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Last Updated: December 18, 2025

Claims for Patent: 12,110,277

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Summary for Patent: 12,110,277

Title:	Synthesis of nirogacestat
Abstract:	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”).
Inventor(s):	Kristin Patterson, Mark Hatcher
Assignee:	SpringWorks Therapeutics Inc
Application Number:	US17/929,153
Patent Claims:	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

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