Data updated: Mar 10, 2026
UKONIQ
UMBRALISIB TOSYLATE
Approved 2021-02-05
1
Indication
--
Phase 3 Trials
1
Priority Reviews
5
Years on Market
Details
- Status
- Discontinued
- First Approved
- 2021-02-05
- Routes
- ORAL
- Dosage Forms
- TABLET
UKONIQ Approval History
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What UKONIQ Treats
1 FDA approvalsOriginally approved for its first indication in 2021 .
- Other (1)
🔬
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.
UKONIQ FDA Label Details
ProUKONIQ Patents & Exclusivity
Latest Patent: May 2035
Exclusivity: Feb 2026
Patents (15 active)
US9969740
Expires May 26, 2035
US10414773
Expires May 26, 2035
US10947244
Expires May 26, 2035
US10072013
Expires Jul 2, 2033
US10570142
Expires Jul 2, 2033
US9669033
Expires Jul 2, 2033
US10981919
Expires Jul 2, 2033
US9150579
Expires Jul 2, 2033
+ 5 more patents
Exclusivity
NCE
Until Feb 2026
Source: FDA Orange Book
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.