Active Ingredient History
Tipiracil is a thymidine phosphorylase inhibitor, that used for the treatment of patients with metastatic colorectal cancer. Tipiracil is used in combination with trifluridine as Lonsurf. Trifluridine is incorporated into DNA via phosphorylation, ultimately inhibiting cell proliferation. Tipiracil increases systemic exposure of trifluridine when coadministered. Lonsurf has recently been approved for the treatment of adult patients with metastatic colorectal cancer (mCRC) who are refractory to or are not considered candidates for, current standard chemotherapy and biological therapy in the EU and USA and in unresectable advanced or recurrent CRC in Japan. The approved regimen of oral twice-daily Lonsurf significantly improved overall survival and progression-free survival and was associated with a significantly higher disease control rate than placebo when added to best supportive care in the multinational, pivotal phase III trial (RECOURSE) and a phase II Japanese trial. Trifluridine/tipiracil was associated with an acceptable tolerability profile, with adverse events generally being managed with dose reductions, temporary interruptions in treatment or administration of granulocyte-colony stimulating factor. The most common grade 3–4 adverse events (>10 %) were anemia, neutropenia, thrombocytopenia, and leukopenia. NCATS
Combination drugs
Organization | Org Type | FDA approvals | Clinical Trials involvement | Org ID | Force Sort |
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Organization | Org Type | FDA approvals | Clinical Trials involvement | Org ID | Force Sort |
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Adenocarcinoma (Phase 2)
Bile Duct Neoplasms (Phase 2)
Breast Neoplasms (Phase 2)
Carcinoma (Phase 3)
Cholangiocarcinoma (Phase 2)
Circulating Tumor DNA (Phase 3)
Colitis, Ulcerative (Phase 4)
Colonic Neoplasms (Phase 2)
Colorectal Neoplasms (Phase 3)
Drugs, Investigational (Phase 3)
Drug Therapy (Phase 1/Phase 2)
Esophageal Neoplasms (Phase 3)
Gallbladder Neoplasms (Phase 2)
Immunotherapy (Phase 2)
Intestinal Neoplasms (Phase 1)
Lung Neoplasms (Phase 2)
Mutation (Phase 1)
Nasopharyngeal Carcinoma (Phase 2)
Neoplasm Metastasis (Phase 2/Phase 3)
Neoplasms (Phase 1)
Neuroendocrine Tumors (Phase 2)
Pancreatic Neoplasms (Phase 2)
Rectal Neoplasms (Phase 2)
Small Cell Lung Carcinoma (Phase 2)
Stomach Diseases (Phase 2)
Stomach Neoplasms (Phase 3)
Urinary Bladder Neoplasms (Phase 2)
Trial | Phase | Start Date | Organizations | Indications |
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