Legacy Healthcare announced today that it will advance its topical botanical solution, Cinainu, into an international Phase 3 clinical trial (RAAINBOW-2) for patients with moderate to severe alopecia areata (AA) following clearance from the U.S. Food and Drug Administration (FDA).
The FDA’s clearance of the company’s Investigational New Drug (IND) application allows Cinainu to progress toward a New Drug Application (NDA) and marks a significant milestone for the development of the botanical therapy.
RAAINBOW-2: A Global Phase 3 Study
RAAINBOW-2 is designed as a double-blind, placebo-controlled, multi-regional study involving at least 500 patients with moderate to severe AA. The trial will build on the success of the earlier RAAINBOW Phase 2/3 study in pediatric populations, which demonstrated clinically meaningful hair regrowth, sustained benefits after treatment discontinuation, and an excellent safety profile.
Legacy Healthcare has also received agreement from Japan’s Pharmaceuticals and Medical Devices Agency (PMDA) to include Japanese adult and pediatric patients (from age 2) in the global trial, supporting potential registration in Japan. Discussions with additional health authorities are underway to expand the study to other regions.
Botanical Innovation with a Strong Safety Profile
“Beyond its efficacy, Cinainu treats autoimmune alopecia areata without the immunosuppression-related adverse events commonly seen with other therapies,” said Saad Harti, Founder and CEO of Legacy Healthcare. “Its persistent effects after discontinuation make it a first in the field. The FDA’s IND clearance validates the potential of botanical drugs to treat complex chronic diseases safely, without synthetic chemicals or long-term health risks.”
Cinainu is currently the first multi-plant botanical drug candidate granted FDA clearance to enter a Phase 3 trial. The topical treatment has demonstrated safety and efficacy across multiple hair loss conditions, including androgenetic alopecia, chemotherapy-induced alopecia, and AA. Over 700 patients have participated in clinical trials of Cinainu, with no reported safety concerns.
Expert-Led Trial and Clinical Significance
The RAAINBOW-2 trial will be led by Dr. Arash Mostaghimi, Vice Chair for Clinical Trials and Innovation at Brigham and Women’s Hospital and Associate Professor at Harvard Medical School.
“The recent approval of oral JAK inhibitors has advanced AA treatment significantly,” said Dr. Mostaghimi. “However, there remains a clear need for a safe, effective, and potentially remittive topical therapy for patients across all levels of disease severity.”
Future Plans and Pipeline Expansion
Legacy Healthcare has initiated fundraising efforts to support the RAAINBOW-2 trial and to expand its pipeline into other conditions, including atopic dermatitis, psoriasis, and cancer-related fatigue, where Cinainu has shown promising efficacy signals in preclinical and early clinical studies.
About Cinainu
Cinainu is a patented topical botanical therapy (patent protection through 2043) that modulates key immune and structural pathways in the scalp. Preclinical and clinical studies have shown it restores peri-follicular Bcl-2 protein, increases Langerhans cell density, reduces pro-inflammatory markers, and improves scalp collagen content, supporting hair regrowth and scalp health.
About Legacy Healthcare
Legacy Healthcare is a biopharmaceutical company focused on transforming plant extracts into FDA-regulated botanical drugs, combining safety with therapeutic potential to address chronic and complex conditions.
