CLINICAL TRIALS PROFILE FOR OXALIPLATIN

505(b)(2) Clinical Trials for Oxaliplatin

This table shows clinical trials for potential 505(b)(2) applications. See the next table for all clinical trials

Trial Type	Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
New Combination	NCT00215982 ↗	Study of Capecitabine With Irinotecan and Oxaliplatin (Eloxatin) in Advanced Colorectal Cancer	Completed	Roche Pharma AG	Phase 2	2004-12-01	The purpose of this study is to find out how effective the new combination of the drugs Capecitabine (Xeloda), Oxaliplatin (Eloxatin), and Irinotecan (Camptosar) are against colon and rectal cancer. All three of these drugs are approved by the Food and Drug Administration (FDA) for the treatment of colon or rectal cancer. This however is the first time that these three drugs have been combined in this schedule for the treatment of colon/rectal cancer.
New Combination	NCT00215982 ↗	Study of Capecitabine With Irinotecan and Oxaliplatin (Eloxatin) in Advanced Colorectal Cancer	Completed	H. Lee Moffitt Cancer Center and Research Institute	Phase 2	2004-12-01	The purpose of this study is to find out how effective the new combination of the drugs Capecitabine (Xeloda), Oxaliplatin (Eloxatin), and Irinotecan (Camptosar) are against colon and rectal cancer. All three of these drugs are approved by the Food and Drug Administration (FDA) for the treatment of colon or rectal cancer. This however is the first time that these three drugs have been combined in this schedule for the treatment of colon/rectal cancer.
New Combination	NCT00356122 ↗	Docetaxel & Oxaliplatin in Combination With Bevacizumab as First-Line Treatment in Subjects With Non-Small Cell Lung Cancer (NSCLC)	Completed	Genentech, Inc.	Phase 2	2006-07-01	The purpose of this study was to see how well three investigational drugs worked together in preventing progression of the disease. This study provided a new combination of chemotherapy drugs - docetaxel and oxaliplatin - as first line therapy in the treatment of lung cancer. The therapy included bevacizumab that may prevent or slow down the blood supply to the tumor and may also prevent tumor growth. The three investigational drugs are United States Food and Drug Administration (FDA) approved.

All Clinical Trials for Oxaliplatin

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00001835 ↗	Oxaliplatin in Cancer Patients With Impaired Kidney Function	Completed	National Cancer Institute (NCI)	Phase 1	1999-09-01	Oxaliplatin is an experimental anti-cancer drug that can shrink tumors such as colon cancer. However, because this drug can damage the kidneys, it is necessary to determine what doses of the drug can safely be given to patients with poor kidney function. Patients with advanced cancer, poorly functioning kidneys, and no good standard treatment options are eligible for this study. Candidates will be screened with imaging tests, such as CT and MRI scans, to determine the size and location of the cancer and with blood and urine tests to evaluate kidney and liver function. Study participants will receive oxaliplatin intravenously (through a vein) every 3 weeks for as long as the cancer is under control and there are no serious side effects from the drug. If significant side effects develop, the dosage will be reduced, or the drug will be stopped. Blood tests to measure blood cell counts will be done at least once a week, and CT scans, chest X-rays, and MRIs will be done about once every 6 weeks to assess the tumor's response to the treatment. Additional blood tests will be done at the beginning of the first two treatment cycles to measure the amount of oxaliplatin in the blood, and urine will be collected during the first 24 hours of drug treatment to determine how much drug is eliminated by the body in urine.
NCT00003260 ↗	Combination Chemotherapy in Treating Patients With Recurrent Metastatic Colorectal Cancer	Unknown status	GERCOR - Multidisciplinary Oncology Cooperative Group	Phase 3	1998-01-01	RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug and giving the drugs in different combinations may kill more tumor cells. It is not yet known whether receiving irinotecan with fluorouracil and leucovorin is more effective than receiving oxaliplatin with fluorouracil and leucovorin in treating recurrent metastatic colorectal cancer PURPOSE: Randomized phase III trial to compare the effectiveness of irinotecan with oxaliplatin followed by fluorouracil and leucovorin in treating patients with recurrent metastatic colorectal cancer.
NCT00003260 ↗	Combination Chemotherapy in Treating Patients With Recurrent Metastatic Colorectal Cancer	Unknown status	Groupe Cooperateur Multidisciplinaire en Oncologie (GERCOR)	Phase 3	1998-01-01	RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug and giving the drugs in different combinations may kill more tumor cells. It is not yet known whether receiving irinotecan with fluorouracil and leucovorin is more effective than receiving oxaliplatin with fluorouracil and leucovorin in treating recurrent metastatic colorectal cancer PURPOSE: Randomized phase III trial to compare the effectiveness of irinotecan with oxaliplatin followed by fluorouracil and leucovorin in treating patients with recurrent metastatic colorectal cancer.

Clinical Trial Conditions for Oxaliplatin

Condition Name

Condition Name for Oxaliplatin
Intervention	Trials
Colorectal Cancer	327
Gastric Cancer	185
Metastatic Colorectal Cancer	134

Condition MeSH

Condition MeSH for Oxaliplatin
Intervention	Trials
Colorectal Neoplasms	691
Adenocarcinoma	366
Stomach Neoplasms	314

Clinical Trial Locations for Oxaliplatin

Trials by Country

Trials by Country for Oxaliplatin
Location	Trials
China	748
Taiwan	78
Brazil	76
Russian Federation	72
Poland	72

Trials by US State

Trials by US State for Oxaliplatin
Location	Trials
California	237
New York	204
Texas	181
Ohio	160
Pennsylvania	159

Clinical Trial Progress for Oxaliplatin

Clinical Trial Phase

Clinical Trial Phase for Oxaliplatin
Clinical Trial Phase	Trials
Phase 4	30
Phase 3	341
Phase 2/Phase 3	66

Clinical Trial Status

Clinical Trial Status for Oxaliplatin
Clinical Trial Phase	Trials
Completed	754
Recruiting	420
Unknown status	268

Clinical Trial Sponsors for Oxaliplatin

Sponsor Name

Sponsor Name for Oxaliplatin
Sponsor	Trials
National Cancer Institute (NCI)	257
Sanofi	132
Sun Yat-sen University	78

Sponsor Type

Sponsor Type for Oxaliplatin
Sponsor	Trials
Other	2391
Industry	925
NIH	259

Clinical Trials Update, Market Analysis, and Projection for Oxaliplatin

Last updated: October 26, 2025

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Introduction

Oxaliplatin, a platinum-based chemotherapeutic agent, remains integral in treating colorectal, gastric, and pancreatic cancers. Since its FDA approval in 2004, it has garnered significant market share within oncology therapeutics. This report consolidates recent clinical trial developments, analyzes the current market landscape, and projects future growth trajectories for oxaliplatin through 2030.

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Clinical Trials Update

Recent Clinical Trials and Outcomes

Oxaliplatin's clinical research focus has shifted toward optimizing dosing strategies, reducing toxicity, and expanding indications. The following summarizes notable recent trials:

• Combination Therapies Enhancement: Multiple Phase III trials have assessed oxaliplatin in combination with immunotherapies. For example, the "OXXEL" trial (NCT0295230) evaluated concurrent oxaliplatin and PD-1 inhibitors in metastatic colorectal cancer, displaying promising response rates and manageable toxicity profiles.

• Adjuvant and Neoadjuvant Studies: Trials such as "FOxTROT" advanced understanding of oxaliplatin's role in early-stage gastric cancers (NCT00772036). Early data suggest improved R0 resection rates with acceptable safety.

• Toxicity Management Trials: Ongoing studies focus on mitigating oxaliplatin-induced neurotoxicity. The "NOR-671" trial explores neuroprotective agents like calcium/Magnesium infusions, reporting reduced sensory neuropathy without compromising efficacy (NCT02175019).

• Biomarker-Driven Trials: Emerging research utilizes genetic markers such as ERCC1 polymorphisms to predict oxaliplatin response, potentially enabling personalized therapy.

Regulatory and Labeling Updates

Recent submissions focus on expanding indications. The European Medicines Agency recently evaluated data on oxaliplatin in combination with targeted agents for metastatic pancreatic cancer, considering approval extensions. The ongoing review underscores a trend towards broader therapeutic applications.

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Market Analysis

Market Size and Key Players

As of 2023, the global oxaliplatin market is valued at approximately USD 1.8 billion, with a CAGR of 6.2% projected through 2030.[1] The predominant manufacturers include:

• Sanofi: Rights holder for Eloxatin, the brand-name formulation.
• Teva Pharmaceuticals: Generic oxaliplatin options.
• Mylan and Hikma: Other significant generics providers.

The market's growth is facilitated by the substantial prevalence of colorectal and gastric cancers, especially in developed countries.

Market Drivers

• Expanding Indications: Clinical evidence supporting oxaliplatin's use in other gastrointestinal cancers broadens its application.
• Combination Regimens: Growing utilization with immunotherapy and targeted agents enhances its market penetration.
• Generic Entry: Increased availability of cost-effective generics reduces treatment costs, promoting earlier adoption.

Market Challenges

• Toxicity Profile: Neurotoxicity remains a limiting factor, necessitating adjunctive solutions that can impact treatment adherence.
• Competition: Emergence of novel targeted therapies and immunotherapies potentially supplant platinum-based chemotherapies in certain settings.
• Regulatory Delays: Pending approval for new indications may constrain future growth.

Regional Market Trends

• North America: Leading market share due to high cancer incidence and advanced healthcare infrastructure.
• Europe and Asia-Pacific: Rapidly expanding markets driven by increasing cancer prevalence and healthcare investments.

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Market Projection (2024-2030)

Based on current trends, the oxaliplatin market is expected to grow steadily, with a CAGR of approximately 6-7%. The factors shaping this projection include:

• Broadened Indications: Successful clinical trials may lead to FDA and EMA approval for additional cancer types, boosting sales.
• R&D Pipeline: Drugs in the pipeline that combine oxaliplatin with novel agents may extend its therapeutic scope.
• Pricing Dynamics: Price competition among generics will sustain affordability, fueling use in emerging markets.

An estimated market value of USD 3.2 billion by 2030 is anticipated, contingent upon successful indication expansion and manageable toxicity profiles.

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Conclusion

Oxaliplatin remains a cornerstone platinum agent in oncology, with ongoing clinical trials poised to refine its application and mitigate adverse effects. Its market is mature but expanding, driven by combination therapies, pipeline innovations, and geographic growth in emerging markets. Strategic focus on toxicity management, personalized medicine integration, and indication expansion will be vital for sustained growth.

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Key Takeaways

• Continuous clinical trial evolution enhances oxaliplatin’s efficacy and safety, facilitating its therapeutic scope expansion.
• Market growth is influenced by combination therapy adoption and the proliferation of generic options.
• Toxicity, especially neurotoxicity, remains a critical hurdle; advances in neuroprotective strategies are key to maximizing patient adherence.
• Regulatory developments and indication approvals are pivotal in shaping future market trajectories.
• The Asia-Pacific region offers significant growth potential owing to rising cancer prevalence and healthcare infrastructure investments.

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FAQs

1. What are the primary indications for oxaliplatin currently?
Oxaliplatin is primarily indicated for colorectal cancer, gastric cancer, and pancreatic adenocarcinoma, often in combination with other chemotherapeutic agents.

2. Are there any new formulations or derivatives of oxaliplatin in development?
Current efforts focus on neurotoxicity mitigation rather than developing new formulations. Some research explores liposomal or nanoparticle delivery systems to improve toxicity profiles.

3. How does oxaliplatin compare to other platinum agents like cisplatin and carboplatin?
Oxaliplatin offers distinct efficacy in colorectal cancers and a different toxicity spectrum, notably less nephrotoxicity but higher neurotoxicity compared to cisplatin and carboplatin.

4. What are the major side effects associated with oxaliplatin?
The most significant adverse effects include peripheral sensory neuropathy, myelosuppression, and gastrointestinal disturbances.

5. How might ongoing clinical trials influence future oxaliplatin use?
Trials investigating combinations with immunotherapies, targeted agents, and neuroprotective interventions could expand its indications and improve tolerability, potentially increasing its utilization.

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References

1. MarketLine. (2023). "Global Oncology Drugs Market Report". Retrieved from MarketLine database.