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# FDA Fast Track for Mallinckrodt Duchenne Drug
- URL: https://www.fdaweb.com/fda-fast-track-for-mallinckrodt-duchenne-drug/
- Published: 2016-08-26T12:00:00.000Z
- Updated: 2026-09-14T21:27:14.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5136629

FDA has granted Mallinckrodt a fast track designation for Synacthen Depot (tetracosactide) and its use in treating Duchenne muscular dystrophy. The synthetic 24 amino acid melanocortin receptor agonist is approved and marketed outside of the U.S. for certain autoimmune and inflammatory conditions. Currently, the first patients have been dosed in an initial Phase 1 trial, according to the company. Tetracosactide works by stimulating the biosynthesis of glucocorticoids, mineralocorticoids and (to a lesser extent) androgens.