Calcitriol
As of the edition of 20 October 2026, Calcitriol is a small molecule: marketed, first approved in 1978 (CH); 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
- Rocaltrol
- First approved
- 18 September 1978 (CH)
- Approvals on record
- 9 in 4 regions
- Holder of the most recent approval
- Galderma; 6 holders in all
- Registered trials
- 104, 21 stopped early
- Disease areas
- Urinary and reproductive; Cancer; Pregnancy and women's health; Nutrition and metabolism; Hormones; Skin and connective tissue
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 Calcitriol.
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 | 20 | 12 | 2 | 3 |
| Phase 1 | 18 | 13 | 1 | 3 |
| Phase 2 | 34 | 22 | 0 | 8 |
| Phase 3 | 9 | 4 | 0 | 3 |
| Phase 4 | 23 | 11 | 1 | 4 |
| All trials | 104 |
Who has held its approvals
| Company | Role | Years |
|---|---|---|
| Abbott | Later holder and Lead sponsor of trials | 1986 to now |
| Roche | Later holder and Earlier holder | 1998 to now |
| Galderma | Later holder | 2009 to now |
| AbbVie | Acquired holder and Lead sponsor of trials | 2010 to now |
| Esjay Pharma | Acquired holder | 2024 to now |