Cholecalciferol
As of the edition of 20 October 2026, Cholecalciferol is a small molecule: marketed, first approved in 1938 (CH); acts on VDR.
Sources: FDA Orange Book and Purple Book, other approval registers, ClinicalTrials.gov, ChEMBL.
The drug
- Status
- Marketed; latest approval 2013
- Kind
- Small molecule
- Brand name
- CERNEVIT-12
- First approved
- 20 January 1938 (CH)
- Approvals on record
- 23 in 7 regions
- Holder of the most recent approval
- B. Braun Medical; 12 holders in all
- Registered trials
- 544, 54 stopped early
- Disease areas
- Nutrition and metabolism; Cancer; Urinary and reproductive; Bones, joints and muscles; Immune system; 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.
Companies that need a new molecule because of this drug
2 companies on route B because of this drug.
Companies on route B for this drug
In the product2 companies are on route B because of Cholecalciferol.
See the 2 companies 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 | 221 | 150 | 23 | 15 |
| Phase 1 | 53 | 36 | 7 | 4 |
| Phase 2 | 111 | 72 | 9 | 18 |
| Phase 3 | 97 | 67 | 4 | 11 |
| Phase 4 | 62 | 42 | 5 | 6 |
| All trials | 544 |
Who has held its approvals
| Company | Role | Years |
|---|---|---|
| Bayer | Applicant | 1984 to now |
| Baxter Healthcare | Later holder | 1987 to now |
| Organon | Applicant, Later holder and Lead sponsor of trials | 2003 to now |
| B. Braun Medical | Later holder | 2024 to now |