Paltusotine
As of the edition of 20 October 2026, Paltusotine is a small molecule: marketed, first approved in 2025 (US); acts on SSTR2; US protection ends in 2039.
Sources: FDA Orange Book and Purple Book, other approval registers, ClinicalTrials.gov, ChEMBL.
The drug
- Status
- Marketed; latest approval 2026
- Kind
- Small molecule
- Brand name
- Palsonify
- First approved
- 25 September 2025 (US)
- Approvals on record
- 3 in 2 regions
- Holder of the most recent approval
- Vertex; 2 holders in all
- Registered trials
- 8, 3 stopped early
- Disease areas
- Bones, joints and muscles; Hormones; Nervous system; Cancer; Chemically induced
US protection
US protection ends in 2039.
The last listed US drug-substance patent ends in 2039. The application that gives this date is held by Vertex.
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 product14 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 Paltusotine.
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 |
|---|---|---|
| SSTR2 | Somatostatin receptor type 2 | P30874 |
Registered trials
| Phase | Trials | Completed | Active | Stopped early |
|---|---|---|---|---|
| Phase 1 | 2 | 2 | 0 | 0 |
| Phase 2 | 3 | 2 | 0 | 1 |
| Phase 3 | 3 | 0 | 1 | 2 |
| All trials | 8 |
Who has held its approvals
| Company | Role | Years |
|---|---|---|
| Vertex | Originator, Applicant and Lead sponsor of trials | 2017 to now |