NDAINJECTIONINJECTABLE
Approved
Dec 1978
Lifecycle
LOE Approaching
Competitive Pressure
30/100
Clinical Trials
20
Data completeness
3/8 — Basic
PLATINOL (cisplatin) by R-Pharm US is cross-links. First approved in 1978.
Drug data last refreshed Yesterday
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
PLATINOL (cisplatin) is a platinum-based chemotherapy agent that cross-links DNA and interferes with transcription and replication mechanisms, triggering cell death in cancer cells. It is indicated across nine solid tumor types including lung, head and neck, pancreatic, gastric, and cervical cancers. PLATINOL is administered intravenously as a classic cytotoxic chemotherapy backbone, often used in combination regimens.
LOE Approaching
As PLATINOL approaches loss of exclusivity with no remaining patent protection, the brand team is likely consolidating and shifting focus toward combination strategies and lifecycle 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)
Gemcitabine, Cisplatin, Nab-paclitaxel (GAP) and Cemiplimab for Locally Advanced Biliary Tract Cancer (BTC)
Started Aug 2026
20 enrolled
Colon and Rectal Cancer
Neoadjuvant Intravesical Nadofaragene Firadenovec With Gemcitabine, Cisplatin and Durvalumab for the Treatment of Muscle Invasive Bladder Cancer, TRIFECTA Trial
Started Jun 2026
33 enrolled
Muscle Invasive Bladder Urothelial CarcinomaStage II Bladder Cancer AJCC v8Stage IIIA Bladder Cancer AJCC v8
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
Disitamab Vedotin Plus Radiotherapy for Adjuvant Treatment of HER2-Expressing Cisplatin-Ineligible Upper Tract Urothelial Carcinoma
Started May 2026
192 enrolled
Upper Tract Urothelial Carcinoma
A Phase II Study of Single Tremelimumab With Regular Interval Durvalumab Plus Gemcitabine and Cisplatin in Locally Advanced Unresectable/Metastatic Combined Hepatocellular-cholangiocarcinoma
Started May 2026
29 enrolled
Combined Hepatocellular and Cholangiocarcinoma
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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.