Ezetimibe
As of the edition of 20 October 2026, Ezetimibe is a small molecule: marketed, first approved in 2002 (US); acts on NPC1L1; no US protection is listed.
Sources: FDA Orange Book and Purple Book, other approval registers, ClinicalTrials.gov, ChEMBL.
The drug
- Status
- Marketed; latest approval 2020
- Kind
- Small molecule
- Brand name
- Zetia
- First approved
- 25 October 2002 (US)
- Approvals on record
- 27 in 7 regions
- Holder of the most recent approval
- Kowa; 11 holders in all
- Registered trials
- 275, 14 stopped early
- Disease areas
- Nutrition and metabolism; Heart and blood vessels; Hormones; Inherited and neonatal; Nervous system; Digestive system
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.
Companies that need a new molecule because of this drug
3 companies on route B because of this drug.
Companies on route B for this drug
In the product3 companies are on route B because of Ezetimibe.
See the 3 companies on route B for this drug, with the facts behind eachRequest access. Nothing is shown until you do.
Target
| Gene | Protein | UniProt |
|---|---|---|
| NPC1L1 | NPC1-like intracellular cholesterol transporter 1 | Q9UHC9 |
Registered trials
| Phase | Trials | Completed | Active | Stopped early |
|---|---|---|---|---|
| Phase not stated | 44 | 22 | 13 | 2 |
| Phase 1 | 32 | 27 | 1 | 0 |
| Phase 2 | 26 | 20 | 2 | 2 |
| Phase 3 | 97 | 81 | 5 | 7 |
| Phase 4 | 76 | 49 | 12 | 3 |
| All trials | 275 |
Who has held its approvals
| Company | Role | Years |
|---|---|---|
| Organon | Applicant, Acquired holder and Lead sponsor of trials | 2000 to now |
| Daiichi Sankyo | Applicant and Lead sponsor of trials | 2005 to now |
| Merck & Co. | Applicant and Lead sponsor of trials | 2006 to now |
| Sanofi | Later holder and Lead sponsor of trials | 2012 to now |
| Kowa | Later holder | 2022 to now |