ZORYVE® (ARQ-151) topical roflumilast cream 0.05%

Development notes

INTEGUMENT-INFANT Trial in 3 months to less than 2 years old. 6/10/25- Enrolled first participant. 10/24/25– Presented new QoF & long-term data at Fall Clinical Dermatology Conf. '25. 11/13/25- Enrollment completed with topline results in Q1 2026. 01/12/26:- INTEGUMENT-INFANT topline Phase 2 data expected Q1 2026; sNDA submission planned in Q3 2026. 02/02/26:- INTEGUMENT-INFANT Ph2 topline showed 58% EASI-75 at Week 4; sNDA submission planned Q2 2026. 02/25/26:- Positive INTEGUMENT-INFANT Ph2 topline in infants; sNDA for ZORYVE cream 0.05% planned in Q2 2026. 03/18/26:- INTEGUMENT-INFANT late-breaking data presented Mar 28, 2026 at AAD. 03/28/26:- INTEGUMENT-INFANT Ph2 late-breaking data showed rapid itch relief; sNDA submission still expected Q2 2026. 04/27/26:- sNDA submitted for infants down to 3 months. Await FDA acceptance for review. 05/06/26:- sNDA submitted for infants 3–24 months; INTEGUMENT-INFANT data and AAD guidelines strongly support ZORYVE 0.05%. 07/08/26:- FDA accepted infant AD sNDA for ZORYVE cream 0.05%; PDUFA set for February 23, 2027. 08/05/26:- Infant AD sNDA acceptance reiterated; PDUFA remains February 23, 2027.