Data updated: May 26, 2026
TOLAK (fluorouracil)
Nucleic Acid Synthesis Inhibitors
Trial Activity: Stable 104 active trials
Dermatology
Approved 2015-09-18
Tolak is a topical cream used for patients with actinic keratosis lesions located on the face, ears, or scalp. This medication helps patients with these specific skin growths by targeting the affected areas directly. It is typically prescribed to manage and clear these lesions through a localized application.
How TOLAK Works
** Fluorouracil is a nucleoside metabolic inhibitor that interferes with DNA synthesis and, to a lesser extent, inhibits RNA formation. It specifically blocks the methylation of deoxyuridylic acid to thymidylic acid within the anabolic pathway. This interference creates a thymine deficiency, leading to unbalanced cell growth and eventual cell death. These effects are most pronounced in rapidly proliferating cells—such as those found in actinic keratosis lesions—which take up fluorouracil at a higher rate than healthy tissue.
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)
1
Indication
--
Phase 3 Trials
10
Years on Market
Details
- Status
- Prescription
- First Approved
- 2015-09-18
- Routes
- TOPICAL
- Dosage Forms
- CREAM
TOLAK Approval History
2016
2017
2018
2019
2020
2021
2022
2023
2024
2025
2026
Original
New Indication
New Form
Label Update
2 FDA actions from 2015 to 2022
What TOLAK Treats
1 indicationsTOLAK is approved for 1 conditions since its original approval in 2015. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Actinic Keratosis
Source: FDA Label
TOLAK Competitive Set
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Clinical Trial Registry
280 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) |
| 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 |
| 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 |
| 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 |
| 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 |
| NCT06094140 NEO-IMPACT | NEO-IMPACT | Ph 2 | active not recruiting | NEO-adjuvant Chemo-immunotherapy in Pancreatic Cancer |
| 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 |
| 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 |
| 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 |
| 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 |
| NCT07543744 | CL01790199 | Ph 1 | recruiting | A Comparative Study of Pharmacokinetics, Safety, and Immunogenicity of RPH-030 and Vectibix® in Patients With Metastatic Colorectal Cancer With Wild-type RAS as First-line Therapy in Combination With FOLFIRI |
| NCT05009069 | ML43050 | Ph 2 | active not recruiting | A Study of Atezolizumab With or Without Tiragolumab Following Neoadjuvant Chemoradiotherapy in Participants With Locally Advanced Rectal Cancer |
| NCT06078709 PHOX | GMROR2241 NCI-2023-07432, GMROR2241 | Ph 2 | recruiting | Preoperative Hypofractionated Radiotherapy With FOLFOX for Esophageal or Gastroesophageal Junction Adenocarcinoma |
| NCT06280495 | INTENSIFY-CRC | Ph 2, Ph 3 | recruiting | Neoadjuvant Serplulimab & Bevacizumab With FOLFOX vs. FOLFOX Alone in RAS/BRAF WT, pMMR/MSS CRC Patients |
| NCT06544655 | CA233-0000 EU 2024-513696-40 | Ph 1 | active not recruiting | A Study of BMS-986484 Alone and Combination Therapy in Participants With Advanced Solid Tumors |
| NCT04615013 | 2020-0122 NCI-2020-05329, 2020-0122 | Ph 1 | recruiting | NBTXR3, Chemotherapy, and Radiation Therapy for the Treatment of Esophageal Cancer |
| NCT07409272 | 3082-CL-0301 | Ph 3 | recruiting | A Study to Evaluate the Effectiveness and Safety of Setidegrasib, Given With Either mFOLFIRINOX or NALIRIFOX Chemotherapies, in People With Pancreatic Cancer |
| NCT03161522 | 2016-0972 NCI-2018-01202, 2016-0972 | Ph 2 | recruiting | Chemotherapy With or Without Radiation or Surgery in Treating Participants With Oligometastatic Esophageal or Gastric Cancer |
| NCT06820463 AndroMETa-CRC | M24-533 EU CT, 2024-512981-33-00 | Ph 2 | recruiting | A Study to Evaluate the Adverse Events, and Efficacy of Intravenous (IV) of Telisotuzumab Adizutecan in Combination With IV Oxaliplatin, Fluorouracil, Folinic Acid/Leucovorin, Bevacizumab, Panitumumab in Adult Participants With Metastatic Colorectal Cancer |
| NCT03776487 | 2018-0012 NCI-2018-02344, 2018-0012 | Ph 2 | active not recruiting | Nivolumab, Ipilimumab and Chemoradiation in Treating Patients With Resectable Gastric Cancer |
| NCT05382559 | 3082-CL-0101 jRCT2031220738, CTR20250465 | Ph 1 | recruiting | A Study of ASP3082 in Adults With Advanced Solid Tumors |
| NCT02688712 | 15-050A | Ph 2 | active not recruiting | ExIST Study of LY2157299 (Galunisertib) in Rectal Cancer |
| NCT06417476 | B2022-714 | Ph 2 | active not recruiting | Short-course Radiotherapy or Long-course Chemoradiation Followed by mFOLFOXIRI Consolidation Chemotherapy for Organ Preservation in Low Rectal Cancer |
Showing 50 of 280 trials
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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.
TOLAK FDA Label Details
Indications & Usage
FDA Label (PDF)TOLAK is indicated for the treatment of Actinic Keratosis.
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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