Clonidine
As of the edition of 20 October 2026, Clonidine is a small molecule: marketed, first approved in 1972 (ES); acts on ADRA2A, ADRA2B and ADRA2C.
Sources: FDA Orange Book and Purple Book, other approval registers, ClinicalTrials.gov, ChEMBL.
The drug
- Status
- Marketed; latest approval 1986
- Kind
- Small molecule
- Brand name
- Catapres
- First approved
- 1 October 1972 (ES)
- Approvals on record
- 23 in 3 regions
- Holder of the most recent approval
- Cmp; 10 holders in all
- Registered trials
- 150, 31 stopped early
- Disease areas
- Nervous system; Mental health; Heart and blood vessels; Chemically induced; Bones, joints and muscles; Inherited and neonatal
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.
Targets
Registered trials
| Phase | Trials | Completed | Active | Stopped early |
|---|---|---|---|---|
| Phase not stated | 31 | 19 | 1 | 8 |
| Phase 1 | 17 | 12 | 2 | 2 |
| Phase 2 | 29 | 18 | 1 | 8 |
| Phase 3 | 24 | 12 | 2 | 6 |
| Phase 4 | 49 | 24 | 6 | 7 |
| All trials | 150 |
Who has held its approvals
| Company | Role | Years |
|---|---|---|
| Astellas | Later holder and Lead sponsor of trials | 1996 to now |
| Hikma Pharmaceuticals | Later holder | 1999 to now |
| Boehringer Ingelheim | Applicant and Lead sponsor of trials | 2000 to now |
| Addrenex Pharmaceuticals | Later holder and Lead sponsor of trials | 2007 to now |
| Tris Pharma | Later holder | 2009 to now |
| Viatris | Acquired holder | 2012 to now |
| Concordia | Acquired holder | 2013 to now |
| Lavipharm | Acquired holder | 2021 to now |
| Azurity Pharmaceuticals | Later holder | 2025 to now |
| Cmp | Later holder | 2026 to now |