Cholic acid
As of the edition of 20 October 2026, Cholic acid is a small molecule: marketed, first approved in 2013 (EU).
Sources: FDA Orange Book and Purple Book, other approval registers, ClinicalTrials.gov, ChEMBL.
The drug
- Status
- Marketed; latest approval 2023
- Kind
- Small molecule
- Brand name
- Cholbam
- First approved
- 12 September 2013 (EU)
- Approvals on record
- 5 in 3 regions
- Holder of the most recent approval
- ReqMed Company, Ltd; 4 holders in all
- Registered trials
- 7, 1 stopped early
- Disease areas
- Digestive system; Nutrition and metabolism; Inherited and neonatal; Nervous system; 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.
Registered trials
| Phase | Trials | Completed | Active | Stopped early |
|---|---|---|---|---|
| Phase not stated | 2 | 0 | 1 | 1 |
| Phase 2 | 2 | 2 | 0 | 0 |
| Phase 3 | 3 | 3 | 0 | 0 |
| All trials | 7 |
Who has held its approvals
| Company | Role | Years |
|---|---|---|
| Mirum Pharmaceuticals | Acquired holder and Lead sponsor of trials | 1992 to now |
| Theravia | Applicant | 2013 to now |
| Retrophin | Applicant | 2015 to now |