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Coacillium (LH-8)

A plant-derived cutaneous solution for alopecia areata in children — filed in Europe, and only now starting its phase 3 in the United States.

Filed with regulatorTopicalOther
Developed by
Legacy Healthcare
Current phase
Filed with regulator

Submitted to a regulator and awaiting a decision.

Indications
Alopecia areata
Also known as
LH-8, LH8, Cinainu
Last public activity
Never
Record confidence
High

How it is meant to work

A 22.25% cutaneous solution of plant-derived origin. The sponsor has not published a mechanism, and this row does not infer one from the composition.

Why it matters

It is the register's sharpest illustration that a filing is not a finish line, and that the answer differs by market. The RAAINBOW phase 2/3 read out positive in January 2023 in children and adolescents with moderate-to-severe disease — statistically superior to placebo on relative SALT change — and the EMA validated a marketing authorisation application later that year. The United States is three years behind that: the FDA cleared an IND only in January 2026, for RAAINBOW-2, an international phase 3 of at least 500 subjects, with Japan’s PMDA agreeing to include Japanese patients. Paediatric alopecia areata has almost nothing approved for it anywhere, which is why a drug developed specifically for children matters even at this stage.

Where it is approved

Marketing authorisation is granted country by country, for a specific indication. A drug approved for hair loss in one market may be approved only for something else — or not at all — in another.

  • 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 ↗

Development history

No phase changes recorded yet.

Registered trials

Pulled automatically from ClinicalTrials.gov. Matching is by name and development code, so occasional gaps are possible — tell us if you spot one.

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.

Sources