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Ogsiveo (NIROGACESTAT)
Nirogacestat works by blocking the gamma secretase enzyme, which is involved in the development and progression of desmoid tumors.
Nirogacestat, also known as Ogsiveo, is a small molecule gamma secretase inhibitor developed by Springworks. It is used to treat progressing desmoid tumors. Nirogacestat works by inhibiting the gamma secretase enzyme, which plays a role in the development and progression of desmoid tumors. The drug was approved by the FDA in 2024 and is currently patented. Key safety considerations include its bioavailability of 19%.
At a glance
| Generic name | NIROGACESTAT |
|---|---|
| Sponsor | Springworks |
| Drug class | Gamma Secretase Inhibitor [EPC] |
| Modality | Small molecule |
| Therapeutic area | Oncology |
| Phase | FDA-approved |
| First approval | 2024 |
Mechanism of action
Nirogacestat is a gamma secretase inhibitor that blocks proteolytic activation of the Notch receptor. When dysregulated, Notch can activate pathways that contribute to tumor growth.
Approved indications
- progressing desmoid tumors
Common side effects
- Diarrhea
- Ovarian toxicity
- Rash
- Nausea
- Fatigue
- Stomatitis
- Abdominal pain
- Cough
- Dyspnea
- Upper respiratory tract infection
- Alopecia
- Headache
Drug interactions
- Strong or moderate CYP3A inhibitors
- Strong or moderate CYP3A inducers
- Gastric acid reducing agents (proton pump inhibitors and H2 blockers)
- Gastric acid reducing agents (antacids)
- CYP3A substrates
- CYP2C19 substrates
- Grapefruit products
- Seville oranges
- Starfruit
Key clinical trials
- A Study of Teclistamab With Other Anticancer Therapies in Participants With Multiple Myeloma (PHASE1)
- A Study of Nirogacestat in Japanese Adults With Desmoid Tumors/Aggressive Fibromatosis (DT/AF) (PHASE2)
- Nirogacestat in Premenopausal Females With Desmoid Tumor/Aggressive Fibromatosis (DT/AF) (PHASE4)
- A Study of Belantamab Mafodotin in Combination With Nirogacestat and Pomalidomide in People With Multiple Myeloma That Has Not Responded to Treatment or Has Come Back After Treatment (PHASE1)
- MagnetisMM-4: Umbrella Study of Elranatamab (PF-06863135) in Combination With Anti-Cancer Treatments in Multiple Myeloma (PHASE2)
- Evaluation of the Response and Non-response of Nirogacestat in Desmoid Tumors- Clinical Study (PHASE2)
- A Study of a New Drug, Nirogacestat, for Treating Desmoid Tumors That Cannot be Removed by Surgery (PHASE2)
- A Study to Examine the Effects of Novel Therapy Linvoseltamab in Combination With Other Cancer Treatments for Adult Patients With Multiple Myeloma That is Resistant to Current Standard of Care Treatments (PHASE1)
Patents
| Patent | Expiry | Type |
|---|---|---|
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| FDA label | Mechanism, indications, dosing, boxed warnings, drug interactions |
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
| FDA Orange Book | Patents + exclusivity |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- Ogsiveo CI brief — competitive landscape report
- Ogsiveo updates RSS · CI watch RSS
- Springworks portfolio CI