Alfacalcidol
As of the edition of 20 October 2026, Alfacalcidol is a small molecule: marketed, first approved in 1979 (FR); acts on VDR.
Sources: FDA Orange Book and Purple Book, other approval registers, ClinicalTrials.gov, ChEMBL.
The drug
- Status
- Marketed; latest approval 1982
- Kind
- Small molecule
- Brand name
- Un Alfa
- First approved
- 11 December 1979 (FR)
- Approvals on record
- 6 in 3 regions
- Holder of the most recent approval
- Cheplapharm Arzneimittel; 2 holders in all
- Registered trials
- 25, 1 stopped early
- Disease areas
- Nutrition and metabolism; Bones, joints and muscles; Pregnancy and women's health; Urinary and reproductive; Hormones; Lungs and airways
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.
Target
| Gene | Protein | UniProt |
|---|---|---|
| VDR | Vitamin D3 receptor | P11473 |
Registered trials
| Phase | Trials | Completed | Active | Stopped early |
|---|---|---|---|---|
| Phase not stated | 7 | 4 | 0 | 0 |
| Phase 2 | 3 | 1 | 1 | 0 |
| Phase 3 | 4 | 2 | 0 | 0 |
| Phase 4 | 11 | 7 | 0 | 1 |
| All trials | 25 |
Who has held its approvals
| Company | Role | Years |
|---|---|---|
| Cheplapharm Arzneimittel | Applicant | 1980 to now |