Q1 2025 Recap: Dermatology News and Updates

In the first quarter of 2025, a variety of advancements in the field of dermatology were covered by the editorial team for HCPLive, with notable clinical trials and a plethora of developments in the field kicking off the year.

Among the HCPLive team’s highlights for this recap of Q1 are a set of decisions by the US Food and Drug Administration (FDA) in atopic dermatitis and bullous pemphigoid, several non-conference interviews with experts in the field regarding developments, and 3 summary articles highlighting conference updates from Q1.

The following highlights represent a cumulative summary of 2025’s first quarter in dermatology news and developments, with a variety of news related to skin diseases and therapeutics being covered by our team. Here is an in-depth look at the top dermatology coverage from Q1 of 2025:

Q1 Regulatory Updates in Dermatology

FDA Accepts Roflumilast Cream sNDA in Atopic Dermatitis for Ages 2-5 Years

A notable regulatory update from Q1 was the FDA acceptance of Arcutis Biotherapeutics’s supplemental New Drug Application (sNDA) for roflumilast cream 0.05% (Zoryve) as a treatment for children aged 2 - 5 years of age with mild to moderate atopic dermatitis. The once-daily, next-generation, topical phosphodiesterase-4 (PDE4) inhibitor was given a PDUFA target action date of October 13, 2025, and its sNDA acceptance was supported by positive results from the phase 3 INTEGUMENT-PED trial, the INTEGUMENT-OLE study, and a phase 1 pharmacokinetic study.

FDA Clears IND Application for Zabalafin Hydrogel Treatment of Atopic Dermatitis

A Q1 announcement of the FDA’s Investigational New Drug (IND) application approval for Zabalafin Hydrogel, a mild-to-moderate atopic dermatitis treatment option, was released by Alphyn Biologics, Inc. The medication was formulated to address various elements of atopic dermatitis simultaneously, with a reduction in pruritus, which dermatologists and patients know to be associated with the disease. It also targets the bacterial component of atopic dermatitis.

FDA Grants Priority Review for Dupilumab in Adults with Bullous Pemphigoid

Another FDA-news update from Q1 was an announcement that officials granted priority review status to the supplemental biologics license application (sBLA) for dupilumab (Dupixent) among adults who live with bullous pemphigoid. Dupilumab will also receive an expedited review process, the announcement highlighted, given the needs of patients with this chronic autoimmune skin condition that is known to mostly affect older individuals and to be driven by type-2 inflammation.

FDA Grants Fast Track Designation to Rezpegaldesleukin for Atopic Dermatitis

Nektar Therapeutics announced the FDA’s decision to grant Fast Track designation to rezpegaldesleukin in Q1 for the treatment of adult and pediatric patients living with moderate-to-severe atopic dermatitis. Respegaldesleukin itself an investigational biologic option that the company formulated to stimulate the proliferation of regulatory T cells via the targeting of the interleukin (IL)-2 receptor complex, aiming to restore immune balance in those with atopic dermatitis.

Q1 Expert Perspectives in Dermatology

Phase 3 Findings on Birch Triterpenes for Epidermolysis Bullosa, with Anna Bruckner, MD

Following the EASE trial’s 24-month, open-label phase, the HCPLive team interviewed trial investigator Anna Bruckner, MD, professor of dermatology and pediatric dermatologist at the University of Colorado, to discuss her team’s findings on birch triterpenes (Filsuvez), also referred to as Oleogel-S10. Brucker spoke about the phase 3 study and its assessment of the long-term efficacy and safety of birch triterpenes among those with dystrophic epidermolysis bullosa (DEB) and junctional EB (JEB).

Impact of Tapinarof Cream Approval for Atopic Dermatitis, with Adelaide Hebert, MD

In another Q1 interview, the HCPLive team spoke with Adelaide A. Hebert, MD, professor of dermatology and pediatrics at UTHealth Houston, about tapinarof’s FDA December 2024 approval as an aryl hydrocarbon receptor agonist that expanded the range of available therapeutics for atopic dermatitis. The approval for Organon’s aryl hydrocarbon receptor agonist had been based on the efficacy results observed in the ADORING clinical trial program, including its 48-week extension study.

Q1 Conference Coverage Highlights

AAD 2025 Preview: 5 Phase 3 Trials to Watch

In this summary article, the American Academy of Dermatology (AAD) Annual Meeting in Orlando’s programming was spotlighted, with a list of phase 3 trials to watch at AAD spanning an array of dermatologic diseases. This list of 5 phase 3 trials to watch at the meeting included the TRuE-PN1 study on ruxolitinib for for prurigo nodularis, the ICONIC LEAD study on icotrokinra for psoriasis, the BRAVE-AA-PEDS study on baricitinib for alopecia areata, the ROCKET HORIZON study on rocatinlimab for atopic dermatitis, and the LIBERTY-BP ADEPT study on dupilumab for bullous pemphigoid.

AAD 2025 Phase 3 Recap: 7 Trials to Know

In another summary of AAD coverage, this article showcased some of the latest developments and breakthroughs observed in the late-breaking sessions, spotlighting 7 phase 3 trials. These data highlighted in the AAD phase 3 recap included research on such drugs as deucravacitinib, baricitinib, icotrokinra, ruxolitinib, and rocatinlimab.

HCPLive Five - Dermatology Updates at AAAAI/WAO 2025

In another iteration of the HCPLive Five series, 5 key dermatology updates covered at the 2025 American Academy of Allergy, Asthma, and Immunology (AAAAI)/World Allergy Organization (WAO) Joint Congress in San Diego were highlighted by the editorial team. This list was designed to offer critical insights into emerging therapeutic options, disease mechanisms, and patient care strategies, with a set of interviews featuring experts in dermatology being highlighted for those who missed the meeting.