Netupitant
As of the edition of 20 October 2026, Netupitant is a small molecule: marketed, first approved in 2014 (US); acts on TACR1; US protection ends in 2035.
Sources: FDA Orange Book and Purple Book, other approval registers, ClinicalTrials.gov, ChEMBL.
The drug
- Status
- Marketed; latest approval 2015
- Kind
- Small molecule
- Brand name
- Akynzeo
- First approved
- 10 October 2014 (US)
- Approvals on record
- 2 in 2 regions
- Holder of the most recent approval
- Helsinn Birex Pharmaceuticals; 2 holders in all
- Registered trials
- 15, 1 stopped early
- Disease areas
- Cancer; Skin and connective tissue; Lungs and airways; Pregnancy and women's health; Urinary and reproductive
US protection
US protection ends in 2035.
The last listed US drug-substance patent ends in 2035. The application that gives this date is held by Helsinn Healthcare.
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 product4 listings count towards this date. The exact date and each listing are in the product.
See the exact date and the 4 listings behind itRequest access. Nothing is shown until you do.
Target
| Gene | Protein | UniProt |
|---|---|---|
| TACR1 | Substance-P receptor | P25103 |
Registered trials
| Phase | Trials | Completed | Active | Stopped early |
|---|---|---|---|---|
| Phase not stated | 1 | 1 | 0 | 0 |
| Phase 1 | 1 | 0 | 1 | 0 |
| Phase 2 | 5 | 4 | 0 | 1 |
| Phase 3 | 6 | 5 | 0 | 0 |
| Phase 4 | 2 | 1 | 1 | 0 |
| All trials | 15 |
Who has held its approvals
| Company | Role | Years |
|---|---|---|
| Helsinn Birex Pharmaceuticals | Applicant | 2015 to now |