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Drug

Somatrogon

Approved medicine
ClassGrowth hormone receptor agonistResearchOngoing clinical research
Also known as 118-145-GONADOTROPIN, CHORIONIC (HUMAN .BETA.-SUBUNIT) FUSION PROTEIN WITH SOMATOTROPIN (HUMAN) FUSION PROTEIN WITH 118-145-CHORIONIC GONADOTROPIN (HUMAN .BETA.-SUBUNIT) FUSION PROTEIN WITH 118-145-CHORIONIC GONADOTROPIN (HUMAN .BETA.-SUBUNIT), CTP-SOMATROPIN FUSION PROTEIN, FUSION PROTEIN OF HUMAN CHORIOGONADOTROPIN SUBUNIT .BETA. (CG- .BETA.)-(118-145)-PEPTIDE (1-28) WITH HUMAN SOMATOTROPIN (GROWTH HORMONE, GH) (29-219) AND TWO TANDEM COPIES OF HUMAN CHORIOGONADOTROPIN SUBUNIT .BETA. (CG-.BETA.)-(118-145)- PEPTIDE (220-247, HUMAN GROWTH HORMONE-CARBOXY-TERMINAL PEPTIDE (CTP) OF THE BETA CHAIN OF HUMAN CHORIONIC GONADOTROPIN FUSION PROTEIN+4 more

118-145-GONADOTROPIN, CHORIONIC (HUMAN .BETA.-SUBUNIT) FUSION PROTEIN WITH SOMATOTROPIN (HUMAN) FUSION PROTEIN WITH 118-145-CHORIONIC GONADOTROPIN (HUMAN .BETA.-SUBUNIT) FUSION PROTEIN WITH 118-145-CHORIONIC GONADOTROPIN (HUMAN .BETA.-SUBUNIT), CTP-SOMATROPIN FUSION PROTEIN, FUSION PROTEIN OF HUMAN CHORIOGONADOTROPIN SUBUNIT .BETA. (CG- .BETA.)-(118-145)-PEPTIDE (1-28) WITH HUMAN SOMATOTROPIN (GROWTH HORMONE, GH) (29-219) AND TWO TANDEM COPIES OF HUMAN CHORIOGONADOTROPIN SUBUNIT .BETA. (CG-.BETA.)-(118-145)- PEPTIDE (220-247, HUMAN GROWTH HORMONE-CARBOXY-TERMINAL PEPTIDE (CTP) OF THE BETA CHAIN OF HUMAN CHORIONIC GONADOTROPIN FUSION PROTEIN, Ngenla, SOMATROPIN-CTP FUSION PROTEIN, MOD-423 hGH analogue, Recombinant human growth hormone long acting (fused w beta chains of HCG).

RxNorm2644503ChEMBLCHEMBL4297830ATCH01AC08UNII6D848RA61B
1
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.

Multicenter Interventional Study: Somatrogon Impact on Outcomes in Naive Small for Gestational Age or Idiopathic Short Stature Pediatric Patients Compared With Daily Growth Hormone

Clinical trial2026-04-30Results expected Q4 2027 · ClinicalTrials.gov

Approval: Ngenla (EMA)

Regulatory2022-02-14EMA

A 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 DEFICIENCY

Clinical trial2021-10-14Results posted · ClinicalTrials.gov

A Phase 1, Single-Center, Randomized, Cross-Over, Clinical Study Investigating the Comparability of Somatrogon in Two Different Drug Product Presentations

Clinical trial2019-04-19Completed · ClinicalTrials.gov

Profile

Identifiers & mechanism

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

Canonical name
Somatrogon
Aliases & brands
118-145-GONADOTROPIN, CHORIONIC (HUMAN .BETA.-SUBUNIT) FUSION PROTEIN WITH SOMATOTROPIN (HUMAN) FUSION PROTEIN WITH 118-145-CHORIONIC GONADOTROPIN (HUMAN .BETA.-SUBUNIT) FUSION PROTEIN WITH 118-145-CHORIONIC GONADOTROPIN (HUMAN .BETA.-SUBUNIT)CTP-SOMATROPIN FUSION PROTEINFUSION PROTEIN OF HUMAN CHORIOGONADOTROPIN SUBUNIT .BETA. (CG- .BETA.)-(118-145)-PEPTIDE (1-28) WITH HUMAN SOMATOTROPIN (GROWTH HORMONE, GH) (29-219) AND TWO TANDEM COPIES OF HUMAN CHORIOGONADOTROPIN SUBUNIT .BETA. (CG-.BETA.)-(118-145)- PEPTIDE (220-247HUMAN GROWTH HORMONE-CARBOXY-TERMINAL PEPTIDE (CTP) OF THE BETA CHAIN OF HUMAN CHORIONIC GONADOTROPIN FUSION PROTEINNgenlaSOMATROPIN-CTP FUSION PROTEINMOD-423 hGH analogueRecombinant human growth hormone long acting (fused w beta chains of HCG)
RxNorm CUI
2644503
ChEMBL ID
CHEMBL4297830
ATC codes
H01AC08
UNII
6D848RA61B
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
2022-02-14
Latest approval
2022-02-14
Authorities
EMA
Total events
1
emaEuropean Medicines Agency· 1 event
2022-02-14Approval
Approval: Ngenla (EMA)

Indication: Indicated for the long-term treatment of paediatric patients with growth disturbance due to insufficient secretion of growth hormone

Evidence ↗

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

Clinical trials

3 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
3
registered trials across all phases
LATEST COMPLETION 2020
1
Active studies
1
Recruiting
2
Late-stage (III+)
2
Completed
PHASE DISTRIBUTIONn = 3
Phase 11Phase 32
References & data sources
  • RxNorm (U.S. National Library of Medicine) — drug identity
  • ChEMBL (EMBL-EBI) & UniProt — pharmacology and targets
  • ClinicalTrials.gov — clinical trials
  • Regulatory event sources are credited in the Regulatory Timeline above.