For research and educational purposes only. Not medical advice.
Lonapegsomatropin Reference
Educational, not medical advice reference for Lonapegsomatropin: GH Release, Hormonal; regulatory status, evidence posture, source review, and s…
Reference summary
Lonapegsomatropin is a label-verified long-acting somatropin product for pediatric and adult growth hormone deficiency. pepSmart surfaces label-reference content only.
Regulatory and posture
- Categories
- GH Release, Hormonal
- Aliases
- Skytrofa, Lonapegsomatropin-tcgd, Long-acting pediatric somatropin
- Evidence posture
- human - Prescription human growth hormone product (pediatric and adult growth hormone deficiency). WADA-prohibited at all times under category S2. Possession or distribution outside an FDA-approved indication is restricted by the Anabolic Steroid Control Act.
- Regulatory status
- FDA-approved prescription medication (Skytrofa). Approved for pediatric growth hormone deficiency in 2021 and, since July 28, 2025, for adults with growth hormone deficiency on the basis of the foresiGHt Phase 3 trial. WADA-prohibited under category S2 at all times. Distribution and possession outside an approved indication is restricted under the United States Anabolic Steroid Control Act.
- Content review status
- label verified
Selected public sources
- DailyMed lonapegsomatropin (Skytrofa) prescribing information
- Ascendis Pharma (GlobeNewswire): FDA approves Skytrofa (lonapegsomatropin-tcgd) for adults with growth hormone deficiency (July 28, 2025; foresiGHt Phase 3)
- WADA prohibited list and resources
Related tools
- Injection-site rotation overview - Public overview of the Pro site-rotation planner.
- Protocol builder overview - Public overview of the Pro protocol builder.