MedPath

Carboplatin

Generic Name
Carboplatin
Brand Names
Paraplatin
Drug Type
Small Molecule
Chemical Formula
C6H12N2O4Pt
CAS Number
41575-94-4
Unique Ingredient Identifier
BG3F62OND5

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
Study of Datopotamab Deruxtecan Plus Carboplatin or Cisplatin Versus Gemcitabine Plus Carboplatin or Cisplatin in Participants With Locally Advanced or Metastatic Urothelial Carcinoma
2025/08/19
NCT07129993
Not Applicable
Not yet recruiting
Daiichi Sankyo
A Study to Assess the Efficacy and Safety of Zipalertinib Versus Placebo for Adjuvant Treatment in Participants With Stage IB-IIIA NSCLC With Uncommon EGFR Mutations, Following Complete Tumor Resection
2025/08/17
NCT07128199
Not Applicable
Not yet recruiting
Taiho Oncology, Inc.
IBI363 Combined With Chemotherapy or Pembrolizumab Combined With Chemotherapy as Neoadjuvant Therapy in Resectable Stage IB-III Non-Squamous Non-Small Cell Lung Cancer
2025/08/14
NCT07122687
Not Applicable
Not yet recruiting
Innovent Biologics (Suzhou) Co. Ltd.
Personalized Neck Radiation Therapy Directed by Sentinel Lymph Node Biopsy for the Treatment of Oral Cavity Squamous Cell Carcinoma, PRECEDENT Trial
2025/08/13
NCT07121595
Not Applicable
Recruiting
University of Michigan Rogel Cancer Center
A Study of Dostarlimab in Combination With Carboplatin-paclitaxel in Chinese Participants With Primary Advanced or Recurrent Endometrial Cancer (EC)
2025/08/07
NCT07108270
Not Applicable
Not yet recruiting
GlaxoSmithKline
Phase 2/3 Trial of Izalontamab Brengitecan vs Platinum-based Chemotherapy for Metastatic Urothelial Cancer With Disease Progression on or After Immunotherapy
2025/08/06
NCT07106762
Not Applicable
Not yet recruiting
Bristol-Myers Squibb
Camrelizumab in Combination With Chemotherapy as Neoadjuvant Treatment in Patients With Early or Locally Advanced Triple-negative Breast Cancer
2025/08/06
NCT07107217
Not Applicable
Not yet recruiting
Blokhin's Russian Cancer Research Center
A Phase 2 Neoadjuvant Study of Zanidatamab in Combination With Chemotherapy in Participants With HER2-positive Breast Cancer
2025/08/03
NCT07102381
Not Applicable
Not yet recruiting
Jazz Pharmaceuticals
Study of Izalontamab Brengitecan (BMS-986507) Versus Platinum-Pemetrexed for EGFR-mutated Non-small Cell Lung Cancer After Failure of EGFR TKI Therapy (IZABRIGHT-Lung01)
2025/08/03
NCT07100080
Not Applicable
Not yet recruiting
Bristol-Myers Squibb
Trial Investigating Visugromab in Combination With Immunochemotherapy in 1L Treatment of Participants With Metastatic NSCLC
2025/08/01
NCT07098988
Not Applicable
Not yet recruiting
CatalYm GmbH

FDA Drug Approvals

Approved Product
Manufacturer
NDC Code
Route
Strength
Effective Date
Carboplatin
Ingenus Pharmaceuticals, LLC
50742-448
INTRAVENOUS
600 mg in 60 mL
7/12/2023
Carboplatin
Ingenus Pharmaceuticals, LLC
50742-447
INTRAVENOUS
450 mg in 45 mL
7/12/2023
CARBOplatin
Teva Parenteral Medicines, Inc.
0703-4248
INTRAVENOUS
10 mg in 1 mL
1/31/2016
Carboplatin
Hospira, Inc.
61703-600
INTRAVENOUS
10 mg in 1 mL
5/23/2022
CARBOPLATIN
BPI Labs LLC
54288-165
INTRAVENOUS
10 mg in 1 mL
11/16/2023
Carboplatin
Hospira, Inc.
61703-360
INTRAVENOUS
10 mg in 1 mL
5/23/2022
CARBOPLATIN
Gland Pharma Limited
68083-190
INTRAVENOUS
10 mg in 1 mL
2/18/2017
KYXATA
Avyxa Pharma, LLC
83831-141
INTRAVENOUS
80 mg in 8 mL
8/11/2025
CARBOplatin
Teva Parenteral Medicines, Inc.
0703-4244
INTRAVENOUS
10 mg in 1 mL
1/31/2016
CARBOplatin
Teva Parenteral Medicines, Inc.
0703-4239
INTRAVENOUS
10 mg in 1 mL
1/31/2016

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
Hospira Australia Pty Ltd
SIN02301P
INJECTION
10 mg/ml
8/16/1988
KEMOCARB CONCENTRATE FOR SOLUTION FOR INFUSION 10MG/ML
Fresenius Kabi Oncology Ltd.
SIN16203P
INFUSION, SOLUTION CONCENTRATE
10.00mg/ ml
5/20/2021
CARBOTINOL INJECTION 50 mg/5 ml
KOREA UNITED PHARMACEUTICAL INC
SIN10356P
INJECTION
50 mg/5 ml
11/3/1998

NMPA Drug Approvals

Approved Product
Company
Approval Number
Drug Type
Dosage Form
Approval Date
No NMPA approvals found for this drug.

PPB Drug Approvals

Approved Product
Registration No.
Company
Licence No.
Strength
Registration Date
No PPB approvals found for this drug.

Health Canada Drug Approvals

Approved Product
Company
DIN
Dosage Form
Strength
Market Date
CARBOPLATIN INJECTION
auro pharma inc
02528916
Solution - Intravenous
10 MG / ML
N/A
CARBOPLATIN INJECTION
omega laboratories limited
02366053
Solution - Intravenous
10 MG / ML
6/10/2013
CARBOPLATIN INJECTION
teva canada limited
02125439
Liquid - Intravenous
10 MG / ML
12/31/1994
CARBOPLATIN INJECTION, BP
Strides Pharma Canada Inc
02420228
Solution - Intravenous
10 MG / ML
N/A
CARBOPLATIN INJECTION BP
Accord Healthcare Inc
02320371
Solution - Intravenous
10 MG / ML
3/11/2015
PARAPLATIN-AQ INJ 10MG/ML
bristol-myers squibb canada
00788759
Liquid - Intravenous
10 MG / ML
12/31/1989
CARBOPLATIN INJECTION
eugia pharma inc.
02535289
Solution - Intravenous
10 MG / ML
N/A
CARBOPLATIN INJECTION LIQ 10MG/ML
david bull laboratories (pty) ltd.
01990438
Liquid - Intravenous
10 MG / ML
12/31/1992
PARAPLATIN INJ 150MG/VIAL
bristol labs division of bristol-myers squibb
00680060
Powder For Solution - Intravenous
150 MG / VIAL
12/31/1986
CARBOPLATIN INJECTION BP
Pfizer Canada Ulc
02126680
Solution - Intravenous
10 MG / ML
7/30/1997

CIMA AEMPS Drug Approvals

Approved Product
Company
Registration Number
Pharmaceutical Form
Prescription Type
Status
CARBOPLATINO AUROVITAS 10 MG/ML CONCENTRADO PARA SOLUCIÓN PARA PERFUSIÓN EFG
Eugia Pharma (Malta) Limited
89044
CONCENTRADO PARA SOLUCIÓN PARA PERFUSIÓN
Uso Hospitalario
Commercialized
CARBOPLATINO HIKMA 10 MG/ML SOLUCION PARA PERFUSION EFG
Hikma Farmaceutica (Portugal) S.A.
83636
SOLUCIÓN PARA PERFUSIÓN
Uso Hospitalario
Commercialized
CARBOPLATINO KABI 10 MG/ML CONCENTRADO PARA SOLUCION PARA PERFUSION EFG
Fresenius Kabi España, S.A.U.
76092
CONCENTRADO PARA SOLUCIÓN PARA PERFUSIÓN
Uso Hospitalario
Not Commercialized
CARBOPLATINO PHARMACIA 10 mg/ml CONCENTRADO PARA SOLUCION PARA PERFUSION EFG
Pharmacia Nostrum S.A.
62123
CONCENTRADO PARA SOLUCIÓN PARA PERFUSIÓN
Uso Hospitalario
Commercialized
PARAPLATIN 150 mg/15 ml SOLUCION PARA PERFUSION
Bristol Myers Squibb S.A.
58452
SOLUCIÓN PARA PERFUSIÓN
Uso Hospitalario
Not Commercialized
PARAPLATIN 450 mg/45 ml SOLUCION PARA PERFUSION
Bristol Myers Squibb S.A.
58520
SOLUCIÓN PARA PERFUSIÓN
Uso Hospitalario
Not Commercialized
CARBOPLATINO TEVA 10 mg/ml CONCENTRADO PARA SOLUCION PARA PERFUSION
Teva Pharma S.L.U.
65108
CONCENTRADO PARA SOLUCIÓN PARA PERFUSIÓN
Uso Hospitalario
Commercialized
CARBOPLATINO ACCORD 10 mg/ml CONCENTRADO PARA SOLUCION PARA PERFUSION EFG
Accord Healthcare S.L.U.
70707
CONCENTRADO PARA SOLUCIÓN PARA PERFUSIÓN
Uso Hospitalario
Commercialized

Philippines FDA Drug Approvals

Approved Product
Company
License Number
Dosage Form
Strength
Approval Date
No Philippines FDA approvals found for this drug.

Saudi SFDA Drug Approvals

Approved Product
Company
License Number
Dosage Form
Strength
Approval Date
No Saudi SFDA approvals found for this drug.

Malaysia NPRA Drug Approvals

Approved Product
Company
Registration Number
Dosage Form
Strength
Approval Date
No Malaysia NPRA approvals found for this drug.

UK EMC Drug Information

Medicine Name
MA Holder
MA Number
Pharmaceutical Form
Active Ingredient
Authorization Date
No UK EMC drug information found for this drug.

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