Data updated: Nov 8, 2026
ELOXATIN (oxaliplatin) · Sanofi
Trial Activity: Stable 315 active trials
Oncology
Approved 2002-08-09
Development Insights
Hoffmann-La Roche conducting 27 trials (4%)
875 indications explored (Broad Platform)
→ gastric cancer (77 trials)
→ colorectal cancer (74 trials)
→ metastatic colorectal cancer (28 trials)
6
Indications
--
Phase 3 Trials
3
Priority Reviews
24
Years on Market
Details
- Status
- Discontinued
- First Approved
- 2002-08-09
- Routes
- INTRAVENOUS
- Dosage Forms
- INJECTABLE
ELOXATIN Approval History
2003
2004
2005
2006
2007
2008
2009
2010
2011
2012
2013
2014
2015
2016
2017
2018
2019
2020
2021
2022
2023
2024
2025
2026
Original
New Indication
New Form
Label Update
71 FDA actions from 2002 to 2023 · 2 indication expansions
Dec 2016 SUPPL
Mfg · Manufacturing (CMC)
Jan 2015 SUPPL
Mfg
Nov 2013 SUPPL
Mfg
Jul 2009 SUPPL
Mfg
Nov 2006 SUPPL
Mfg
What ELOXATIN Treats
6 FDA approvalsOriginally approved for its first indication in 2002 . Covers 6 distinct patient populations.
- Other (6)
Other
(6 approvals)Sanofi's other novel FDA approvals
Other CDER-designated drugs from the same sponsor (2016–2025).
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Clinical Trial Registry
713 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT04379596 DG-03 | D967LC00001 2019-004483-22, 2019 | Ph 2 | active not recruiting | Ph1b/2 Study of the Safety and Efficacy of T-DXd Combinations in Advanced HER2-expressing Gastric Cancer (DESTINY-Gastric03) |
| NCT03017326 PHITT | RG_15-114 | Ph 3 | active not recruiting | Paediatric Hepatic International Tumour Trial |
| NCT07365592 Neo-CD | SAHZU Jun LI | Ph 1, Ph 2 | recruiting | Neoadjuvant Chemotherapy, Anti-PD-1 Antibody and Sitagliptin for Locally Advanced pMMR CRC |
| NCT06696768 | NCI-2024-09416 NCI-2024-09416, 10655 | Ph 1 | recruiting | Clinical Trial of an Anti-cancer Drug, CA-4948 (Emavusertib), in Combination With Chemotherapy Treatment (FOLFOX Plus Bevacizumab) in Metastatic Colorectal Cancer |
| NCT03321643 | NCI-2017-01957 NCI-2017-01957, PHI-96 | Ph 1 | active not recruiting | Testing the Addition of an Immunotherapy Agent, Atezolizumab, When Given With the Usual Chemo-Immunotherapy Drug Combination (Rituximab Plus Gemcitabine and Oxaliplatin) for Relapsed/Refractory (That Has Come Back or Not Responded to Treatment) Transformed Diffuse Large B-Cell Lymphoma |
| NCT05564403 | NCI-2022-07833 NCI-2022-07833, EAY191-A6 | Ph 2 | active not recruiting | Study of Chemotherapy, With or Without Binimetinib in Advanced Biliary Tract Cancers in 2nd Line Setting (A ComboMATCH Treatment Trial) |
| NCT04210115 | 3475-975 MK-3475-975, KEYNOTE-975 | Ph 3 | completed | Study of Pembrolizumab (MK-3475) Versus Placebo in Participants With Esophageal Carcinoma Who Are Receiving Chemotherapy and Radiation Therapy (MK-3475-975/KEYNOTE-975) |
| NCT05836584 | NCI-2023-03192 NCI-2023-03192, EA2212 | Ph 2 | active not recruiting | Testing Immunotherapy (Atezolizumab) With or Without Chemotherapy in Locoregional MSI-H/dMMR Gastric and Gastroesophageal Junction (GEJ) Cancer |
| NCT07113275 | XHZDZLK | Ph 3 | recruiting | A Clinical Trial Comparing Long-Course Versus Short-Course Radiotherapy Followed by Immunotherapy Combined With Total Neoadjuvant Therapy (TNT) to Long-Course Radiotherapy Followed by TNT in Locally Advanced Rectal Cancer |
| NCT02997228 | NCI-2016-01961 NCI-2016-01961, NRG-GI004/S1610 | Ph 3 | active not recruiting | Testing the Addition of Atezolizumab to Combination Chemotherapy or Atezolizumab Alone for Metastatic Colon or Rectal Cancer, the COMMIT Study |
| NCT05564377 | NCI-2022-06842 NCI-2022-06842, EAY191 | Ph 2 | recruiting | Targeted Therapy Directed by Genetic Testing in Treating Patients With Locally Advanced or Advanced Solid Tumors, The ComboMATCH Screening Trial |
| NCT07582315 | BL-B01D1-317 | Ph 3 | recruiting | A Study Comparing BL-B01D1 With Treatment of Physician's Choice in Patients With Locally Advanced or Metastatic Biliary Tract Cancer After Failure of Platinum-based Chemotherapy(PANKU-BTC01) |
| NCT06764875 | D702AC00001 2024-512583-57-00 | Ph 3 | recruiting | A Phase Ⅲ Study of Rilvegostomig in Combination With Fluoropyrimidine and Trastuzumab Deruxtecan as the First-line Treatment for HER2-positive Gastric Cancer |
| NCT07580339 | J2652 IRB00536619 | Ph 2 | not yet recruiting | Combining DCSZ11 With Radiation and Chemotherapy as Neoadjuvant Treatment for pMMR Locally Advanced Rectal Cancer |
| NCT06205485 NEO-RT | CCTG-CO32 CCTG-CO32, NCI-2023-10515 | Ph 3 | recruiting | Neoadjuvant Chemotherapy, Excision And Observation vs Chemoradiotherapy For Rectal Cancer |
| NCT07043400 | BGB-A317-316 2025-522862-58-00, 2025 | Ph 3 | recruiting | A Study to Investigate Tislelizumab Administered as Subcutaneous Injection Versus Intravenous Infusion Plus Chemotherapy in Patients With Unresectable or Metastatic Gastric or Gastroesophageal Junction Adenocarcinoma |
| NCT07554521 | BGB-A317-217 | Ph 2 | recruiting | A Study to Evaluate Efficacy and Safety of Tislelizumab Plus Chemotherapy for Locally Advanced Unresectable or Metastatic Gastric or Gastroesophageal Adenocarcinoma and Esophageal Squamous Cell Carcinoma in Racial and Ethnic Minority Patients in the United States |
| NCT07318805 | C6321001 2025-524387-38-00, 2025 | Ph 1 | recruiting | A Study to Learn About the Study Medicine Called PF-08032562 in People With Advanced or Metastatic Solid Tumors |
| NCT05139017 | 2140-003 VLS-101, MK-2140-003 | Ph 2, Ph 3 | recruiting | A Study of Zilovertamab Vedotin (MK-2140) in Combination With Standard of Care in Participants With Relapsed or Refractory Diffuse Large B-Cell Lymphoma (rrDLBCL) (MK-2140-003) |
| NCT06662786 OrigAMI-2 | 61186372COR3001 2024-513852-13-00 | Ph 3 | recruiting | A Study of Amivantamab and mFOLFOX6 or FOLFIRI Versus Cetuximab and mFOLFOX6 or FOLFIRI as First-line Treatment in Participants With KRAS/NRAS and BRAF Wild-type Unresectable or Metastatic Left-sided Colorectal Cancer |
| NCT05568095 STAR-221 | STAR-221 jRCT2051220179, MOH_2023-04-30_012590 | Ph 3 | completed | A Clinical Trial of a New Combination Treatment, Domvanalimab and Zimberelimab, Plus Chemotherapy, for People With an Upper Gastrointestinal Tract Cancer That Cannot be Removed With Surgery That Has Spread to Other Parts of the Body |
| NCT04864067 NOAHS-ARC | FONDECYT 11201291 | Ph 2 | completed | No Operation After Short Course Radiotherapy Followed By Consolidation Chemotherapy In Locally Advanced Rectal Cancer |
| NCT05379595 OrigAMI-1 | CR109215 61186372GIC2002, 2021-006629-23 | Ph 1, Ph 2 | recruiting | A Study of Amivantamab Monotherapy and in Addition to Standard-of-Care Chemotherapy in Participants With Advanced or Metastatic Colorectal Cancer |
| NCT05677490 | A022102 NCI-2022-08569 | Ph 3 | recruiting | mFOLFIRINOX Versus mFOLFOX With or Without Nivolumab for the Treatment of Advanced, Unresectable, or Metastatic HER2 Negative Esophageal, Gastroesophageal Junction, and Gastric Adenocarcinoma |
| NCT07308132 | 95566692LYM1001 95566692LYM1001, 2025-523297-16-00 | Ph 1 | recruiting | A Study of JNJ-95566692 in Participants With Non-Hodgkin Lymphoid Malignancies |
| NCT05171647 SUNMO results posted | GO43643 | Ph 3 | active not recruiting | A Study Evaluating Efficacy and Safety of Mosunetuzumab in Combination With Polatuzumab Vedotin Compared to Rituximab in Combination With Gemcitabine Plus Oxaliplatin in Participants With Relapsed or Refractory Aggressive B-Cell Non-Hodgkin's Lymphoma |
| NCT03801876 | NRG-GI006 NCI-2018-03378, NRG-GI006 | Ph 3 | active not recruiting | Comparing Proton Therapy to Photon Radiation Therapy for Esophageal Cancer |
| NCT07335497 ASCEND | CR-001-101 2025-523590-42-00, 2025 | Ph 1, Ph 2 | recruiting | CR-001 in Adult Participants With Locally Advanced or Metastatic Solid Tumors |
| NCT07570823 | SCTB35-B301 | Ph 3 | recruiting | A Study to Evaluate the Safety and Efficacy of SCTB35 in Combination With Gemcitabine and Oxaliplatin in Patients With Relapsed or Refractory Diffuse Large B-Cell Lymphoma |
| NCT06094140 NEO-IMPACT | NEO-IMPACT | Ph 2 | active not recruiting | NEO-adjuvant Chemo-immunotherapy in Pancreatic Cancer |
| NCT07281768 | J25118 IRB00505702 | Ph 2 | recruiting | Capecitabine/Oxaliplatin Chemotherapy and Cemiplimab With or Without Fianlimab or REGN7075 in Locally Advanced Rectal Cancer |
| NCT07570914 | CSPC-TJ-CRC-05 | Ph 2 | not yet recruiting | Hepatic Arterial Infusion of Liposomal Irinotecan Plus Oxaliplatin and Capecitabine as Adjuvant Therapy for Colorectal Cancer Liver Metastases |
| NCT07076212 | 103973 | Ph 2 | recruiting | Evaluating NALIRIFOX vs Modified Gemcitabine, Nab-Paclitaxel and Cisplatin in Patients With Locally Advanced and Metastatic Pancreatic Adenocarcinoma |
| NCT03784326 | 2018-0678 NCI-2018-02828, 2018-0678 | Ph 2 | active not recruiting | Phase I/II Study of Perioperative Chemotherapy Plus Immunotherapy Followed by Surgery in Localized Esophageal and Gastroesophageal Adenocarcinoma |
| NCT05365581 | 2138-CL-0101 jRCT2031210644, CTR20241945 | Ph 1 | recruiting | A Study of ASP2138 Given by Itself or Given With Other Cancer Treatments in Adults With Stomach Cancer, Gastroesophageal Junction Cancer, or Pancreatic Cancer |
| NCT05355701 | C4761001 BRAF Class 2 | Ph 1 | active not recruiting | A Study to Learn About the Study Medicine Called PF-07799933 in People With Advanced Solid Tumors With BRAF Alterations. |
| NCT05863195 | EA2222 NCI-2023-02357, EA2222 | Ph 3 | recruiting | Testing Pump Chemotherapy in Addition to Standard of Care Chemotherapy Versus Standard of Care Chemotherapy Alone for Patients With Unresectable Colorectal Liver Metastases: The PUMP Trial |
| NCT04248452 | EA2183 NCI-2019-06460, EA2183 | Ph 3 | active not recruiting | Testing the Addition of Radiotherapy to the Usual Treatment (Chemotherapy) for Patients With Esophageal and Gastric Cancer That Has Spread to a Limited Number of Other Places in the Body |
| NCT06941857 | J2541 IRB00486324 | Ph 2 | recruiting | NC410 and FOLFIRINOX in Combination With Nivolumab With or Without Ipilimumab in Patients With Untreated Metastatic Pancreatic Cancer |
| NCT07503756 | JS212-005-II-CRC | Ph 2 | recruiting | JS212 Combination Therapies in Metastatic Colorectal Cancer |
| NCT05083481 | 1570-CL-0101 jRCT2031220527, KEYNOTE-E59 | Ph 1 | terminated | A Study of ASP1570 Taken by Itself, or ASP1570 Taken Together With Either Pembrolizumab, Standard Therapies, or Both, in Adults With Solid Tumors |
| NCT02912559 results posted | NCI-2016-01417 NCI-2016-01417, A021502 | Ph 3 | active not recruiting | Combination Chemotherapy With or Without Atezolizumab in Treating Patients With Stage III Colon Cancer and Deficient DNA Mismatch Repair |
| NCT06958328 LAP100 | NRG-GI011 NCI-2025-01624, NRG-GI011 | Ph 3 | recruiting | Testing Higher Dose Radiation Therapy for Locally Advanced Pancreatic Cancer |
| NCT04481204 | 2020-0075 NCI-2020-04886, 2020-0075 | Ph 2 | withdrawn | New and Emerging Therapies for the Treatment of Resectable, Borderline Resectable, or Locally Advanced Pancreatic Cancer, PIONEER-Panc Study |
| NCT03504397 Spotlight results posted | 8951-CL-0301 2017-002567-17, CTR20190258 | Ph 3 | active not recruiting | A Study to Compare Zolbetuximab (IMAB362) and Chemotherapy With Placebo and Chemotherapy in Adults With Gastric Cancer. |
| NCT05067283 KANDLELIT-001 | 1084-001 MK-1084-001, jRCT2041220034 | Ph 1 | recruiting | A Study of Calderasib (MK-1084) in KRAS Mutant Advanced Solid Tumors (MK-1084-001) |
| NCT06624085 | GO44900 | Ph 1 | active not recruiting | A Study Evaluating the Safety and Efficacy of Glofitamab + Gemcitabine + Oxaliplatin in U.S. Patients With Relapsed or Refractory Diffuse Large B-Cell Lymphoma |
| NCT06225999 | S095013-169 | Ph 2 | completed | Phase 2 Study of Irinotecan Liposome Injection, Oxaliplatin, 5-fluorouracil/Levoleucovorin in Japanese Participants Not Previously Treated for Metastatic Adenocarcinoma of the Pancreas |
| NCT06469944 | 3475-06C MK-3475-06C, KEYMAKER-06C | Ph 1, Ph 2 | recruiting | Substudy 06C: A Study of Investigational Agents With Pembrolizumab (MK-3475) and Chemotherapy in Participants With First-Line Locally Advanced Unresectable/Metastatic Gastroesophageal Adenocarcinoma (MK-3475-06C/KEYMAKER-U06) |
| NCT07561060 TNTIT | TNTIT | Ph 1, Ph 2 | recruiting | Low Rectal Cancer Treated With Total Neoadjuvant Therapy Plus Concurrent Tislelizumab Immunotherapy |
Showing 50 of 713 trials
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Pro Active Pipeline
Ongoing clinical trials by development phase
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Pro Key Completed Trials
Completed studies with published results, ranked by significance
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Trial Timeline
Full development history with FDA approval milestones
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Understanding FDA Approval Types
| Count | Type | What it means |
|---|---|---|
| - | ORIG | Original approval - drug first enters market |
| - | SUPPL - Efficacy | New indication (new disease/condition approved) |
| - | SUPPL - Labeling | Label text changes (warnings, dosing updates) |
| - | SUPPL - Manufacturing | Production changes (new facility) |
| - | SUPPL - Chemistry | Formulation changes (new dosage strength) |
Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.
ELOXATIN FDA Label Details
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.
How We Calculate These Metrics
Trial Activity Stage
Measures the current development activity pattern based on trial phases, status, and trends. Important: This measures R&D activity, not commercial lifecycle.
Trial statuses: "Active" means recruiting or ongoing. "Completed" means reached planned endpoint. "Terminated" means stopped early—often due to safety, efficacy, or business reasons.
- Growth: High proportion of early-phase trials (Phase 1/2), active development
- Expansion: Significant Phase 3 activity, approaching or pursuing approvals
- Mature: Substantial Phase 4 post-marketing studies
- Stable: Mixed phase distribution, steady development
- Declining: Low active trial ratio, reduced R&D investment