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# FDA Fast Tracks Arialys’ ART5803
- URL: https://www.fdaweb.com/fda-fast-tracks-arialys-art5803/
- Published: 2026-07-09T12:00:00.000Z
- Updated: 2026-09-14T13:42:38.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5161429

FDA has granted Fast Track designation to Arialys Therapeutics’ ART5803, described as the first precision therapeutic candidate in development to treat anti-NMDA receptor encephalitis (ANRE). A company [statement](https://www.businesswire.com/news/home/20260709531316/en/Arialys-Therapeutics-Announces-U.S.-FDA-Fast-Track-Designation-for-ART5803-the-First-Precision-Therapeutic-Candidate-in-Development-for-the-Treatment-of-Anti-NMDA-Receptor-Encephalitis?ref=fdaweb.com) says FDA also has granted the drug orphan drug and rare pediatric disease designations.

The company says its scientists used crystallographic structures and pharmacological assessments to develop ART5803, which directly inhibits the pathological effects of autoantibodies on the NMDA receptor. ART5803 is described as a humanized, monoclonal antibody that is being assessed in an open-label Phase 2a signal-seeking study in ANRE patients. FDA has cleared an IND for a separate Phase 2 study, Arialys says.