Umbralisib
As of the edition of 20 October 2026, Umbralisib is a small molecule: withdrawn from the market in 2022; acts on ABL1 and PIK3CD; US protection ends in 2035.
Sources: FDA Orange Book and Purple Book, other approval registers, ClinicalTrials.gov, ChEMBL.
The drug
- Status
- Withdrawn from market, 2022
- Kind
- Small molecule
- Brand name
- Ukoniq
- First approved
- 5 February 2021 (US)
- Approvals on record
- 1 in 1 region
- Holder of the most recent approval
- TG Therapeutics
- Withdrawn from market
- 1 January 2022 (in some regions)
- Registered trials
- 34, 19 stopped early
- Disease areas
- Cancer; Blood and lymph; Immune system; Heart and blood vessels; Digestive system; Hormones
US protection
US protection ends in 2035.
The last listed US drug-substance patent ends in 2035. The application that gives this date is held by TG Therapeutics.
This is the US only, and it is not the date generics or biosimilars can enter.
The exact date and the listings behind it
In the product8 listings count towards this date. The exact date and each listing are in the product.
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Companies that need a new molecule because of this drug
2 company-target rows on route A because of this drug.
Companies on route A for this drug
In the product2 company-target rows are on route A because of Umbralisib.
See the 2 company-target rows on route A for this drug, with the facts behind eachRequest access. Nothing is shown until you do.
Targets
Registered trials
| Phase | Trials | Completed | Active | Stopped early |
|---|---|---|---|---|
| Phase 1 | 11 | 8 | 1 | 2 |
| Phase 2 | 20 | 3 | 3 | 14 |
| Phase 3 | 3 | 0 | 0 | 3 |
| All trials | 34 |
Who has held its approvals
| Company | Role | Years |
|---|---|---|
| TG Therapeutics | Originator and Lead sponsor of trials | 2013 to now |