Pipeline Updates on the Horizon From Arcutis Biotherapeutics

“A lot of the initiatives that we have within the medical affairs team are really focused on trying to understand what's important to the dermatology community: what's important to dermatologists, nurse practitioners, and physician assistants, and being able to work with them to advance that,” said Patrick Burnett, MD, PhD, in an interview with Dermatology Times.

Burnett, a board-certified dermatologist and the chief medical officer of Arcutis Biotherapeutics, recently discussed new pipeline updates from Arcutis expected in 2025. In a previous interview, Burnett reviewed Arcutis’ new initiative with Odell Beckham Jr. to bring more awareness to seborrheic dermatitis and the positive impact of roflumilast foam (Zoryve) 0.3%.¹

Regarding updates from Arcutis in 2025, Burnett is looking forward to the continued expansion of roflumilast foam for scalp and body psoriasis, a pivotal readout of data for a topical JAK inhibitor for alopecia areata, the introduction of ARQ-234 for atopic dermatitis, and additional engagement with dermatology clinicians through medical education initiatives.

A key focus of Arcutis’ plans in 2025 includes the continued expansion of roflumilast foam. While already FDA-approved for seborrheic dermatitis, Arcutis expects FDA approval in May 2025 for an additional indication—scalp and body psoriasis. The company has also submitted a lower-dose formulation (0.05%) for atopic dermatitis in children aged 2 to 5 years, with approval anticipated later in the year. Given the high prevalence of pediatric atopic dermatitis, this expansion could significantly impact treatment options.

Beyond roflumilast, Arcutis is advancing its broader dermatology pipeline. The company expects a pivotal readout in the first half of 2025 for its topical JAK inhibitor in alopecia areata. While JAK inhibitors have shown efficacy in treating alopecia, delivering them topically remains a challenge, according to Burnett. A successful topical formulation could offer an early-stage treatment alternative before systemic therapy is required. Additionally, Arcutis plans to submit an investigational new drug IND application for ARQ-234, a CD200R agonist in development as a biologic therapy for atopic dermatitis.

Arcutis is also engaging closely with the dermatology community through medical education initiatives. One such effort focuses on improving the management of seborrheic dermatitis in patients with tightly coiled hair, a subset often underrepresented in clinical discussions. The company is also exploring how the rise of nonsteroidal topical treatments—including roflumilast—is reshaping treatment algorithms, historically centered on systemic therapies and biologics.

Burnett emphasized the importance of connecting product development with real-world patient impact. He cited the company’s collaboration with Odell Beckham Jr. as an example of how roflumilast foam has directly benefited individuals, reinforcing Arcutis’ commitment to patient-centered innovation.

Reference

Odell Beckham Jr. and Arcutis tackle seborrheic dermatitis in a “Clear Win for Your Skin.” News release. Arcutis Biotherapeutics. February 4, 2025. Accessed March 3, 2025. https://www.arcutis.com/odell-beckham-jr-and-arcutis-tackle-seborrheic-dermatitis-in-a-clear-win-for-your-skin/