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Cisplatin for injection
Cisplatin for injection is a Platinum-based chemotherapy agent Small molecule drug developed by Shanghai Guangsheng Biopharmaceutical Co., Ltd. It is currently in Phase 3 development for Metastatic testicular cancer, Metastatic ovarian cancer, Advanced bladder cancer.
Cisplatin is a platinum-based chemotherapy agent that forms DNA crosslinks, preventing DNA replication and transcription in cancer cells.
Cisplatin for injection is a small molecule used to treat various types of cancer, including breast cancer, bile duct carcinoma, gall bladder cancer, biliary tract cancer, and cholangiocarcinoma. It is typically administered as part of a combination therapy, such as with gemcitabine, and has been studied in clinical trials for its effectiveness in these conditions.
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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 | Cisplatin for injection |
|---|---|
| Sponsor | Shanghai Guangsheng Biopharmaceutical Co., Ltd |
| Drug class | Platinum-based chemotherapy agent |
| Target | DNA |
| Modality | Small molecule |
| Therapeutic area | Oncology |
| Phase | Phase 3 |
Mechanism of action
Cisplatin binds to DNA and forms intrastrand and interstrand crosslinks, which distort the DNA helix and block DNA synthesis and transcription. This leads to apoptosis and cell death in rapidly dividing cancer cells. The drug is non-cell-cycle specific and acts as an alkylating agent.
Approved indications
- Metastatic testicular cancer
- Metastatic ovarian cancer
- Advanced bladder cancer
- Head and neck cancer
- Lung cancer
- Gastric cancer
Common side effects
- Nephrotoxicity
- Ototoxicity
- Nausea and vomiting
- Myelosuppression
- Peripheral neuropathy
- Electrolyte abnormalities (hypomagnesemia, hypokalemia)
- Anemia
Key clinical trials
- Dinutuximab With Chemotherapy, Surgery and Stem Cell Transplantation for the Treatment of Children With Newly Diagnosed High Risk Neuroblastoma (PHASE3)
- Testing the Addition of MEDI4736 (Durvalumab) to Chemotherapy Before Surgery for Patients With High-Grade Upper Urinary Tract Cancer (PHASE2, PHASE3)
- A Study to Evaluate the Bioavailability of Pembrolizumab (MK-3475) Via Subcutaneous (SC) Injection of Pembrolizumab Formulated With Berahyaluronidase Alfa (MK-5180) [MK-3475A] In Advanced Solid Tumors (MK-3475A-C18) (PHASE1)
- Testing the Use of Investigational Drugs Atezolizumab and/or Bevacizumab With or Without Standard Chemotherapy in the Second-Line Treatment of Advanced-Stage Head and Neck Cancers (PHASE2, PHASE3)
- A Study Comparing the Combination of Pembrolizumab and Sacituzumab Govitecan Versus Standard of Care in the Treatment of Advanced Urothelial Cancer (PHASE3)
- Fulzerasib Sequential Sintilimab Plus Platinum-Doublet Neoadjuvant Therapy for Resectable KRAS G12C-Mutant NSCLC (PHASE2)
- Multicenter Phase 2 Study of Envafolimab in Biliary Tract Cancers (PHASE2)
- A Study of Pembrolizumab (MK-3475) With or Without Intismeran Autogene (V940) in Participants With Non-small Cell Lung Cancer (V940-009/INTerpath-009) (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:
- Cisplatin for injection CI brief — competitive landscape report
- Cisplatin for injection updates RSS · CI watch RSS
- Shanghai Guangsheng Biopharmaceutical Co., Ltd portfolio CI
Frequently asked questions about Cisplatin for injection
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Related
- Drug class: All Platinum-based chemotherapy agent drugs
- Target: All drugs targeting DNA
- Manufacturer: Shanghai Guangsheng Biopharmaceutical Co., Ltd — full pipeline
- Therapeutic area: All drugs in Oncology
- Indication: Drugs for Metastatic testicular cancer
- Indication: Drugs for Metastatic ovarian cancer
- Indication: Drugs for Advanced bladder cancer
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing