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# Menlo Gains Breakthrough Status for Pruritus Therapy
- URL: https://www.fdaweb.com/menlo-gains-breakthrough-status-for-pruritus-therapy/
- Published: 2019-01-15T12:00:00.000Z
- Updated: 2026-09-15T00:54:25.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5143154

FDA has granted Menlo Therapeutics a breakthrough therapy designation for serlopitant for treating pruritus associated with prurigo nodularis (PN). The designation is based on data from a Phase 2 clinical trial in pruritus associated with PN, according to the company. In the 127-patient trial, serlopitant met its primary and multiple secondary efficacy endpoints, it says. At week eight, the serlopitant 5 mg group showed a 36 mm improvement from baseline in average itch (measured by the itch visual analog scale) compared with a 19 mm improvement for the placebo group, Menlo says. Currently, patients are enrolling in two Phase 3 clinical trials (one in the U.S. and one in Europe) to evaluate the indication, with data expected by the first quarter of 2020\. Serlopitant is a once-daily oral NK1 receptor antagonist being developed for the treatment of pruritus associated with various conditions such as prurigo nodularis, psoriasis and chronic pruritus of unknown origin.