Nirogacestat - PharmaKB

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

Clinical

Drug

Target

Variants

Financial

Trends

Safety

Events Timeline

YTD

Max

Events

FDA approval date

EMA approval date

Patent expiration date

Study first post date

Last update post date

Start date

Primary completion date

Completion date

Results first post date

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Commercial

Therapeutic Areas

Therapeutic Area	MeSH
neoplasms	D009369

Trade Name

FDA

EMA

Ogsiveo

Drug Products

FDA

EMA

New Drug Application (NDA)

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	2024-04-09

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

No data

HCPCS

No data

Clinical

Clinical Trials

30 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	—	4	1	1	2	8

Indications Phases 3

Indication	MeSH	Ontology	ICD-10	Ph 1	Ph 2	Ph 3	Ph 4	Other	Total
Fibroma	D005350	—	M72.9	—	1	1	—	—	2
Aggression	D000374	EFO_0003015	—	—	—	1	—	—	1

Indications Phases 2

Indication	MeSH	Ontology	ICD-10	Ph 1	Ph 2	Ph 3	Ph 4	Other	Total
Neoplasms	D009369	—	C80	—	2	—	—	2	4
Ovarian neoplasms	D010051	EFO_0003893	C56	—	1	—	—	—	1
Granulosa cell tumor	D006106	—	—	—	1	—	—	—	1

Indications Phases 1

Indication	MeSH	Ontology	ICD-10	Ph 1	Ph 2	Ph 3	Ph 4	Other	Total
Healthy volunteers/patients	—	—	—	1	—	—	—	—	1

Indications Without Phase

No data

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