Somatrogon
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Also known as Ctp-somatropin fusion proteinMod-4023MOD4023NgenlaPF-06836922PF06836922Somatrogon-ghlaSomatropin-ctp fusion protein
Summary
Somatrogon (CHEMBL4297830) is an approved protein (ATC H01AC08) targeting GHR; indicated across 1 condition including pituitary dwarfism.
At a glance
- Status: Approved (max clinical phase 4)
- Modality: Protein
- ATC class: H01AC08
- Targets: 1 (GHR)
- Indications: 1 condition
- Clinical trials: 13
Identifiers
Drug identity and classification
| Field | Value |
|---|---|
| ChEMBL ID | CHEMBL4297830 |
| Name | Somatrogon |
| Type | Protein |
| Max phase | 4 |
| ATC | H01AC08 |
Also known as: Ctp-somatropin fusion protein, Mod-4023, MOD-4023, MOD4023, Ngenla, PF-06836922, PF06836922, Somatrogon, Somatrogon-ghla, Somatropin-ctp fusion protein, SOMATROGON
Targets
Targets
Primary targets (GtoPdb curated mechanism): the Cancer dependency column is the DepMap CRISPR fitness signal (% of screened cell lines dependent on the target).
| Gene | Target | Action | pAffinity | Cancer dependency | UniProt |
|---|---|---|---|---|---|
| GHR | Growth hormone receptor | Agonist | 8.2 | 0% | P10912 |
Bioactivity
No ChEMBL bioactivity rows at pChembl ≥ 5 (expected for biologics / antibodies).
Target pathways
Aggregated over 1 target gene(s): GHR.
Top Reactome pathways
2 total, by targets touching each:
| Pathway | Targets | Genes |
|---|---|---|
| Prolactin receptor signaling | 1 | GHR |
| Growth hormone receptor signaling | 1 | GHR |
Dominant GO biological processes
| GO term | Targets |
|---|---|
| endocytosis | 1 |
| cell surface receptor signaling pathway via JAK-STAT | 1 |
| positive regulation of cell population proliferation | 1 |
| response to gravity | 1 |
| hormone-mediated signaling pathway | 1 |
| cytokine-mediated signaling pathway | 1 |
| taurine metabolic process | 1 |
| receptor internalization | 1 |
| response to food | 1 |
| regulation of response to nutrient levels | 1 |
| response to estradiol | 1 |
| cellular response to insulin stimulus | 1 |
| cellular response to hormone stimulus | 1 |
| regulation of multicellular organism growth | 1 |
| positive regulation of multicellular organism growth | 1 |
Indications & clinical
Indications
1 indication (1 at ChEMBL trial phase 4). Phase below is the highest clinical-trial phase recorded for this drug against each disease — not the molecule’s overall approval status (that is in the Summary).
| Indication | Trial phase | MONDO | EFO |
|---|---|---|---|
| pituitary dwarfism | 4 | MONDO:0006909 | EFO:1001109 |
Clinical trials
Total trials: 13.
Phase distribution
| Phase | Trials |
|---|---|
| PHASE3 | 5 |
| PHASE2 | 3 |
| Not specified | 3 |
| PHASE1 | 2 |
Top trials by phase / activity
| NCT | Phase | Status | Title |
|---|---|---|---|
| NCT07226089 | PHASE3 | RECRUITING | Comparison of Weekly Somatrogon to Daily Genotropin in Children Born Small for Gestational Age or With Idiopathic Short Stature. |
| NCT01909479 | PHASE3 | TERMINATED | A Phase 3, Multicenter Study To Evaluate The Efficacy And Safety Of MOD-4023 In Adults With Growth Hormone Deficiency |
| NCT02968004 | PHASE3 | COMPLETED | Safety and Efficacy Phase 3 Study of Long-acting hGH (MOD-4023) in Growth Hormone Deficient Children |
| NCT03831880 | PHASE3 | COMPLETED | Patient Perception of Treatment Burden in Weekly Versus Daily Growth Hormone Injections in Children With GHD |
| NCT03874013 | PHASE3 | COMPLETED | Safety and Efficacy Study of MOD-4023 to Treat Children With Growth Hormone Deficiency |
| NCT01225666 | PHASE2 | COMPLETED | MOD-4023 (Long-Lasting Human Growth Hormone (hGH)) Study in Growth Hormone Deficient Adults (GHDA) |
| NCT01592500 | PHASE2 | COMPLETED | Safety and Efficacy Phase 2 Study of Long-acting hGH (MOD-4023) in Growth Hormone Deficient Children |
| NCT02500316 | PHASE2 | COMPLETED | Long Term Follow up Study of Long-acting hGH (MOD-4023) in Growth Hormone Deficient Children |
| NCT02418767 | PHASE1 | COMPLETED | Pharmacokinetics and Pharmacodynamics of Long Acting Human Growth Hormone (hGH) Product (MOD-4023) in Healthy Caucasian and Japanese Volunteers |
| NCT03810664 | PHASE1 | COMPLETED | A Clinical Study Investigating the Comparability of Somatrogon in Two Different Drug Product Presentations |
| NCT05509894 | Not specified | ACTIVE_NOT_RECRUITING | Korean Post-marketing Surveillance Ngenla® Pre-filled Pen Injection for the Treatment of Pediatric Patients With Growth Disturbance Due to Insufficient Secretion of Growth Hormone |
| NCT05602766 | Not specified | ACTIVE_NOT_RECRUITING | Ngenla Subcutaneous Injection Special Investigation |
| NCT06587035 | Not specified | RECRUITING | A Study to Learn About Somatrogon in Patients With Pediatric Growth Hormone Deficiency (p GHD) in India. |
Clinical evidence (CIViC)
No CIViC predictive evidence (expected for non-precision-medicine drugs).
Pharmacology
Pharmacogenomics
No PharmGKB pharmacogenomic data curated for this drug.
Related molecules
Related molecules
Molecules sharing ≥1 of this drug’s curated primary targets, merged from two biobtree sources and ranked by shared-target count, then clinical phase: ChEMBL clinical-stage candidates (development phase ≥2) and PubChem drug-class bioactivity (approved / known drugs acting on the target). Deduplicated by drug name; the drug’s own salt forms are excluded. Note: for a drug with few primary targets a shared-target match can reflect off-target / promiscuous binding rather than the same therapeutic mechanism — the phase ordering surfaces bona-fide therapeutics first.
1 molecules share ≥1 primary target. Top 1 by shared-target count:
| Molecule | Source | Status | Shared targets |
|---|---|---|---|
| Enzalutamide | PubChem | Approved | GHR |
Related Atlas pages
- Genes: GHR
- Diseases: pituitary dwarfism
- Drugs: Enzalutamide