Organon Launches Phase 3 Study on Tapinarof Cream for Atopic Dermatitis in Infants

Organon & Co. (OGN) announced an update on their ongoing clinical study.

Organon & Co. has initiated a Phase 3 clinical study titled A Randomized, Double-Blind, Vehicle-Controlled (Period 1) and Open-Label (Period 2) Phase 3 Study to Investigate the Safety and Efficacy of Tapinarof Cream, 1% in Pediatric Participants Ages 3 Months to < 24 Months With Atopic Dermatitis. The study aims to assess the safety and efficacy of tapinarof cream, 1% in young children with atopic dermatitis, a common skin condition. This research is significant as it targets a vulnerable age group, potentially offering a new treatment option.

The intervention being tested is tapinarof cream, 1%, which is applied topically. It is designed to treat atopic dermatitis by reducing inflammation and skin irritation.

The study is interventional, with participants randomly assigned to receive either the active treatment or a placebo in a parallel model. It involves a double-blind phase followed by an open-label phase, ensuring comprehensive data collection on the treatment’s effectiveness and safety. The primary purpose is treatment, with masking involving participants, care providers, investigators, and outcomes assessors.

The study is set to begin on November 21, 2025, with a primary completion date yet to be determined. The last update was submitted on December 2, 2025. These dates are crucial for tracking the study’s progress and anticipating results.

For investors, this study could impact Organon’s stock performance, particularly if the results demonstrate significant efficacy and safety, potentially leading to a new marketable product. The study’s outcome may also influence investor sentiment and position Organon competitively within the dermatological treatment industry.

The study is ongoing, with further details available on the ClinicalTrials portal.

To learn more about OGN’s potential, visit the Organon & Co. drug pipeline page.