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
Price :
$35
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At a glance
- Drugs Benzoyl peroxide/tretinoin (Primary)
- Indications Acne vulgaris
- Focus Registrational; Therapeutic Use
- Sponsors Sol-Gel Technologies
- 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.