Iloperidone
As of the edition of 20 October 2026, Iloperidone is a small molecule: marketed, first approved in 2009 (US); acts on HTR2A; US protection ends in 2027.
Sources: FDA Orange Book and Purple Book, other approval registers, ClinicalTrials.gov, ChEMBL.
The drug
- Status
- Marketed; latest approval 2009
- Kind
- Small molecule
- Brand name
- Fanapt
- First approved
- 6 May 2009 (US)
- Approvals on record
- 7 in 1 region
- Holder of the most recent approval
- Vanda Pharmaceuticals
- Registered trials
- 23, 3 stopped early
- Disease areas
- Mental health; Heart and blood vessels; Nervous system
US protection
US protection ends in 2027.
The last listed US exclusivity ends in 2027. The application that gives this date is held by Vanda Pharmaceuticals.
This is the US only, and it is not the date generics or biosimilars can enter.
The exact date and the listings behind it
In the product7 listings count towards this date. The exact date and each listing are in the product.
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Companies that need a new molecule because of this drug
1 company on route B because of this drug.
Companies on route B for this drug
In the product1 company is on route B because of Iloperidone.
See the 1 company on route B for this drug, with the facts behind eachRequest access. Nothing is shown until you do.
Target
| Gene | Protein | UniProt |
|---|---|---|
| HTR2A | 5-hydroxytryptamine receptor 2A | P28223 |
Registered trials
| Phase | Trials | Completed | Active | Stopped early |
|---|---|---|---|---|
| Phase not stated | 2 | 2 | 0 | 0 |
| Phase 1 | 5 | 4 | 0 | 0 |
| Phase 2 | 5 | 2 | 1 | 2 |
| Phase 3 | 5 | 3 | 1 | 0 |
| Phase 4 | 6 | 4 | 1 | 1 |
| All trials | 23 |
Who has held its approvals
| Company | Role | Years |
|---|---|---|
| Vanda Pharmaceuticals | Originator and Lead sponsor of trials | 2005 to now |