Coacillium (LH-8)

A 22.25% cutaneous solution of four plant extracts, guarana, cacao, onion and lemon, which the sponsor describes as acting through flavonoids, polyphenols and methylxanthines by a pleiotropic mechanism; no single target is named, and this row does not infer one.

It is the register's sharpest illustration that a filing is not a finish line. The RAAINBOW Phase 2/3 in children and adolescents with moderate to severe disease reported in January 2023 a statistically significant advantage over placebo on relative SALT change, published in 2026 with a difference of 26.3 points and a confidence interval that only just cleared zero, from 62 of 107 randomised patients in the primary analysis. The EMA validated a marketing application that June, the CHMP gave a negative opinion in November 2024, finding the main study did not show effectiveness, and Legacy withdrew the application in February 2025 during re-examination. In January 2026 the company said the FDA had cleared an IND for RAAINBOW-2, an international Phase 3 of at least 500 children and adults, with Japan's PMDA agreeing to include Japanese patients; no registry lists it yet. Moderate alopecia areata in children has no approved treatment, which is why a drug developed for them stays worth following through a regulatory failure.

• European UnionEMANot approved

  Pelade modérée à sévère de l'enfant et de l'adolescent

  Marketing authorisation application validated by the EMA in 2023. Validation means the dossier was accepted for review, not that it was approved; no approval has been announced.

  Company release ↗
• United StatesFDANot approved

  IND cleared January 2026 for RAAINBOW-2, an international phase 3 of at least 500 subjects. The United States is at the start of the pivotal programme, three years after the European filing.

  Company release ↗

No phase changes recorded yet.

No trials matched to this programme in ClinicalTrials.gov.

Listing a trial is not a recommendation to join one. Eligibility, risks and costs vary enormously — discuss any trial with your own doctor first.

• RAAINBOW: LH-8 cutaneous solution in children and adolescents with alopecia areata — ClinicalTrials.gov
• Legacy Healthcare to Advance Topical Solution Cinainu into International Phase 3 Trial for Alopecia Areata following US FDA Clearance — Company release, January 2026
• Coacillium cutaneous solution in children and adolescents with moderate to severe alopecia areata (RAAINBOW), Blume-Peytavi et al. — Peer-reviewed, January 2026
• Cinainu (Coacillium): withdrawal of the marketing authorisation application, European Medicines Agency — Regulator filing, February 2025
• Legacy Healthcare Announces EMA Validation of Marketing Authorisation Application for Coacillium — Company release, June 2023
• Legacy Healthcare Announces Positive Top-Line Results from Phase 2/3 Trial of Coacillium cutaneous solution in Children and Adolescents with Moderate and Severe Alopecia Areata — Company release, January 2023

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