The designation follows results from the RAAINBOW Phase 2/3 trial, which evaluated 107 participants aged 2 to 17. Unlike existing oral Janus kinase (JAK) inhibitors—which are currently restricted to severe cases in older patients and carry significant safety warnings regarding infections and cardiovascular risks—CINAINU® aims to address the needs of patients with moderate forms of the disease. The drug has demonstrated meaningful hair regrowth and a favorable tolerability profile in early testing.
In section Releases
Legacy Healthcare’s CINAINU® Wins FDA Breakthrough Status
The U.S. Food and Drug Administration has granted Breakthrough Therapy Designation to CINAINU®, an investigational botanical solution for moderate-to-severe alopecia areata. This regulatory milestone covers a broad patient demographic, including adults, adolescents, and children as young as two years old, marking a potential shift in how the condition is managed.
Saad Harti, CEO of Legacy Healthcare, described the FDA decision as a recognition of the drug's potential to fill a critical gap in dermatological care. The company is now preparing a global pivotal Phase 3 program to further validate these findings. With six granted patents extending protection through 2043, CINAINU® stands as the first FDA-regulated multi-plant botanical drug to receive this accelerated review status.
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