Legacy Healthcare announced today that its topical botanical drug candidate, Cinainu, has received FDA clearance to advance into a multi-regional Phase 3 trial (RAAINBOW-2) targeting patients with moderate to severe alopecia areata (AA).
The FDA’s approval of the company’s Investigational New Drug (IND) application allows Cinainu to proceed with an international Phase 3 study aimed at supporting a New Drug Application (NDA). This milestone follows the successful completion of the Phase 2/3 RAAINBOW trial in children and adolescents with moderate-to-severe AA and regulatory alignment with Japan’s Pharmaceuticals and Medical Devices Agency (PMDA) for inclusion of Japanese adult and pediatric patients from age two. Legacy Healthcare plans to engage other global health authorities to expand RAAINBOW-2 to additional regions.
In the original RAAINBOW study, published in the British Journal of Dermatology, Cinainu demonstrated clinically meaningful hair regrowth in pediatric patients while maintaining an excellent safety profile and showing sustained benefits even after treatment discontinuation.
“Beyond its efficacy, Cinainu has shown the ability to treat autoimmune AA without immunosuppression-related adverse events, and with persistent effects post-treatment—both of which are, to our knowledge, firsts,” said Saad Harti, Founder and CEO of Legacy Healthcare. “The FDA-regulated botanical drug pathway is often overlooked, but our results demonstrate that botanical drugs can address complex chronic diseases without synthetic chemical intervention or long-term health risks. FDA IND clearance to proceed to Phase 3 marks a key milestone for Cinainu and highlights the potential of botanical drug innovation. To our knowledge, Cinainu is the first multi-plant botanical drug candidate granted FDA clearance to advance into Phase 3.”
The RAAINBOW-2 trial will be led by Dr. Arash Mostaghimi, Vice Chair of Clinical Trials and Innovation and Co-Director of the Complex Medical Dermatology Fellowship Program at Brigham and Women’s Hospital, as well as Associate Professor at Harvard Medical School.
“The approval of three oral JAK inhibitors over the past three years has been a breakthrough for severe AA,” Dr. Mostaghimi said. “However, there remains a clear need for a safe, effective, and potentially remittive topical therapy for patients across all severities of AA.”
Legacy Healthcare has also initiated fundraising to support the RAAINBOW-2 Phase 3 program and pipeline expansion, which includes trials for atopic dermatitis and psoriasis—conditions where Cinainu has shown efficacy signals—as well as cancer-related fatigue, in which an oral form of the product demonstrated positive results in an NIH-sponsored preclinical study.
About Cinainu
Cinainu is a topical botanical drug candidate with a strong safety record and patent protection through 2043. Preclinical and clinical studies show that Cinainu restores peri-follicular anti-apoptotic protein Bcl-2, increases epidermal Langerhans cell density, reduces endothelial expression of pro-inflammatory markers (IL-8, E-selectin, ICAM-1), and improves scalp collagen content. Clinical trials in over 700 patients—including those with androgenetic alopecia, persistent chemotherapy-induced alopecia, and alopecia areata—reported positive hair regrowth outcomes and no safety concerns over periods up to 12 months.
About Legacy Healthcare
Legacy Healthcare is a biopharmaceutical company dedicated to developing FDA-regulated botanical drugs that leverage the pleiotropic potential and safety of plant extracts to treat complex diseases.
