# Nirogacestat

Nirogacestat (Ogsiveo, Merck Europe B.V.) has 1 EU-approved indication in 1 tumour type.

## Approved indications

### Desmoid tumour

| Biomarker requirement | Regimen | Setting | Conditions |
|---|---|---|---|
| None | Monotherapy | Any line | Progressing; requiring systemic treatment |

## Products

### Ogsiveo

- Company: Merck Europe B.V.
- Target: Gamma secretase inhibitor
- Class: Other antineoplastic agents
- ATC: L01XX81
- EU approval: 14 Aug 2025
- Label revised: 2 Sep 2026
- Status: orphan medicine
- SmPC (EN): https://www.ema.europa.eu/en/documents/product-information/ogsiveo-epar-product-information_en.pdf
- Fachinformation (DE): https://www.ema.europa.eu/de/documents/product-information/ogsiveo-epar-product-information_de.pdf
- EPAR: https://www.ema.europa.eu/en/medicines/human/EPAR/ogsiveo

Mechanism (SmPC section 5.1): Reversibly and non-competitively inhibits gamma secretase, blocking the proteolytic activation of Notch receptors.

## Label wording

- **Nirogacestat** (Ogsiveo), Desmoid tumour, any line: “Ogsiveo as monotherapy is indicated for the treatment of adult patients with progressing desmoid tumours who require systemic treatment.” [SmPC](https://www.ema.europa.eu/en/documents/product-information/ogsiveo-epar-product-information_en.pdf)

Source: section 4.1 of each summary of product characteristics (SmPC), EMA data as of 5 Nov 2026. AI models structured these entries and no person has checked them yet. oncolabels is a non-commercial reference for education and research and gives no medical advice; the current SmPC takes precedence.

Data under CC BY 4.0: credit oncolabels and the European Medicines Agency. Page: https://oncolabels.com/drugs/nirogacestat