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
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:
- 1,2-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]
- 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]
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 |
TGA Drug Approvals
Approved Product | ARTG ID | Sponsor | Registration Type | Status | Registration Date |
---|---|---|---|---|---|
OXALIPLATIN WKT oxaliplatin 100mg/20 ml concentrate for solution for infusion vial | 276496 | Medicine | A | 10/13/2017 | |
OXALIPLATIN AN oxaliplatin 200 mg/40 mL concentrated injection vial | 177984 | Medicine | A | 3/27/2012 | |
DBL OXALIPLATIN oxaliplatin concentrate for infusion vial 50mg/10mL | 131754 | Medicine | A | 2/20/2009 | |
OXALIPLATIN AG oxaliplatin 50 mg/10 mL concentrated injection vial | 177994 | Medicine | A | 3/27/2012 | |
Oxaliplatin Juno oxaliplatin 100mg/20mL concentrated injection vial | 245533 | Medicine | A | 5/24/2016 | |
OXALIPLATIN ACCORD oxaliplatin 100 mg/20 mL concentrated injection vial | 352809 | Medicine | A | 4/30/2021 | |
OXALIPLATIN INTAS oxaliplatin 50 mg/10 mL concentrated injection vial | 352806 | Medicine | A | 4/30/2021 | |
Hospira Oxaliplatin 5 mg/mL Concentrate for Solution for Infusion, 100 mg/20 mL | 146110 | Medicine | A | 10/17/2007 | |
Hospira Oxaliplatin for Injection 50 mg vial | 142482 | Medicine | A | 7/24/2007 | |
OXALIPLATIN AN oxaliplatin 100 mg powder for injection vial | 178093 | Medicine | A | 3/27/2012 |
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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