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# Fast Track for Primary Mitochondrial Myopathies Drug
- URL: https://www.fdaweb.com/fast-track-for-primary-mitochondrial-myopathies-drug/
- Published: 2021-03-24T12:00:00.000Z
- Updated: 2026-09-14T16:51:58.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5148958

FDA has granted Reneo Pharmaceuticals a Fast Track designation for REN001 and its use in treating patients with primary mitochondrial myopathies (PMM). The company describes REN001 as an oral selective peroxisome proliferator-activated receptor delta agonist currently in clinical development for genetic mitochondrial diseases that typically present with myopathy and have high unmet medical needs. In addition to PMM, the therapy is also being evaluated in long-chain fatty acid oxidation disorders and glycogen storage disorder type V (McArdle disease).