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Data updated: Mar 10, 2026

CISPLATIN

CISPLATIN
Oncology Approved 1978-12-19
11
Indications
--
Phase 3 Trials
47
Years on Market

Details

Status
Prescription
First Approved
1978-12-19
Routes
INJECTION
Dosage Forms
INJECTABLE

CISPLATIN Approval History

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What CISPLATIN Treats

3 indications

CISPLATIN is approved for 3 conditions since its original approval in 1978. These indications span multiple therapeutic areas including oncology, immunology, and more.

  • Testicular Cancer
  • Ovarian Cancer
  • Bladder Cancer
Source: FDA Label

CISPLATIN Boxed Warning

WARNING Cisplatin should be administered under the supervision of a qualified physician experienced in the use of cancer chemotherapeutic agents. Appropriate management of therapy and complications is possible only when adequate diagnostic and treatment facilities are readily available. Cumulative renal toxicity associated with cisplatin is severe. Other major dose-related toxicities are myelosuppression, nausea, and vomiting. Ototoxicity, which may be more pronounced in children, and is manifes...

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Ongoing clinical trials by development phase

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Key Completed Trials

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Completed studies with published results, ranked by significance

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Trial Timeline

Full development history with FDA approval milestones

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Understanding FDA Approval Types
Count Type What it means
- ORIG Original approval - drug first enters market
- SUPPL - Efficacy New indication (new disease/condition approved)
- SUPPL - Labeling Label text changes (warnings, dosing updates)
- SUPPL - Manufacturing Production changes (new facility)
- SUPPL - Chemistry Formulation changes (new dosage strength)

Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.

CISPLATIN FDA Label Details

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Indications & Usage

FDA Label (PDF)

Cisplatin Injection is indicated as therapy to be employed as follows: Metastatic Testicular Tumors In established combination therapy with other approved chemotherapeutic agents in patients with metastatic testicular tumors who have already received appropriate surgical and/or radio therapeutic procedures. Metastatic Ovarian Tumors In established combination therapy with other approved chemotherapeutic agents in patients with metastatic ovarian tumors who have already received appropriate surgical and/or radiotherapeutic procedures. An established combination consists of cisplatin and cycloph...

โš ๏ธ BOXED WARNING

WARNING Cisplatin should be administered under the supervision of a qualified physician experienced in the use of cancer chemotherapeutic agents. Appropriate management of therapy and complications is possible only when adequate diagnostic and treatment facilities are readily available. Cumulative r...

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Data Sources

Data sourced from official FDA and NIH databases. Click links to verify on original sources.