Knight Therapeutics Announces Health Canada Approval for WYNZORA(TM) to Treat Psoriasis Vulgaris

Executive Summary

• Health Canada approved WYNZORA® (calcipotriol 0.05 mg/g + betamethasone dipropionate 0.5 mg/g) for the topical treatment of psoriasis vulgaris in adults and adolescents (12‑17 years) for up to 8 weeks.
• The approval stems from two Phase 3 trials demonstrating statistically superior efficacy versus vehicle and non‑inferiority to CAL/BDP gel/suspension, with favorable safety (adverse reactions <1%).
• Knight Therapeutics acquired Canadian rights to WYNZORA® via its June 2025 acquisition of Paladin Pharma’s assets; the product will be commercialized in Canada under Knight’s portfolio.

Key Details

• Product: WYNZORA® – fixed‑dose combination cream (0.05 mg/g calcipotriol, 0.5 mg/g betamethasone dipropionate).
• Indication: Topical treatment of psoriasis vulgaris in adults and adolescents aged 12‑17 years, up to an 8‑week course.
• Regulatory Milestone: Health Canada approval announced 18 Dec 2025.
• Acquisition Background: Canadian rights obtained through Knight’s June 2025 acquisition of Paladin Pharma Inc.’s assets.
• Clinical Evidence:
• Trial MC2‑01‑C2 (primary endpoint): PGA treatment success at Week 8 – WYNZORA® superior to vehicle (p < 0.0001); non‑inferior to CAL/BDP gel/suspension (Δ 14.6%, 95 % CI 7.6‑21.6%).
• Trial MC2‑01‑C7 (primary endpoint): % change in mPASI at Week 8 – WYNZORA® superior to vehicle; non‑inferior to CAL/BDP (Δ −4.2, 95 % CI −9.6‑1.2).
• Safety: Most frequent adverse reactions were application‑site events (irritation, pain, pruritus, eczema, exfoliation, telangiectasia, folliculitis) each occurring in <1 % of subjects.
• Commercial Partner History: MC2 Therapeutics (Denmark/UK) originally licensed WYNZORA® to Paladin; MC2 holds the formulation and PAD™ drug‑delivery technology.
• Previous Approvals: FDA approval (USA) – 20 Jul 2020; first European approval – 9 Jul 2021.

Notable Quotes

“By uniting two proven mechanisms in a once‑daily cream, WYNZORA® addresses the twin challenges of adherence and symptom control… expands the treatment landscape with an evidence‑based, practical therapy.” – Dr. Charles Lynde, MD, Dermatologist, The Lynde Institute for Dermatology

“We are proud to introduce WYNZORA® to patients in Canada… this launch underscores our commitment to improving quality of life for Canadian patients while continuing our broader mission…” – Samira Sakhia, President & CEO, Knight Therapeutics Inc.