Cinainu Receives FDA Breakthrough Therapy Designation for Alopecia Areata

The U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation to CINAINU® (LH-8), an investigational topical treatment for moderate-to-severe alopecia areata. Legacy Healthcare, a biopharmaceutical company based in Epalinges, Switzerland, announced the decision on October 13, 2026. The designation covers adults, adolescents and children aged 2 years and older.

A botanical drug first

CINAINU® is a cutaneous solution applied to the skin. It is a botanical prescription drug made from several plants. According to Legacy Healthcare, it is the first FDA-regulated multi-plant botanical drug to receive Breakthrough Therapy Designation. Six granted patents protect the product, with coverage running to 2043.

Breakthrough Therapy Designation is not an approval. The FDA grants it to speed the development and review of treatments that show early evidence of a substantial improvement over existing options.

The evidence: RAAINBOW

The designation rests on RAAINBOW, a randomized, double-blind, placebo-controlled Phase 2/3 trial in 107 children and adolescents aged 2 to 17. Results were published in the British Journal of Dermatology (Blume-Peytavi et al., 2026;194:37–46, DOI 10.1093/bjd/ljaf279).

According to the company, the trial showed meaningful hair regrowth, a favorable tolerability profile and a sustained benefit. The press release gives no response rates or endpoint figures.

“This is a major milestone for CINAINU®,” said Saad Harti, CEO of Legacy Healthcare. He said the company aims to offer patients “meaningful hair regrowth, favorable tolerability and sustained benefit.”

Open question: add the trial’s headline efficacy figures from the BJD paper before publishing.

Filling a gap in care

Alopecia areata is an autoimmune disease that causes patchy or total hair loss. Today, oral JAK inhibitors are the only approved treatment, and only for severe disease in adults and adolescents. That leaves two large groups with no approved option:

• Patients with moderate disease, who make up the majority of cases
• Children

JAK inhibitors also have drawbacks. Hair loss returns quickly when treatment stops, and the drugs carry FDA boxed warnings for serious infections, cancer, cardiovascular events and blood clots.

Legacy Healthcare positions CINAINU® as a potential first-line treatment for moderate and severe disease at all ages. With further study, it could also serve as a follow-on therapy after JAK inhibitors. The company is now preparing a global pivotal Phase 3 program in adults, adolescents and children.

➡️ Sources: CINAINU® Receives FDA Breakthrough Therapy Designation for Alopecia Areata, Legacy Healthcare press release, 13 October 2026 | 📸 ©Legacy Healthcare