Pitolisant
As of the edition of 20 October 2026, Pitolisant is a small molecule: marketed, first approved in 2016 (EU); acts on HRH3; US protection ends in 2033.
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
- Wakix
- First approved
- 31 March 2016 (EU)
- Approvals on record
- 4 in 2 regions
- Holder of the most recent approval
- Bioprojet Pharma; 2 holders in all
- Registered trials
- 34, 4 stopped early
- Disease areas
- Nervous system; Mental health; Lungs and airways; Nutrition and metabolism; Chemically induced; Inherited and neonatal
US protection
US protection ends in 2033.
The last listed US exclusivity ends in 2033. The application that gives this date is held by Harmony Biosciences.
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 product12 listings count towards this date. The exact date and each listing are in the product.
See the exact date and the 12 listings behind itRequest access. Nothing is shown until you do.
Target
| Gene | Protein | UniProt |
|---|---|---|
| HRH3 | Histamine H3 receptor | Q9Y5N1 |
Registered trials
| Phase | Trials | Completed | Active | Stopped early |
|---|---|---|---|---|
| Phase not stated | 3 | 1 | 1 | 0 |
| Phase 1 | 6 | 4 | 0 | 2 |
| Phase 2 | 5 | 3 | 1 | 1 |
| Phase 3 | 19 | 14 | 4 | 1 |
| Phase 4 | 1 | 0 | 0 | 0 |
| All trials | 34 |
Who has held its approvals
| Company | Role | Years |
|---|---|---|
| Bioprojet Pharma | Applicant | 2016 to now |
| Harmony Biosciences | Acquired holder and Lead sponsor of trials | 2020 to now |