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Gemcitabin/cisplatin
Gemcitabin/cisplatin is a Chemotherapy combination (nucleoside analog + platinum alkylating agent) Small molecule drug developed by Kuwait Cancer Control Center. It is currently in Phase 3 development for Various solid tumors (specific indications depend on phase 3 trial design).
Gemcitabine and cisplatin work together as a chemotherapy combination, with gemcitabine inhibiting ribonucleotide reductase to disrupt DNA synthesis and cisplatin forming DNA crosslinks to prevent replication.
Gemcitabine and cisplatin work together as a chemotherapy combination, with gemcitabine inhibiting ribonucleotide reductase to disrupt DNA synthesis and cisplatin forming DNA crosslinks to prevent replication. Used for Various solid tumors (specific indications depend on phase 3 trial design).
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Baseline phase 3 → approval rate
+58.3pp
Industry-wide phase 3 drugs reach approval ~58.3% of the time (BIO/Informa 2023 industry benchmark across all therapeutic areas). -
Oncology Phase 3 boost
+3.0pp
Oncology Phase 3 trials have higher approval rates (~61%) than the cross-industry average due to clearer endpoints and FDA oncology pathway.
| Regulator | Country | Likely year | Lag vs FDA |
|---|---|---|---|
| FDA | US | 2028–2030 | — |
| EMA | EU | 2029–2031 | +0.7 yr |
| MHRA | GB | 2029–2031 | +0.7 yr |
| Health Canada | CA | 2029–2032 | +0.9 yr |
| TGA | AU | 2029–2032 | +1.2 yr |
| PMDA | JP | 2029–2032 | +1.5 yr |
| NMPA | CN | 2030–2033 | +2.3 yr |
| MFDS | KR | 2029–2032 | +1.4 yr |
| CDSCO | IN | 2029–2033 | +1.8 yr |
| ANVISA | BR | 2030–2033 | +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 | Gemcitabin/cisplatin |
|---|---|
| Sponsor | Kuwait Cancer Control Center |
| Drug class | Chemotherapy combination (nucleoside analog + platinum alkylating agent) |
| Modality | Small molecule |
| Therapeutic area | Oncology |
| Phase | Phase 3 |
Mechanism of action
Gemcitabine is a nucleoside analog that interferes with DNA synthesis by inhibiting ribonucleotide reductase and being incorporated into DNA, leading to chain termination. Cisplatin is a platinum-based alkylating agent that forms covalent crosslinks with DNA, preventing strand separation and replication. Together, they provide synergistic cytotoxic effects against rapidly dividing cancer cells.
Approved indications
- Various solid tumors (specific indications depend on phase 3 trial design)
Common side effects
- Myelosuppression (neutropenia, thrombocytopenia, anemia)
- Nausea and vomiting
- Nephrotoxicity
- Neurotoxicity (peripheral neuropathy)
- Fatigue
- Alopecia
Key clinical trials
- Testing the Addition of an Anti-cancer Drug, BAY 1895344, to the Usual Chemotherapy Treatment (Cisplatin, or Cisplatin and Gemcitabine) for Advanced Solid Tumors With Emphasis on Urothelial Cancer (PHASE1)
- Novel Combination Therapy in the Treatment of Relapsed and Refractory Aggressive B-Cell Lymphoma (PHASE2)
- Study BT8009-230 in Participants With Locally Advanced or Metastatic Urothelial Cancer (Duravelo-2) (PHASE2, PHASE3)
- Durvalumab With Gemcitabine and Cisplatin for the Treatment of High-Risk Resectable Liver Cancer Before Surgery (PHASE2)
- Testing the Addition of BMS-986016 (Relatlimab) to the Usual Immunotherapy After Initial Treatment for Recurrent or Metastatic Nasopharyngeal Cancer (PHASE2)
- A Study Using Nivolumab, in Combination With Chemotherapy Drugs to Treat Nasopharyngeal Carcinoma (NPC) (PHASE2)
- MP0317 in Combination With Chemoimmunotherapy in First Line Treatment for Patients With Advanced Biliary Tract Carcinoma (PHASE2)
- Testing the Addition of the Immunotherapy Drug, Pembrolizumab, to Radiation Therapy Compared to the Usual Chemotherapy Treatment During Radiation Therapy for Bladder Cancer, PARRC Trial (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:
- Gemcitabin/cisplatin CI brief — competitive landscape report
- Gemcitabin/cisplatin updates RSS · CI watch RSS
- Kuwait Cancer Control Center portfolio CI
Frequently asked questions about Gemcitabin/cisplatin
What is Gemcitabin/cisplatin?
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Related
- Drug class: All Chemotherapy combination (nucleoside analog + platinum alkylating agent) drugs
- Manufacturer: Kuwait Cancer Control Center — full pipeline
- Therapeutic area: All drugs in Oncology
- Indication: Drugs for Various solid tumors (specific indications depend on phase 3 trial design)
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing