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Cisplatin （neoadjuvant）
Cisplatin （neoadjuvant） is a Platinum-based chemotherapy agent Small molecule drug developed by Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University. It is currently in Phase 3 development for Neoadjuvant treatment for various solid tumors (specific indication dependent on trial protocol).
Cisplatin is a platinum-based chemotherapy agent that forms DNA crosslinks, preventing DNA replication and triggering cancer cell death.
Cisplatin is a platinum-based chemotherapy agent that forms DNA crosslinks, preventing DNA replication and triggering cancer cell death. Used for Neoadjuvant treatment for various solid tumors (specific indication dependent on trial protocol).
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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 （neoadjuvant） |
|---|---|
| Sponsor | Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University |
| 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 inhibit DNA synthesis and transcription. This leads to apoptosis in rapidly dividing cancer cells. In the neoadjuvant setting, it is administered before primary surgery to shrink tumors and improve surgical outcomes.
Approved indications
- Neoadjuvant treatment for various solid tumors (specific indication dependent on trial protocol)
Common side effects
- Nephrotoxicity
- Ototoxicity
- Nausea and vomiting
- Myelosuppression
- Peripheral neuropathy
- Electrolyte abnormalities (hypomagnesemia, hypokalemia)
Key clinical trials
- Phase II Trial of Neoadjuvant Chemotherapy (NAC) Alone or in Combination With Immunotherapy Vaccine PRGN-2009 in Subjects With Newly Diagnosed HPV-Associated Oropharyngeal (Head and Neck) Cancer (PHASE2)
- 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)
- Testing the Addition of Chemotherapy or Chemo-Immunotherapy to the Usual Surgery for Advanced Head and Neck Cancer (PHASE2)
- Sacituzumab Govitecan, Preceding Radical Cystectomy, in Treating Patients With Muscle-invasive Bladder Cancer (PHASE2)
- A Study to Assess Efficacy and Safety of Pembrolizumab With or Without Sacituzumab Tirumotecan (MK- 2870) in Adult Participants With Resectable Non Small Cell Lung Cancer (NSCLC) Not Achieving Pathological Complete Response (pCR) (MK-2870-019) (PHASE3)
- Testing the Addition of Cemiplimab (REGN2810) to Chemotherapy Treatment Given Prior to Surgery in Patients With Sinonasal Squamous Cell Carcinoma (PHASE2)
- Neoadjuvant Inhaled Azacytidine With Platinum-Based Chemotherapy and Durvalumab (MEDI4736) - a Combined Epigenetic-Immunotherapy (AZA-AEGEAN) Regimen for Operable Early-Stage Non-Small Cell Lung Cancer (NSCLC) (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:
- Cisplatin （neoadjuvant） CI brief — competitive landscape report
- Cisplatin （neoadjuvant） updates RSS · CI watch RSS
- Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University portfolio CI
Frequently asked questions about Cisplatin （neoadjuvant）
What is Cisplatin （neoadjuvant）?
How does Cisplatin （neoadjuvant） work?
What is Cisplatin （neoadjuvant） used for?
Who makes Cisplatin （neoadjuvant）?
What drug class is Cisplatin （neoadjuvant） in?
What development phase is Cisplatin （neoadjuvant） in?
What are the side effects of Cisplatin （neoadjuvant）?
What does Cisplatin （neoadjuvant） target?
Related
- Drug class: All Platinum-based chemotherapy agent drugs
- Target: All drugs targeting DNA
- Manufacturer: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University — full pipeline
- Therapeutic area: All drugs in Oncology
- Indication: Drugs for Neoadjuvant treatment for various solid tumors (specific indication dependent on trial protocol)
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing