Lumateperone
As of the edition of 20 October 2026, Lumateperone is a small molecule: marketed, first approved in 2019 (US); acts on DRD2, HTR2A and SLC6A4; US protection ends in 2029.
Sources: FDA Orange Book and Purple Book, other approval registers, ClinicalTrials.gov, ChEMBL.
The drug
- Status
- Marketed; latest approval 2019
- Kind
- Small molecule
- Brand name
- Caplyta
- First approved
- 20 December 2019 (US)
- Approvals on record
- 3 in 1 region
- Holder of the most recent approval
- Johnson & Johnson
- Registered trials
- 36, 3 stopped early
- Disease areas
- Mental health; Nervous system; Nutrition and metabolism
US protection
US protection ends in 2029.
The last listed US drug-substance patent ends in 2029. The application that gives this date is held by Johnson & Johnson.
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 product13 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-target row on route B because of this drug.
Companies on route B for this drug
In the product1 company-target row is on route B because of Lumateperone.
See the 1 company-target row 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 1 | 4 | 4 | 0 | 0 |
| Phase 2 | 6 | 4 | 1 | 1 |
| Phase 3 | 20 | 12 | 7 | 1 |
| Phase 4 | 6 | 0 | 5 | 1 |
| All trials | 36 |
Who has held its approvals
| Company | Role | Years |
|---|---|---|
| Johnson & Johnson | Originator and Lead sponsor of trials | 2011 to now |