{"id":40088,"date":"2026-10-21T10:07:04","date_gmt":"2026-10-21T08:07:04","guid":{"rendered":"https:\/\/ggba.swiss\/?p=40088"},"modified":"2026-10-21T10:07:05","modified_gmt":"2026-10-21T08:07:05","slug":"legacy-healthcares-botanical-treatment-receives-fda-breakthrough-therapy-designation","status":"publish","type":"post","link":"https:\/\/ggba.swiss\/en\/legacy-healthcares-botanical-treatment-receives-fda-breakthrough-therapy-designation\/","title":{"rendered":"Legacy Healthcare&#8217;s botanical treatment receives FDA Breakthrough Therapy designation"},"content":{"rendered":"\n<p class=\"wp-block-paragraph\"><a href=\"https:\/\/legacyhealthcare.ch\/\">Legacy Healthcare<\/a>, which develops botanical prescription medicines and has offices in Switzerland, France, the United States and Japan, announced on 13 October 2026 that the <a href=\"https:\/\/www.fda.gov\/\">U.S. Food and Drug Administration<\/a> (FDA) has granted Breakthrough Therapy designation to Cinainu (LH-8). The investigational topical solution targets moderate-to-severe alopecia areata, an autoimmune form of hair loss, in adults, adolescents and children from the age of two. The designation is meant to speed up the development and review of therapies with preliminary evidence of substantial improvement over available treatments. It does not mean the drug is approved. According to the company, Cinainu is the first FDA-regulated multiplant botanical drug to receive it.<\/p>\n\n\n\n<h4 class=\"wp-block-heading\">Results from the RAAINBOW trial<\/h4>\n\n\n\n<p class=\"wp-block-paragraph\">The designation is supported by RAAINBOW, an international, double-blind, placebo-controlled phase 2\/3 trial in 107 patients aged 2 to 17, randomized 2:1 to Cinainu or placebo. Treatment lasted 24 weeks, followed by 24 weeks without treatment, and the results were published in the British Journal of Dermatology. At week 24, 26.2% of patients treated with Cinainu reached at least a 40% improvement in their SALT score, which measures scalp hair loss, compared with 5.0% on placebo. The difference between the groups was larger at week 48, after treatment had stopped. No serious adverse events were related to Cinainu.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">Cinainu combines four botanical extracts with proposed anti-inflammatory, antiapoptotic and antioxidant effects. The company sees it as a potential first-line option for moderate-to-severe alopecia areata and, subject to further study, as continuation therapy after oral JAK inhibitors, the only approved treatments for the disease today.<\/p>\n\n\n\n<h4 class=\"wp-block-heading\">Heading to a global phase 3<\/h4>\n\n\n\n<p class=\"wp-block-paragraph\">Legacy Healthcare is preparing a pivotal phase 3 program. RAAINBOW-2 is planned as a large, multiregional, double-blind, placebo-controlled trial of at least 500 patients, intended to support a future new drug application. It has received IND clearance from the FDA, and Japan&#8217;s PMDA has agreed to the conduct of the global trial, which includes Japanese adult and pediatric patients from the age of two. Saad Harti, CEO of Legacy Healthcare, calls the FDA decision a &#8220;major milestone for Cinainu.&#8221;<\/p>\n","protected":false},"excerpt":{"rendered":"<p>Biop\u00f4le-based Legacy Healthcare has received Breakthrough Therapy designation from the U.S. FDA for Cinainu, a topical botanical drug for moderate-to-severe alopecia areata in patients aged two and older.<\/p>\n","protected":false},"author":6,"featured_media":40089,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"inline_featured_image":false,"mc4wp_mailchimp_campaign":[],"footnotes":""},"categories":[833],"tags":[890,886,901],"class_list":["post-40088","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-life-science","tag-healthcare","tag-rd","tag-technology-park"],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v27.2 - https:\/\/yoast.com\/product\/yoast-seo-wordpress\/ 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