Calcifediol anhydrous
As of the edition of 20 October 2026, Calcifediol anhydrous is a small molecule: marketed, first approved in 1976 (ES); acts on VDR.
Sources: FDA Orange Book and Purple Book, other approval registers, ClinicalTrials.gov, ChEMBL.
The drug
- Status
- Marketed; latest approval 1997
- Kind
- Small molecule
- Brand name
- Calderol
- First approved
- 1 October 1976 (ES)
- Approvals on record
- 5 in 3 regions
- Holder of the most recent approval
- OPKO Health; 4 holders in all
- Registered trials
- 27, 1 stopped early
- Disease areas
- Nutrition and metabolism; Urinary and reproductive; Hormones; Lungs and airways; Pregnancy and women's health; Heart and blood vessels
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 because of this drug.
Companies on route B for this drug
In the product1 company is on route B because of Calcifediol anhydrous.
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 |
|---|---|---|
| VDR | Vitamin D3 receptor | P11473 |
Registered trials
| Phase | Trials | Completed | Active | Stopped early |
|---|---|---|---|---|
| Phase not stated | 4 | 3 | 0 | 0 |
| Phase 1 | 8 | 8 | 0 | 0 |
| Phase 2 | 6 | 5 | 1 | 0 |
| Phase 3 | 5 | 4 | 0 | 1 |
| Phase 4 | 4 | 3 | 1 | 0 |
| All trials | 27 |
Who has held its approvals
| Company | Role | Years |
|---|---|---|
| Organon | Acquired holder | 2003 to now |
| OPKO Health | Acquired holder and Lead sponsor of trials | 2010 to now |
| Pfizer | Earlier holder |