EMA · European Union
somapacitan — EMA regulatory status
somapacitan (SOGROYA) regulatory status in the European Union is tracked from public EMA records and cross-linked clinical and patent datasets on NovaPharmaNews. Current status: EMA approved.
Status snapshot
- Status
- EMA approved
- Brand
- SOGROYA
- Mechanism
- Growth hormone receptor agonist
- Target
- Growth hormone receptor
- Structured fields
- 6
Pharmacology context used for competitive intelligence: Growth hormone receptor agonist. Target: Growth hormone receptor. This page is a status aggregation for professional reference — not prescribing advice.
Regional decision snapshot — EMA: approved.
Linked evidence on this spoke: 5 published clinical programs and 0 related patent records. Use the tables below for NCT identifiers, phases, and exclusivity dates; verify against primary sources before BD or medical decisions.
Regulatory timeline
| Regulator | Region | Status | Date | Source |
|---|---|---|---|---|
| EMA | European Union | approved | — | Evidence |
Linked clinical programs
| Program | Phase | Sponsor | NCT |
|---|---|---|---|
| NN8640-4263 | Phase 3 | NovoThirteen | 2023-506829-11-00 |
| NN8640-4467 | Phase 3 | NovoThirteen | 2023-506927-27-00 |
| Somapacitan | Phase 3 | Novo Nordisk A/S | NCT03811535, NCT04970654 |
| somapacitan | Phase 3 | Novo Nordisk A/S | NCT02229851 |
| NN8640-4245 | Phase 2 | NovoThirteen | 2023-506830-66-00 |
Related hubs
FAQ
What is the EMA approval status of somapacitan?
somapacitan currently shows EMA approved in our European Union regulatory index. Confirm on the official EMA label or EPAR before clinical or commercial use.
Where does NovaPharmaNews get somapacitan regulatory data?
Status fields are joined from public sources (openFDA / EMA / regional agencies), ClinicalTrials.gov-linked programs, and patent registries. See /about/data-sources for attribution.
How many clinical programs are linked to somapacitan?
This spoke lists 5 published programs associated with somapacitan in our pipeline index.