Doxercalciferol
As of the edition of 20 October 2026, Doxercalciferol is a small molecule: marketed, first approved in 1999 (US); acts on VDR; US protection ends in 2028.
Sources: FDA Orange Book and Purple Book, other approval registers, ClinicalTrials.gov, ChEMBL.
The drug
- Status
- Marketed; latest approval 1999
- Kind
- Small molecule
- Brand name
- Hectorol
- First approved
- 9 June 1999 (US)
- Approvals on record
- 7 in 1 region
- Holder of the most recent approval
- Pfizer; 2 holders in all
- Registered trials
- 17, 4 stopped early
- Disease areas
- Hormones; Urinary and reproductive; Pregnancy and women's health; Nutrition and metabolism; Bones, joints and muscles; Cancer
US protection
US protection ends in 2028.
The last listed US exclusivity ends in 2028. The application that gives this date is held by Sanofi.
This is the US only, and it is not the date generics or biosimilars can enter.
The exact date and the listings behind it
In the product3 listings count towards this date. The exact date and each listing are in the product.
See the exact date and the 3 listings behind itRequest access. Nothing is shown until you do.
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 Doxercalciferol.
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 | 2 | 1 | 1 | 0 |
| Phase 1 | 1 | 0 | 0 | 1 |
| Phase 2 | 3 | 2 | 0 | 1 |
| Phase 3 | 3 | 2 | 0 | 1 |
| Phase 4 | 8 | 7 | 0 | 1 |
| All trials | 17 |