Somatrogon
SYSTEMIC HORMONAL PREPARATIONS, EXCL. SEX HORMONES AND INSULINS
Also known as: MOD-4023, ngenla, somatrogon (genetical recombination)
Data last refreshed: (DrugCentral release 2024-11-01)
Key facts
Somatrogon is a drug catalogued in DrugCentral. It was first approved by the PMDA in 2022. DrugCentral lists 2 molecular targets, including Ghr and GHR. Recorded indications include Growth hormone deficiency.
- Molecular targets: Ghr and GHR (2 listed in DrugCentral).
- Indications: Growth hormone deficiency.
- ATC code: H01AC08 (Somatropin and somatropin agonists).
Indications & contraindications
Drug–disease relationships curated by DrugCentral (OMOP / SNOMED concepts).
Indications (1)
- Growth hormone deficiency
Contraindications (7)
- Active intracranial tumours
- Acute respiratory failure
- Children with closed epiphyses
- Complications following abdominal surgery
- Complications following open heart surgery
- Multiple accidental trauma
- Tumour growth
Mechanism & targets
Molecular targets (2)
| Target | Gene | Action | Activity |
|---|---|---|---|
| Growth hormone receptor, GH receptor | Ghr | agonist | Kd 8.29 |
| Growth hormone receptor | GHR | agonist | Kd 8.20 |
Regulatory approvals (3)
| Date | Agency | Marketed as | Applicant | Orphan |
|---|---|---|---|---|
| 2023-06-27 | FDA | — | PFIZER IRELAND PHARMACEUTICALS | Yes |
| 2022-02-14 | EMA | — | PFIZER EUROPE MA EEIG | Yes |
| 2022-01-20 | PMDA | — | PFIZER JAPAN INC. |
ATC classification
| ATC code | Therapeutic hierarchy |
|---|---|
H01AC08 | SYSTEMIC HORMONAL PREPARATIONS, EXCL. SEX HORMONES AND INSULINS › PITUITARY AND HYPOTHALAMIC HORMONES AND ANALOGUES › ANTERIOR PITUITARY LOBE HORMONES AND ANALOGUES › Somatropin and somatropin agonists |
Reported adverse-event signals
Strongest FDA FAERS disproportionality signals (log-likelihood ratio). A signal is a statistical association in spontaneous reports, not proof that the drug causes the event.
| MedDRA term | LLR |
|---|---|
| Injection site pain | 2955.1 |
| Patient-device incompatibility | 148.1 |
| Incorrect dose administered by device | 116.0 |
Chemical structure
| Molecular formula | — |
|---|---|
| Molecular weight | — |
| CAS number | 1663481-09-1 |
| InChIKey | — |
| PubChem CID | — |
Frequently asked questions
Answers are generated from the structured data on this page, not written by hand.
What is Somatrogon used for?
DrugCentral lists the following indications for Somatrogon: Growth hormone deficiency.
How does Somatrogon work?
Its molecular targets in DrugCentral include Ghr (agonist) and GHR (agonist).
When was Somatrogon first approved?
Somatrogon was first approved by the PMDA in 2022.
Browse: all drugs starting with S · drug guides by category · protein targets A–Z.
Sources
- DrugCentral drug card 5517 — structure, indications, targets, approvals, pharmacologic classes (CC BY-SA 4.0)
- ChEMBL CHEMBL4297830 — compound record and bioactivity
- DrugBank DB14960 — drug record
- FDA UNII 6D848RA61B — substance identity
- DailyMed: FDA labels for Somatrogon — current prescribing information (label search)
- UniProt P10912 (GHR) — target protein
- FDA Adverse Event Reporting System (openFDA FAERS) — adverse-event signals, as aggregated by DrugCentral
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