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Home/Compounds/Somapacitan
Growth hormoneFDA approvedRx required

Somapacitan

Also known as: Sogroya
Brands: Sogroya

Once-weekly long-acting recombinant human growth hormone derivative (albumin-binding).

A
Grade A
Multiple human RCTs
Human studies27
PubMed citations28
Routesubcutaneous
Regulatory (US)FDA approved · Rx
Last verified2 days ago

Mechanism of action

rhGH modified with an albumin-binding moiety that extends half-life; enables once-weekly dosing instead of daily.

Evidence summary

27
Human studies
28
PubMed citations
21
Clinical trials
A
Evidence grade

Evidence summary in progress. See the citations section below for the underlying research papers.

Dosing protocols

Educational information only. Consult a licensed provider before using any peptide.
Administration routes
subcutaneous

Side effects & safety

From the FDA label
Source
abdominal painarthralgiaback paindiarrheadizzinessdyspepsiaheadacheinjection site paininjection site reactionnauseapancreatitisurticariavomiting

Terms pulled directly from the referenced source. We don't fabricate frequencies — when a label doesn't publish a percentage, we don't either.

Interactions

No documented drug interactions on file.

Regulatory status

United States
FDA approved

FDA approved for adult and pediatric growth hormone deficiency (Sogroya)

Compounding
Not permitted

Not available via 503A/503B compounding pharmacies.

Regulatory data last verified 4/19/2026

Clinical trials

NCT06803589Low-dose Growth Hormone for the Treatment of GastroparesisRecruiting · Phase 1 · Gastroparesis · n=10NCT05230550Post-Marketing Surveillance (Special Use-results Surveillance on Long-term Use) With Sogroya® A Multi-centre, Prospective, Open Label, Single-arm, Observational, Non-interventional Post-marketing Study to Investigate the Long-term Safety and Clinical Parameters of Sogroya® Therapy in Patients With Adult Growth Hormone Deficiency (AGHD) (Only Severe Case) Under Normal Clinical Practice Conditions in JapanActive Not Recruiting · Adult Growth Hormone Deficiency · n=200NCT05718570A Multi-national, Multi-centre, Prospective, Single-arm, Observational, Non-interventional Post-authorisation Safety Study to Investigate Long-term Safety of Sogroya® (Somapacitan) in Adults With Growth Hormone Deficiency (AGHD) Under Routine Clinical PracticeEnrolling By Invitation · Adult Growth Hormone Deficiency · n=400NCT06709040A Non-interventional, Observational, Registry-based Study to Investigate Long-term Safety and Clinical Parameters of Somapacitan Treatment in Paediatric Patients With Growth Hormone Deficiency During Routine Clinical PracticeEnrolling By Invitation · Growth Hormone Deficiency · n=500NCT05330325A 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 StatureActive Not Recruiting · Phase 3 · SGA, Turner Syndrome, Noonan Syndrome, ISS · n=412NCT02616562A 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 DeficiencyCompleted · Phase 2 · Growth Hormone Disorder · n=76NCT04970654A Trial Comparing the Efficacy and Safety of Once Weekly Dosing of Somapacitan With Daily Norditropin® in Chinese Children With Growth Hormone DeficiencyCompleted · Phase 3 · Growth Hormone Deficiency in Children · n=110NCT03811535A Trial Comparing the Effect and Safety of Once Weekly Dosing of Somapacitan With Daily Norditropin® in Children With Growth Hormone DeficiencyCompleted · Phase 3 · Growth Hormone Deficiency in Children · n=200NCT03878446A 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 OlderActive Not Recruiting · Phase 2 · Short Stature Children Born Small for Gestational Age (SGA) · n=62NCT05723835A 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 StatureActive Not Recruiting · Phase 3 · SGA · n=47NCT06109935A Multi-centre, Prospective, Open Label, Single-arm, Non-interventional Post-marketing Study to Investigate the Long-term Safety and Clinical Parameters of Sogroya® Treatment in Children With Short Stature Due to Growth Hormone Deficiency Where Epiphysial Discs Are Not Closed Under Normal Clinical Practice Conditions in Japan Special Use-results Surveillance on Long Term Use of Sogroya® in Children With Short Stature Due to Growth Hormone Deficiency (GHD) Where Epiphysial Discs Are Not ClosedEnrolling By Invitation · Growth Hormone Deficiency in Children · n=200NCT01973244A Randomised, Open-labelled, Active-controlled, Multinational, Dose-escalation Trial Investigating Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of a Single Dose of Long-acting Growth Hormone (NNC0195-0092, Somapacitan) Compared to Daily Dosing of Norditropin® SimpleXx® in Children With Growth Hormone DeficiencyCompleted · Phase 1 · Growth Hormone Disorder · n=32

Showing 12 of 21 indexed studies. View all on ClinicalTrials.gov →

Citations

PMID 40107502Jensterle M, Herman R et al. · Efficacy of Somapacitan in Treatment-Fatigue Adult Patients With Growth Hormone Deficiency Previously Treated With Once-Daily Growth Hormone Injections: A 24-Week Randomized Active-Controlled Trial.Endocrine practice : official journal of the American College of Endocrinology and the American Association of Clinical Endocrinologists (2025)HumanPMID 40702497Woelfle J, Kreitschmann-Andermahr I et al. · First 100 patients receiving long-acting growth hormone therapy: real-world evaluation from INSIGHTS-GHT registry.Orphanet journal of rare diseases (2025)HumanPMID 40104568Backeljauw PF, Boettcher C et al. · Growth Response to Weekly Somapacitan Therapy in Children With GH Deficiency Is Related to GH Thresholds in GH Stimulation Testing.Journal of the Endocrine Society (2025)HumanPMID 39991735Otsuka F, Rasmussen MH et al. · Efficacy in Japanese adults with growth hormone deficiency receiving weekly somapacitan or daily growth hormone: results from phase 3 REAL 1 trial.Frontiers in endocrinology (2025)HumanPMID 40159984Iughetti L, Insalaco A et al. · Long-acting growth hormone in the treatment of children with growth hormone deficiency.Expert review of endocrinology & metabolism (2025)HumanPMID 41173798Al-Rayess H, Miller BS · A pharmacological profile of somapacitan for the treatment of growth hormone deficiency.Expert review of clinical pharmacology (2025)HumanPMID 40324364Fu J, Cheng X et al. · Somapacitan Is Effective and Well Tolerated in Chinese Children with Growth Hormone Deficiency: A Randomized Controlled Phase 3 Study.Hormone research in paediatrics (2025)PMID 38397339Tsurayya G, Nazhifah CA et al. · Once-Weekly Somapacitan as an Alternative Management of Growth Hormone Deficiency in Prepubertal Children: A Systematic Review and Meta-Analysis of Randomized Controlled Trial.Children (Basel, Switzerland) (2024)HumanPMID 38112103Velazquez EP, Miller BS et al. · Somatrogon injection for the treatment of pediatric growth hormone deficiency with comparison to other LAGH products.Expert review of endocrinology & metabolism (2024)HumanPMID 38333899Miller BS, Blair J et al. · Developments in the Management of Growth Hormone Deficiency: Clinical Utility of Somapacitan.Drug design, development and therapy (2024)HumanPMID 38580693Zhu J, Yuan K et al. · Long-acting growth hormone in the treatment of growth hormone deficiency in children: a systematic literature review and network meta-analysis.Scientific reports (2024)HumanPMID 39493440Akhtar S, Berg B et al. · Patients with Growth-Related Disorders and Caregivers Prefer the Somapacitan Device to the Somatrogon Device: Results from a Randomized Crossover Study Assessing Device Preference and Ease of Use Following Simulated Injections.Medical devices (Auckland, N.Z.) (2024)HumanPMID 38992799Yuen KCJ · Utilizing Somapacitan, a Long-acting Growth Hormone Formulation, for the Treatment of Adult Growth Hormone Deficiency: A Guide for Clinicians.Endocrine practice : official journal of the American College of Endocrinology and the American Association of Clinical Endocrinologists (2024)HumanPMID 38368603Mori J, Ohata Y et al. · Effective growth hormone replacement with once-weekly somapacitan in Japanese children with growth hormone deficiency: Results from REAL4, a phase 3 clinical trial.Clinical endocrinology (2024)HumanPMID 38066644Garner T, Clayton P et al. · Gene Expression Signatures Predict First-Year Response to Somapacitan Treatment in Children With Growth Hormone Deficiency.The Journal of clinical endocrinology and metabolism (2024)HumanPMID 37406251Miller BS, Blair JC et al. · Effective GH Replacement With Somapacitan in Children With GHD: REAL4 2-year Results and After Switch From Daily GH.The Journal of clinical endocrinology and metabolism (2023)HumanPMID 36619571Bidlingmaier M, Biller BMK et al. · Guidance for the treatment of adult growth hormone deficiency with somapacitan, a long-acting growth hormone preparation.Frontiers in endocrinology (2023)HumanPMID 36995872Sävendahl L, Battelino T et al. · Weekly Somapacitan in GH Deficiency: 4-Year Efficacy, Safety, and Treatment/Disease Burden Results From REAL 3.The Journal of clinical endocrinology and metabolism (2023)HumanPMID 36305544Paton DM · Somapacitan: a long-acting growth hormone derivative for treatment of growth hormone deficiency.Drugs of today (Barcelona, Spain : 1998) (2022)HumanPMID 34964458Sävendahl L, Battelino T et al. · Effective GH Replacement With Once-weekly Somapacitan vs Daily GH in Children with GHD: 3-year Results From REAL 3.The Journal of clinical endocrinology and metabolism (2022)Human

Showing 20 of 28 papers. View all on PubMed →