# Edesa Biotech Cleared by FDA for Phase 2 Vitiligo Study

- URL: https://stocks.freetheai.org/news/edesa-biotech-cleared-by-fda-for-phase-2-vitiligo-study-0f2a24
- Published: 2026-10-15T13:23:00Z
- Category: company_news; sentiment: mixed; impact: medium
- Symbols: [NASDAQ:EDSA](https://stocks.freetheai.org/symbols/NASDAQ-EDSA)
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Edesa Biotech, Inc. (EDSA) has received Investigational New Drug clearance from the U.S. Food and Drug Administration to start opening U.S. study sites for a Phase 2 trial of its candidate EB06. The clinical trial will evaluate the drug in adults with moderate-to-severe nonsegmental vitiligo.

The double-blind, placebo-controlled study plans to enroll up to 80 participants who will be assigned in a 1-to-1 ratio to receive either EB06 or a placebo through Week 22. The trial's primary endpoint will measure the mean percentage change in facial Vitiligo Area Scoring Index at Week 28. Researchers will also evaluate total-body scores, safety, and pharmacokinetics.

Clinical locations in the U.S. are anticipated to begin enrolling patients next quarter, with topline results expected in the fourth quarter of 2027. Following the update, shares of Edesa Biotech were down 6.85% to $2.65.

## Key points

- FDA cleared the IND for EB06 in a Phase 2 trial for moderate-to-severe nonsegmental vitiligo.
- The trial will enroll up to 80 adult patients randomized 1:1 to EB06 or placebo through Week 22.
- Primary endpoint measures mean percent change in facial VASI at Week 28.
- U.S. enrollment starts next quarter, with initial results expected in Q4 2027.

## Questions and answers

### What did the FDA approve for Edesa Biotech?

The FDA cleared an Investigational New Drug application for EB06, allowing Edesa Biotech to expand a Phase 2 vitiligo study into U.S. clinical sites.

### How will the EB06 Phase 2 trial be conducted?

Up to 80 adults with moderate-to-severe nonsegmental vitiligo will be randomized 1:1 to receive EB06 or a placebo through Week 22, with primary results evaluated at Week 28.

### When will Edesa Biotech report data from the trial?

Enrollment at U.S. sites is expected to begin next quarter, and topline trial results are anticipated in the fourth quarter of 2027.