Overview
Carboplatin is an organoplatinum antineoplastic alkylating agent used in the treatment of advanced ovarian carcinoma. Early clinical studies of carboplatin were performed in 1982. Carboplatin was developed as an analog of cisplatin with reduced nephrotoxicity and vomiting. Carboplatin was granted FDA approval on 3 March 1989.
Indication
Carboplatin is indicated in combination with an established combination of chemotherapeutic agents for the initial treatment of advanced ovarian carcinoma. Carboplatin is also indicated for the palliative treatment of ovarian carcinoma, recurrent after prior chemotherapy.
Associated Conditions
- Advanced Cervical Cancer
- Advanced Endometrial Cancer
- Advanced Esophageal Cancers
- Advanced Head and Neck Cancer
- Advanced Melanoma
- Advanced Non-Small Cell Lung Cancer (NSCLC)
- Advanced Ovarian Carcinoma
- Advanced Sarcoma
- Malignant Pleural Mesothelioma (MPM)
- Merkel Cell Carcinoma
- Metastatic Breast Cancer
- Refractory Hodgkin Lymphoma
- Retinoblastoma
- Thymoma
- Advanced Bladder cancer
- Advanced Small cell lung cancer
- Advanced Testicular cancer
- Advanced Thymoma
- Refractory Non-Hodgkin's lymphoma
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
|---|---|---|---|---|---|
2025/07/11 | Not Applicable | Not yet recruiting | |||
2025/06/29 | Not Applicable | Not yet recruiting | |||
2025/06/17 | Phase 2 | Recruiting | |||
2025/06/17 | Phase 2 | Not yet recruiting | |||
2025/06/15 | Phase 2 | Recruiting | |||
2025/06/13 | Phase 2 | Not yet recruiting | |||
2025/06/12 | Phase 2 | Not yet recruiting | |||
2025/06/11 | Phase 2 | Not yet recruiting | Vandana Abramson | ||
2025/06/06 | Phase 1 | Recruiting | |||
2025/06/05 | Phase 3 | Not yet recruiting |
FDA Drug Approvals
Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
|---|---|---|---|---|---|
| Ingenus Pharmaceuticals, LLC | 50742-448 | INTRAVENOUS | 600 mg in 60 mL | 7/12/2023 | |
| Ingenus Pharmaceuticals, LLC | 50742-447 | INTRAVENOUS | 450 mg in 45 mL | 7/12/2023 | |
| Teva Parenteral Medicines, Inc. | 0703-4248 | INTRAVENOUS | 10 mg in 1 mL | 1/31/2016 | |
| Hospira, Inc. | 61703-600 | INTRAVENOUS | 10 mg in 1 mL | 5/23/2022 | |
| BPI Labs LLC | 54288-165 | INTRAVENOUS | 10 mg in 1 mL | 11/16/2023 | |
| Hospira, Inc. | 61703-360 | INTRAVENOUS | 10 mg in 1 mL | 5/23/2022 | |
| Gland Pharma Limited | 68083-190 | INTRAVENOUS | 10 mg in 1 mL | 2/18/2017 | |
| Teva Parenteral Medicines, Inc. | 0703-4244 | INTRAVENOUS | 10 mg in 1 mL | 1/31/2016 | |
| Teva Parenteral Medicines, Inc. | 0703-4239 | INTRAVENOUS | 10 mg in 1 mL | 1/31/2016 | |
| Meitheal Pharmaceuticals Inc. | 71288-100 | INTRAVENOUS | 10 mg in 1 mL | 12/2/2022 |
EMA Drug Approvals
Approved Product | Authorization Holder | Status | Issued Date |
|---|---|---|---|
| No EMA approvals found for this drug. | |||
HSA Drug Approvals
Approved Product | Manufacturer | Approval Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| DBL CARBOPLATIN INJECTION 10 mg/ml | SIN02301P | INJECTION | 10 mg/ml | 8/16/1988 | |
| KEMOCARB CONCENTRATE FOR SOLUTION FOR INFUSION 10MG/ML | SIN16203P | INFUSION, SOLUTION CONCENTRATE | 10.00mg/ ml | 5/20/2021 | |
| CARBOTINOL INJECTION 50 mg/5 ml | SIN10356P | INJECTION | 50 mg/5 ml | 11/3/1998 |
NMPA Drug Approvals
Approved Product | Company | Approval Number | Drug Type | Dosage Form | Approval Date |
|---|---|---|---|---|---|
| Carboplatin Injection | 国药准字H20253909 | 化学药品 | 注射剂 | 4/15/2025 | |
| Carboplatin Injection | 国药准字H20253912 | 化学药品 | 注射剂 | 4/15/2025 | |
| Carboplatin Injection | 国药准字H20253910 | 化学药品 | 注射剂 | 4/15/2025 | |
| Carboplatin Injection | 国药准字H20253911 | 化学药品 | 注射剂 | 4/15/2025 | |
| Carboplatin Injection | 国药准字H20203353 | 化学药品 | 注射剂 | 7/29/2020 | |
| Carboplatin Injection | 国药准字H20020180 | 化学药品 | 注射剂 | 4/20/2020 | |
| Carboplatin Injection | 国药准字H20249713 | 化学药品 | 注射剂 | 12/6/2024 | |
| Carboplatin Injection | 国药准字H20020181 | 化学药品 | 注射剂 | 4/20/2020 | |
| Carboplatin Injection | 国药准字H20227083 | 化学药品 | 注射剂 | 6/16/2022 | |
| Carboplatin Injection | 国药准字H20227082 | 化学药品 | 注射剂 | 6/16/2022 |
PPB Drug Approvals
Approved Product | Registration No. | Company | Licence No. | Strength | Registration Date |
|---|---|---|---|---|---|
| No PPB approvals found for this drug. | |||||
TGA Drug Approvals
Approved Product | ARTG ID | Sponsor | Registration Type | Status | Registration Date |
|---|---|---|---|---|---|
| CARBOPLATIN ACCORD carboplatin 50 mg / 5 mL solution for injection vial | 215852 | Medicine | A | 11/21/2014 | |
| Carboplatin Injection 450 mg in 45 mL (5) | 303644 | Medicine | A | 5/29/2018 | |
| Hospira Carboplatin Injection 50 mg/5 mL vial | 144549 | Medicine | A | 9/11/2007 | |
| Carboplatin Injection 50 mg in 5 mL (3) | 302238 | Medicine | A | 4/24/2018 | |
| PFIZER Carboplatin Injection 450 mg/45 mL | 469426 | Medicine | A | 11/20/2024 | |
| Hospira Carboplatin Injection 10 mg/mL Solution 50 mg/5 mL vial | 144551 | Medicine | A | 9/11/2007 | |
| Carboplatin Injection 150mg in 15mL (8) | 400798 | Medicine | A | 12/8/2022 | |
| Carboplatin Injection 150 mg in 15 mL (3) | 302241 | Medicine | A | 4/24/2018 | |
| Pfizer Carboplatin Injection 10 mg/mL | 462506 | Medicine | A | 9/20/2024 | |
| Carboplatin Injection 150mg in 15mL (4) | 303318 | Medicine | A | 5/22/2018 |
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