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Last Updated: December 16, 2025

Claims for Patent: 12,234,210

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Summary for Patent: 12,234,210

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:	US18/304,202
Patent Claims:	1. A composition comprising 98.0% to 99.9% by weight of Compound 1 or a salt thereof prepared by a process comprising the steps of combining Compound 10 with Compound 11 to form Compound 1, and optionally treating Compound 1 with an acid in a solvent to form a salt of Compound 1 wherein the composition comprises at least one of: (a) 0.7% to 0.01% by weight of Compound 2 having the formula or a pharmaceutically acceptable salt thereof, (b) 0.7% to 0.01% by weight of Compound 3 having the formula or a pharmaceutically acceptable salt thereof, or (c) 0.7% to 0.01% by weight of Compound 4 having the formula or a pharmaceutically acceptable salt thereof. 2. The composition of claim 1, wherein the composition comprises 0.7% to 0.01% by weight of Compound 2 or a pharmaceutically acceptable salt thereof. 3. The composition of claim 1, wherein the composition comprises 0.7% to 0.01% by weight of Compound 3 having the formula or a pharmaceutically acceptable salt thereof. 4. The composition of claim 1, wherein the composition comprises 0.7% to 0.01% by weight of Compound 4 having the formula or a pharmaceutically acceptable salt thereof.

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