Last Updated: June 9, 2026

CLINICAL TRIALS PROFILE FOR TRIFLURIDINE


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505(b)(2) Clinical Trials for TRIFLURIDINE

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 NCT07235293 ↗ A Study to Test DSP107 in Combination With Atezolizumab in Comparison With Fruquintinib as a New Treatment for Colorectal Cancer. NOT_YET_RECRUITING Novotech (Australia) Pty Limited PHASE2 2025-11-15 This clinical study is testing whether a new combination of medicines (DSP107 and atezolizumab) is more effective and safer than an existing treatment (fruquintinib) for people with advanced colorectal cancer that is microsatellite stable (MSS). Participants will be randomly assigned to receive one of the two treatments, and researchers will monitor how well the cancer responds, how safe the treatments are, and how the body processes them. The study hopes to show that the new combination can improve outcomes for patients with this type of colorectal cancer.
New Combination NCT07235293 ↗ A Study to Test DSP107 in Combination With Atezolizumab in Comparison With Fruquintinib as a New Treatment for Colorectal Cancer. NOT_YET_RECRUITING Kahr Bio Australia Pty Ltd PHASE2 2025-11-15 This clinical study is testing whether a new combination of medicines (DSP107 and atezolizumab) is more effective and safer than an existing treatment (fruquintinib) for people with advanced colorectal cancer that is microsatellite stable (MSS). Participants will be randomly assigned to receive one of the two treatments, and researchers will monitor how well the cancer responds, how safe the treatments are, and how the body processes them. The study hopes to show that the new combination can improve outcomes for patients with this type of colorectal cancer.
>Trial Type >Trial ID >Title >Status >Phase >Start Date >Summary

All Clinical Trials for TRIFLURIDINE

Trial ID Title Status Sponsor Phase Start Date Summary
NCT00000138 ↗ Herpetic Eye Disease Study (HEDS) I Unknown status National Eye Institute (NEI) Phase 3 1989-05-01 To evaluate the efficacy of topical corticosteroids in treating herpes simplex stromal keratitis in conjunction with topical trifluridine. To evaluate the efficacy of oral acyclovir in treating herpes simplex stromal keratitis in patients receiving concomitant topical corticosteroids and trifluridine. To evaluate the efficacy of oral acyclovir in treating herpes simplex iridocyclitis in conjunction with treatment with topical corticosteroids and trifluridine.
NCT00000635 ↗ Treatment of Acyclovir-Resistant Mucocutaneous Herpes Simplex Disease in Patients With AIDS: Open Label Pilot Study of Topical Trifluridine Completed Glaxo Wellcome N/A 1969-12-31 To determine the safety, effectiveness, and toxicity of topical (local) trifluridine in treating mucocutaneous (at the nasal, oral, vaginal, and anal openings) Herpes simplex virus ( HSV ) disease that has shown resistance to acyclovir in HIV-infected patients. HSV infection in patients with AIDS is often associated with skin sores and frequent recurrences. Treatment with the drug acyclovir results in healing for most patients, but repeated treatment sometimes results in resistance of the virus to acyclovir. Thus, when this happens, other treatments need to be used. Trifluridine is an antiviral drug that is used for the treatment of Herpes infections that occur in the eye. This study attempts to determine if trifluridine is useful for treating HSV sores that have not healed after treatment with acyclovir.
NCT00000635 ↗ Treatment of Acyclovir-Resistant Mucocutaneous Herpes Simplex Disease in Patients With AIDS: Open Label Pilot Study of Topical Trifluridine Completed National Institute of Allergy and Infectious Diseases (NIAID) N/A 1969-12-31 To determine the safety, effectiveness, and toxicity of topical (local) trifluridine in treating mucocutaneous (at the nasal, oral, vaginal, and anal openings) Herpes simplex virus ( HSV ) disease that has shown resistance to acyclovir in HIV-infected patients. HSV infection in patients with AIDS is often associated with skin sores and frequent recurrences. Treatment with the drug acyclovir results in healing for most patients, but repeated treatment sometimes results in resistance of the virus to acyclovir. Thus, when this happens, other treatments need to be used. Trifluridine is an antiviral drug that is used for the treatment of Herpes infections that occur in the eye. This study attempts to determine if trifluridine is useful for treating HSV sores that have not healed after treatment with acyclovir.
NCT00002037 ↗ Evaluation of the Therapeutic Benefit of r-metHuIFN- Gamma in AIDS Patients With Disseminated Mycobacterium Avium-Intracellulare (MAI) Infection: A Multi-Centered Pilot Study Completed Amgen N/A 1969-12-31 To examine the effectiveness of subcutaneous gamma interferon in reducing severity of Mycobacterium avium- intracellulare (MAI) bacillemia episodes in AIDS patients in an open-label dose-randomized multi-center pilot clinical investigation. To evaluate the safety of gamma interferon given by subcutaneous injection (SC) in the AIDS patient in the presence and absence of AZT therapy.
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for TRIFLURIDINE

Condition Name

Condition Name for TRIFLURIDINE
Intervention Trials
Metastatic Colorectal Cancer 22
Colorectal Cancer 11
Stage IV Colorectal Cancer AJCC v8 7
Stage IVB Colorectal Cancer AJCC v8 6
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Condition MeSH

Condition MeSH for TRIFLURIDINE
Intervention Trials
Colorectal Neoplasms 63
Adenocarcinoma 17
Colonic Neoplasms 9
Carcinoma 9
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Clinical Trial Locations for TRIFLURIDINE

Trials by Country

Trials by Country for TRIFLURIDINE
Location Trials
United States 162
China 48
Italy 28
Japan 23
Australia 16
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Trials by US State

Trials by US State for TRIFLURIDINE
Location Trials
Texas 15
California 15
Florida 11
Illinois 9
Minnesota 8
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Clinical Trial Progress for TRIFLURIDINE

Clinical Trial Phase

Clinical Trial Phase for TRIFLURIDINE
Clinical Trial Phase Trials
PHASE3 5
PHASE2 24
PHASE1 7
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Clinical Trial Status

Clinical Trial Status for TRIFLURIDINE
Clinical Trial Phase Trials
Recruiting 51
Not yet recruiting 15
NOT_YET_RECRUITING 12
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Clinical Trial Sponsors for TRIFLURIDINE

Sponsor Name

Sponsor Name for TRIFLURIDINE
Sponsor Trials
National Cancer Institute (NCI) 15
Servier 6
Taiho Oncology, Inc. 5
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Sponsor Type

Sponsor Type for TRIFLURIDINE
Sponsor Trials
Other 102
Industry 46
NIH 18
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