For research and educational purposes only. Not medical advice.
Somapacitan Reference
Educational, not medical advice reference for Somapacitan: GH Release, Hormonal; regulatory status, evidence posture, source review, and schedul…
Reference summary
Somapacitan is a label-verified long-acting somatropin analog dosed once weekly across adult and pediatric growth-disorder indications. pepSmart surfaces label-reference content only.
Regulatory and posture
- Categories
- GH Release, Hormonal
- Aliases
- Sogroya, Long-acting somatropin analog
- Evidence posture
- human - Recombinant human growth hormone analog. WADA-prohibited at all times under category S2. Prescription-only; possession or distribution outside an FDA-approved indication is restricted by the Anabolic Steroid Control Act.
- Regulatory status
- FDA-approved prescription medication (Sogroya). Indicated for adults with growth hormone deficiency (2020) and for pediatric patients 2.5 years and older with GHD (2023); on February 27, 2026 the FDA added three pediatric indications: short stature born small for gestational age without catch-up growth, growth failure associated with Noonan syndrome, and idiopathic short stature. 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 somapacitan (Sogroya) prescribing information
- Novo Nordisk: FDA approves Sogroya (somapacitan) for three additional pediatric indications (February 27, 2026)
- WADA prohibited list and resources
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