGF-1 and glucose.

Same four pathways as the Sourcing guide.

Specialty-tier, prior auth, and often a hub program. Coverage is indication-locked: HIV-associated excess abdominal fat, not general fat loss or 'anti-aging.' Cash price is high without a benefit.

Research-chemical GHRH analogs (CJC-1295, mod GRF) are sold as stand-ins. They are not tesamorelin, do not share its label, and are not covered.

Strand does not list vendors. See the grey market.

Common labelled adverse reactions include arthralgia, injection-site reactions, pain in extremity, peripheral edema, and myalgia. Labels warn about increased risk of neoplasms, elevated IGF-1, fluid retention, glucose intolerance or diabetes mellitus, hypersensitivity, injection-site reactions, and increased mortality in acute critical illness. Section 4 contraindications (WR and SV): disruption of the hypothalamic-pituitary axis (hypophysectomy, hypopituitarism, pituitary tumor/surgery, head irradiation or trauma); active malignancy; known hypersensitivity to tesamorelin or product excipients; pregnancy. Pediatric use: safety and effectiveness have not been established and the products are not indicated in pediatric patients (label §8.4)—not listed as a §4 contraindication enum on Strand. Hypothalamic-pituitary disruption and hypersensitivity are stated in safety/regulatory prose because they lack Strand contraindication enums.

• Edema, arthralgia, glucose worsening, injection-site reactions.
• Avoid in active malignancy. IGF-1 monitoring is part of labeled use.
• Off-label anti-aging use is not what the trials measured.

• Falutz et al. NEJM 2007 · 2007 · N Engl J Med

  Metabolic effects of a growth hormone-releasing factor in patients with HIV. Study 1 / NCT00123253 publication; VAT primary. PMID 18057338.

• EGRIFTA WR DailyMed SPL

  Tesamorelin for injection 11.6 mg/vial. Indication, limitations, §4 contraindications, WR vs SV not substitutable, Study 1/2 VAT data.

• EGRIFTA SV DailyMed SPL

  Tesamorelin for injection 2 mg/vial. Same labelled HIV-lipodystrophy VAT indication and aligned §4 / clinical-studies bridge.