Paliperidone
As of the edition of 20 October 2026, Paliperidone is a small molecule: marketed, first approved in 2006 (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 2010
- Kind
- Small molecule
- Brand name
- Invega
- First approved
- 19 December 2006 (US)
- Approvals on record
- 45 in 6 regions
- Holder of the most recent approval
- Luye Innomind Pharma; 6 holders in all
- Registered trials
- 92, 9 stopped early
- Disease areas
- Mental health; Nervous system; Chemically induced; Digestive system; Hormones; 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.
Targets
Registered trials
| Phase | Trials | Completed | Active | Stopped early |
|---|---|---|---|---|
| Phase not stated | 8 | 5 | 0 | 3 |
| Phase 1 | 17 | 17 | 0 | 0 |
| Phase 2 | 6 | 5 | 0 | 1 |
| Phase 3 | 28 | 26 | 0 | 1 |
| Phase 4 | 33 | 23 | 3 | 4 |
| All trials | 92 |
Who has held its approvals
| Company | Role | Years |
|---|---|---|
| Johnson & Johnson | Applicant, Later holder, Earlier holder and Lead sponsor of trials | 2003 to now |
| Luye Innomind Pharma | Later holder | 2024 to now |