drug · small molecule
futibatinib
Marketedupdated 3mo agoby Taiho Oncology Inc🔗 ChEMBL
Approvedcommunity read0 votes
🐶 often sniffed alongside
top 5Small molecule drug with a maximum clinical stage of Approval (across all indications), with 5 approved and 1 investigational indication.
targets
Fibroblast growth factor receptor
all catalysts(3)
Trials studying futibatinib
- phase2TAPUR: Testing the Use of Food and Drug Administration (FDA) Approved Drugs That Target a Specific Abnormality in a Tumor Gene in People With Advanced Stage Cancer
- phase2Phase 2 Futibatinib in Combination With PD-1 Antibody Based Standard of Care in Solid Tumors
- phase3Futibatinib in Patients Previously Enrolled in an Antecedent Futibatinib as Monotherapy or Combination Therapy.
- phase1Study of the CHK1 Inhibitor BBI-355, an ecDNA-directed Therapy (ecDTx), and the RNR Inhibitor BBI-825, in Subjects With Tumors With Oncogene Amplifications
- phase2Futibatinib and Pembrolizumab Combination in the Treatment of Advanced or Metastatic Urothelial Carcinoma
- phase2A Study of TAS-120 in Patients With Metastatic Breast Cancer
- phase2Futibatinib in Patients With Specific FGFR Aberrations
- phase3Personalized Medicine for Advanced Biliary Cancer Patients
Patent cliff
source: FDA Orange Bookfirst barrier falls
Sep 30, 2027
~1.1 years out
Earliest of all listed patents + FDA exclusivities. Generic / biosimilar entry typically only becomes possible AFTER both patent and exclusivity barriers expire.
patents (6)
- Nov 5, 2039formulationUS 11833151
- Nov 5, 2039formulationUS 11833151
- Mar 31, 2036compositionUS 10434103
- Mar 31, 2036compositionUS 10434103
- Feb 13, 2033compositionUS 9108973
- Feb 13, 2033compositionUS 9108973
FDA exclusivities (4)
- Sep 30, 2029ODE*ODE*3.1y
- Sep 30, 2029ODE-410Orphan Drug (7y)3.1y
- Sep 30, 2027NCENew Chemical Entity (5y)1.1y
- Sep 30, 2027NCENew Chemical Entity (5y)1.1y
News(1)
- Cullinan tees up J&J fight—and $100M payday—as Taiho-partnered drug hits phase 3 cancer goalTaiho Pharmaceutical and Cullinan Therapeutics have celebrated a second phase 3 victory for their small-molecule EGFR inhibitor, teeing up the partners to challenge Johnson & Johnson in a lung canc…fiercebiotech · 7d ago
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