Clozapine
As of the edition of 20 October 2026, Clozapine is a small molecule: marketed, first approved in 1989 (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 2018
- Kind
- Small molecule
- Brand name
- Clozaril
- First approved
- 26 September 1989 (US)
- Approvals on record
- 15 in 5 regions
- Holder of the most recent approval
- Heritage Life Sciences Barbados; 7 holders in all
- Registered trials
- 55, 9 stopped early
- Disease areas
- Mental health; Nervous system; Chemically induced; Blood and lymph; Cancer; Immune 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
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 Clozapine.
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 | 16 | 8 | 1 | 2 |
| Phase 1 | 4 | 3 | 1 | 0 |
| Phase 2 | 4 | 3 | 0 | 0 |
| Phase 3 | 9 | 4 | 1 | 3 |
| Phase 4 | 22 | 10 | 6 | 4 |
| All trials | 55 |
Who has held its approvals
| Company | Role | Years |
|---|---|---|
| Novartis | Originator and Lead sponsor of trials | 1989 to now |
| Heritage Life Sciences Barbados | Acquired holder | 2015 to now |
| Jazz Pharmaceuticals | Acquired holder | 2019 to now |
| Douglas Pharmaceuticals | Acquired holder | 2025 to now |