Paliperidone palmitate
As of the edition of 20 October 2026, Paliperidone palmitate is a small molecule: marketed, first approved in 2009 (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 2013
- Kind
- Small molecule
- Brand name
- Invega Sustenna
- First approved
- 31 July 2009 (US)
- Approvals on record
- 28 in 3 regions
- Holder of the most recent approval
- Luye Innomind Pharma; 3 holders in all
- Registered trials
- 49, 3 stopped early
- Disease areas
- Mental health; Chemically induced
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 | 6 | 0 | 0 |
| Phase 1 | 5 | 5 | 0 | 0 |
| Phase 2 | 2 | 2 | 0 | 0 |
| Phase 3 | 19 | 19 | 0 | 0 |
| Phase 4 | 15 | 10 | 1 | 3 |
| All trials | 49 |
Who has held its approvals
| Company | Role | Years |
|---|---|---|
| Johnson & Johnson | Originator, Applicant, Acquired holder and Lead sponsor of trials | 2003 to now |
| Luye Innomind Pharma | Later holder | 2024 to now |