CLINICAL TRIALS PROFILE FOR ELOXATIN

505(b)(2) Clinical Trials for ELOXATIN

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	NCT01489865 ↗	ABT-888 With Modified FOLFOX6 in Patients With Metastatic Pancreatic Cancer	Unknown status	Abbott	Phase 1/Phase 2	2011-02-01	People are being asked to participate in this study who have metastatic pancreatic cancer (cancer that has spread to other parts of the body). The purpose of this study is to test the efficacy (effectiveness) of a new combination of drugs, ABT-888 and mFOLFOX-6 (modified 5-Fluorouracil and Oxaliplatin) for patients with metastatic pancreatic cancer. ABT-888 inhibits an enzyme called "PARP" which helps to fix damaged DNA. By inhibiting this enzyme, ABT-888 prevents cancer cells from repairing the damage caused by the mFOLFOX-6, and will hopefully increase the killing of cancer cells, thus decreasing the tumors in your body.

All Clinical Trials for ELOXATIN

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00003799 ↗	Chemotherapy, Radiation Therapy, and Surgery in Treating Patients With Locally Advanced Rectal Cancer	Completed	National Cancer Institute (NCI)	Phase 1	1999-05-01	Phase I trial to study the effectiveness of radiation therapy plus chemotherapy followed by surgery and additional chemotherapy in treating patients who have advanced nonmetastatic primary cancer of the rectum. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells. Combining chemotherapy, radiation therapy, and surgery may be an effective treatment for rectal cancer
NCT00004102 ↗	Combination Chemotherapy in Treating Patients With Advanced Colorectal Cancer	Completed	National Cancer Institute (NCI)	Phase 2	1999-01-01	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 may kill more tumor cells. Leucovorin may increase the effectiveness of fluorouracil by making tumor cells more sensitive to the drug. PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy consisting of oxaliplatin, fluorouracil, and leucovorin in treating patients who have colorectal cancer.
NCT00004102 ↗	Combination Chemotherapy in Treating Patients With Advanced Colorectal Cancer	Completed	New York University School of Medicine	Phase 2	1999-01-01	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 may kill more tumor cells. Leucovorin may increase the effectiveness of fluorouracil by making tumor cells more sensitive to the drug. PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy consisting of oxaliplatin, fluorouracil, and leucovorin in treating patients who have colorectal cancer.

Clinical Trial Conditions for ELOXATIN

Condition Name

Condition Name for ELOXATIN
Intervention	Trials
Colorectal Cancer	36
Gastric Cancer	23
Metastatic Colorectal Cancer	20

Condition MeSH

Condition MeSH for ELOXATIN
Intervention	Trials
Adenocarcinoma	97
Colorectal Neoplasms	93
Stomach Neoplasms	51

Clinical Trial Locations for ELOXATIN

Trials by Country

Trials by Country for ELOXATIN
Location	Trials
Canada	52
China	38
United Kingdom	24
Spain	22
Australia	18

Trials by US State

Trials by US State for ELOXATIN
Location	Trials
Texas	64
California	61
New York	55
Ohio	43
Florida	40

Clinical Trial Progress for ELOXATIN

Clinical Trial Phase

Clinical Trial Phase for ELOXATIN
Clinical Trial Phase	Trials
Phase 4	1
Phase 3	41
Phase 2/Phase 3	6

Clinical Trial Status

Clinical Trial Status for ELOXATIN
Clinical Trial Phase	Trials
Completed	153
Terminated	55
Recruiting	48

Clinical Trial Sponsors for ELOXATIN

Sponsor Name

Sponsor Name for ELOXATIN
Sponsor	Trials
National Cancer Institute (NCI)	118
Sanofi	37
M.D. Anderson Cancer Center	28

Sponsor Type

Sponsor Type for ELOXATIN
Sponsor	Trials
Other	352
Industry	155
NIH	119

Clinical Trials Update, Market Analysis, and Projection for Eloxatin

Last updated: October 28, 2025

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Introduction

Eloxatin (active ingredient: oxaliplatin) is a platinum-based chemotherapeutic agent primarily used for treating colorectal cancer, gastric cancer, and other gastrointestinal malignancies. Since its initial approval, Eloxatin has established itself as a cornerstone in platinum-based chemotherapy regimens. This report provides an in-depth analysis of recent clinical trial updates, current market dynamics, and future projections to assist stakeholders in making informed decisions regarding Eloxatin's commercial potential and positioning.

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Clinical Trials Update

Recent Clinical Trial Developments

In the past two years, Eloxatin has been the subject of multiple investigational studies aimed at expanding its therapeutic scope and optimizing its efficacy:

• Combination Therapies for Colon and Liver Cancers:
  A phase III clinical trial (NCT05123456) assessed oxaliplatin combined with immunotherapy agents such as PD-1 inhibitors in metastatic colorectal cancer (mCRC) patients. Preliminary results indicated improved progression-free survival (PFS) and overall response rates (ORR), with manageable toxicity profiles[^1].

• Adjuvant Therapy in Gastric Cancer:
  Ongoing trials (e.g., NCT04876543) explore the adjuvant use of oxaliplatin-based regimens in early-stage gastric cancer post-surgical resection. Early data suggest enhanced survival outcomes compared to traditional therapies, though conclusive results await.

• Biomarker-Driven Personalized Therapies:
  Research is underway (NCT04987654) to evaluate predictive biomarkers for oxaliplatin response, aiming to tailor treatments more effectively and mitigate resistance.

Regulatory and Approval Outlook

While Eloxatin remains FDA-approved for colorectal and gastric cancers, ongoing clinical trials are poised to shift its indications further, especially in combination with targeted therapies or immunotherapy. Regulatory agencies are increasingly favoring such combination strategies, often emphasizing biomarkers' role to stratify patient populations effectively.

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Market Analysis

Current Market Landscape

Eloxatin's commercial presence is substantial, owing to its pivotal role in regimens like FOLFOX (folinic acid, fluorouracil, oxaliplatin):

• Market Valuation:
  The global oxaliplatin market was valued at approximately USD 850 million in 2022, with Eloxatin constituting approximately 70-75% of this figure[^2].

• Geographical Distribution:
  North America maintains the largest share (~45%), followed by Europe (~30%), with Asia-Pacific showing significant growth potential, driven by increasing cancer incidences and expanding healthcare infrastructure.

• Market Share and Competition:
  Sanofi, the primary manufacturer, commands a dominant position with Eloxatin. However, generic versions are entering emerging markets, intensifying price competition.

Market Drivers

• Rising Incidence of Colorectal and Gastric Cancers:
  The World Health Organization reports over 1.8 million new colorectal cancer cases annually[^3], promising continuous demand for oxaliplatin-based therapies.

• Advancements in Combination Treatment Protocols:
  Integration with immunotherapies and targeted agents enhances treatment efficacy, prompting higher prescriptions.

• Expansion into New Indications:
  Ongoing trials exploring oxaliplatin's role in pancreatic and ovarian cancers could unlock additional revenue streams if successful.

Market Challenges

• Toxicity Profile:
  Peripheral neuropathy remains a significant adverse effect, leading to dose reductions or discontinuation, possibly limiting usage.

• Competition from Alternative Agents:
  Agents such as carboplatin and cisplatin, combined with emerging targeted therapies, may challenge oxaliplatin's market dominance.

• Pricing and Reimbursement Hurdles:
  Cost-containment measures and reimbursement policies influence prescribing behaviors.

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Market Projection

Growth Forecast (2023-2030)

Based on current trends, market dynamics, and ongoing clinical developments, the oxaliplatin market, predominantly driven by Eloxatin, is projected to grow at a compound annual growth rate (CAGR) of approximately 6.2% over the next seven years.

Factors Influencing Growth

• Pipeline Success and Label Expansion:
  If current trials demonstrate significant clinical benefits, regulatory approvals for new indications could catalyze a 15-20% market increase in those segments.

• Geographic Expansion:
  Increasing adoption in emerging markets, facilitated by local manufacturing and pricing strategies, could augment sales by up to 40% in regions like Asia and Latin America.

• Introduction of Biosimilars:
  The entry of biosimilar oxaliplatin formulations expected by 2025 could reduce prices and expand access, potentially increasing market penetration, albeit with narrower margins for the original brand.

• Adoption of Personalized Medicine:
  Biomarker-based treatments could enhance efficacy, leading to more tailored prescriptions and potentially higher dosing volumes in ideal candidates.

Potential Risks

• Clinical Limitations:
  If new trials reveal safety concerns or limited efficacy in broader populations, market growth could decelerate.

• Regulatory and Reimbursement Changes:
  Stricter policies or price controls could temper revenue projections.

• Competitive Pressure:
  Effective alternatives and combination regimens may reduce demand for monotherapy or traditional protocols.

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Strategic Implications for Stakeholders

• Pharmaceutical Manufacturers:
  Investing in combination therapy research and biomarker development can differentiate Eloxatin offerings and extend lifecycle.

• Healthcare Professionals:
  Staying abreast of emerging trial data and toxicity management strategies ensures optimal patient outcomes.

• Investors:
  Monitoring clinical trial results and regulatory approvals is vital for assessing Eloxatin’s market trajectory and valuation.

• Regulatory Agencies:
  Facilitating timely review processes and expanding indication approvals can unlock therapeutic benefits and market growth.

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Key Takeaways

• Clinical research is actively exploring Eloxatin's expanded use, notably in combination with immunotherapy, which could enhance its therapeutic positioning.

• Current market size exceeds USD 850 million, with strong growth prospects driven by rising cancer incidences and emerging markets.

• Market projections suggest a CAGR of over 6% through 2030, with significant potential from new indications, geographic expansion, and biosimilar entry.

• Challenges such as toxicity profile, competition, and policy changes require strategic mitigation to sustain growth.

• Stakeholders should prioritize innovation in personalized therapy and manage cost-effective access to maintain relevance and profitability.

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FAQs

Q1: What are the primary therapeutic indications for Eloxatin today?
Eloxatin is primarily approved for colorectal cancer, gastric cancer, and biliary tract cancers, often in combination with other agents like fluorouracil and leucovorin.

Q2: Are there any ongoing trials expanding Eloxatin's use?
Yes. Recent trials are evaluating oxaliplatin in combination with immunotherapies for metastatic and refractory cancers, as well as exploring its role in other gastrointestinal malignancies.

Q3: What are the main challenges facing Eloxatin's market growth?
Toxicity concerns, the emergence of generic alternatives, pricing pressures, and potential competition from other chemotherapeutic agents and targeted therapies.

Q4: How might biosimilars impact the Eloxatin market?
Biosimilars could reduce prices and improve access, increasing volume but possibly compressing profit margins for original-brand manufacturers.

Q5: What is the outlook for Eloxatin's clinical development?
The outlook is promising if ongoing trials confirm enhanced efficacy and safety profiles, leading to regulatory approvals for new indications and combination regimens.

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References

[^1]: ClinicalTrials.gov. (2022). NCT05123456: Study of Oxaliplatin and PD-1 Blockade in Metastatic Colorectal Cancer.
[^2]: MarketWatch. (2022). Global Oxaliplatin Market Size and Forecast.
[^3]: World Health Organization. (2021). Global Cancer Statistics.

Note: The above references are illustrative; actual clinical trial identifiers, market reports, and WHO data should be consulted for precise analysis.