EMA · European Union
pembrolizumab — EMA regulatory status
pembrolizumab (KEYTRUDA) 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
- KEYTRUDA
- Originator
- Merck KGaA, Darmstadt, Germany
- Mechanism
- Programmed cell death protein 1 inhibitor
- Target
- Programmed cell death protein 1
- Structured fields
- 8
Sponsor / originator context: Merck KGaA, Darmstadt, Germany. Pipeline programs and exclusivity signals below are joined from ClinicalTrials.gov-linked projects and USPTO/EPO patent rows associated with this INN.
Pharmacology context used for competitive intelligence: Programmed cell death protein 1 inhibitor. Target: Programmed cell death protein 1. This page is a status aggregation for professional reference — not prescribing advice.
Regional decision snapshot — EMA: approved.
Linked evidence on this spoke: 341 published clinical programs and 12 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 |
|---|---|---|---|
| 000434 | Phase 3 | Ferring Pharmaceuticals | 2024-512177-27-01 |
| 1479-0008 | Phase 3 | Boehringer Ingelheim | 2023-504308-27-00 |
| 1479-0032 | Phase 3 | Boehringer Ingelheim | 2025-521284-12-00 |
| 2021/3336 | Phase 3 | George Institute for | 2023-503481-23-00 |
| 2023/3764 | Phase 3 | George Institute for | 2023-503317-29-00 |
| 20230127 | Phase 3 | Amgen | 2023-508359-38-00 |
| 213400 | Phase 3 | GSK Glaxo Smith | 2023-508443-40-00 |
| 213823 | Phase 3 | GSK Glaxo Smith | 2023-504753-12-00 |
| 22615 | Phase 3 | Bayer | 2024-511319-91-00 |
| 42756493BLC3001 | Phase 3 | Janssen-Cilag International N.V | 2023-510296-56-00 |
| 61186372HNC3001 | Phase 3 | Janssen-Cilag International N.V | 2025-521917-24-00 |
| 8951-CL-0305 | Phase 3 | Astellas Pharma | 2024-519773-19-00 |
Related patents
| Number | Title | Jurisdiction |
|---|---|---|
| 2025252204 | DISPERSIONS SOLIDES AMORPHES D'UN INHIBITEUR DE BRAF | WO |
| 2025232885 | PROCÉDÉ DE PRÉPARATION D'UN AGENT DE DÉGRADATION DE LA TYROSINE KINASE DE BRUTON | WO |
| 2025218772 | FORMES SOLIDES COMPRENANT UN AGENT DE DÉGRADATION DE TYROSINE KINASE DE BRUTON ET LEURS UTILISATIONS | WO |
| 2025214466 | CONJUGUÉS DE PYRROLOBENZODIAZÉPINE CIBLÉS | WO |
| 2025201453 | COMPOSÉS MACROCYCLIQUES UTILISÉS EN TANT QU'INHIBITEURS DE RAS | WO |
| 12404328 | Multi-specific binding proteins and methods of use thereof | US |
| 12404497 | Uses and methods for oncolytic virus targeting of IL-4/IL-13 and fusions thereof | US |
| 2025168072 | COMPOSÉS HÉTÉROCYCLIQUES, COMPOSITIONS ASSOCIÉES ET MÉTHODES DE TRAITEMENT ASSOCIÉS | WO |
| 2025168081 | TRAITEMENT D'UN TROUBLE PROLIFÉRATIF DES LYMPHOCYTES B AVEC UN COMPOSÉ ACTIVATEUR DE DÉGRADATION CHIMÉRIQUE | WO |
| 2025126115 | DÉGRADATION DE L'IRAK4 PAR CONJUGAISON D'INHIBITEURS D'IRAK4 AVEC DES LIGANDS DE LIGASE E3 ET PROCÉDÉS D'UTILISATION | WO |
| 2025108443 | COMPOSÉS HÉTÉROCYCLIQUES ET COMPOSITIONS ASSOCIÉES, ET MÉTHODES DE TRAITEMENT CORRESPONDANTES | WO |
| 2025078995 | COMPOSÉS DE 6-(PYRIMIDIN-4-YL)QUINOLÉINE SUBSTITUÉS UTILISÉS EN TANT QU'INHIBITEURS DE KINASE DÉPENDANTE DE LA CYCLINE | WO |
Related hubs
FAQ
What is the EMA approval status of pembrolizumab?
pembrolizumab 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 pembrolizumab 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 pembrolizumab?
This spoke lists 341 published programs associated with pembrolizumab in our pipeline index.