Data updated: May 26, 2026
TIPIRACIL HYDROCHLORIDE AND TRIFLURIDINE (tipiracil hydrochloride)
Oncology
Approved 2023-06-13
2
Indications
--
Phase 3 Trials
2
Years on Market
Details
- Status
- Prescription
- First Approved
- 2023-06-13
- Routes
- ORAL
- Dosage Forms
- TABLET
TIPIRACIL HYDROCHLORIDE AND TRIFLURIDINE Approval History
2024
2025
2026
Original
New Indication
New Form
Label Update
4 FDA actions from 2023 to 2025
Jan 2025 ORIGINAL
Update
What TIPIRACIL HYDROCHLORIDE AND TRIFLURIDINE Treats
2 FDA approvalsOriginally approved for its first indication in 2023 . Covers 2 distinct patient populations.
- Other (2)
Other
(2 approvals)- • Approved indication (Jun 2023)Letter
- • Approved indication (Jan 2025)
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Pro Active Pipeline
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.
TIPIRACIL HYDROCHLORIDE AND TRIFLURIDINE FDA Label Details
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.