Nirogacestat
As of the edition of 20 October 2026, Nirogacestat is a small molecule: marketed, first approved in 2023 (US); acts on PSEN1; US protection ends in 2039.
Sources: FDA Orange Book and Purple Book, other approval registers, ClinicalTrials.gov, ChEMBL.
The drug
- Status
- Marketed; latest approval 2025
- Kind
- Small molecule
- Brand name
- Ogsiveo
- First approved
- 27 November 2023 (US)
- Approvals on record
- 4 in 2 regions
- Holder of the most recent approval
- Merck KGaA; 2 holders in all
- Registered trials
- 29, 8 stopped early
- Disease areas
- Cancer; Blood and lymph; Immune system; Heart and blood vessels; Hormones; Skin and connective tissue
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 Merck KGaA.
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 product21 listings count towards this date. The exact date and each listing are in the product.
See the exact date and the 21 listings behind itRequest access. Nothing is shown until you do.
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 Nirogacestat.
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 |
|---|---|---|
| PSEN1 | Presenilin-1 | P49768 |
Registered trials
| Phase | Trials | Completed | Active | Stopped early |
|---|---|---|---|---|
| Phase not stated | 2 | 0 | 0 | 0 |
| Phase 1 | 8 | 2 | 3 | 3 |
| Phase 2 | 17 | 2 | 10 | 5 |
| Phase 3 | 1 | 1 | 0 | 0 |
| Phase 4 | 1 | 0 | 1 | 0 |
| All trials | 29 |
Who has held its approvals
| Company | Role | Years |
|---|---|---|
| Merck KGaA | Originator, Applicant and Lead sponsor of trials | 2022 to now |