FDA Approved Growth Hormone Axis

Somapacitan

also known as: Sogroya, NN8640, somapacitan-beco

Novo Nordisk's once-weekly growth hormone (Sogroya) — FDA-approved in 2020 for adult GH deficiency and in 2023 for pediatric GH deficiency in children aged 2.5+ years.

A once-weekly recombinant human growth hormone derivative engineered with a fatty-acid-based albumin-binding side chain that extends plasma half-life to approximately 2–3 days, allowing weekly subcutaneous administration. FDA-approved as Sogroya for adult growth hormone deficiency in August 2020 and extended in April 2023 to pediatric GH deficiency in children aged 2.5 years and older — the second weekly GH formulation to reach both adult and pediatric indications in the US.

Mechanism of action

Binds the GH receptor with affinity comparable to native somatropin, triggering JAK2/STAT5 signaling and downstream IGF-1 production. The L101C albumin-binding side chain reversibly binds circulating albumin (>99% bound), which shields the molecule from rapid renal and receptor-mediated clearance and produces the extended weekly PK profile. Unbound fraction engages the GH receptor and dissociates from albumin to replenish the active pool as it is cleared.

Primary uses

  • Adult growth hormone deficiency
  • Pediatric growth hormone deficiency (age 2.5+)

Typical dosing

0.04–0.16 mg/kg/week once weekly (subcutaneous)

Adult GHD: 1.5 mg weekly starting, titrated to IGF-1 target (typically 2–8 mg/week). Pediatric GHD: 0.16 mg/kg/week weight-based dosing.

Regulatory status

FDA-approved August 2020 as Sogroya (Novo Nordisk) for replacement of endogenous growth hormone in adults with GHD. Extended April 2023 to pediatric patients aged 2.5 years and older with GH deficiency. Also approved by EMA, Health Canada, Japanese PMDA, and other regulators.

References

  1. [fda-pi] Sogroya (somapacitan-beco) Prescribing Information. Novo Nordisk.
  2. [pubmed] Johannsson G, et al. "Safety and convenience of once-weekly somapacitan in adult GH deficiency: a 26-week randomized, controlled trial." Eur J Endocrinol, 2018;178:491-499.
  3. [clinical-trial] Miller BS, et al. "Efficacy and Safety of Once-Weekly Somapacitan in Children with Growth Hormone Deficiency: REAL 4 Phase 3 Trial." J Clin Endocrinol Metab, 2022;107:3378-3391.

Related peptides

Somatropin (HGH)

FDA-approved recombinant human growth hormone — the direct hormone replacement, with multiple clinical indications, prescription-only status, and specific federal criminal provisions against off-label distribution.

Lonapegsomatropin

Ascendis Pharma's once-weekly growth hormone prodrug (Skytrofa) — the first weekly GH to receive FDA approval (August 2021) for pediatric GH deficiency in patients aged 1+ years weighing at least 11.5 kg.

Somatrogon

Pfizer/OPKO's once-weekly growth hormone (Ngenla) — FDA-approved in June 2023 for pediatric GH deficiency in children aged 3+ years; uses a CTP-fusion strategy borrowed from long-acting follitropin alfa.

Sermorelin

The N-terminal 29 amino acids of native GHRH — a former FDA-approved diagnostic and pediatric GH-deficiency therapy, now widely compounded for adult anti-aging protocols.
Disclaimer

This entry is for educational purposes only and does not constitute medical advice. Dosing information reflects published regulatory or research data and is not a recommendation. Many compounds described here are not approved for human use in the United States. Consult a licensed medical professional before considering any peptide therapy.