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Pemprolizumab
Pemprolizumab is a Small molecule drug developed by University Medical Center Groningen. It is currently in Phase 2 development. Also known as: MK3475.
Pembrolizumab is a medication used in combination with VMD-928 to treat solid tumors or lymphoma driven by TrkA overexpression. It is also being studied as a treatment for various types of cancer, including head and neck carcinoma, adenoid cystic carcinoma, lung cancer, non-small cell lung cancer, and pancreatic cancer.
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Baseline phase 2 → approval rate
+15.3pp
Industry-wide phase 2 drugs reach approval ~15.3% of the time (BIO/Informa 2023 industry benchmark across all therapeutic areas).
| Regulator | Country | Likely year | Lag vs FDA |
|---|---|---|---|
| FDA | US | 2031–2034 | — |
| EMA | EU | 2032–2035 | +0.7 yr |
| MHRA | GB | 2032–2035 | +0.7 yr |
| Health Canada | CA | 2032–2036 | +0.9 yr |
| TGA | AU | 2032–2036 | +1.2 yr |
| PMDA | JP | 2032–2036 | +1.5 yr |
| NMPA | CN | 2033–2037 | +2.3 yr |
| MFDS | KR | 2032–2036 | +1.4 yr |
| CDSCO | IN | 2032–2037 | +1.8 yr |
| ANVISA | BR | 2033–2037 | +2.3 yr |
Hover any row for the lag rationale. Lag estimates are reduced when the drug has FDA Breakthrough or EMA PRIME designation (sponsors file globally in parallel).
Estimate based on the BIO/Informa industry phase transition rates plus per-drug modifiers for therapeutic area, sponsor type, FDA designations, mechanism, and trial design. Per-jurisdiction lags from Tufts CSDD international approval studies. Not investment, clinical or regulatory advice. Methodology: /methodology#likelihood.
At a glance
| Generic name | Pemprolizumab |
|---|---|
| Also known as | MK3475 |
| Sponsor | University Medical Center Groningen |
| Modality | Small molecule |
| Therapeutic area | Other |
| Phase | Phase 2 |
Approved indications
Common side effects
Key clinical trials
- NT-I7 (Efineptakin Alfa) in Combination With Pembrolizumab in Participants With Advanced Solid Tumors (PHASE1, PHASE2)
- VMD-928 Monotherapy and in Combination With Pembrolizumab to Treat TrkA Overexpression Driven Solid Tumors or Lymphoma (PHASE1, PHASE2)
- Retrospective Analysis of Response Markers and Adverse Events in Melanoma Patients Treated With Pembrolizumab
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- Pemprolizumab CI brief — competitive landscape report
- Pemprolizumab updates RSS · CI watch RSS
- University Medical Center Groningen portfolio CI
Frequently asked questions about Pemprolizumab
What is Pemprolizumab?
Who makes Pemprolizumab?
Is Pemprolizumab also known as anything else?
What development phase is Pemprolizumab in?
Related
- Manufacturer: University Medical Center Groningen — full pipeline
- Therapeutic area: All drugs in Other
- Also known as: MK3475
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing