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nirogacestat 🐶 Veterinary Use | Indications/Contra | FAERs-F | FAERs-M | Orange Bk | PK/Tox | Related Drugs | BioActivity |
| Stem definition | Drug id | CAS RN |
|---|---|---|
| gamma-secretase inhibitors | 5753 | 1290543-63-3 |
Description:
| Molecule | Description |
|---|---|
|
Synonyms:
|
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.
Legend: OFP - off patent OFM - off market ONP - on patent |
Drug dosage:
None
ADMET properties:
None
Predicted pharmacokinetic/toxicological properties (PK-AZ):
| Property | Description | Value | Unit | Confidence | Similarity |
|---|---|---|---|---|---|
| kinase-safety-class | ACVR2B,CDK5,EIF2AK3,GRK2,PDK1,PDK2,PDK4 | 7 | |||
| kinase-selectivity-class | AXL,BRAF,CAMK2D,PDK1 | 4 | |||
| pfas-class | PFAS structural alert (1 = True, 0 = False) | 0 |
Approvals:
| Date | Agency | Company | Orphan |
|---|---|---|---|
| Nov. 27, 2023 | FDA | SPRINGWORKS |
FDA Adverse Event Reporting System (Female)
| MedDRA adverse event term | Likelihood ratio | Likelihood ratio threshold | Patients taking drug having adverse event | Patients taking drug not having adverse event | Patients not taking drug having adverse event | Patients not taking drug not having adverse event |
|---|---|---|---|---|---|---|
| Diarrhoea | 67.55 | 49.02 | 37 | 206 | 939153 | 89689051 |
FDA Adverse Event Reporting System (Male)
None
FDA Adverse Event Reporting System (Geriatric)
| MedDRA adverse event term | Likelihood ratio | Likelihood ratio threshold | Patients taking drug having adverse event | Patients taking drug not having adverse event | Patients not taking drug having adverse event | Patients not taking drug not having adverse event |
|---|---|---|---|---|---|---|
| Diarrhoea | 81.82 | 44.89 | 44 | 237 | 1139461 | 109449557 |
| Hidradenitis | 70.06 | 44.89 | 12 | 269 | 5168 | 110583850 |
FDA Adverse Event Reporting System (Pediatric)
None
Pharmacologic Action:
| Source | Code | Description |
|---|---|---|
| ATC | L01XX81 | ANTINEOPLASTIC AND IMMUNOMODULATING AGENTS ANTINEOPLASTIC AGENTS OTHER ANTINEOPLASTIC AGENTS Other antineoplastic agents |
| MeSH PA | D000091062 | Gamma Secretase Inhibitors and Modulators |
| MeSH PA | D000970 | Antineoplastic Agents |
| MeSH PA | D004791 | Enzyme Inhibitors |
| FDA MoA | N0000185607 | Cytochrome P450 2C19 Inducers |
| FDA MoA | N0000190114 | Cytochrome P450 3A Inhibitors |
| FDA EPC | N0000194115 | Gamma Secretase Inhibitor |
| FDA MoA | N0000194116 | Gamma Secretase Inhibitors |
| CHEBI has role | CHEBI:35610 | antineoplastic agent |
| CHEBI has role | CHEBI:48668 | γ-secretase modulator |
Related Drugs by ATC class:
L01XX Other antineoplastic agents 33 drugs
Drug Use | Suggest Off label Use Form| |View source of the data|
| Disease | Relation | SNOMED_ID | DOID |
|---|---|---|---|
| Progressing desmoid tumors | indication | 725049005 |
🐶 Veterinary Drug Use
None
🐶 Veterinary products
None
Acid dissociation constants calculated using MoKa v3.0.0
None
Orange Book patent data (new drug applications)
| Formulation strength | Trade name | Applicant | Application number | Approval date | Type | Dose form | Route | Patent number | Patent expiration date | Patent use |
|---|---|---|---|---|---|---|---|---|---|---|
| EQ 100MG BASE | OGSIVEO | SPRINGWORKS | N217677 | April 4, 2024 | RX | TABLET | ORAL | 10710966 | Aug. 9, 2039 | TREATMENT OF ADULT PATIENTS WITH PROGRESSING DESMOID TUMORS |
| EQ 100MG BASE | OGSIVEO | SPRINGWORKS | N217677 | April 4, 2024 | RX | TABLET | ORAL | 10941118 | Aug. 9, 2039 | TREATMENT OF ADULT PATIENTS WITH PROGRESSING DESMOID TUMORS |
| EQ 100MG BASE | OGSIVEO | SPRINGWORKS | N217677 | April 4, 2024 | RX | TABLET | ORAL | 11845732 | Aug. 9, 2039 | TREATMENT OF ADULT PATIENTS WITH PROGRESSING DESMOID TUMORS |
| EQ 150MG BASE | OGSIVEO | SPRINGWORKS | N217677 | April 4, 2024 | RX | TABLET | ORAL | 10710966 | Aug. 9, 2039 | TREATMENT OF ADULT PATIENTS WITH PROGRESSING DESMOID TUMORS |
| EQ 150MG BASE | OGSIVEO | SPRINGWORKS | N217677 | April 4, 2024 | RX | TABLET | ORAL | 10941118 | Aug. 9, 2039 | TREATMENT OF ADULT PATIENTS WITH PROGRESSING DESMOID TUMORS |
| EQ 150MG BASE | OGSIVEO | SPRINGWORKS | N217677 | April 4, 2024 | RX | TABLET | ORAL | 11845732 | Aug. 9, 2039 | TREATMENT OF ADULT PATIENTS WITH PROGRESSING DESMOID TUMORS |
| EQ 50MG BASE | OGSIVEO | SPRINGWORKS | N217677 | Nov. 27, 2023 | DISCN | TABLET | ORAL | 10710966 | Aug. 9, 2039 | TREATMENT OF ADULT PATIENTS WITH PROGRESSING DESMOID TUMORS |
| EQ 50MG BASE | OGSIVEO | SPRINGWORKS | N217677 | Nov. 27, 2023 | DISCN | TABLET | ORAL | 10941118 | Aug. 9, 2039 | TREATMENT OF ADULT PATIENTS WITH PROGRESSING DESMOID TUMORS |
| EQ 50MG BASE | OGSIVEO | SPRINGWORKS | N217677 | Nov. 27, 2023 | DISCN | TABLET | ORAL | 11845732 | Aug. 9, 2039 | TREATMENT OF ADULT PATIENTS WITH PROGRESSING DESMOID TUMORS |
| EQ 100MG BASE | OGSIVEO | SPRINGWORKS | N217677 | April 4, 2024 | RX | TABLET | ORAL | 11612588 | July 8, 2042 | TREATMENT OF ADULT PATIENTS WITH PROGRESSING DESMOID TUMORS |
| EQ 150MG BASE | OGSIVEO | SPRINGWORKS | N217677 | April 4, 2024 | RX | TABLET | ORAL | 11612588 | July 8, 2042 | TREATMENT OF ADULT PATIENTS WITH PROGRESSING DESMOID TUMORS |
| EQ 50MG BASE | OGSIVEO | SPRINGWORKS | N217677 | Nov. 27, 2023 | DISCN | TABLET | ORAL | 11612588 | July 8, 2042 | TREATMENT OF ADULT PATIENTS WITH PROGRESSING DESMOID TUMORS |
| EQ 100MG BASE | OGSIVEO | SPRINGWORKS | N217677 | April 4, 2024 | RX | TABLET | ORAL | 11807611 | Sept. 8, 2042 | TREATMENT OF ADULT PATIENTS WITH PROGRESSING DESMOID TUMORS |
| EQ 100MG BASE | OGSIVEO | SPRINGWORKS | N217677 | April 4, 2024 | RX | TABLET | ORAL | 11844780 | Sept. 8, 2042 | TREATMENT OF ADULT PATIENTS WITH PROGRESSING DESMOID TUMORS |
| EQ 150MG BASE | OGSIVEO | SPRINGWORKS | N217677 | April 4, 2024 | RX | TABLET | ORAL | 11807611 | Sept. 8, 2042 | TREATMENT OF ADULT PATIENTS WITH PROGRESSING DESMOID TUMORS |
| EQ 150MG BASE | OGSIVEO | SPRINGWORKS | N217677 | April 4, 2024 | RX | TABLET | ORAL | 11844780 | Sept. 8, 2042 | TREATMENT OF ADULT PATIENTS WITH PROGRESSING DESMOID TUMORS |
| EQ 50MG BASE | OGSIVEO | SPRINGWORKS | N217677 | Nov. 27, 2023 | DISCN | TABLET | ORAL | 11807611 | Sept. 8, 2042 | TREATMENT OF ADULT PATIENTS WITH PROGRESSING DESMOID TUMORS |
| EQ 50MG BASE | OGSIVEO | SPRINGWORKS | N217677 | Nov. 27, 2023 | DISCN | TABLET | ORAL | 11844780 | Sept. 8, 2042 | TREATMENT OF ADULT PATIENTS WITH PROGRESSING DESMOID TUMORS |
| EQ 100MG BASE | OGSIVEO | SPRINGWORKS | N217677 | April 4, 2024 | RX | TABLET | ORAL | 11872211 | May 19, 2043 | TREATMENT OF ADULT PATIENTS WITH PROGRESSING DESMOID TUMORS |
| EQ 100MG BASE | OGSIVEO | SPRINGWORKS | N217677 | April 4, 2024 | RX | TABLET | ORAL | 11925619 | May 19, 2043 | TREATMENT OF ADULT PATIENTS WITH PROGRESSING DESMOID TUMORS |
| EQ 100MG BASE | OGSIVEO | SPRINGWORKS | N217677 | April 4, 2024 | RX | TABLET | ORAL | 11925620 | May 19, 2043 | TREATMENT OF ADULT PATIENTS WITH PROGRESSING DESMOID TUMORS |
| EQ 100MG BASE | OGSIVEO | SPRINGWORKS | N217677 | April 4, 2024 | RX | TABLET | ORAL | 11938116 | May 19, 2043 | TREATMENT OF ADULT PATIENTS WITH PROGRESSING DESMOID TUMORS |
| EQ 100MG BASE | OGSIVEO | SPRINGWORKS | N217677 | April 4, 2024 | RX | TABLET | ORAL | 11951096 | May 19, 2043 | TREATMENT OF ADULT PATIENTS WITH PROGRESSING DESMOID TUMORS |
| EQ 100MG BASE | OGSIVEO | SPRINGWORKS | N217677 | April 4, 2024 | RX | TABLET | ORAL | 11957662 | May 19, 2043 | TREATMENT OF ADULT PATIENTS WITH PROGRESSING DESMOID TUMORS |
| EQ 100MG BASE | OGSIVEO | SPRINGWORKS | N217677 | April 4, 2024 | RX | TABLET | ORAL | 12011434 | May 19, 2043 | TREATMENT OF ADULT PATIENTS WITH PROGRESSING DESMOID TUMORS |
| EQ 100MG BASE | OGSIVEO | SPRINGWORKS | N217677 | April 4, 2024 | RX | TABLET | ORAL | 12011435 | May 19, 2043 | TREATMENT OF ADULT PATIENTS WITH PROGRESSING DESMOID TUMORS |
| EQ 100MG BASE | OGSIVEO | SPRINGWORKS | N217677 | April 4, 2024 | RX | TABLET | ORAL | 12036207 | May 19, 2043 | TREATMENT OF ADULT PATIENTS WITH PROGRESSING DESMOID TUMORS |
| EQ 100MG BASE | OGSIVEO | SPRINGWORKS | N217677 | April 4, 2024 | RX | TABLET | ORAL | 12138246 | May 19, 2043 | TREATMENT OF ADULT PATIENTS WITH PROGRESSING DESMOID TUMORS |
| EQ 150MG BASE | OGSIVEO | SPRINGWORKS | N217677 | April 4, 2024 | RX | TABLET | ORAL | 11872211 | May 19, 2043 | TREATMENT OF ADULT PATIENTS WITH PROGRESSING DESMOID TUMORS |
| EQ 150MG BASE | OGSIVEO | SPRINGWORKS | N217677 | April 4, 2024 | RX | TABLET | ORAL | 11925619 | May 19, 2043 | TREATMENT OF ADULT PATIENTS WITH PROGRESSING DESMOID TUMORS |
| EQ 150MG BASE | OGSIVEO | SPRINGWORKS | N217677 | April 4, 2024 | RX | TABLET | ORAL | 11925620 | May 19, 2043 | TREATMENT OF ADULT PATIENTS WITH PROGRESSING DESMOID TUMORS |
| EQ 150MG BASE | OGSIVEO | SPRINGWORKS | N217677 | April 4, 2024 | RX | TABLET | ORAL | 11938116 | May 19, 2043 | TREATMENT OF ADULT PATIENTS WITH PROGRESSING DESMOID TUMORS |
| EQ 150MG BASE | OGSIVEO | SPRINGWORKS | N217677 | April 4, 2024 | RX | TABLET | ORAL | 11951096 | May 19, 2043 | TREATMENT OF ADULT PATIENTS WITH PROGRESSING DESMOID TUMORS |
| EQ 150MG BASE | OGSIVEO | SPRINGWORKS | N217677 | April 4, 2024 | RX | TABLET | ORAL | 11957662 | May 19, 2043 | TREATMENT OF ADULT PATIENTS WITH PROGRESSING DESMOID TUMORS |
| EQ 150MG BASE | OGSIVEO | SPRINGWORKS | N217677 | April 4, 2024 | RX | TABLET | ORAL | 12011434 | May 19, 2043 | TREATMENT OF ADULT PATIENTS WITH PROGRESSING DESMOID TUMORS |
| EQ 150MG BASE | OGSIVEO | SPRINGWORKS | N217677 | April 4, 2024 | RX | TABLET | ORAL | 12011435 | May 19, 2043 | TREATMENT OF ADULT PATIENTS WITH PROGRESSING DESMOID TUMORS |
| EQ 150MG BASE | OGSIVEO | SPRINGWORKS | N217677 | April 4, 2024 | RX | TABLET | ORAL | 12036207 | May 19, 2043 | TREATMENT OF ADULT PATIENTS WITH PROGRESSING DESMOID TUMORS |
| EQ 150MG BASE | OGSIVEO | SPRINGWORKS | N217677 | April 4, 2024 | RX | TABLET | ORAL | 12138246 | May 19, 2043 | TREATMENT OF ADULT PATIENTS WITH PROGRESSING DESMOID TUMORS |
| EQ 50MG BASE | OGSIVEO | SPRINGWORKS | N217677 | Nov. 27, 2023 | DISCN | TABLET | ORAL | 11872211 | May 19, 2043 | TREATMENT OF ADULT PATIENTS WITH PROGRESSING DESMOID TUMORS |
| EQ 50MG BASE | OGSIVEO | SPRINGWORKS | N217677 | Nov. 27, 2023 | DISCN | TABLET | ORAL | 11925619 | May 19, 2043 | TREATMENT OF ADULT PATIENTS WITH PROGRESSING DESMOID TUMORS |
| EQ 50MG BASE | OGSIVEO | SPRINGWORKS | N217677 | Nov. 27, 2023 | DISCN | TABLET | ORAL | 11925620 | May 19, 2043 | TREATMENT OF ADULT PATIENTS WITH PROGRESSING DESMOID TUMORS |
| EQ 50MG BASE | OGSIVEO | SPRINGWORKS | N217677 | Nov. 27, 2023 | DISCN | TABLET | ORAL | 11938116 | May 19, 2043 | TREATMENT OF ADULT PATIENTS WITH PROGRESSING DESMOID TUMORS |
| EQ 50MG BASE | OGSIVEO | SPRINGWORKS | N217677 | Nov. 27, 2023 | DISCN | TABLET | ORAL | 11951096 | May 19, 2043 | TREATMENT OF ADULT PATIENTS WITH PROGRESSING DESMOID TUMORS |
| EQ 50MG BASE | OGSIVEO | SPRINGWORKS | N217677 | Nov. 27, 2023 | DISCN | TABLET | ORAL | 11957662 | May 19, 2043 | TREATMENT OF ADULT PATIENTS WITH PROGRESSING DESMOID TUMORS |
| EQ 50MG BASE | OGSIVEO | SPRINGWORKS | N217677 | Nov. 27, 2023 | DISCN | TABLET | ORAL | 12011434 | May 19, 2043 | TREATMENT OF ADULT PATIENTS WITH PROGRESSING DESMOID TUMORS |
| EQ 50MG BASE | OGSIVEO | SPRINGWORKS | N217677 | Nov. 27, 2023 | DISCN | TABLET | ORAL | 12011435 | May 19, 2043 | TREATMENT OF ADULT PATIENTS WITH PROGRESSING DESMOID TUMORS |
| EQ 50MG BASE | OGSIVEO | SPRINGWORKS | N217677 | Nov. 27, 2023 | DISCN | TABLET | ORAL | 12036207 | May 19, 2043 | TREATMENT OF ADULT PATIENTS WITH PROGRESSING DESMOID TUMORS |
| EQ 50MG BASE | OGSIVEO | SPRINGWORKS | N217677 | Nov. 27, 2023 | DISCN | TABLET | ORAL | 12138246 | May 19, 2043 | TREATMENT OF ADULT PATIENTS WITH PROGRESSING DESMOID TUMORS |
Orange Book exclusivity data (new drug applications)
| Formulation strength | Trade name | Applicant | Application number | Approval date | Type | Dose form | Route | Exclusivity date | Description |
|---|---|---|---|---|---|---|---|---|---|
| EQ 100MG BASE | OGSIVEO | SPRINGWORKS | N217677 | April 4, 2024 | RX | TABLET | ORAL | Nov. 27, 2028 | NEW CHEMICAL ENTITY |
| EQ 150MG BASE | OGSIVEO | SPRINGWORKS | N217677 | April 4, 2024 | RX | TABLET | ORAL | Nov. 27, 2028 | NEW CHEMICAL ENTITY |
| EQ 50MG BASE | OGSIVEO | SPRINGWORKS | N217677 | Nov. 27, 2023 | DISCN | TABLET | ORAL | Nov. 27, 2028 | NEW CHEMICAL ENTITY |
| EQ 100MG BASE | OGSIVEO | SPRINGWORKS | N217677 | April 4, 2024 | RX | TABLET | ORAL | Nov. 27, 2030 | FDA HAS NOT RECOGNIZED ORPHAN-DRUG EXCLUSIVITY (ODE) FOR THIS DRUG, BUT IT CONTAINS THE SAME ACTIVE MOIETY OR MOIETIES AS ANOTHER DRUG(S) THAT WAS ELIGIBLE FOR ODE, AND ALSO SHARES ODE-PROTECTED USE(S) OR INDICATION(S) WITH THAT DRUG(S). AN APPLICATION SEEKING APPROVAL FOR THE SAME ACTIVE MOIETY OR MOIETIES, INCLUDING AN ANDA THAT CITES THIS NDA AS ITS BASIS OF SUBMISSION, MAY NOT BE APPROVED FOR SUCH ODE-PROTECTED USE(S) AND INDICATION(S) |
| EQ 150MG BASE | OGSIVEO | SPRINGWORKS | N217677 | April 4, 2024 | RX | TABLET | ORAL | Nov. 27, 2030 | FDA HAS NOT RECOGNIZED ORPHAN-DRUG EXCLUSIVITY (ODE) FOR THIS DRUG, BUT IT CONTAINS THE SAME ACTIVE MOIETY OR MOIETIES AS ANOTHER DRUG(S) THAT WAS ELIGIBLE FOR ODE, AND ALSO SHARES ODE-PROTECTED USE(S) OR INDICATION(S) WITH THAT DRUG(S). AN APPLICATION SEEKING APPROVAL FOR THE SAME ACTIVE MOIETY OR MOIETIES, INCLUDING AN ANDA THAT CITES THIS NDA AS ITS BASIS OF SUBMISSION, MAY NOT BE APPROVED FOR SUCH ODE-PROTECTED USE(S) AND INDICATION(S) |
| EQ 50MG BASE | OGSIVEO | SPRINGWORKS | N217677 | Nov. 27, 2023 | DISCN | TABLET | ORAL | Nov. 27, 2030 | FOR ADULT PATIENTS WITH PROGRESSING DESMOID TUMORS WHO REQUIRE SYSTEMIC TREATMENT |
Bioactivity Summary:
| Target | Class | Pharos | UniProt | Action | Type | Activity value (-log[M]) | Mechanism action | Bioact source | MoA source |
|---|---|---|---|---|---|---|---|---|---|
| Presenilin-1 | Enzyme | INHIBITOR | IC50 | 8.21 | DRUG LABEL | DRUG LABEL |
External reference:
| ID | Source |
|---|---|
| CHEBI:229217 | CHEBI |
| O6U | PDB_CHEM_ID |
| CHEMBL1770916 | ChEMBL_ID |
| C550722 | MESH_SUPPLEMENTAL_RECORD_UI |
| 7746 | IUPHAR_LIGAND_ID |
| DB12005 | DRUGBANK_ID |
| 272081000179107 | SNOMEDCT_US |
| 4042810 | VANDF |
| C4519277 | UMLSCUI |
| CHEMBL4298153 | ChEMBL_ID |
| 10404 | INN_ID |
| 1962925-29-6 | SECONDARY_CAS_RN |
| 46224413 | PUBCHEM_CID |
| 375262 | MMSL |
| 42239 | MMSL |
| d10147 | MMSL |
| 019620 | NDDF |
| 019621 | NDDF |
| QZ62892OFJ | UNII |
| 2670631 | RXNORM |
| D10960 | KEGG_DRUG |
Pharmaceutical products:
| Product | Category | Ingredients | NDC | Form | Quantity | Route | Marketing | Label |
|---|---|---|---|---|---|---|---|---|
| OGSIVEO | HUMAN PRESCRIPTION DRUG LABEL | 1 | 82448-050 | TABLET, FILM COATED | 50 mg | ORAL | NDA | 27 sections |
| OGSIVEO | HUMAN PRESCRIPTION DRUG LABEL | 1 | 82448-100 | TABLET, FILM COATED | 100 mg | ORAL | NDA | 27 sections |
| OGSIVEO | HUMAN PRESCRIPTION DRUG LABEL | 1 | 82448-100 | TABLET, FILM COATED | 100 mg | ORAL | NDA | 27 sections |
| OGSIVEO | HUMAN PRESCRIPTION DRUG LABEL | 1 | 82448-150 | TABLET, FILM COATED | 150 mg | ORAL | NDA | 27 sections |
| OGSIVEO | HUMAN PRESCRIPTION DRUG LABEL | 1 | 82448-150 | TABLET, FILM COATED | 150 mg | ORAL | NDA | 27 sections |