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Home/Compounds/Somatrogon
Growth hormoneFDA approvedRx required

Somatrogon

Also known as: Ngenla
Brands: Ngenla

Once-weekly long-acting recombinant human growth hormone (C-terminal peptide fusion).

A
Grade A
Multiple human RCTs
Human studies25
PubMed citations29
Routesubcutaneous
Regulatory (US)FDA approved · Rx
Last verified2 days ago

Mechanism of action

rhGH fused with three copies of the C-terminal peptide of hCG β-subunit. CTP domains extend half-life and support weekly dosing.

Evidence summary

25
Human studies
29
PubMed citations
9
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 painarthralgiaheadacheinjection site erythemainjection site paininjection site prurituspancreatitispruritusrashvomiting

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 pediatric growth hormone deficiency (Ngenla)

Compounding
Not permitted

Not available via 503A/503B compounding pharmacies.

Regulatory data last verified 4/19/2026

Clinical trials

NCT07226089Multicenter Interventional Study: Somatrogon Impact on Outcomes in Naive Small for Gestational Age or Idiopathic Short Stature Pediatric Patients Compared With Daily Growth HormoneRecruiting · Phase 3 · ISS · n=254NCT07173036Evaluation of (Cardio)Metabolic and Auxological Outcomes of GHD Patients Under Recombinant Human or Long-acting Growth Hormone With Stratification According to IGF-1 LevelsNot Yet Recruiting · N/A · Growth Hormone Deficiency · n=300NCT05509894Post Marketing Surveillance (PMS) Study for Ngenla Prefilled Pen in Pediatric Patients Who Have Endogenous Growth Failure Due to an Inadequate Secretion of Endogenous Growth Hormone in KoreaActive Not Recruiting · Pediatric Growth Hormone Deficiency · n=565NCT06587035A Multicenter, Non-interventional Prospective Active Surveillance Study Among Participants Receiving Somatrogon Under Routine Clinical Care in IndiaRecruiting · Dwarfism, Pituitary · n=50NCT05602766Ngenla® Subcutaneous Injection Special InvestigationActive Not Recruiting · Growth Hormone Deficiency Without Epiphyseal Closure · n=1NCT02968004A Phase 3, Open-label, Randomized, Multicenter, 12 Months, Efficacy and Safety Study of Weekly MOD-4023 Compared to Daily Genotropin - Therapy in Pre-pubertal Children With Growth Hormone DeficiencyCompleted · Phase 3 · Pediatric Growth Hormone Deficiency · n=224NCT03831880A PHASE 3, RANDOMIZED, MULTICENTER, OPEN-LABEL, CROSSOVER STUDY ASSESSING SUBJECT PERCEPTION OF TREATMENT BURDEN WITH USE OF WEEKLY GROWTH HORMONE (SOMATROGON) VERSUS DAILY GROWTH HORMONE (GENOTROPIN (REGISTERED)) INJECTIONS IN CHILDREN WITH GROWTH HORMONE DEFICIENCYCompleted · Phase 3 · Growth Hormone Deficiency · n=87NCT03874013A Phase 3, Open-Label, Randomized, Multicenter, 12-month, Efficacy and Safety Study of Weekly MOD-4023 Compared to Daily Genotropin® Therapy in Japanese Pre-pubertal Children With Growth Hormone DeficiencyCompleted · Phase 3 · Growth Hormone Deficiency · n=44NCT03810664A Phase 1, Single-Center, Randomized, Cross-Over, Clinical Study Investigating the Comparability of Somatrogon in Two Different Drug Product PresentationsCompleted · Phase 1 · Healthy Male Volunteers · n=49

Citations

PMID 41241277Cohen-Sela E, Oren A et al. · Introduction of Somatrogon in Pediatric Growth Hormone Deficiency: Real-World Insights From a National Survey of Pediatric Endocrinologists.Endocrine practice : official journal of the American College of Endocrinology and the American Association of Clinical Endocrinologists (2026)HumanPMID 41183961Horikawa R, Tanaka T et al. · Efficacy and safety of once-weekly somatrogon following up to 4 years of treatment in Japanese children with growth hormone deficiency: results from an open-label extension of a phase 3 study.Endocrine journal (2026)HumanPMID 39872400Nayak S, Wajnrajch MP et al. · IGF-1 Assessment During Weekly Somatrogon Treatment in Pediatric Patients With GH Deficiency.Journal of the Endocrine Society (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 40049670Maniatis AK, Wajnrajch MP et al. · Somatrogon in pediatric growth hormone deficiency: a comprehensive review of clinical trials and real-world considerations.Annals of pediatric endocrinology & metabolism (2025)HumanPMID 39810511Rodaro C, Tamaro G et al. · Long-acting growth hormones: innovations in treatment and guidance on patient selection in pediatric growth hormone deficiency.Annals of pediatric endocrinology & metabolism (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 40049668Kim YM · Commentary on "Somatrogon in pediatric growth hormone deficiency: a comprehensive review of clinical trials and real-world considerations".Annals of pediatric endocrinology & metabolism (2025)PMID 41268180Gomez R, Khadilkar V et al. · Comparing the efficacy and safety of weekly somatrogon with daily somatropin in Asian children living with growth hormone deficiency: a plain language summary of publication.Therapeutic advances in endocrinology and metabolism (2025)PMID 41025548Awad MH, Ghanim R et al. · Real-World Efficacy of Weekly Somatrogon on Growth and Bone Health in Pediatric Growth Hormone Deficiency: A 12-Month Retrospective Cohort Study.Journal of clinical research in pediatric endocrinology (2025)HumanPMID 40416193Katsoudas S, Tsitsekli E et al. · Comparative Efficacy of Once-Weekly Somatrogon Versus Daily Growth Hormone Therapy in Children With Idiopathic Growth Hormone Deficiency: A Real-World Retrospective Study From Greece.Cureus (2025)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 39526285Deal CL, Steelman J et al. · Comparing the efficacy and safety of weekly somatrogon with daily somatropin to treat children with growth hormone deficiency: a plain language summary of publication.Therapeutic advances in endocrinology and metabolism (2024)PMID 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 38717038Gomez R, Khadilkar V et al. · Post hoc subgroup analysis of Asian children with paediatric GHD from the global phase 3 efficacy and safety study of once-weekly somatrogon vs. once-daily somatropin.Journal of pediatric endocrinology & metabolism : JPEM (2024)HumanPMID 39493411Maniatis AK, Carakushansky M et al. · Understanding the burden of weekly somatrogon injections compared with daily somatropin injections in children with growth hormone deficiency: a plain language summary of publication.Therapeutic advances in endocrinology and metabolism (2024)PMID 39261416de Fries Jensen L, Antavalis V et al. · Efficacy and Safety of Somapacitan Relative to Somatrogon and Lonapegsomatropin in Pediatric Growth Hormone Deficiency: Systematic Literature Review and Network Meta-analysis.Advances in therapy (2024)HumanPMID 38053515Loftus J, Quitmann J et al. · Health-related quality of life in pre-pubertal children with pediatric growth hormone deficiency: 12-month results from a phase 3 clinical trial of once-weekly somatrogon versus once-daily somatropin.Current medical research and opinion (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)Human

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