Psoriasis in 2025: Year in Review

In the year 2025, a variety of notable headlines in dermatology news were highlighted by the HCPLive team related to the treatment of plaque psoriasis, including new approvals by the US Food and Drug Administration (FDA) and significant trial data.

In addition to psoriasis research and decisions by the FDA, the year 2025 also saw a variety of podcast episodes featured on the HCPLive website highlighting emerging research and expert opinions on psoriasis management. In this Year in Review summary, the team has included some of the most notable developments and expert commentaries posted on the HCPLive website, providing an in-depth glance at psoriasis news and a sneak peek into the year ahead:

FDA News

FDA Approves Once-Daily Roflumilast (ZORYVE) Foam 0.3% for Scalp and Body Psoriasis

Roflumilast (Zoryve) foam 0.3% was approved in May 2025 as a once-daily topical therapy for adults and adolescents aged 12 years and older with psoriasis. Approximately 9 million individuals in the US live with psoriasis, and over half of such patients report scalp involvement. Previous clinical research showed significant efficacy in clearing plaques and providing rapid itch relief among such patients, with positive findings being seen in phase 2 and 3 trials. The approval of the non-steroidal psoriasis therapeutic option was announced by Arcutis Biotherapeutics, Inc.

FDA Approves Guselkumab (Tremfya) for Pediatric Plaque Psoriasis, Psoriatic Arthritis

Johnson & Johnson’s guselkumab (Tremfya) was approved in September 2025 for the treatment of children ≥ 6 years of age with moderate to severe plaque psoriasis who also weigh ≥ 40 kg (88 lbs) and are candidates for systemic drugs or phototherapy. It was also approved for active psoriatic arthritis (PsA). Guselkumab’s FDA approval made the drug the first and only interleukin (IL)-23 inhibitor approved for these pediatric indications. The decision followed the initial approvals by FDA officials for adults living with moderate to severe psoriasis in 2017 and active PsA in 2020.

FDA Accepts sNDA for Roflumilast Cream 0.3% in Children Ages 2 to 5 with Psoriasis

In November 2025, the FDA accepted a supplemental New Drug Application (sNDA) for roflumilast (Zoryve) cream 0.3% in children aged 2-5 years with psoriasis. This decision could potentially expand the treatment’s indication. Roflumilast cream 0.3% was designed as a topical PDE4 inhibitor for children with psoriasis and is now pending approval. The topical demonstrated safety, tolerability, and efficacy in children aged 2-11 under maximal use conditions. Arcutis Biotherapeutics, Inc. also highlighted the drug’s PDUFA target action date of June 29, 2026, for roflumilast cream’s potential approval in this new age range.

Trial Updates and New Guidelines

Oral IL-23 Blocker Icotrokinra Sustains High Clearance in Scalp and Genital Psoriasis

In October 2025, Johnson & Johnson released new 52-week results from the phase 3 ICONIC-TOTAL study assessing icotrokinra for adults and adolescents ≥12 years with psoriasis involving high-impact and difficult-to-treat regions of the body, such as the scalp, hands, genitals, and feet. The treatment is a first-in-class, oral peptide designed to selectively block the IL-23 receptor. Its findings were presented at the 2025 Fall Clinical Dermatology Conference in Las Vegas, Nevada.

Once-Daily Oral Zasocitinib Delivers Strong Phase 3 Efficacy in Plaque Psoriasis

In December 2025, Takeda announced positive topline findings for a pair of phase 3 multicenter, randomized, double-blind, placebo- and active comparator-controlled studies of zasocitinib (TAK-279). The treatment is a next-generation, highly selective oral tyrosine kinase 2 (TYK2) inhibitor and is designed to treat adults with moderate-to-severe psoriasis. The Latitude studies demonstrated superiority of zasocitinib compared to placebo for the co-primary endpoints of static Physician Global Assessment (sPGA) 0/1 and Psoriasis Area and Severity Index (PASI) 75 at the 16-week mark. Investigators noted a significantly greater PASI 75 response rate as early as 4 weeks in and continuing to increase through Week 24. All 44 ranked secondary endpoints were also met against placebo and apremilast.

ICONIC-ADVANCE: Icotrokinra Beats Deucravacitinib for Plaque Psoriasis

In September 2025, Johnson & Johnson’s icotrokinra, a first-in-class investigational targeted oral IL-23 inhibitor, was shown in new data to be superior to deucravacitinib (Sotyktu) for attainment of skin clearance among patients with moderate-to-severe plaque psoriasis at the 16 and 24-week marks. Icotrokinra also demonstrated comparable rates of adverse events (AEs) to placebo in 52-week data from the ICONIC-LEAD study. Both the ICONIC-ADVANCE and ICONIC-LEAD studies’ findings were presented at the European Association of Dermatology and Venereology (EADV) 2025 Congress in Paris, France.

Feature Content/Podcasts

AI in Dermatology: Discussing Downsides to the Adoption of Artificial Intelligence

One notable feature article included in the ‘This Year in Medicine’ series was titled ‘AI in Dermatology: Discussing Downsides to the Adoption of Artificial Intelligence.’ In this feature, the evolving topic of artificial intelligence (AI), its practical application in fields such as medicine, and the possible downsides of its implementation were highlighted. Despite the view among many in the field suggesting AI is beneficial for addressing the needs of patients with diseases such as psoriasis, this feature highlighted 3 experts’ varied opinions on AI and recent data highlighting possible issues with reliance on such technologies.

Opportunities for TYK2 Inhibition in Moderate Psoriasis

In this episode of the Peers & Perspectives series, a set of expert panelists discussed a series of questions related to TYK2 inhibition for psoriasis. The 2 experts featured in this iteration of the series were Christopher G. Bunick, MD, PhD, associate professor of Dermatology at the Yale School of Medicine, and April W. Armstrong, MD, MPH, professor and chief of Dermatology at the University of California, Los Angeles (UCLA). Armstrong and Bunick touched on emerging TYK2 inhibitors, such as zasocitinib and ESK-001, IMMpulse trial findings, and opportunities for TYK2 inhibitors to be used earlier in appropriate patients.

Icotrokinra vs Deucravacitinib: Results from the ICONIC-ADVANCE 1 and 2 Trials

In this iteration of the Peer Exchange series on HCPLive’s website, 3 panelists spoke about recent findings from the ICONIC-ADVANCE 1 and 2 studies, comparing icotrokinra with deucravacitinib. The 3 panelists on this episode were Linda Stein Gold, MD, of the Henry Ford Health System, Jennifer Soung, MD, of the Clinical Faculty at Harbor University of California, and David Cotter, MD, PhD, of Las Vegas Dermatology. The panelists highlighted, among other topics, gaps in psoriasis care, the International Psoriasis Council’s (IPC) new definition of “topical failure,” the icotrokinra (ICO) clinical development program, the ICONIC-ADVANCE 1 and 2 trials, and new week 52 ICONIC-LEAD data showing sustained clearance and no new safety signals in adults and adolescents using icotrokinra.