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Pembrolizumab Dose D
Pembrolizumab Dose D is a Biologic drug developed by Merck Sharp & Dohme LLC. It is currently in Phase 1 development. Also known as: KEYTRUDA®, MK-3475.
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Baseline phase 1 → approval rate
+9.6pp
Industry-wide phase 1 drugs reach approval ~9.6% of the time (BIO/Informa 2023 industry benchmark across all therapeutic areas). -
Big-pharma sponsor
+3.0pp
Merck Sharp & Dohme LLC is a top-20 pharma sponsor — historical approval rates run ~3pp above average due to scale, regulatory experience, and trial-design quality.
| Regulator | Country | Likely year | Lag vs FDA |
|---|---|---|---|
| FDA | US | 2033–2036 | — |
| EMA | EU | 2034–2037 | +0.7 yr |
| MHRA | GB | 2034–2037 | +0.7 yr |
| Health Canada | CA | 2034–2038 | +0.9 yr |
| TGA | AU | 2034–2038 | +1.2 yr |
| PMDA | JP | 2034–2038 | +1.5 yr |
| NMPA | CN | 2035–2039 | +2.3 yr |
| MFDS | KR | 2034–2038 | +1.4 yr |
| CDSCO | IN | 2034–2039 | +1.8 yr |
| ANVISA | BR | 2035–2039 | +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 | Pembrolizumab Dose D |
|---|---|
| Also known as | KEYTRUDA®, MK-3475 |
| Sponsor | Merck Sharp & Dohme LLC |
| Modality | Biologic |
| Phase | Phase 1 |
Approved indications
Common side effects
Key clinical trials
- A Clinical Study of Raludotatug Deruxtecan in People With Ovarian Cancer (MK-5909-003) (PHASE1, PHASE2)
- Study of Nanrilkefusp Alfa Alone and With Pembrolizumab in Adult Patients With Advanced/Metastatic Solid Tumors (PHASE1)
- A Dose Escalation/Expansion Study of ERAS-601 in Patients With Advanced or Metastatic Solid Tumors (PHASE1)
- Pembrolizumab and Standard Therapy in Treating Patients With Glioblastoma (PHASE2)
- Personalized Immunotherapy in Adults With Advanced Cancers Immunotherapy in Adults With Advanced Cancers (PHASE1)
- A Study of Enfortumab Vedotin Alone or With Other Therapies for Treatment of Urothelial Cancer (PHASE1, PHASE2)
- A Study Evaluating the Safety, Activity, and Pharmacokinetics of Divarasib as a Single Agent or in Combination With Other Anti-Cancer Therapies in Participants With Previously Untreated Advanced or Metastatic Non-Small Cell Lung Cancer With a KRAS G12C Mutation (PHASE1, PHASE2)
- S-531011 as Monotherapy and in Combination With an Immune Checkpoint Inhibitor in Advanced or Metastatic Solid Tumors (PHASE1, PHASE2)
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:
- Pembrolizumab Dose D CI brief — competitive landscape report
- Pembrolizumab Dose D updates RSS · CI watch RSS
- Merck Sharp & Dohme LLC portfolio CI
Frequently asked questions about Pembrolizumab Dose D
What is Pembrolizumab Dose D?
Who makes Pembrolizumab Dose D?
Is Pembrolizumab Dose D also known as anything else?
What development phase is Pembrolizumab Dose D in?
Related
- Manufacturer: Merck Sharp & Dohme LLC — full pipeline
- Also known as: KEYTRUDA®, MK-3475
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing