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# FDA OKs Resumption of Enrollment in Masitinib Trial
- URL: https://www.fdaweb.com/fda-oks-resumption-of-enrollment-in-masitinib-trial/
- Published: 2021-11-18T12:00:00.000Z
- Updated: 2026-09-14T17:22:46.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5150611

FDA has approved the resumption of enrollment in an AB Science Phase 3 confirmatory study of masitinib in patients with amyotrophic lateral sclerosis (ALS). A company [announcement](https://shepherdgazette.com/ab-science-received-authorization-from-the-fda-to-resume-patient-enrollment-in-the-confirmatory-phase-3-study-of-masitinib-ab19001-in-patients-with-als/?ref=fdaweb.com) says the study is actively enrolling in 15 countries in Europe, the U.S., and other regions.

The study has three parallel groups to compare the efficacy and safety of masitinib in combination with riluzole (Rilutek) versus placebo in combination with riluzole for treating patients with ALS.

The study recruitment is aimed at people with ALS who have a mild or moderate functional impairment at the start of the study, AB Science says.