Legacy Healthcare announced plans to advance topical solution Cinainu into a multi-regional Phase 3 trial (RAAINBOW-2) for moderate to severe AA following US Food and Drug Administration (FDA) clearance.

The FDA cleared the company’s IND filing for Cinainu, allowing the botanical drug-candidate to proceed with an international Phase 3 study in patients with moderate to severe AA for New Drug Application (NDA) purpose. The FDA clearance follows the successful international Phase 2/3 study (RAAINBOW) in children and adolescents with moderate-to-severe AA, and the agreement from Japan’s Pharmaceuticals and Medical Devices Agency (PMDA) on the conduct of a global Phase 3 trial including Japanese adult and pediatric patients (from age 2) to support registration in Japan. Discussions with other health authorities to extend the Phase 3 RAAINBOW-2 trial to additional regions will follow.

In the first RAAINBOW study, conducted in pediatric populations with moderate to severe AA and published in the British Journal of Dermatology, Cinainu demonstrated clinically meaningful effect sizes, while maintaining an excellent safety profile and showing sustained benefits after treatment discontinuation.