Cinacalcet
As of the edition of 20 October 2026, Cinacalcet is a small molecule: marketed, first approved in 2004 (US); acts on CASR; no US protection is listed.
Sources: FDA Orange Book and Purple Book, other approval registers, ClinicalTrials.gov, ChEMBL.
The drug
- Status
- Marketed; latest approval 2004
- Kind
- Small molecule
- Brand name
- Sensipar
- First approved
- 8 March 2004 (US)
- Approvals on record
- 4 in 2 regions
- Holder of the most recent approval
- Amgen; 2 holders in all
- Withdrawn from market
- 18 December 2025 (in some regions)
- Registered trials
- 55, 6 stopped early
- Disease areas
- Hormones; Urinary and reproductive; Pregnancy and women's health; Nutrition and metabolism; Bones, joints and muscles; Cancer
US protection
No US protection is listed.
The FDA registers list no drug-substance patent or exclusivity that counts for this drug.
This is the US only.
Target
| Gene | Protein | UniProt |
|---|---|---|
| CASR | Extracellular calcium-sensing receptor | P41180 |
Registered trials
| Phase | Trials | Completed | Active | Stopped early |
|---|---|---|---|---|
| Phase not stated | 7 | 6 | 0 | 1 |
| Phase 1 | 2 | 2 | 0 | 0 |
| Phase 2 | 14 | 12 | 0 | 2 |
| Phase 3 | 14 | 11 | 0 | 2 |
| Phase 4 | 18 | 17 | 0 | 1 |
| All trials | 55 |
Who has held its approvals
| Company | Role | Years |
|---|---|---|
| Amgen | Originator and Lead sponsor of trials | 1998 to now |