Nirogacestat
Ogsiveo (nirogacestat) is a small molecule pharmaceutical. Nirogacestat was first approved as Ogsiveo on 2023-11-27. It is used to treat desmoid tumors in the USA.
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Commercial
Trade Name
FDA
EMA
Ogsiveo
Drug Products
FDA
EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
Nirogacestat hydrobromide
Tradename | Company | Number | Date | Products |
|---|---|---|---|---|
| OGSIVEO | SpringWorks Therapeutics | N-217677 RX | 2023-11-27 | 3 products, RLD |
Labels
FDA
EMA
Brand Name | Status | Last Update |
|---|---|---|
| ogsiveo | New Drug Application | 2025-10-20 |
Indications
FDA
EMA
Indication | Ontology | MeSH | ICD-10 |
|---|---|---|---|
| desmoid tumors | — | D018222 | D48.11 |
Agency Specific
FDA
EMA
Expiration | Code | ||
|---|---|---|---|
NIROGACESTAT HYDROBROMIDE, OGSIVEO, SPRINGWORKS | |||
| 2030-11-27 | ODE-452 | ||
| 2028-11-27 | NCE | ||
Patent Expiration
Patent | Expires | Flag | FDA Information |
|---|---|---|---|
| Nirogacestat Hydrobromide, Ogsiveo, Springworks | |||
| 11872211 | 2043-05-19 | U-3754 | |
| 11807611 | 2042-09-08 | DP | U-3754 |
| 11844780 | 2042-09-08 | DP | U-3754 |
| 11504354 | 2042-07-08 | DP | |
| 11612588 | 2042-07-08 | DP | U-3754 |
| 10590087 | 2039-08-09 | DP | |
| 10710966 | 2039-08-09 | DP | U-3754 |
| 10941118 | 2039-08-09 | DP | U-3754 |
| 11820748 | 2039-08-09 | DP | |
| 11845732 | 2039-08-09 | DP | U-3754 |
| 11884634 | 2039-08-09 | DP | |
| 11884635 | 2039-08-09 | DP | |
| 11905255 | 2039-08-09 | DP | |
| 7342118 | 2025-08-18 | DP | |
| 7795447 | 2025-08-18 | DP | |
| 7951958 | 2025-03-11 | DP | |
ATC Codes
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HCPCS
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Clinical
Clinical Trials
31 clinical trials
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Indications Phases 4
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Desmoid tumors | D018222 | — | D48.11 | — | 5 | 1 | 1 | 2 | 9 |
Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Fibroma | D005350 | — | M72.9 | — | 2 | 1 | — | — | 3 |
| Aggression | D000374 | EFO_0003015 | — | — | 1 | 1 | — | — | 2 |
Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Multiple myeloma | D009101 | — | C90.0 | 8 | 4 | — | — | — | 10 |
| Neoplasms | D009369 | — | C80 | 3 | 3 | — | — | 2 | 7 |
| Plasma cell neoplasms | D054219 | — | — | 5 | 2 | — | — | — | 5 |
| Breast neoplasms | D001943 | EFO_0003869 | C50 | 1 | 2 | — | — | — | 3 |
| Triple negative breast neoplasms | D064726 | — | — | — | 2 | — | — | — | 2 |
| Pancreatic neoplasms | D010190 | EFO_0003860 | C25 | — | 1 | — | — | — | 1 |
| Sarcoma | D012509 | — | — | — | 1 | — | — | — | 1 |
| Hiv infections | D015658 | EFO_0000764 | B20 | — | 1 | — | — | — | 1 |
| Kaposi sarcoma | D012514 | — | C46 | — | 1 | — | — | — | 1 |
| Hematologic diseases | D006402 | EFO_0005803 | D75.9 | 1 | 1 | — | — | — | 1 |
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Indications Phases 1
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Healthy volunteers/patients | — | — | — | 2 | — | — | — | — | 2 |
| Leukemia | D007938 | — | C95 | 1 | — | — | — | — | 1 |
| Neoplasms by histologic type | D009370 | — | — | 1 | — | — | — | — | 1 |
Indications Without Phase
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Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
| Drug common name | Nirogacestat |
| INN | nirogacestat |
| Description | Nirogacestat is a member of the class of imidazoles that is 1H-imidazole substituted by a 1-[(2,2-dimethylpropyl)amino]-2-methylpropan-2-yl group at position 1 and a {N-[(2S)-6,8-difluoro-1,2,3,4-tetrahydronaphthalen-2-yl]-L-norvalyl}amino group at position 4. It is a gamma-secretase inhibitor whose hydrobromide salt is indicated for adult patients with progressing desmoid tumours who require systemic treatment. It has a role as an antineoplastic agent and a gamma-secretase modulator. It is a member of tetralins, an organofluorine compound, a secondary carboxamide, a secondary amino compound and a member of imidazoles. It is a conjugate base of a nirogacestat(2+). |
| Classification | Small molecule |
| Drug class | enzyme inhibitors: gamma secretase inhibitors |
| Image (chem structure or protein) |  |
| Structure (InChI/SMILES or Protein Sequence) | CCC[C@H](N[C@H]1CCc2cc(F)cc(F)c2C1)C(=O)Nc1cn(C(C)(C)CNCC(C)(C)C)cn1 |
Identifiers
| PDB | — |
| CAS-ID | 1290543-63-3 |
| RxCUI | — |
| ChEMBL ID | CHEMBL1770916 |
| ChEBI ID | — |
| PubChem CID | 46224413 |
| DrugBank | DB12005 |
| UNII ID | QZ62892OFJ (ChemIDplus, GSRS) |
Target
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Ogsiveo – SpringWorks Therapeutics
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Trends
PubMed Central
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Additional graphs summarizing 925 documents
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Safety
Black-box Warning
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Adverse Events
Top Adverse Reactions
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804 adverse events reported
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