Quetiapine
As of the edition of 20 October 2026, Quetiapine is a small molecule: marketed, first approved in 1997 (US); acts on DRD2 and HTR2A; 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
- Seroquel
- First approved
- 26 September 1997 (US)
- Approvals on record
- 25 in 5 regions
- Holder of the most recent approval
- Astellas; 3 holders in all
- Registered trials
- 268, 32 stopped early
- Disease areas
- Mental health; Nervous system; Chemically induced; Nutrition and metabolism; Pregnancy and women's health; Urinary and reproductive
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
4 company-target rows on route B because of this drug.
Companies on route B for this drug
In the product4 company-target rows are on route B because of Quetiapine.
See the 4 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 | 42 | 28 | 3 | 3 |
| Phase 1 | 25 | 20 | 1 | 2 |
| Phase 2 | 26 | 19 | 0 | 6 |
| Phase 3 | 95 | 77 | 4 | 12 |
| Phase 4 | 80 | 59 | 1 | 9 |
| All trials | 268 |
Who has held its approvals
| Company | Role | Years |
|---|---|---|
| AstraZeneca | Originator, Later holder and Lead sponsor of trials | 1997 to now |
| Astellas | Applicant and Lead sponsor of trials | 2009 to now |
| Cheplapharm Arzneimittel | Acquired holder | 2025 to now |