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A combination of Gemcitabine and cisplatin
A combination of Gemcitabine and cisplatin is a Small molecule drug developed by Cancer Hospital of Guangxi Medical University. It is currently in Phase 2 development. Also known as: GP.
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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 | A combination of Gemcitabine and cisplatin |
|---|---|
| Also known as | GP |
| Sponsor | Cancer Hospital of Guangxi Medical University |
| Modality | Small molecule |
| Phase | Phase 2 |
Approved indications
Common side effects
- Anaemia
- Nausea
- Decreased appetite
- Constipation
- Neutrophil count decreased
- Platelet count decreased
- Fatigue
- Neutropenia
- Asthenia
- Vomiting
- White blood cell count decreased
- Diarrhoea
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)
- 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)
- A Study to Determine Whether Chemotherapy and Atezolizumab is Better Than Chemotherapy, Bevacizumab and Atezolizumab in Patients With Advanced Liver Cancer (PHASE2)
- Romidepsin, Gemcitabine, Dexamethasone and Cisplatin in the Treatment of Peripheral T-Cell and Diffuse Large B-Cell Lymphoma (PHASE1)
- Testing the Addition of a Type of Drug Called Immunotherapy to the Usual Chemotherapy Treatment for Non-small Cell Lung Cancer, an ALCHEMIST Treatment Trial (Chemo-IO [ACCIO]) (PHASE3)
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:
- A combination of Gemcitabine and cisplatin CI brief — competitive landscape report
- A combination of Gemcitabine and cisplatin updates RSS · CI watch RSS
- Cancer Hospital of Guangxi Medical University portfolio CI
Frequently asked questions about A combination of Gemcitabine and cisplatin
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Is A combination of Gemcitabine and cisplatin also known as anything else?
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Related
- Manufacturer: Cancer Hospital of Guangxi Medical University — full pipeline
- Also known as: GP
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing