Trial Profile

First pivotal trial of TWIN for the treatment of acne vulgaris in USA

Status: Recruiting

Phase of Trial: Phase III

Latest Information Update: 11 Aug 2021

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At a glance

27 Jul 2021 According to a Sol-Gel Technologies media release, Food and Drug Administration (FDA) has approved its first proprietary drug product, TWYNEO, indicated for the treatment of acne vulgaris in adults and pediatric patients nine years of age and older. This approval triggers a milestone payment from Galderma.
07 Dec 2020 Results presented in a Sol-Gel Technologies Media Release.
07 Dec 2020 According to a Sol-Gel Technologies media release, New Drug Application (NDA) for Twyneo for the treatment of acne vulgaris, has been accepted for filing by the U.S. Food and Drug Administration (FDA). The Prescription Drug User Fee Act (PDUFA) goal date assigned by the FDA for Twyneo is August 1, 2021.

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