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Placebo , cisplatin
Placebo , cisplatin is a Platinum-based chemotherapy agent Small molecule drug developed by Jiangsu Simcere Pharmaceutical Co., Ltd.. It is currently in Phase 3 development for Various solid tumors (specific indication in this Phase 3 trial unknown without additional context).
Cisplatin is a platinum-based chemotherapy agent that forms DNA crosslinks to inhibit cancer cell replication and induce apoptosis.
Cisplatin is a platinum-based chemotherapy agent that forms DNA crosslinks to inhibit cancer cell replication and induce apoptosis. Used for Various solid tumors (specific indication in this Phase 3 trial unknown without additional context).
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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 | Placebo , cisplatin |
|---|---|
| Sponsor | Jiangsu Simcere Pharmaceutical 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, preventing DNA replication and transcription. This leads to cell cycle arrest and triggers apoptotic pathways in rapidly dividing cancer cells. The drug is non-cell-cycle specific and effective against a broad range of malignancies.
Approved indications
- Various solid tumors (specific indication in this Phase 3 trial unknown without additional context)
Common side effects
- Nephrotoxicity
- Ototoxicity
- Nausea and vomiting
- Myelosuppression
- Peripheral neuropathy
- Electrolyte abnormalities
Key clinical trials
- Pemetrexed Disodium and Cisplatin With or Without Cediranib Maleate in Treating Patients With Malignant Pleural Mesothelioma (PHASE1, PHASE2)
- Genetic Testing in Screening Patients With Stage IB-IIIA Non-small Cell Lung Cancer That Has Been or Will Be Removed by Surgery (The ALCHEMIST Screening Trial) (NA)
- A Study of First-Line Olomorasib (LY3537982) and Pembrolizumab With or Without Chemotherapy in Patients With Advanced KRAS G12C-Mutant Non-small Cell Lung Cancer (PHASE3)
- SSRI Antidepressant Fluoxetine Improving Immunotherapy Efficacy in Advanced Hepatobiliary Malignancy Patients With Depression and Anxiety (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)
- Pembrolizumab (MK-3475) Plus Gemcitabine/Cisplatin Versus Placebo Plus Gemcitabine/Cisplatin for First-Line Advanced and/or Unresectable Biliary Tract Carcinoma (BTC) (MK-3475-966/KEYNOTE-966) (PHASE3)
- A Study to Evaluate LY3537021 for the Treatment of Nausea and Vomiting Caused by Chemotherapy in Adults With Cancer (PHASE2)
- Durvalumab or Placebo in Combination With Gemcitabine/Cisplatin in Patients With 1st Line Advanced Biliary Tract Cancer (TOPAZ-1) (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:
- Placebo , cisplatin CI brief — competitive landscape report
- Placebo , cisplatin updates RSS · CI watch RSS
- Jiangsu Simcere Pharmaceutical Co., Ltd. portfolio CI
Frequently asked questions about Placebo , cisplatin
What is Placebo , cisplatin?
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Related
- Drug class: All Platinum-based chemotherapy agent drugs
- Target: All drugs targeting DNA
- Manufacturer: Jiangsu Simcere Pharmaceutical Co., Ltd. — full pipeline
- Therapeutic area: All drugs in Oncology
- Indication: Drugs for Various solid tumors (specific indication in this Phase 3 trial unknown without additional context)
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing