Drug · Small Molecule
Nirogacestat
CI-DRUG-00000410Explore in graph →NCIt C82383 CHEMBL1770916 CIViC Approved
Regulatory
Approvals (2)
Each record names the authority, jurisdiction, indication text and status. A drug approved in one jurisdiction for one indication is not 'approved' in general.
emaProvenance
- Source
- EMA — European public assessment reports (centrally authorised medicines)
- Dataset
- EMA medicines data (xlsx)
- Version
- ema-medicines-2026-09-11T06:00
- Retrieved
- Sep 11, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Evidence
- regulatory
- License
- EMA copyright — reproduction and distribution permitted for non-commercial and commercial purposes provided EMA is acknowledged as the source (https://www.ema.europa.eu/en/about-us/legal-notice)
- Run
- ING-EMA-20260911-000001
| Jurisdiction · authority | Cancer | Indication | Status | Approval date | Source |
|---|---|---|---|---|---|
| EU EMA | — | Ogsiveo as monotherapy is indicated for the treatment of adult patients with progressing desmoid tumours who require systemic treatment. | approved | Aug 14, 2025 | ema |
| US FDA | — | OGSIVEO is indicated for adult patients with progressing desmoid tumors who require systemic treatment. OGSIVEO is a gamma secretase inhibitor indicated for adult patients with progressing desmoid tumors who require systemic treatment. ( 1 ) | approved | Nov 27, 2023 | openfda |
Data updated 2 days agoSource updated unknown
Derived
Development pipeline
Most advanced stage across all cancers, then per top-level cancer reached through trial conditions or approval indications. Approval in any ingested jurisdiction outranks trial phase; counts are interventional studies.
| Scope | Stage | Max phase | Active | Recruiting | Phase 3 | Trials | Approvals | Jurisdictions | First approval | First trial |
|---|---|---|---|---|---|---|---|---|---|---|
| All cancers | Approved | Phase 4 | 14 | 5 | 1 | 25 | 2 | EU, US | Nov 27, 2023 | Jun 25, 2009 |
| Multiple Myeloma | Phase2 | Phase 2 | 8 | 2 | 0 | 10 | 0 | — | — | Sep 23, 2019 |
| Non-Hodgkin Lymphoma | Phase2 | Phase 2 | 8 | 2 | 0 | 10 | 0 | — | — | Sep 23, 2019 |
| Kaposi Sarcoma | Phase2 | Phase 2 | 1 | 0 | 0 | 1 | 0 | — | — |
Curated evidence
Clinical evidence (2)
CIViC items in which this therapy appears, grouped by cancer context, then molecular profile. 50 items per page.
civicProvenance
- Source
- CIViC — Clinical Interpretation of Variants in Cancer
- Dataset
- CIViC evidence items
- Version
- civic-2026-09-08
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Evidence
- expert curation
- License
- CC0 1.0
- PMID
- 26407235
- Run
- ING-CIVIC-20260908-000001
| Therapy | Cancer | Type | Level | Direction · significance | Rating (1–5) | Status | Evidence | Source |
|---|---|---|---|---|---|---|---|---|
| NOTCH1 L1678P1 | ||||||||
| Nirogacestat | Adult T-Cell Leukemia/Lymphoma | |||||||
Clinical trials
Trials with this intervention (27)
Most recently updated first, 50 per page.
clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Dataset
- ClinicalTrials.gov API v2 studies
- Retrieved
- Sep 29, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
| NCT | Title | Status | Phase | Enrollment (n) | Sponsor | Countries | Last update | Source |
|---|---|---|---|---|---|---|---|---|
| NCT04722146 | A Study of Teclistamab With Other Anticancer Therapies in Participants With Multiple Myeloma(MajesTEC-2) | active not recruiting | Phase 1 | 140 | Janssen Research & Development, LLCINDUSTRY | 5 | Sep 28, 2026 | clinicaltrials |
| NCT07170644 | A Study of Nirogacestat in Japanese Adults With Desmoid Tumors/Aggressive Fibromatosis (DT/AF) |