Data updated: May 26, 2026
CISPLATIN
Oncology
Approved 1978-12-19
CISPLATIN is indicated for the treatment of Testicular Cancer; Ovarian Cancer; Bladder Cancer.
Source: FDA Label • Hikma
11
Indications
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Phase 3 Trials
47
Years on Market
Details
- Status
- Prescription
- First Approved
- 1978-12-19
- Routes
- INJECTION
- Dosage Forms
- INJECTABLE
Companies
Hikma Fresenius Kabi ACCORD HLTHCARE PHARMOBEDIENT QILU HQ SPCLT PHARMA GLAND Teva PHARMACHEMIE BV BEDFORD
Active Ingredient: CISPLATIN
Website: ↗
CISPLATIN Approval History
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168 FDA actions from 1978 to 2024 · 2 indication expansions
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Dec 1978 ORIGINAL
New Drug
What CISPLATIN Treats
3 indicationsCISPLATIN 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...
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 manifested by tinnitus, and/or loss of high frequency hearing and occasionally deafness, is significant. Anaphylactic-like reactions to cisplatin have been reported. Facial edema, bronchoconstriction, tachycardia, and hypotension may occur within minutes of cisplatin administration. Epinephrine, corticosteroids, and antihistamines have been effectively employed to alleviate symptoms (see WARNINGS and ADVERSE REACTIONS ). Exercise caution to prevent inadvertent cisplatin overdose . Doses greater than 100 mg/m 2 /cycle once every 3 to 4 weeks are rarely used. Care must be taken to avoid inadvertent cisplatin overdose due to confusion with carboplatin or prescribing practices that fail to differentiate daily doses from total dose per cycle.
CISPLATIN Competitive Set
ProThree rings of competition based on shared molecular targets and treated indications.
Indication competitors
10
Same indication, different mechanism — what else might this patient receive?
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What's emerging in CISPLATIN's indications
See all emerging drugs →Phase 3 candidates targeting molecules with no FDA-approved drug, in indications CISPLATIN treats. First-in-class if their pivotal trials read out positive.
Tiragolumab MTIG7192A / RG6058 ~ Mixed — Ph3 readout
Hoffmann-La Roche TIGIT · monoclonal antibody (anti-TIGIT) · 10 Phase 3 trials
Brigimadlin BI 907828
Boehringer Ingelheim MDM2 · small-molecule MDM2-p53 inhibitor · 3 Phase 3 trials
Ceralasertib AZD6738 ~ Mixed — Ph3 readout
AstraZeneca ATR · small-molecule ATR kinase inhibitor · 2 Phase 3 trials
Drugs Similar to CISPLATIN
3 of 18FDA-approved drugs for similar conditions. Compare mechanisms and indications to understand treatment alternatives.
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Clinical Trial Registry
1256 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT06770582 | NCI-2025-00008 NCI-2025-00008, NRG-GU014 | Ph 2 | recruiting | Testing the Addition of the Immunotherapy Drug, Pembrolizumab, to Radiation Therapy Compared to the Usual Chemotherapy Treatment During Radiation Therapy for Bladder Cancer, PARRC Trial |
| NCT06406465 | 10001601 001601-C | Ph 2 | recruiting | A UGT1A1 Genotype-Directed Study of Belinostat Pharmacokinetics and Toxicity |
| NCT06172296 | NCI-2023-08530 NCI-2023-08530, ANBL2131 | Ph 3 | recruiting | Dinutuximab With Chemotherapy, Surgery and Stem Cell Transplantation for the Treatment of Children With Newly Diagnosed High Risk Neuroblastoma |
| NCT04628767 | NCI-2020-09850 NCI-2020-09850, EA8192 | Ph 2, Ph 3 | recruiting | Testing the Addition of MEDI4736 (Durvalumab) to Chemotherapy Before Surgery for Patients With High-Grade Upper Urinary Tract Cancer |
| NCT05172245 | NCI-2021-13901 NCI-2021-13901, 032204 | Ph 1 | recruiting | Testing the Addition of Ipatasertib to Usual Chemotherapy and Radiation for Head and Neck Cancer |
| NCT06050252 | NCI-2023-07031 NCI-2023-07031, 2024-0230 | Ph 2 | recruiting | Testing the Combination of the Anticancer Drug Durvalumab With Chemotherapy (Gemcitabine and Cisplatin) at Improving Outcomes for High-Risk Resectable Liver Cancer Before Surgery |
| NCT05211323 | NCI-2022-00151 NCI-2022-00151, EA2205 | Ph 2 | active not recruiting | A Study to Determine Whether Chemotherapy and Atezolizumab is Better Than Chemotherapy, Bevacizumab and Atezolizumab in Patients With Advanced Liver Cancer |
| NCT05691478 | NCI-2022-08567 NCI-2022-08567, AOST2032 | Ph 2, Ph 3 | recruiting | A Study to Test the Addition of the Drug Cabozantinib to Chemotherapy in Patients With Newly Diagnosed Osteosarcoma |
| NCT06591650 GCND | Huashan010 | Ph 2 | recruiting | Gemcitabine Hydrochloride, Cisplatin, Nab-Paclitaxel, and Durvalumab in Treating Patients With Locally Advanced or Metastatic Gallbladder Cancer |
| NCT04379596 DG-03 | D967LC00001 2019-004483-22 | Ph 2 | recruiting | Ph1b/2 Study of the Safety and Efficacy of T-DXd Combinations in Advanced HER2-expressing Gastric Cancer (DESTINY-Gastric03) |
| NCT06875310 | CA239-0004 CA2390004 | Ph 3 | recruiting | A Study of Adagrasib Plus Pembrolizumab Plus Chemotherapy vs. Placebo Plus Pembrolizumab Plus Chemotherapy in Participants With Previously Untreated Non-squamous Non-small Cell Lung Cancer With KRAS G12C Mutation (KRYSTAL-4) |
| NCT01810913 | NCI-2013-00500 NCI-2013-00500, RTOG-1216 | Ph 2, Ph 3 | recruiting | Testing Docetaxel-Cetuximab or the Addition of an Immunotherapy Drug, Atezolizumab, to the Usual Chemotherapy and Radiation Therapy in High-Risk Head and Neck Cancer |
| NCT07281417 | NCI-2025-09016 NCI-2025-09016, 10721 | Ph 2 | recruiting | Testing the Addition of Cemiplimab (REGN2810) to Chemotherapy Treatment Given Prior to Surgery in Patients With Sinonasal Squamous Cell Carcinoma |
| NCT03017326 PHITT | RG_15-114 | Ph 3 | active not recruiting | Paediatric Hepatic International Tumour Trial |
| NCT05019716 | NCI-2021-08926 NCI-2021-08926, 10507 | Ph 1, Ph 2 | recruiting | Testing the Safety and Efficacy of the Addition of a New Anti-cancer Drug, ZEN003694, to Chemotherapy Treatment (Cisplatin and Etoposide or Carboplatin and Paclitaxel) for Adult and Pediatric Patients (12-17 Years) With NUT Carcinoma |
| NCT07129993 | DS1062-328 | Ph 2, Ph 3 | recruiting | Study of Datopotamab Deruxtecan Plus Carboplatin or Cisplatin Versus Gemcitabine Plus Carboplatin or Cisplatin in Participants With Locally Advanced or Metastatic Urothelial Carcinoma |
| NCT07005102 | M25-287 2024-518586-10 | Ph 2, Ph 3 | recruiting | A Study to Assess Adverse Events, Change in Disease Activity of Intravenous Telisotuzumab Adizutecan in Combination With Osimertinib as First-Line Treatment in Adult Participants With Locally Advanced Unresectable or Metastatic EGFR-Mutated Non-Squamous Non-Small Cell Lung Cancer |
| NCT04369937 results posted | HCC 19-082 | Ph 2 | completed | HPV-16 Vaccination and Pembrolizumab Plus Cisplatin for "Intermediate Risk" HPV-16-associated Head and Neck Squamous Cell Carcinoma |
| NCT07583511 | TNBG-IIT001 | Ph 2 | recruiting | Teniposide, Cisplatin and Serplulimab for Treatment of ES-SCLC, a Randomized Controlled Study |
| NCT04216290 | NCI-2019-08628 NCI-2019-08628, EA8185 | Ph 2 | active not recruiting | A Study of Chemotherapy and Radiation Therapy Compared to Chemotherapy and Radiation Therapy Plus MEDI4736 (Durvalumab) Immunotherapy for Bladder Cancer Which Has Spread to the Lymph Nodes, INSPIRE Trial |
| NCT07583550 | 2026 049 A | Ph 2 | not yet recruiting | Low-dose Thoracic Radiotherapy Followed by Adebrelimab Plus Chemotherapy, and Then Sequential Maintenance Therapy With Adebrelimab for Extensive-stage Small Cell Lung Cancer |
| NCT06524544 | NCI-2024-06208 NCI-2024-06208, EA8231 | Ph 3 | recruiting | A Study Comparing the Combination of Pembrolizumab and Sacituzumab Govitean-hziy Versus Standard of Care in the Treatment of Advanced Urothelial Cancer |
| NCT06151574 | 1479-0008 2023-504308-27-00, U1111-1294-1407 | Ph 3 | active not recruiting | Beamion LUNG-2: A Study to Test Whether Zongertinib (BI 1810631) Helps People With Advanced Non-small Cell Lung Cancer With HER2 Mutations Compared With Standard Treatment |
| NCT07061977 | NCI-2025-04695 NCI-2025-04695, NRG-GY037 | Ph 3 | recruiting | Induction Pembrolizumab and Chemotherapy Followed by Pembrolizumab Before Chemoradiation and Pembrolizumab Maintenance Compared to Standard Chemoradiation With Pembrolizumab Followed by Pembrolizumab Maintenance in High-Risk Cervical Cancer |
| NCT05063552 | NCI-2021-10021 NCI-2021-10021, EA3202 | Ph 2, Ph 3 | active not recruiting | Testing the Use of Investigational Drugs Atezolizumab and/or Bevacizumab With or Without Standard Chemotherapy in the Second-Line Treatment of Advanced-Stage Head and Neck Cancers |
| NCT04210115 | 3475-975 MK-3475-975, KEYNOTE-975 | Ph 3 | active not recruiting | Study of Pembrolizumab (MK-3475) Versus Placebo in Participants With Esophageal Carcinoma Who Are Receiving Chemotherapy and Radiation Therapy (MK-3475-975/KEYNOTE-975) |
| NCT07195734 | NCI-2025-06920 NCI-2025-06920, NRG-HN015 | Ph 2 | recruiting | Testing the Addition of Chemotherapy or Chemo-Immunotherapy to the Usual Surgery for Advanced Head and Neck Cancer |
| NCT06772623 | M24-536 2024-514465-18, 2024-514465-18-00 | Ph 1, Ph 2 | recruiting | Study to Evaluate Adverse Events and Efficacy of Intravenous (IV) Telisotuzumab Adizutecan in Combination With a PD-1 Immune Checkpoint Inhibitor in Adult Participants With Advanced or Metastatic Non-Squamous NSCLC With No Prior Treatment for Advanced Disease, and No Actionable Genomic Alterations |
| NCT06702033 MINT-2 | 202501127 | Ph 2 | recruiting | The Minimalist Trial-2 |
| NCT05058651 | NCI-2021-09851 NCI-2021-09851, S2012 | Ph 2, Ph 3 | recruiting | Evaluating the Addition of the Immunotherapy Drug Atezolizumab to Standard Chemotherapy Treatment for Advanced or Metastatic Neuroendocrine Carcinomas That Originate Outside the Lung |
| NCT03811015 | NCI-2019-00179 NCI-2019-00179, EA3161 | Ph 3 | active not recruiting | Testing Immunotherapy Versus Observation in Patients With HPV Throat Cancer |
| NCT07444710 | NCI-2026-01137 NCI-2026-01137, PHI-158 | Ph 1 | not yet recruiting | Testing the Addition of an Anti-Cancer Drug, Glofitamab, to the Usual Chemotherapy Treatment (Alternating R-CHOP/R-DHAP) for Previously Untreated Mantle Cell Lymphoma |
| NCT04267848 | NCI-2020-00751 NCI-2020-00751, A081801 | Ph 3 | recruiting | Testing the Addition of a Type of Drug Called Immunotherapy to the Usual Chemotherapy Treatment for Non-small Cell Lung Cancer, an ALCHEMIST Treatment Trial (Chemo-IO [ACCIO]) |
| NCT06694454 | 10001609 001609-C | Ph 1, Ph 2 | recruiting | 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) |
| NCT06029270 | NCI-2023-06678 NCI-2023-06678, NRG-HN011 | Ph 2 | recruiting | Testing the Addition of BMS-986016 (Relatlimab) to the Usual Immunotherapy After Initial Treatment for Recurrent or Metastatic Nasopharyngeal Cancer |
| NCT06064097 | NCI-2023-07208 NCI-2023-07208, ARAR2221 | Ph 2 | recruiting | A Study Using Nivolumab, in Combination With Chemotherapy Drugs to Treat Nasopharyngeal Carcinoma (NPC) |
| NCT05198830 | NCI-2021-14403 NCI-2021-14403, CASE1522 | Ph 2 | recruiting | Testing the Addition of an Anti-Cancer Drug, TRC102, to the Usual Chemotherapy Treatment (Pemetrexed, Cisplatin or Carboplatin) During Radiation Therapy for Stage III Non-Squamous Non-Small Cell Lung Cancer |
| NCT05541016 | GMROR2271 22-004443, DART 2.0 | Ph 2 | recruiting | De-Escalated Adjuvant and Definitive Radiation Therapy Informed by DART 2.0 ctHPV-DNA |
| NCT07579195 | RG1126354 NCI-2026-02920, FHIRB0021260 | Ph 1, Ph 2 | not yet recruiting | Consolidative Therapy After EV + Pembrolizumab in Muscle Invasive Bladder Cancer, REINFORCE Trial |
| NCT06764875 | D702AC00001 2024-512583-57-00 | Ph 3 | recruiting | A Phase Ⅲ Study of Rilvegostomig in Combination With Fluoropyrimidine and Trastuzumab Deruxtecan as the First-line Treatment for HER2-positive Gastric Cancer |
| NCT06119581 SUNRAY-01 | 18612 J3M-MC-JZQB, U1111-1288-0565 | Ph 3 | recruiting | 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 |
| NCT06132113 | 1438-0007 U1111-1292-1400, 2023-505870-13-00 | Ph 1 | recruiting | DAREON™-7: A Study to Test How Well Different Doses of BI 764532 in Addition to Chemotherapy Are Tolerated by People With Advanced Neuroendocrine Cancers |
| NCT03819465 MAGELLAN | D933IC00001 2018-001748-74 | Ph 1 | active not recruiting | A Study of Novel Anti-cancer Agents in Patients With Previously Untreated NSCLC |
| NCT02445391 results posted | EA1131 NCI-2014-01820, EA1131 | Ph 3 | active not recruiting | Platinum in Treating Patients With Residual Triple-Negative Breast Cancer Following Neoadjuvant Chemotherapy |
| NCT05351788 | SKB264-Ⅱ-05 | Ph 2 | recruiting | SKB264 Combinatiton Therapy in Patients With Advanced or Metastatic Non-small Cell Lung Cancer. |
| NCT07106762 | CA244-0012 EU CTR, WHO | Ph 2, Ph 3 | recruiting | Phase 2/3 Trial of Izalontamab Brengitecan vs Platinum-based Chemotherapy for Metastatic Urothelial Cancer With Disease Progression on or After Immunotherapy |
| NCT04436965 | 2019-FXY-348-NPC | Ph 3 | recruiting | Effect of Standard Nutrition Therapy on Nutritional Status and Prognosis in Locoregionally Advanced Nasopharyngeal Carcinoma Patients With Malnutrition |
| NCT06793215 Krascendo 2 | CO45042 | Ph 3 | recruiting | A Study Evaluating the Efficacy and Safety of Divarasib and Pembrolizumab Versus Pembrolizumab and Pemetrexed and Carboplatin or Cisplatin in Participants With Previously Untreated, KRAS G12C-Mutated, Advanced or Metastatic Non-Squamous Non-Small Cell Lung Cancer |
| NCT06230224 OLYMPIA-4 | R1979-HM-2299 2022-502783-21-00 | Ph 3 | active not recruiting | A Trial to Learn How Effective and Safe Odronextamab is Compared to Standard of Care for Adult Participants With Previously Treated Aggressive B-cell Non-Hodgkin Lymphoma |
| NCT06323239 | SBRT/LDRT+PD-1+GP for r/mNPC | Ph 2 | recruiting | SBRT and LDRT Combined With PD-1 Antibody and Chemotherapy in r/m Nasopharyngeal Carcinoma |
Showing 50 of 1256 trials
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Pro Key Completed Trials
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
Indications & Usage
FDA Label (PDF)CISPLATIN is indicated for the treatment of Testicular Cancer; Ovarian Cancer; Bladder Cancer.
⚠️ 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
FDA Approval: ANDA075036 → Label: DailyMed → Patents: FDA Orange Book → Trials: ClinicalTrials.gov →
Data sourced from official FDA and NIH databases. Click links to verify on original sources.