Data updated: May 26, 2026
FLUOROURACIL
Nucleic Acid Synthesis Inhibitors
Trial Activity: Stable 104 active trials
Oncology
Approved 1962-04-25
FLUOROURACIL is indicated for the treatment of Actinic Keratosis; Solar Keratosis; Basal Cell Carcinoma.
Source: FDA Label • TARO
Development Insights
Merck Sharp & Dohme LLC conducting 19 trials (6%)
272 indications explored (Broad Platform)
→ colorectal cancer (30 trials)
→ gastric cancer (24 trials)
→ metastatic colorectal cancer (24 trials)
31
Indications
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Phase 3 Trials
1
Priority Reviews
64
Years on Market
Details
- Status
- Prescription
- First Approved
- 1962-04-25
- Routes
- TOPICAL, INJECTION, Injection
- Dosage Forms
- SOLUTION, INJECTABLE, CREAM, Injectable
Companies
TARO ABRAXIS PHARM Novartis EXTROVIS SAGENT PHARMS INC GLAND EUGIA PHARMA SPECLTS ENCUBE Dr. Reddy's BEDFORD ACCORD HLTHCARE KINDOS Fresenius Kabi Teva MARCHAR SMITH AND NEPHEW EBEWE PHARMA QUAD PHARMS NOVAST LABS ABIC ALEMBIC SPECTRUM PHARMS
Active Ingredient: FLUOROURACIL
Website: ↗
FLUOROURACIL Approval History
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Original
New Indication
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Label Update
205 FDA actions from 1962 to 2026 · 1 indication expansions
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Apr 1962 ORIGINAL Priority
New Drug
What FLUOROURACIL Treats
3 indicationsFLUOROURACIL is approved for 3 conditions since its original approval in 1962. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Actinic Keratosis
- Solar Keratosis
- Basal Cell Carcinoma
Source: FDA Label
FLUOROURACIL Competitive Set
ProThree rings of competition based on shared molecular targets and treated indications.
Indication competitors
10
Same indication, different mechanism — what else might this patient receive?
Unlock 8 more competitors across all three rings.
Upgrade to Pro Filters applied: drops same-active-ingredient (505(b)(2) reformulations), route-mismatch (topical vs systemic), and cross-therapeutic-area matches in same-indication rings.
What's emerging in FLUOROURACIL's indications
See all emerging drugs →Phase 3 candidates targeting molecules with no FDA-approved drug, in indications FLUOROURACIL treats. First-in-class if their pivotal trials read out positive.
Drugs Similar to FLUOROURACIL
3 of 9FDA-approved drugs for similar conditions. Compare mechanisms and indications to understand treatment alternatives.
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Clinical Trial Registry
582 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT06770582 | NCI-2025-00008 NCI-2025-00008, NRG-GU014 | Ph 2 | recruiting | Testing the Addition of the Immunotherapy Drug, Pembrolizumab, to Radiation Therapy Compared to the Usual Chemotherapy Treatment During Radiation Therapy for Bladder Cancer, PARRC Trial |
| NCT06654037 | NCI-2024-08691 NCI-2024-08691, 10670 | Ph 1 | recruiting | Testing the Addition of an Anti-Cancer Drug, Abemaciclib, to the Usual Chemotherapy Treatment (5-Fluorouracil) for Metastatic, Refractory Colorectal Cancer |
| NCT04929028 | NCI-2021-06041 NCI-2021-06041, AMC-110 | Ph 2 | active not recruiting | Therapy Adapted for High Risk and Low Risk HIV-Associated Anal Cancer |
| NCT04216290 | NCI-2019-08628 NCI-2019-08628, EA8185 | Ph 2 | active not recruiting | A Study of Chemotherapy and Radiation Therapy Compared to Chemotherapy and Radiation Therapy Plus MEDI4736 (Durvalumab) Immunotherapy for Bladder Cancer Which Has Spread to the Lymph Nodes, INSPIRE Trial |
| 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 |
| 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 | active not recruiting | 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 |
| 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 | not yet 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 and PD-1/PD-L1 Monoclonal Antibody Therapy(PANKU-BTC01) |
| NCT07579195 | RG1126354 NCI-2026-02920, FHIRB0021260 | Ph 1, Ph 2 | not yet recruiting | Consolidative Therapy After EV + Pembrolizumab in Muscle Invasive Bladder Cancer, REINFORCE Trial |
| 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 |
| NCT07566156 | C5701009 EV-309, 2026-525612-34-00 | Ph 3 | recruiting | Enfortumab Vedotin in Combination With Pembrolizumab vs. Concurrent Chemoradiotherapy (cCRT) in People With Muscle Invasive Bladder Cancer ( EV-309 ) |
| NCT07318805 | C6321001 2025-524387-38-00 | Ph 1 | recruiting | A Study to Learn About the Study Medicine Called PF-08032562 in People With Advanced or Metastatic Solid Tumors |
| 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 | active not recruiting | 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 |
| NCT06750094 OrigAMI-3 | 61186372COR3002 2024-513853-66-00 | Ph 3 | recruiting | A Study of Amivantamab and FOLFIRI Versus Cetuximab/Bevacizumab and FOLFIRI in Participants With KRAS/NRAS and BRAF Wild-type Colorectal Cancer Who Have Previously Received Chemotherapy |
| 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 |
| NCT02135042 | NRG-HN001 U10CA180868, U10CA021661 | Ph 2, Ph 3 | active not recruiting | Individualized Treatment Treating Patients With Stage II-IVB Nasopharyngeal Cancer Based on EBV DNA |
| NCT03801876 | NRG-GI006 NCI-2018-03378, NRG-GI006 | Ph 3 | recruiting | Comparing Proton Therapy to Photon Radiation Therapy for Esophageal Cancer |
| NCT04083599 | GCT1042-01 2018-003716-47, IRAS ID: 263292 | Ph 1, Ph 2 | active not recruiting | GEN1042 Safety Trial and Anti-tumor Activity in Participants With Malignant Solid Tumors |
| NCT06094140 NEO-IMPACT | NEO-IMPACT | Ph 2 | active not recruiting | NEO-adjuvant Chemo-immunotherapy in Pancreatic Cancer |
| 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 |
| NCT05721755 | EA3211 NCI-2022-10141, EA3211 | Ph 3 | active not recruiting | Combining Radiation Therapy With Immunotherapy for the Treatment of Metastatic Squamous Cell Carcinoma of the Head and Neck |
| NCT05355701 | C4761001 BRAF Class 2 | Ph 1 | 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 |
| NCT05083481 | 1570-CL-0101 jRCT2031220527, KEYNOTE-E59 | Ph 1, Ph 2 | active not recruiting | A Study of ASP1570 Taken by Itself, or ASP1570 Taken Together With Either Pembrolizumab, Standard Therapies, or Both, in Adults With Solid Tumors |
| NCT04166318 | EA2182 NCI-2019-02259, EA2182 | Ph 2 | active not recruiting | Lower-Dose Chemoradiation in Treating Patients With Early-Stage Anal Cancer, the DECREASE Study |
| NCT04233866 | EA2186 NCI-2019-08286, EA2186 | Ph 2 | active not recruiting | Comparing Two Treatment Combinations, Gemcitabine and Nab-Paclitaxel With 5-Fluorouracil, Leucovorin, and Liposomal Irinotecan for Older Patients With Pancreatic Cancer That Has Spread |
| NCT06057038 | GCT1042-03 jRCT2031230438 | Ph 1 | active not recruiting | A Safety Trial of GEN1042 in Japanese Subjects With Malignant 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. |
| NCT07097142 | NRG-GU015 NCI-2025-04136, NRG-GU015 | Ph 3 | recruiting | Testing Shorter Duration Radiation Therapy Versus the Usual Radiation Therapy in Patients Receiving the Usual Chemotherapy Treatment for Bladder Cancer, ARCHER Study |
| 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) |
| NCT03775265 | NCI-2018-03264 NCI-2018-03264, S1806 | Ph 3 | active not recruiting | Chemoradiotherapy With or Without Atezolizumab in Treating Patients With Localized Muscle Invasive Bladder Cancer |
| NCT00980460 results posted | NCI-2011-01975 NCI-2011-01975, AHEP0731 | Ph 3 | active not recruiting | Risk-Based Therapy in Treating Younger Patients With Newly Diagnosed Liver Cancer |
| NCT00588770 results posted | NCI-2009-00507 NCI-2009-00507, E1305 | Ph 3 | active not recruiting | Chemotherapy With or Without Bevacizumab in Treating Patients With Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma |
| NCT07214298 | I-4316824 NCI-2025-06680, I-4316824 | Ph 1, Ph 2 | recruiting | Pegcetacoplan in Combination With Modified FOLFIRINOX for the Treatment of Metastatic Pancreatic Ductal Adenocarcinoma |
| NCT05329766 EDGE-Gastric | ARC-21 2021-006291-16, 2024-511917-40-00 | Ph 2 | active not recruiting | A Safety and Efficacy Study of Treatment Combinations With and Without Chemotherapy in Adult Participants With Advanced Upper Gastrointestinal Tract Malignancies |
| NCT06997497 | 1084-012 MK-1084-012, KANDLELIT-012 | Ph 3 | recruiting | A Clinical Study of Calderasib (MK-1084) With Targeted Therapy and Chemotherapy in People With Colorectal Cancer (MK-1084-012/KANDLELIT-012) |
| NCT04662710 results posted | 7902-015 MK-7902-015, E7080-G000-321 | Ph 3 | completed | Efficacy and Safety of Lenvatinib (E7080/MK-7902) Plus Pembrolizumab (MK-3475) Plus Chemotherapy in Participants With Advanced/Metastatic Gastroesophageal Adenocarcinoma (MK-7902-015/E7080-G000-321/LEAP-015) |
| NCT07554456 | BL-B01D1-315 | Ph 2, Ph 3 | not yet recruiting | A Study of BL-B01D1 in Combination With Tislelizumab ±5-Fluorouracil Versus Platinum-Based Chemotherapy Plus Tislelizumab as First-line Treatment in Patients With Unresectable, Locally Advanced Recurrent or Metastatic Esophageal Squamous Cell Carcinoma(PANKU-Esophagus02) |
| NCT07441369 | GWK-2026-002 | Ph 2 | enrolling by invitation | Abemaciclib Combined With FOLFOX/FOLFIRI Regimen in Patients With Advanced Colorectal Liver Metastases Cancer |
Showing 50 of 582 trials
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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.
FLUOROURACIL FDA Label Details
Indications & Usage
FDA Label (PDF)FLUOROURACIL is indicated for the treatment of Actinic Keratosis; Solar Keratosis; Basal Cell Carcinoma.
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FAVLYXA
Full clinical data, patents, trials, and competitive landscape for fluorouracil.
Data Sources
FDA Approval: ANDA076526 → Label: DailyMed → Patents: FDA Orange Book → Trials: ClinicalTrials.gov →
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