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Drug

Somapacitan

Approved · EMA
ClassGrowth hormone receptor agonistEmerging researchLate-stage development

Also known as Sogroya.

RxNorm2557373ChEMBLCHEMBL3707290ATCH01AC07UNII8FOJ430U94
2
Research papers
3
Active clinical trials
Growth hormone receptor
Primary target
1
Regulatory events
Latest activity
beta

Recent clinical, regulatory, research and industry developments relating to this drug.

A Study Evaluating the Safety and Efficacy of Once-weekly Dosing of Somapacitan in a Basket Study Design in Paediatric Participants With Short Stature Either Born Small for Gestational Age or With Turner Syndrome, Noonan Syndrome or Idiopathic Short Stature

Clinical trial2026-07-09Results posted · ClinicalTrials.gov

A Dose-finding Trial Evaluating the Effect and Safety of Once-weekly Treatment of Somapacitan Compared to Daily Norditropin® in Children With Short Stature Born Small for Gestational Age With no Catch-up Growth by 2 Years of Age or Older

Clinical trial2026-06-10Results posted · ClinicalTrials.gov

A Trial Comparing the Effect and Safety of Once Weekly Dosing of Somapacitan With Daily Norditropin® in Children With Growth Hormone Deficiency

Clinical trial2026-05-22Results posted · ClinicalTrials.gov

A Randomised, Multinational, Active-controlled, (Open-labelled), Dose Finding, (Double-blinded), Parallel Group Trial Investigating Efficacy and Safety of Once-weekly NNC0195-0092 Treatment Compared to Daily Growth Hormone Treatment (Norditropin® FlexPro®) in Growth Hormone Treatment naïve Pre-pubertal Children With Growth Hormone Deficiency

Clinical trial2026-01-16Results posted · ClinicalTrials.gov

A Trial Comparing the Efficacy and Safety of Once Weekly Dosing of Somapacitan With Daily Norditropin® in Chinese Children With Growth Hormone Deficiency

Clinical trial2026-01-06Results posted · ClinicalTrials.gov

A Study Comparing the Effect and Safety of Once Weekly Dosing of Somapacitan With Daily Norditropin® as Well as Evaluating Long-term Safety of Somapacitan in a Basket Study Design in Children With Short Stature Either Born Small for Gestational Age or With Turner Syndrome, Noonan Syndrome, or Idiopathic Short Stature

Clinical trial2024-08-05Primary completion · ClinicalTrials.gov

Investigation of the metabolic and endocrinological differences between daily and weekly growth hormone replacement therapy, somapacitan, in patients with adult growth hormone deficiency: A real-world pilot study.

Research2023-09-01Medicine

Approval: Sogroya (EMA)

Regulatory2021-03-31EMA

A Multicentre, Multinational, Randomised, Parallel-group, Placebo-controlled (Double Blind) and Active-controlled (Open) Trial to Compare the Efficacy and Safety of Once Weekly Dosing of NNC0195-0092 (Somapacitan) With Once Weekly Dosing of Placebo and Daily Norditropin® FlexPro® in Adults With Growth Hormone Deficiency for 35 Weeks, Followed by a 53-week Open-label Extension Period

Clinical trial2020-11-23Results posted · ClinicalTrials.gov

A Multicentre, Randomised, Open-labelled, Parallel-group, Activecontrolled Trial to Evaluate the Safety of Once Weekly Dosing of Somapacitan (NNC0195-0092) and Daily Norditropin® FlexPro® for 52 Weeks in Previously Human Growth Hormone Treated Japanese Adults With Growth Hormone Deficiency

Clinical trial2020-11-23Results posted · ClinicalTrials.gov

Similar safety and efficacy in previously treated adults with growth hormone deficiency randomized to once-weekly somapacitan or daily growth hormone.

Research2020-08-14Clinical endocrinology

A Multicentre, Multinational, Randomised, Open-labelled, Parallel-group, Active-controlled 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

Clinical trial2020-07-09Results posted · ClinicalTrials.gov

Profile

Identifiers & mechanism

Canonical identifiers, marketed brand names and mechanism, resolved across RxNorm, ChEMBL and ATC.

Canonical name
Somapacitan
Aliases & brands
Sogroya
RxNorm CUI
2557373
ChEMBL ID
CHEMBL3707290
ATC codes
H01AC07
UNII
8FOJ430U94
Primary mechanism
Growth hormone receptor agonist
Regulatory jurisdictions
ema

Pharmacology & targets

1 target

Known molecular targets and mechanisms supported by curated pharmacology databases.

Growth hormone receptor
GHR · P10912
AGONISTGrowth hormone receptor agonist

Regulatory timeline

1 event

The complete regulatory record, grouped by authority — approvals, safety advisories and label changes. Each authority shows its most recent events; expand one to read its full history.

Earliest approval
2021-03-31
Latest approval
2021-03-31
Authorities
EMA
Total events
1
emaEuropean Medicines Agency· 1 event
2021-03-31Approval
Approval: Sogroya (EMA)
Indication: Sogroya is indicated for the replacement of endogenous growth hormone (GH) in children  aged 3  years and above, and adolescents with growth failure due to growth… Show full indication

Sogroya is indicated for the replacement of endogenous growth hormone (GH) in children  aged 3  years and above, and adolescents with growth failure due to growth hormone deficiency (paediatric GHD), and in adults with growth hormone deficiency (adult GHD).

Evidence ↗

Contains information from the European Medicines Agency (European Medicines Agency), © EMA, reused under CC BY 4.0.

Clinical trials

16 trials

The current development programme across all trial phases — status mix, phase distribution and the late-stage studies shaping the evidence base.

Development programme
CLINICALTRIALS.GOV · LIVE REGISTRY
16
registered trials across all phases
LATEST COMPLETION 2025
3
Active studies
7
Late-stage (III+)
13
Completed
PHASE DISTRIBUTIONn = 16
Phase 17Phase 22Phase 37

Late-stage studies

Phase III+ trials still open or recently active — where late-stage evidence is being generated.

A Study Comparing the Effect and Safety of Once Weekly Dosing of Somapacitan With Daily Norditropin® as Well as Evaluating Long-term Safety of Somapacitan in a Basket Study Design in Children With Short Stature Either Born Small for Gestational Age or With Turner Syndrome, Noonan Syndrome, or Idiopathic Short Stature

Active, not recruitingPH IIINovo Nordisk A/Sn=4122027

A Study Evaluating the Safety and Efficacy of Once-weekly Dosing of Somapacitan in a Basket Study Design in Paediatric Participants With Short Stature Either Born Small for Gestational Age or With Turner Syndrome, Noonan Syndrome or Idiopathic Short Stature

Active, not recruitingPH IIINovo Nordisk A/Sn=472027

A Trial Comparing the Effect and Safety of Once Weekly Dosing of Somapacitan With Daily Norditropin® in Children With Growth Hormone Deficiency

CompletedPH IIINovo Nordisk A/Sn=2002025

A Trial Comparing the Efficacy and Safety of Once Weekly Dosing of Somapacitan With Daily Norditropin® in Chinese Children With Growth Hormone Deficiency

CompletedPH IIINovo Nordisk A/Sn=1102023

A Multicentre, Randomised, Open-labelled, Parallel-group, Activecontrolled Trial to Evaluate the Safety of Once Weekly Dosing of Somapacitan (NNC0195-0092) and Daily Norditropin® FlexPro® for 52 Weeks in Previously Human Growth Hormone Treated Japanese Adults With Growth Hormone Deficiency

CompletedPH IIINovo Nordisk A/Sn=622018

Recent completions

Trials that read out recently, adding to the completed evidence base.

A Trial Comparing the Effect and Safety of Once Weekly Dosing of Somapacitan With Daily Norditropin® in Children With Growth Hormone Deficiency

CompletedPH IIINovo Nordisk A/Sn=2002025

A Randomised, Multinational, Active-controlled, (Open-labelled), Dose Finding, (Double-blinded), Parallel Group Trial Investigating Efficacy and Safety of Once-weekly NNC0195-0092 Treatment Compared to Daily Growth Hormone Treatment (Norditropin® FlexPro®) in Growth Hormone Treatment naïve Pre-pubertal Children With Growth Hormone Deficiency

CompletedPH IINovo Nordisk A/Sn=762024

A Trial Comparing the Efficacy and Safety of Once Weekly Dosing of Somapacitan With Daily Norditropin® in Chinese Children With Growth Hormone Deficiency

CompletedPH IIINovo Nordisk A/Sn=1102023

A Randomised, Double-blind, Single Dose, Three Period, Complete Cross Over Trial in Healthy Subjects Investigating the Pharmacokinetics of Subcutaneous Injections of Somapacitan 5 mg/1.5 mL and 10 mg/1.5 mL

CompletedPH INovo Nordisk A/Sn=332019

A Multicentre, Randomised, Open-labelled, Parallel-group, Activecontrolled Trial to Evaluate the Safety of Once Weekly Dosing of Somapacitan (NNC0195-0092) and Daily Norditropin® FlexPro® for 52 Weeks in Previously Human Growth Hormone Treated Japanese Adults With Growth Hormone Deficiency

CompletedPH IIINovo Nordisk A/Sn=622018

Investigation of Pharmacokinetics, Pharmacodynamics, Safety and Tolerability of Multiple Doses of Somapacitan in Subjects With Various Degrees of Impaired Renal Function Compared to Subjects With Normal Renal Function

CompletedPH INovo Nordisk A/Sn=442018

Research activity

2 papers

Key research shaping understanding of this drug, combining the latest publications with the most influential evidence.

Publications over time
20202023
Major research themes3
Human Growth Hormone2Dwarfism, Pituitary1Endocrinology1
Journals, researchers & institutions
Top journals
  • Clinical endocrinology1
  • Medicine1
Leading researchers
  • Abe I1
  • Abe M1
  • Fujita Y1
  • Højby Rasmussen M1
  • Kobayashi K1
  • Koga M1
  • Kudo T1
  • Mukoubara S1
Leading institutions
free-text, unnormalised
  • Clinical Research Support Center1
  • Fukuoka University1
  • Fukuoka University Chikushi Hospital1
  • Kitasato University1
  • Kobe University Graduate School of Medicine1
  • Nagasaki Prefecture Iki Hospital1

Related drugs

3 matches

Drugs sharing diseases, protein targets and literature with this one. Ranked by graph evidence (shared targets + diseases weighted above co-mentions).

Histidine

Frequently co-studied with Somapacitan in the research literature.

1 shared paper
Mannitol

Frequently co-studied with Somapacitan in the research literature.

1 shared paper
Phenol

Frequently co-studied with Somapacitan in the research literature.

1 shared paper
References & data sources
  • RxNorm (U.S. National Library of Medicine) — drug identity
  • ChEMBL (EMBL-EBI) & UniProt — pharmacology and targets
  • Europe PMC — research literature
  • ClinicalTrials.gov — clinical trials
  • Regulatory event sources are credited in the Regulatory Timeline above.