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IndexedBuilt automatically from public databases on 2026-09-30. Not yet hand-reviewed by PLOBT.How this works →

Somapacitan

FDA approved · Rx

Long-acting growth hormone analog

Also known as: Sogroya, NNC0195-0092, NN8640, somapacitanum, NN-8640, NNC-0195-0092

Evidence score
89/ 100
Strong evidence

Strong, human-grade evidence

  • Regulatory standing. FDA-approved prescription medicine
  • Human trials. Backed by controlled human studies
  • Registered human trials. 21 registered studies on ClinicalTrials.gov, most advanced Phase 3
  • 2 cited sources. Includes primary / regulatory sources

Computed with the same four public criteria as every profile. The human-evidence grade on an indexed profile is set automatically and may change when it is hand-reviewed. It is not a safety score, not a purity rating, and not medical advice, and not a claim that this compound treats, cures, or prevents any condition.

What it is

Somapacitan, sold as Sogroya, is a modified form of human growth hormone designed to last longer in the body. It has a single amino acid change and an attached albumin-binding side chain, which slows its clearance and allows less frequent administration. It acts on growth hormone receptors in the same way as natural growth hormone.

What the evidence shows

Automatic summaryHuman trials

Somapacitan is FDA approved for growth hormone deficiency, including in adults and in children, supported by Phase 3 trials among 21 registered human studies and over 100 published papers. Uses outside its approved indications are not established.

Key facts

Molecular formula
C54H95N13O20S2
Molecular weight
1310.5 g/mol
FDA approval
Confirmed on openFDA

Registered human trials

Live from ClinicalTrials.gov, refreshed daily.

21registered studies
Phase 3most advanced phase
13completed (sample)
1recruiting (sample)

A Trial to Compare the Safety of Once Weekly Dosing of Somapacitan With Daily Norditropin® FlexPro® for 26 Weeks in Previously Human Growth Hormone Treated Adults With Growth Hormone Deficiency

Phase 3CompletedNCT02382939

Trial to Compare the Efficacy and Safety of NNC0195-0092 (Somapacitan) With Placebo and Norditropin® FlexPro® (Somatropin) in Adults With Growth Hormone Deficiency.

Phase 3CompletedNCT02229851

A Trial Investigating the Absorption, Metabolism and Excretion of Somapacitan After Single Dosing in Healthy Male Subjects

Phase 1CompletedNCT02962440

A Research Study to Compare Somapacitan Once a Week With Norditropin® Once a Day in Children Who Need Help to Grow

Phase 3Active Not RecruitingNCT05330325

Published literature

Live from Europe PMC. This is how much has been published, not how much is proven in humans.

112papers referencing Somapacitan

Weekly Somapacitan is Effective and Well Tolerated in Children With GH Deficiency: The Randomized Phase 3 REAL4 Trial.

J Clin Endocrinol Metab2022

Once-weekly Somapacitan is Effective and Well Tolerated in Adults with GH Deficiency: A Randomized Phase 3 Trial.

J Clin Endocrinol Metab2020

Safety and convenience of once-weekly somapacitan in adult GH deficiency: a 26-week randomized, controlled trial.

Eur J Endocrinol2018

Once-Weekly Somapacitan vs Daily GH in Children With GH Deficiency: Results From a Randomized Phase 2 Trial.

J Clin Endocrinol Metab2020

Sources

Risks, side effects and study doses are only published on hand-reviewed profiles. Want this one reviewed, or spotted something wrong? Tell us.