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# FDA Accepts PharmaTher Ketamine IND for ALS
- URL: https://www.fdaweb.com/fda-accepts-pharmather-ketamine-ind-for-als/
- Published: 2022-01-12T12:00:00.000Z
- Updated: 2026-09-14T17:28:20.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5150920

FDA has accepted a PharmaTher investigator-initiated IND to proceed with a Phase 2 trial to evaluate ketamine to treat amyotrophic lateral sclerosis (ALS), also known as Lou Gehrig’s disease. The company [says](https://www.marketwatch.com/press-release/pharmather-announces-fda-approval-of-investigational-new-drug-ind-application-for-ketamine-to-treat-als-2022-01-12?tesla=y&ref=fdaweb.com) the agency previously had granted an orphan drug designation for ketamine to treat ALS.

If the trial is successful, the company says, PharmaTher will request a meeting with FDA to seek agreement on a plan for a Phase 3 trial and accelerated marketing approval.

PharmaTher says ketamine may indirectly attenuate NMDA receptor-related glutamate excitotoxicity and may slow disease progression, alleviate symptoms, and/or prolong survival to positively affect the lives of ALS patients and their family members.