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# AlgoTherapeutix ATX01 Orphan Drug Status
- URL: https://www.fdaweb.com/algotherapeutix-atx01-orphan-drug-status/
- Published: 2020-06-08T12:00:00.000Z
- Updated: 2026-09-14T16:17:27.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5146952

FDA has granted AlgoTherapeutix an orphan drug designation for ATX01 (topical amitriptyline) for treating erythromelalgia. The rare condition primarily affects the feet and less commonly the hands. It is characterized by intense, burning pain, severe redness and increased skin temperature either episodic or almost continuous.

The company says the ATX01 development program primarily targets chemotherapy-induced peripheral neuropathy. Pre-clinical studies demonstrated an anti-nociceptive activity of topical amitriptyline on voltage-gated sodium-channels and peripheral sensory nerve fibers, it says. A Phase 1 trial of ATX01 is planned for late 2020.