Growth hormone & IGF Protein

Somapacitan

Also known as: Sogroya

FDA-approved

Last verified: October 30, 2026

At a glance

FDA approval FDA-approved 1 application

Randomized controlled trials 22 of 95 publications on PubMed

Registered clinical trials 21 8 active

Adverse event reports 166 104 classified as serious

Somapacitan is an FDA-approved drug, marketed as Sogroya (first approval: August 28, 2020).
PubMed lists 95 publications mentioning it, including 22 randomized controlled trials and 2 animal-only studies.
ClinicalTrials.gov lists 21 registered studies testing it (8 active).
FDA's adverse event system (FAERS) holds 166 reports mentioning it; 104 classified as serious. Reports do not prove causation.

Research topics

Human Growth Hormone 64
Dwarfism, Pituitary 30
Insulin-Like Growth Factor I 26
Histidine 22
Mannitol 22
Phenol 22
Growth Hormone 19
Body Height 17
Growth Disorders 17
Hormone Replacement Therapy 10

Most frequent MeSH subject headings in the latest PubMed records (English, as indexed).

Regulatory status

Drugs@FDA applications

Application	Product	Status	First approval	Sponsor
BLA761156	SOGROYA	Approved, marketed	August 28, 2020	NOVO NORDISK INC

Source: Drugs@FDA (openFDA) · verified October 30, 2026 · API query

FDA compounding safety list

Not on FDA's list of bulk drug substances that may present significant safety risks in compounding.

Source: FDA.gov — Category 2 bulk drug substances · verified October 30, 2026

Removal of a substance from a regulatory list does not mean it has been approved. A "research use only" label does not make a product safe or legal for human use.

Scientific publications

All publications 95
Human (MeSH) 64
Animal only 2
Clinical trials 25
Randomized controlled trials 22
Systematic reviews & meta-analyses 10
Case reports 2
Retracted 0

Counts are PubMed records that mention the peptide in the title or abstract. Categories overlap, and a mention is not the same as testing the peptide as a treatment. Each number opens the exact PubMed search. Effects seen in laboratory or animal studies may not occur in humans. A registered clinical trial does not show that a substance is effective or safe.

Latest publications

Somapacitan Treatment in Children and Adolescents Born SGA: Two-Year Efficacy and Preference Over Daily GH. Unclassified 2026 The Journal of clinical endocrinology and metabolism
Weekly long-acting growth hormone versus daily growth hormone therapy on quality of life, efficacy, and safety in children with short stature: a systematic review and meta-analysis. Systematic review 2026 Frontiers in endocrinology
Injection-site pain after switching from somatrogon to somapacitan in children reporting pain or discomfort during once-weekly growth hormone therapy: a prospective single-arm switch study. Human study 2026 Frontiers in endocrinology
Treatment of growth hormone deficiency with long-acting growth hormones in children, adolescents and adults: Clinical evidence and practical considerations. Review 2026 Annales d'endocrinologie
Once-weekly somapacitan enhances linear growth in girls with Turner syndrome: a randomized controlled phase 3 study. Unclassified 2026 The Journal of clinical endocrinology and metabolism
Long-Acting Growth Hormone Versus Daily Growth Hormone for Growth Hormone Deficiency Patients: A Network Meta-Analysis of Clinical Trials. Review 2026 Endocrinology, diabetes & metabolism
Model-based somapacitan dosing and IGF-I response in children born SGA or with ISS, Noonan or Turner syndromes. Unclassified 2026 Journal of the Endocrine Society
Efficacy and Safety of Somapacitan versus Daily Growth Hormone in Children with Growth Hormone Deficiency: A Pooled Analysis of Randomised Trial Data. Unclassified 2026 Hormone research in paediatrics
Effects of switching from somatropin to somapacitan on thyroid hormone levels in adult growth hormone deficiency: A pilot study. Unclassified 2026 Growth hormone & IGF research : official journal of the Growth Hormone Research Society and the International IGF Research Society
Comparison of efficacy and safety between long-acting growth hormone and short-acting growth hormone in isolated growth hormone deficiency: a systematic review and meta-analysis of 16 randomized controlled trials involving 2,435 pediatric patients. Unclassified 2026 Frontiers in pediatrics

Source: PubMed (NCBI) · verified October 30, 2026

Clinical trials

Registered: 21
Active: 8
With posted results: 8

Conditions studied

Adult Growth Hormone Deficiency 9
Growth Hormone Disorder 9
Growth Hormone Deficiency in Children 8
Growth Hormone Deficiency 2
Healthy 2
Neoplasms 1
Diabetes Mellitus Type 2 1
Gastroparesis 1
SGA 1
Turner Syndrome 1
Noonan Syndrome 1
ISS 1

Study	Status	Phase	Start
A Study to Follow Paediatric Participants With Growth Hormone Deficiency Treated With Somapacitan for Long Term Safety Information and Clinical Parameters NCT06709040 Novo Nordisk A/S	Enrolling by invitation	—	December 13, 2024
Growth Hormone for the Treatment of Gastroparesis NCT06803589 Mayo Clinic	Recruiting	Early phase 1	October 22, 2024
Special Use-results Surveillance on Long Term Use of Sogroya® in Children With Short Stature Due to Growth Hormone Deficiency Where Epiphysial Discs Are Not Closed NCT06109935 Novo Nordisk A/S	Enrolling by invitation	—	October 4, 2023
A Study to Follow Patients With Adult Growth Hormone Deficiency (AGHD) Treated With Sogroya® for Long Term Safety Information NCT05718570 Novo Nordisk A/S	Enrolling by invitation	—	February 3, 2023
A Research Study Looking at How Safe Somapacitan is and How Well it Works in Children Who Need Help to Grow - REAL 9 NCT05723835 Novo Nordisk A/S Results posted	Active, not recruiting	Phase 3	February 1, 2023
A Research Study to Compare Somapacitan Once a Week With Norditropin® Once a Day in Children Who Need Help to Grow NCT05330325 Novo Nordisk A/S	Active, not recruiting	Phase 3	August 10, 2022
Post-Marketing Surveillance (Special Use-results Surveillance on Long-term Use) With Sogroya® NCT05230550 Novo Nordisk A/S	Active, not recruiting	—	February 3, 2022
A Research Study in Children Born Small and Who Stayed Small. Treatment is Somapacitan Once a Week Compared to Norditropin® Once a Day NCT03878446 Novo Nordisk A/S Results posted	Active, not recruiting	Phase 2	July 4, 2019
A Research Study in Chinese Children With a Low Level of Hormone to Grow. Treatment is Somapacitan Once a Week Compared to Norditropin® Once a Day. NCT04970654 Novo Nordisk A/S Results posted	Completed	Phase 3	July 22, 2021
A Research Study in Children With a Low Level of Hormone to Grow. Treatment is Somapacitan Once a Week Compared to Norditropin® Once a Day (REAL4) NCT03811535 Novo Nordisk A/S Results posted	Completed	Phase 3	May 20, 2019

Show 11 more studies

Study	Status	Phase	Start
A Study to Compare the Uptake Into the Blood of Two Strengths of Somapacitan After Injection Under the Skin in Healthy Subjects NCT03905850 Novo Nordisk A/S	Completed	Phase 1	March 29, 2019
Investigation of Pharmacokinetics, Pharmacodynamics, Safety and Tolerability of Multiple Doses of Somapacitan in Subjects With Mild and Moderate Degrees of Hepatic Impairment Compared to Subjects With Normal Hepatic Function. NCT03212131 Novo Nordisk A/S	Completed	Phase 1	August 16, 2017
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 NCT03186495 Novo Nordisk A/S	Completed	Phase 1	June 20, 2017
A 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 NCT03075644 Novo Nordisk A/S Results posted	Completed	Phase 3	March 3, 2017
A Trial Investigating the Absorption, Metabolism and Excretion of Somapacitan After Single Dosing in Healthy Male Subjects NCT02962440 Novo Nordisk A/S	Completed	Phase 1	Nov 2016
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 NCT02616562 Novo Nordisk A/S Results posted	Completed	Phase 2	March 31, 2016
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 NCT02382939 Novo Nordisk A/S Results posted	Completed	Phase 3	February 12, 2015
Trial to Compare the Efficacy and Safety of NNC0195-0092 (Somapacitan) With Placebo and Norditropin® FlexPro® (Somatropin) in Adults With Growth Hormone Deficiency. NCT02229851 Novo Nordisk A/S Results posted	Completed	Phase 3	October 31, 2014
A Trial Investigating Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of a Single Dose of Long-acting Growth Hormone (Somapacitan) Compared to Daily Dosing of Norditropin® SimpleXx® in Children With Growth Hormone Deficiency NCT01973244 Novo Nordisk A/S	Completed	Phase 1	December 16, 2013
A Trial Investigating the Safety, Tolerability, Availability and Distribution in the Body of Once-weekly Long-acting Growth Hormone (Somapacitan) Compared to Once Daily Norditropin NordiFlex® in Adults With Growth Hormone Deficiency NCT01706783 Novo Nordisk A/S	Completed	Phase 1	October 12, 2012
First Human Dose Trial of NNC0195-0092 (Somapacitan) in Healthy Subjects NCT01514500 Novo Nordisk A/S	Completed	Phase 1	January 16, 2012

All 21 studies on ClinicalTrials.gov ↗

Source: ClinicalTrials.gov · verified October 30, 2026

Adverse event reports

Reports: 166
Serious: 104
With death outcome: 11

Most reported reactions

Headache 14
Arthralgia 8
Rash 7
Pyrexia 6
Condition aggravated 5
Hypoglycaemia 5
Pain in extremity 5
Vomiting 5
Weight increased 5
Abdominal pain 4
Drug hypersensitivity 4
Drug ineffective 4

Adverse event reports do not prove that the substance caused these effects. Side effects not listed here may still occur. Reaction terms are MedDRA terms as reported to FAERS.

Source: FDA FAERS (FAERS data as of July 30, 2026) · verified October 30, 2026 · API query

FDA prescribing information

Official US prescribing information. Dosing sections are intentionally not shown.

SOGROYA HUMAN PRESCRIPTION DRUG Novo Nordisk February 25, 2026

Source: DailyMed / openFDA

Change history

No changes since monitoring began on October 30, 2026.