Ursodiol
As of the edition of 20 October 2026, Ursodiol is a small molecule: marketed, first approved in 1984 (ES); acts on NR1H4.
Sources: FDA Orange Book and Purple Book, other approval registers, ClinicalTrials.gov, ChEMBL.
The drug
- Status
- Marketed; latest approval 2011
- Kind
- Small molecule
- Brand name
- Actigall
- First approved
- 1 May 1984 (ES)
- Approvals on record
- 6 in 3 regions
- Holder of the most recent approval
- Laboratoires Mayoly Spindler; 4 holders in all
- Registered trials
- 108, 11 stopped early
- Disease areas
- Digestive system; Nutrition and metabolism; Cancer; Inherited and neonatal; Pregnancy and women's health; Urinary and reproductive
US protection
No US approval on record.
With no US approval on record there are no listed US patents or exclusivities.
This is the US only.
Companies that need a new molecule because of this drug
1 company on route B and 1 company on route A because of this drug.
Companies on route B for this drug
In the product1 company is on route B because of Ursodiol.
See the 1 company on route B for this drug, with the facts behind eachRequest access. Nothing is shown until you do.
Companies on route A for this drug
In the product1 company is on route A because of Ursodiol.
See the 1 company on route A for this drug, with the facts behind eachRequest access. Nothing is shown until you do.
Target
| Gene | Protein | UniProt |
|---|---|---|
| NR1H4 | Bile acid receptor | Q96RI1 |
Registered trials
| Phase | Trials | Completed | Active | Stopped early |
|---|---|---|---|---|
| Phase not stated | 24 | 8 | 6 | 3 |
| Phase 1 | 15 | 10 | 2 | 0 |
| Phase 2 | 24 | 12 | 4 | 3 |
| Phase 3 | 27 | 10 | 5 | 3 |
| Phase 4 | 18 | 9 | 4 | 2 |
| All trials | 108 |