ZUG, Switzerland, May 22, 2026
Galderma announced that the U.S. Food and Drug Administration (FDA) has approved the Prescription-to-Over-the-Counter (OTC) switch for Differin® Epiduo® Acne Gel (Adapalene 0.1% and Benzoyl Peroxide 2.5%), significantly expanding access to a dermatologist-trusted acne treatment for consumers aged 12 years and older. The approval marks a major milestone in acne care, positioning Galderma to strengthen its leadership in the global dermatology and OTC skincare market.
FDA Approval Expands Access to Prescription-Strength Acne Care
The newly approved OTC formulation combines adapalene, a third-generation retinoid originally developed by Galderma, with benzoyl peroxide, creating a dual-action acne treatment designed to target multiple biological causes of acne simultaneously. The therapy works by helping clear clogged pores, reducing inflammation, killing acne-causing bacteria, and preventing future breakouts more effectively than either ingredient alone.
Originally launched as a prescription product more than 15 years ago, Epiduo® became one of the first FDA-approved stable fixed-dose combinations pairing a retinoid with benzoyl peroxide. The OTC transition now allows millions of acne sufferers in the United States to access a clinically proven prescription-strength treatment without requiring a doctor’s prescription.
Galderma stated that the approval reflects the company’s long-term Integrated Dermatology strategy, which focuses on leveraging innovations developed within its therapeutic dermatology business to strengthen its consumer skincare portfolio.
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Clinical Studies Demonstrated Strong Efficacy and Tolerability
The FDA approval was supported by multiple randomized Phase 3 clinical studies demonstrating that the adapalene and benzoyl peroxide combination consistently outperformed adapalene alone, benzoyl peroxide alone, and placebo gel across inflammatory and non-inflammatory acne lesions. Clinical data also showed meaningful acne reduction as early as the first week of treatment, with antimicrobial activity beginning on Day 1.
According to Galderma, patients experienced up to a 70.3% reduction in inflammatory acne lesions by Week 12, while long-term studies demonstrated sustained acne control and approximately 65% total lesion reduction through 12 months of continued use. The treatment also showed favorable tolerability across diverse patient populations and different skin tones.
The product utilizes Galderma’s proprietary Simulgel™ Gel Base technology, which stabilizes and evenly distributes both active ingredients while improving tolerability and maintaining benzoyl peroxide effectiveness. The formulation supports a simple once-daily application designed to improve treatment adherence and long-term acne management outcomes.
Bill Andriopoulos, Ph.D., Head of Global Medical Affairs at Galderma, said the approval reinforces the company’s longstanding expertise in acne and retinoid science and aligns with dermatology treatment guidelines recommending multimodal acne therapy combining retinoids and antimicrobial agents.
Galderma Strengthens Leadership in Global Acne Market
With the OTC approval of Differin Epiduo, Galderma further expands its footprint in the highly competitive acne treatment market. The company emphasized that millions of Epiduo prescriptions have been written globally, supported by more than ten Galderma-sponsored studies involving over 3,200 patients, along with extensive third-party clinical research.
Differin Epiduo OTC is expected to become available during summer 2026 through major U.S. retailers including Walmart, Target, Ulta, and Amazon. Galderma also plans to support the launch through its broader Differin skincare portfolio, which includes acne cleansers, moisturizers, and supportive treatment products.
The approval also highlights growing industry momentum toward Prescription-to-OTC switches in dermatology, allowing pharmaceutical companies to broaden consumer access while maintaining evidence-based treatment standards. As acne remains one of the most common dermatological conditions worldwide, Galderma’s move positions the company to capture increasing demand for clinically validated OTC skincare products backed by strong medical science.
Source: Galderma, press release
