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# Sun Pharma NDA for Alopecia Areata
- URL: https://www.fdaweb.com/sun-pharma-nda-for-alopecia-areata/
- Published: 2023-10-06T12:00:00.000Z
- Updated: 2026-09-14T19:01:05.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5155504

FDA has accepted for review a Sun Pharmaceutical Industries NDA for deuruxolitinib, an investigational oral selective inhibitor of Janus kinases JAK1 and JAK2 for treating adults with moderate to severe alopecia areata. The submission is based on data from two pivotal Phase 3 trials (THRIVE-AA1 and THRIVE-AA2), which included over 1,200 patients across more than 135 clinical trial sites.

“Significant differences in achieving the clinically-meaningful SALT score less than or equal to 20 for the treatment arm compared to placebo were seen as early as Week 8 and were maintained throughout the studies,” the company says. The Severity of Alopecia Tool (SALT) evaluates hair loss by scalp quadrant and assigns a score using the weighted sum of percentage of hair loss in the four scalp quadrants (SALT score of 0 means no hair loss, while a SALT score of 100 is total hair loss).

Sun says that treatment with deuruxolitinib was generally well-tolerated and patient satisfaction was significantly higher for the 8 (XXX INSERT SPACE XXX)mg dose compared with placebo.