Rolapitant
As of the edition of 20 October 2026, Rolapitant is a small molecule: marketed, first approved in 2015 (US); acts on TACR1; US protection ends in 2028.
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
- Varubi
- First approved
- 1 September 2015 (US)
- Approvals on record
- 2 in 1 region
- Holder of the most recent approval
- TerSera Therapeutics
- Registered trials
- 12, 2 stopped early
- Disease areas
- Cancer; Lungs and airways
US protection
US protection ends in 2028.
The last listed US drug-substance patent ends in 2028. The application that gives this date is held by TerSera Therapeutics.
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.
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Companies that need a new molecule because of this drug
2 companies on route B because of this drug.
Companies on route B for this drug
In the product2 companies are on route B because of Rolapitant.
See the 2 companies on route B for this drug, with the facts behind eachRequest 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 | 0 | 1 | 0 |
| Phase 1 | 3 | 3 | 0 | 0 |
| Phase 2 | 5 | 3 | 0 | 2 |
| Phase 3 | 3 | 3 | 0 | 0 |
| All trials | 12 |
Who has held its approvals
| Company | Role | Years |
|---|---|---|
| GSK | Originator and Lead sponsor of trials | 2012 to now |
| TerSera Therapeutics | Acquired holder | 2018 to now |