Last reviewed 2026-04-20 · How we verify

TESAMORELIN

Tesamorelin is a marketed drug specifically indicated for the reduction of excess abdominal fat in patients with HIV lipodystrophy. Its key strength lies in being the only FDA-approved treatment for this indication, providing a unique competitive advantage. The primary risk is the key composition patent expiry in 2028, which could lead to increased competition from generics.

At a glance

Approved indications

• Reduction of excess abdominal fat in HIV lipodystrophy

Common side effects

• Injection site reaction
• Arthralgia
• Pain in extremity
• Myalgia
• Peripheral edema
• Paresthesia
• Hypoesthesia
• Rash
• Dyspepsia
• Musculoskeletal pain
• Pain
• Pruritus

Serious adverse events

• Increased risk of neoplasms
• Glucose intolerance or diabetes mellitus
• Fluid retention
• Elevated IGF-1 levels
• Hypersensitivity reactions

Key clinical trials

• Tesamorelin for Reduction of Liver Fat in Adults With Fatty Liver Disease (Mock Study) (PHASE2)
• Phase II Trial of Tesamorelin for Cognition in Aging HIV-Infected Persons (PHASE2)
• Growth Hormone Releasing Hormone Analog to Improve Nonalcoholic Fatty Liver Disease and Associated Cardiovascular Risk (PHASE2)
• Tesamorelin to Improve Functional Outcomes After Peripheral Nerve Injury (PHASE2)
• Tesamorelin as an Adjunct to Exercise for Improving Physical Function in HIV (PHASE2)
• Body Composition and Adipose Tissue in HIV (PHASE4)
• TH9507 Extension Study in Patients With HIV-Associated Lipodystrophy (PHASE3)
• Growth Hormone Dynamics and Cardiac Steatosis in HIV

Primary sources

Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.

Competitive intelligence

For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:

• TESAMORELIN CI brief — competitive landscape report
• TESAMORELIN updates RSS · CI watch RSS