The Food and Drug Administration (FDA) has accepted for filing the New Drug Application (NDA) for Twyneo® (microencapsulated benzoyl peroxide, 3% and microencapsulated tretinoin, 0.1%; Sol-Gel Technologies) cream for the treatment of acne vulgaris.

Twyneo is an investigational, fixed-dose combination of tretinoin 0.1%, a retinoid, and benzoyl peroxide 3%, a topical antibacterial. According to the Company, the proprietary microencapsulation technology delivers a stable drug combination of each active ingredient, extending drug delivery time, and reducing potential irritation.

The NDA is supported by data from 2 multicenter, double-blind, vehicle-controlled phase 3 trials (SGT-65-04 and SGT-65-05) that evaluated the efficacy and safety of Twyneo in 858 patients aged 9 years and older with moderate to severe acne. Findings from both trials showed that treatment with Twyneo was associated with statistically significant improvements based on the proportion of patients who had at least a 2 grade reduction from baseline and “clear” (0) or “almost clear” (1) at week 12 (on a 5-point Investigator’s Global Assessment scale). Additionally, a statistically significant improvement was observed with Twyneo with regard to inflammatory and non-inflammatory lesion counts.

“We are proud that by using our proprietary microencapsulation technology we have managed to overcome the instability of tretinoin when combined with benzoyl peroxide,” said Dr Alon Seri-Levy, Chief Executive Officer of Sol-Gel. “If approved, Twyneo has the potential to provide relief for many of the approximately 40-50 million people in the United States who suffer from acne vulgaris.”

A Prescription Drug User Fee Act (PDUFA) target date of August 1, 2021 has been set for this application.

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Sol-Gel Technologies announces FDA acceptance for filing of New Drug Application for Twyneo® for the treatment of acne vulgaris. [press release]. Ness Ziona, Israel: Sol-Gel Technologies, Ltd; December 7, 2020.