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Oxaliplatin

Generic Name
Oxaliplatin
Drug Type
Small Molecule
Chemical Formula
C8H14N2O4Pt
CAS Number
61825-94-3
Unique Ingredient Identifier
04ZR38536J

Overview

Oxaliplatin is a platinum-based chemotherapy drug in the same family as cisplatin and carboplatin. Compared to cisplatin the two amine groups are replaced by diamino cyclohexane (DACH) group to provide a greater antitumor effect. However, this leads to poorer water solubility, which was compensated by the addition of the chloride moieties. Due to this chemical moiety, oxaliplatin readily undergoes non-enzymatic biotransformation, thus complicating oxaliplatin's pharmacokinetics. Like most platinum-based compounds, oxaliplatin's mechanism of action is primarily through DNA damage through DNA crosslinking, particularly intrastrand and interstrand crosslinking. However, due to the structure of oxaliplatin, its adducts make the binding of mismatch repair protein to DNA harder compared to cisplatin or carboplatin's adducts, resulting in greater cytotoxic effects. The DACH moiety also prevents cross-resistance with cisplatin and carboplatin. Although oxaliplatin has been investigated as a monotherapy, it is typically administered in combination with fluorouracil and leucovorin, known as the FOLFOX regimen, for the treatment of colorectal cancer. This is an effective combination treatment both as a first-line treatment and in patients refractory to an initial fluorouracil and leucovorin combination. Ongoing trials have also shown promising results for oxaliplatin use in nonHodgkin’s lymphoma, breast cancer, mesothelioma, and non-small cell lung cancer. Oxaliplatin was approved by the FDA on January 9, 2004 and is currently marketed by Sanofi-Aventis under the trademark Eloxatin®.

Indication

Oxaliplatin, in combination with infusional fluorouracil and leucovorin, is indicated for the treatment of advanced colorectal cancer and adjuvant treatment of stage III colon cancer in patients who have undergone complete resection of the primary tumor.

Associated Conditions

  • Advanced Colorectal Cancer
  • Stage III Colon Cancer

Research Report

Published: Jul 16, 2025

A Comprehensive Monograph on Oxaliplatin: Pharmacology, Clinical Efficacy, and Safety

Section I: Drug Identification and Physicochemical Properties

1.1 Overview and Classification

Oxaliplatin is a third-generation platinum coordination complex that functions as a potent antineoplastic agent.[1] It is categorized pharmacologically as an alkylating agent and is structurally defined as a diaminocyclohexane (DACH) platinum derivative.[2] This specific chemical lineage distinguishes it from its predecessors, cisplatin and carboplatin, granting it a unique profile of efficacy and toxicity.[1] As a small molecule drug, Oxaliplatin has become a cornerstone of modern chemotherapy, particularly in the management of colorectal cancer.[1]

1.2 Chemical Identity and Structure

The therapeutic activity and distinct clinical behavior of Oxaliplatin are direct consequences of its unique molecular architecture. Its formal International Union of Pure and Applied Chemistry (IUPAC) name is (SP-4-2)-[ethanedioato(2-)-kO1,kO2]-platinum.[6] It is also referred to as

cis-\ [oxalato(2-)- O,O'] platinum.[7]

Structurally, Oxaliplatin is an organoplatinum complex built around a central platinum (II) atom.[8] This platinum atom is coordinated with two distinct ligands that define its function:

  1. 1,2-Diaminocyclohexane (DACH): A bulky, non-leaving side chain that replaces the two simple amine groups found on cisplatin. This modification is not merely incidental; it is the primary structural feature responsible for Oxaliplatin's enhanced cytotoxicity and, critically, its ability to overcome certain mechanisms of platinum resistance.[1]
  2. Oxalate Ligand: A bidentate oxalate group that acts as a labile "leaving group." In the physiological environment of the body, this ligand is displaced, which is the essential step in activating the drug to its cytotoxic form.[8]

Continue reading the full research report

Clinical Trials

Title
Posted
Study ID
Phase
Status
Sponsor
2025/08/20
Not Applicable
Not yet recruiting
First Affiliated Hospital of Guangxi Medical University
2025/08/15
Not Applicable
Recruiting
2025/08/12
Not Applicable
Recruiting
CSPC ZhongQi Pharmaceutical Technology Co., Ltd.
2025/08/08
Not Applicable
Not yet recruiting
Tao Zhang
2025/07/31
Not Applicable
Not yet recruiting
2025/07/31
Not Applicable
Not yet recruiting
2025/07/22
Not Applicable
Not yet recruiting
2025/07/17
Not Applicable
Not yet recruiting
2025/07/09
Not Applicable
Recruiting
Zhejiang Doer Biologics Co., Ltd.
2025/06/29
Not Applicable
Not yet recruiting

FDA Drug Approvals

Approved Product
Manufacturer
NDC Code
Route
Strength
Effective Date
Sanja Pharmaceuticals Company
57277-001
INTRAVENOUS
5 mg in 1 mL
9/9/2017
Meitheal Pharmaceuticals Inc.
71288-101
INTRAVENOUS
5 mg in 1 mL
10/18/2018
Sandoz Inc
0781-9317
INTRAVENOUS
5 mg in 1 mL
2/25/2016
Winthrop U.S, a business of sanofi-aventis U.S. LLC
0955-1733
INTRAVENOUS
5 mg in 1 mL
12/7/2023
NorthStar Rx LLC
72603-301
INTRAVENOUS
5 mg in 1 mL
2/1/2019
Teva Parenteral Medicines, Inc.
0703-3986
INTRAVENOUS
100 mg in 20 mL
7/31/2022
BluePoint Laboratories
68001-468
INTRAVENOUS
5 mg in 1 mL
8/31/2023
Fresenius Kabi USA, LLC
63323-750
INTRAVENOUS
5 mg in 1 mL
9/30/2020
Winthrop U.S, a business of sanofi-aventis U.S. LLC
0955-1725
INTRAVENOUS
5 mg in 1 mL
12/7/2023
Gland Pharma Limited
68083-176
INTRAVENOUS
5 mg in 1 mL
8/25/2023

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
OLIPLAT INJECTION 5 MG/ML
Mylan Laboratories Limited [OTL]
SIN14242P
INJECTION, SOLUTION, CONCENTRATE
5 mg/ml
10/2/2012
OXALIPLATIN SANDOZ CONCENTRATE FOR SOLUTION FOR INFUSION 5MG/ML
SIN14481P
INFUSION, SOLUTION CONCENTRATE
5mg/ml
1/13/2014
Oxaliplatin Hospira 5mg/mL, 100mg/20mL
SIN13943P
INFUSION, SOLUTION CONCENTRATE
100mg
4/1/2011
OLIPLAT POWDER FOR SOLUTION FOR INJECTION 100 mg/vial
Mylan Laboratories Limited [OTL]
SIN14243P
INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
100.00 mg
10/2/2012
HOVID OXALIPLATIN POWDER FOR CONCENTRATE FOR SOLUTION FOR INFUSION 100MG/VIAL
SIN15911P
INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
100 mg/vial
3/16/2020
HOVID OXALIPLATIN POWDER FOR CONCENTRATE FOR SOLUTION FOR INFUSION 50MG/VIAL
SIN15910P
INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
50 mg/vial
3/16/2020
Oxaliplatin Hospira 5mg/mL, 50mg/10mL
SIN13942P
INFUSION, SOLUTION CONCENTRATE
50mg
4/1/2011
OXALIPLATIN ADVAGEN CONCENTRATE FOR SOLUTION FOR INFUSION 5MG/ML
SIN16353P
INFUSION, SOLUTION CONCENTRATE
5mg/mL
10/26/2021
Oxitan Injection 5mg/ml
SIN14231P
INJECTION
5mg/ml
9/20/2012
Eloxatin 5mg/ml Concentrate for solution for infusion
SIN13237P
INJECTION, SOLUTION, CONCENTRATE
5mg/ml
3/12/2007

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
OXALIPLATIN CONCENTRATE FOR SOLUTION FOR INFUSION 100MG/20ML
N/A
N/A
N/A
1/6/2023

Health Canada Drug Approvals

Approved Product
Company
DIN
Dosage Form
Strength
Market Date
OXALIPLATIN INJECTION
teva canada limited
02435071
Solution - Intravenous
5 MG / ML
12/16/2015
OXALIPLATIN INJECTION
02436957
Solution - Intravenous
5 MG / ML
12/17/2015
OXALIPLATIN INJECTION
generic medical partners inc
02454084
Solution - Intravenous
5 MG / ML
N/A
OXALIPLATIN INJECTION, USP
dr reddy's laboratories ltd
02458403
Solution - Intravenous
5 MG / ML
7/13/2022
OXALIPLATIN FOR INJECTION
hospira healthcare ulc
02413841
Powder For Solution - Intravenous
100 MG / VIAL
N/A
ELOXATIN
sanofi-aventis canada inc
02296268
Powder For Solution - Intravenous
50 MG / VIAL
6/27/2008
ACT OXALIPLATIN
actavis pharma company
02432617
Solution - Intravenous
5 MG / ML
12/16/2015
ACT OXALIPLATIN
actavis pharma company
02430533
Powder For Solution - Intravenous
100 MG / VIAL
N/A
TARO-OXALIPLATIN
02449692
Solution - Intravenous
5 MG / ML
2/15/2017
TEVA-OXALIPLATIN INJECTION
teva canada limited
02446227
Solution - Intravenous
5 MG / ML
N/A

CIMA AEMPS Drug Approvals

Approved Product
Company
Registration Number
Pharmaceutical Form
Prescription Type
Status
OXALIPLATINO GP-PHARM 5 mg/ml, POLVO PARA SOLUCION PARA PERFUSION EFG
Gp Pharm S.A.
72666
POLVO PARA SOLUCIÓN PARA PERFUSIÓN
Uso Hospitalario
Not Commercialized
OXALIPLATINO HOSPIRA 5 mg/ml CONCENTRADO PARA SOLUCION PARA PERFUSION EFG
Pfizer S.L.
69518
CONCENTRADO PARA SOLUCIÓN PARA PERFUSIÓN
Uso Hospitalario
Not Commercialized
OXALIPLATINO ACCORD 5 mg/ml CONCENTRADO PARA SOLUCION PARA PERFUSION EFG
72386
CONCENTRADO PARA SOLUCIÓN PARA PERFUSIÓN
Uso Hospitalario
Commercialized
OXALIPLATINO HIKMA 5 MG/ML CONCENTRADO PARA SOLUCION PARA PERFUSION EFG
86380
CONCENTRADO PARA SOLUCIÓN PARA PERFUSIÓN
Uso Hospitalario
Commercialized
OXALIPLATINO QILU 5 MG/ML CONCENTRADO PARA SOLUCION PARA PERFUSION EFG
81823
CONCENTRADO PARA SOLUCIÓN PARA PERFUSIÓN
Uso Hospitalario
Commercialized
ELOXATIN 5 mg/ml CONCENTRADO PARA SOLUCION PARA PERFUSION
Sanofi Aventis S.A.
67390
CONCENTRADO PARA SOLUCIÓN PARA PERFUSIÓN
Uso Hospitalario
Not Commercialized
OXALIPLATINO KABI 5 mg/ml CONCENTRADO PARA SOLUCION PARA PERFUSION EFG
Fresenius Kabi España, S.A.U.
71346
CONCENTRADO PARA SOLUCIÓN PARA PERFUSIÓN
Uso Hospitalario
Commercialized
OXALIPLATINO CADIASUN 5 MG/ML POLVO PARA SOLUCIÓN PARA PERFUSIÓN EFG
Cadiasun Pharma Gmbh
77233
POLVO PARA SOLUCIÓN PARA PERFUSIÓN
Uso Hospitalario
Not Commercialized
OXALIPLATINO KALCEKS 5 MG/ML CONCENTRADO PARA SOLUCION PARA PERFUSION EFG
Kalceks As
89397
CONCENTRADO PARA SOLUCIÓN PARA PERFUSIÓN
Uso Hospitalario
Not Commercialized
OXALIPLATINO AUROVITAS 5 mg/ml CONCENTRADO PARA SOLUCIÓN PARA PERFUSIÓN EFG
Aurovitas Spain, S.A.U.
74655
CONCENTRADO PARA SOLUCIÓN PARA PERFUSIÓN
Uso Hospitalario
Not 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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