Guanfacine
As of the edition of 20 October 2026, Guanfacine is a small molecule: marketed, first approved in 1986 (US); acts on ADRA2A, ADRA2B and ADRA2C; no US protection is listed.
Sources: FDA Orange Book and Purple Book, other approval registers, ClinicalTrials.gov, ChEMBL.
The drug
- Status
- Marketed; latest approval 2017
- Kind
- Small molecule
- Brand name
- Tenex
- First approved
- 27 October 1986 (US)
- Approvals on record
- 16 in 5 regions
- Holder of the most recent approval
- Takeda; 4 holders in all
- Registered trials
- 65, 5 stopped early
- Disease areas
- Mental health; Nervous system; Chemically induced; Inherited and neonatal; Heart and blood vessels; Nutrition and metabolism
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
12 company-target rows on route B because of this drug.
Companies on route B for this drug
In the product12 company-target rows are on route B because of Guanfacine.
See the 12 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 | 9 | 6 | 0 | 1 |
| Phase 1 | 6 | 5 | 1 | 0 |
| Phase 2 | 19 | 15 | 4 | 0 |
| Phase 3 | 12 | 12 | 0 | 0 |
| Phase 4 | 19 | 14 | 0 | 4 |
| All trials | 65 |
Who has held its approvals
| Company | Role | Years |
|---|---|---|
| Pfizer | Originator and Applicant | 1986 to now |
| Takeda | Applicant, Later holder and Lead sponsor of trials | 2003 to now |
| Dr. Reddy's | Acquired holder | 2008 to now |
| Shionogi | Applicant | 2017 to now |