Dexmedetomidine
As of the edition of 20 October 2026, Dexmedetomidine is a small molecule: marketed, first approved in 1999 (US); acts on ADRA2A, ADRA2B and ADRA2C; no US protection of its own is listed.
Sources: FDA Orange Book and Purple Book, other approval registers, ClinicalTrials.gov, ChEMBL.
The drug
- Status
- Marketed; latest approval 2022
- Kind
- Small molecule
- Brand name
- Precedex
- First approved
- 17 December 1999 (US)
- Approvals on record
- 22 in 7 regions
- Holder of the most recent approval
- Baxter Healthcare; 9 holders in all
- Registered trials
- 1,063, 85 stopped early
- Disease areas
- Nervous system; Mental health; Heart and blood vessels; Cancer; Lungs and airways; Injuries
US protection
No US protection of its own is listed.
The FDA registers list no drug-substance patent or exclusivity of its own that counts for this drug.
BioXcel Therapeutics holds a later exclusivity on its own new formulation or combination product, ending 2028; it does not protect the original drug.
This is the US only.
Companies that need a new molecule because of this drug
9 company-target rows on route B because of this drug.
Companies on route B for this drug
In the product9 company-target rows are on route B because of Dexmedetomidine.
See the 9 company-target rows on route B for this drug, with the facts behind eachRequest access. Nothing is shown until you do.
Targets
Registered trials
| Phase | Trials | Completed | Active | Stopped early |
|---|---|---|---|---|
| Phase not stated | 402 | 231 | 71 | 20 |
| Phase 1 | 69 | 36 | 9 | 8 |
| Phase 2 | 75 | 35 | 14 | 14 |
| Phase 3 | 141 | 68 | 26 | 16 |
| Phase 4 | 376 | 200 | 54 | 27 |
| All trials | 1,063 |
Who has held its approvals
| Company | Role | Years |
|---|---|---|
| Pfizer | Applicant, Acquired holder and Lead sponsor of trials | 2005 to now |
| Orion Pharma | Applicant | 2011 to now |
| Hq Specialty Pharma | Later holder | 2015 to now |
| BioXcel Therapeutics | Later holder and Lead sponsor of trials | 2019 to now |
| Baxter Healthcare | Later holder | 2021 to now |
| Abbott | Originator | 1999 to 2005 |