Arcutis’ 2026 Pipeline Expansion into Vitiligo, HS, and Systemic Biologics

In a continuing conversation, Patrick Burnett, MD, PhD, Chief Medical Officer of Arcutis, discussed the company’s broader pipeline and strategic plans extending beyond pediatrics, outlining what dermatologists can expect from the company in 2026. Central to this expansion are 2 newly initiated phase 2 proof-of-concept studies evaluating roflumilast 0.3% foam in vitiligo and hidradenitis suppurativa. Burnett noted that early patient experiences have been encouraging and emphasized that these studies aim to determine whether a full clinical development program is warranted in either condition. The results will shape Arcutis’ decisions on advancing topical PDE4 inhibition into new therapeutic spaces where steroid-sparing, anti-inflammatory options remain limited.
“We're really kind of just getting started on this journey, but it's been exciting to hear what experiences patients have had so far...and then potentially develop a full clinical development program down the road,” Burnett said.

Looking ahead, 2026 will also mark Arcutis’ entry into systemic biologic development. The company plans to initiate a phase 1 trial of ARQ-234, a fusion protein designed as a potent, highly selective CD200R checkpoint agonist, intended as a systemic treatment for atopic dermatitis. Burnett described ARQ-234 as an important step toward diversifying the company’s immunomodulatory portfolio and advancing beyond topical therapies, with the goal of addressing disease more comprehensively across varying severities.

Reflecting on the state of the field, Burnett offered a “holiday gift” he would give to dermatology: unrestricted patient access to innovative therapies, independent of insurance barriers or socioeconomic constraints. He emphasized the frustration clinicians often face when highly effective treatments exist but remain difficult for patients to obtain. Ensuring equitable access, he argued, would have the greatest impact on patient outcomes.

To close, Burnett reaffirmed Arcutis’ commitment to a sustained partnership with the dermatology community. Alongside ongoing work to expand existing roflumilast formulations into new indications and younger patient populations, the company aims to advance entirely new therapeutic platforms such as biologics. He characterized 2025 as a “fantastic year” and expressed optimism that the progress made will set the stage for a transformative 2026, with continued innovation across both established and emerging disease areas.