NDAINJECTIONINJECTABLE
Approved
Dec 1978
Lifecycle
LOE Approaching
Competitive Pressure
30/100
Clinical Trials
20
Data completeness
4/8 — Partial
CISPLATIN (cisplatin) by R-Pharm US is cross-links. First approved in 1978.
Drug data last refreshed 17h ago · AI intelligence enriched 1mo ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
Cisplatin is a platinum-based chemotherapy agent approved in 1978 that cross-links DNA to interfere with transcription and replication, triggering cytotoxic cell death. It is a foundational cancer treatment used across multiple solid tumor indications. The drug is administered by injection and represents a cornerstone of combination chemotherapy regimens.
LOE Approaching
As a 45+ year-old generic approaching patent loss with moderate competitive pressure, teams focus on cost optimization and supply chain management rather than growth initiatives.
Mechanism of Action
cross-links. This interferes with normal transcription and/or DNA replication mechanisms and triggers cytotoxic processes that lead to cell death.
Pharmacologic Class:
Platinum-based Drug
Indications
Indication data is being enriched from DailyMed and FDA labeling. Check back soon for approved therapeutic uses.
Clinical Trials (20)
Neoadjuvant Intravesical Nadofaragene Firadenovec With Gemcitabine, Cisplatin and Durvalumab for the Treatment of Muscle Invasive Bladder Cancer, TRIFECTA Trial
Started Dec 2026
33 enrolled
Muscle Invasive Bladder Urothelial CarcinomaStage II Bladder Cancer AJCC v8Stage IIIA Bladder Cancer AJCC v8
A Prospective, Multi-Center, Phase 4, Single Arm Study To Assess The Safety and Tolerability of Perioperative Durvalumab in Combination With Neoadjuvant Gemcitabine Plus Cisplatin in Indian Patients With Muscle-Invasive Bladder Cancer Cle-Invasive
Started Oct 2026
50 enrolled
Muscle-Invasive Bladder Cancer (MIBC)
A Phase II Study of Single Tremelimumab With Regular Interval Durvalumab Plus Gemcitabine and Cisplatin in Locally Advanced Unresectable/Metastatic Combined Hepatocellular-cholangiocarcinoma
Started Oct 2026
29 enrolled
Combined Hepatocellular and Cholangiocarcinoma
Gemcitabine, Cisplatin, Nab-paclitaxel (GAP) and Cemiplimab for Locally Advanced Biliary Tract Cancer (BTC)
Started Aug 2026
20 enrolled
Colon and Rectal Cancer
Ph. I/II Sodium Thiosulfate for OtoProtection During Cisplatin (STOP-CIS)
Started May 2026
25 enrolled
Solid Tumor MalignanciesTesticular CancerHead and Neck Cancer+1 more
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Data Sources
- Drug label: DailyMed / FDA
- Clinical trials: ClinicalTrials.gov
- Patent data: FDA Orange Book
- Spending data: CMS Medicare
The information on this page is for informational purposes only and should not be used as a substitute for professional medical advice. Drug information is sourced from FDA, DailyMed, and other government databases. Adverse event data from FAERS does not establish causation. Always consult a healthcare professional for medical decisions.