Chenodiol
As of the edition of 20 October 2026, Chenodiol is a small molecule: marketed, first approved in 1983 (US); acts on NR1H4; no US protection of its own is listed.
Sources: FDA Orange Book and Purple Book, other approval registers, ClinicalTrials.gov, ChEMBL.
The drug
- Status
- Marketed; latest approval 2025
- Kind
- Small molecule
- Brand name
- Chenix
- First approved
- 28 July 1983 (US)
- Approvals on record
- 4 in 3 regions
- Holder of the most recent approval
- Fujimoto Pharmaceutical Corporation; 4 holders in all
- Registered trials
- 13, 3 stopped early
- Disease areas
- Nutrition and metabolism; Inherited and neonatal; Digestive system; Hormones; Nervous system; Pregnancy and women's health
US protection
No US protection of its own is listed.
The FDA registers list no drug-substance patent or exclusivity of its own that counts for this drug.
Mirum Pharmaceuticals holds a later exclusivity on its own new formulation or combination product, ending 2032; it does not protect the original drug.
This is the US only.
Companies that need a new molecule because of this drug
1 company on route B because of this drug.
Companies on route B for this drug
In the product1 company is on route B because of Chenodiol.
See the 1 company on route B 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 | 4 | 2 | 0 | 2 |
| Phase 1 | 1 | 1 | 0 | 0 |
| Phase 2 | 2 | 1 | 0 | 0 |
| Phase 3 | 1 | 0 | 0 | 1 |
| Phase 4 | 5 | 5 | 0 | 0 |
| All trials | 13 |
Who has held its approvals
| Company | Role | Years |
|---|---|---|
| Solvay Pharmaceuticals | Earlier holder | 1983 to now |
| Leadiant Biosciences | Applicant, Acquired holder and Lead sponsor of trials | 2014 to now |
| Mirum Pharmaceuticals | Later holder | 2025 to now |