Solid state forms of (s)-2-(((s)-6,8-difluoro-1,2,3,4-tetrahydronaphthalen-2-yl)amino)-n-(1-(2-methyl-1-(neopentylamino)propan-2-yl)-1h-imidazol-4-yl)pentanamide and uses thereof
US-2021269407-A1 · Sep 2, 2021 · US
US12110277B2 · US · B2
| Field | Value |
|---|---|
| Publication number | US-12110277-B2 |
| Application number | US-202217929153-A |
| Country | US |
| Kind code | B2 |
| Filing date | Sep 1, 2022 |
| Priority date | Sep 1, 2021 |
| Publication date | Oct 8, 2024 |
| Grant date | Oct 8, 2024 |
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The present disclosures are directed to processes for synthesizing (S)-2-(((S)-6,8-difluoro-1,2,3,4-tetrahydronaphthalen-2-yl)amino)-N-(1-(2-methyl-1-(neopentylamino)propan-2-yl)-1H-imidazol-4-yl)pentanamide (“nirogacestat”).
Opening claim text (preview).
What is claimed is: 1. A pharmaceutical composition comprising: (1) 98.0% to 99.9% of nirogacestat, or a pharmaceutically acceptable salt thereof; and (2) 0.6% to 0.01% of Compound 2 or a pharmaceutically acceptable salt thereof, wherein the composition is substantially free of Compound 13 2. The composition of claim 1 , wherein the nirogacestat, or a pharmaceutically acceptable salt thereof, is present in an amount of about 1 mg to about 200 mg. 3. The composition of claim 1 , wherein the nirogacestat, or a pharmaceutically acceptable salt thereof, is present in an amount of about 1 mg to about 150 mg. 4. The composition of claim 1 , wherein the nirogacestat, or a pharmaceutically acceptable salt thereof, is present in an amount of about 1 mg to about 100 mg. 5. The composition of claim 1 , wherein the nirogacestat, or a pharmaceutically acceptable salt thereof, is present in an amount of about 1 mg to about 75 mg. 6. The composition of claim 1 , wherein the nirogacestat, or a pharmaceutically acceptable salt thereof, is present in an amount of about 10 mg to about 60 mg. 7. A pharmaceutical composition comprising: (1) 98.0% to 99.9% of nirogacestat, or a pharmaceutically acceptable salt thereof; and (2) 0.3% to 0.01% of Compound 3 or a pharmaceutically acceptable salt thereof, wherein the composition is substantially free of Compound 13 8. A pharmaceutical composition comprising: (1) 98.0% to 99.9% of nirogacestat, or a pharmaceutically acceptable salt thereof; and (2) 0.5% to 0.01% of Compound 4 or a pharmaceutically acceptable salt thereof, wherein the composition is substantially free of Compound 13 9. A pharmaceutical composition comprising: (1) 98.0% to 99.9% of nirogacestat, or a pharmaceutically acceptable salt thereof; and (2) 0.5% to 0.01% of Compound 5 or a pharmaceutically acceptable salt thereof, wherein the composition is substantially free of Compound 13 10. A pharmaceutical composition comprising: (1) 98.0% to 99.9% of nirogacestat, or a pharmaceutically acceptable salt thereof; and (2) 0.5% to 0.01% of Compound 6 or a pharmaceutically acceptable salt thereof, wherein the composition is substantially free of Compound 13 11. A pharmaceutical composition comprising: (1) 98.0% to 99.9% of nirogacestat, or a pharmaceutically acceptable salt thereof; and (2) 0.5% to 0.01% of Compound 7 or a pharmaceutically acceptable salt thereof, wherein the composition is substantially free of Compound 13 12. A pharmaceutical composition comprising: (1) 98.0% to 99.9% of nirogacestat, or a pharmaceutically acceptable salt thereof; and (2) 0.5% to 0.01% of Compound 8 or a pharmaceutically acceptable salt thereof, wherein the composition is substantially free of Compound 13 13. A pharmaceutical composition comprising: (1) 98.0% to 99.9% of nirogacestat, or a pharmaceutically acceptable salt thereof; and (2) 0.05% to 0.005% of imidazole, or a pharmaceutically acceptable salt thereof, wherein the composition is substantially free of Compound 13
Two oxygen atoms · CPC title
from compounds containing carboxyl groups by reaction with HCN, or a salt thereof, and amines, or from aminonitriles · CPC title
the other ring being six-membered, e.g. tetraline · CPC title
Optical isomers · CPC title
Imidazole-alkylamines, e.g. histamine, phentolamine · CPC title
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