Dermatology Times 2025 Year in Review: Psoriasis

Historically, treatment for psoriasis involved topical agents and phototherapy for mild disease, with systemic biologics and oral therapies reserved for moderate to severe cases. In 2025, the therapeutic landscape has expanded meaningfully, driven by regulatory milestones for novel agents and pivotal phase 2/3 trial results that bring forward both injectable biologics and oral systemic options. These advances not only enhance skin clearance and durability of response, but also broaden choice for patients based on mechanism of action, route of administration, comorbidity profile, and patient preference.

Regulatory Milestones and Expanded Approvals

In 2025, notable regulatory progress centered on expanding indications for established therapies and refining topical treatment options. Among these, the FDA’s action on roflumilast foam 0.3% (Zoryve; Arcutis Biotherapeutics) marked a meaningful step for localized psoriasis, particularly scalp and body disease. Supported by the ARRECTOR phase 3 program, the submission reflects strong co‑primary efficacy endpoints and long‑term safety, addressing an unmet need in areas traditionally difficult to treat with creams or ointments.

Roflumilast sNDA Accepted for Plaque Psoriasis in Patients 2 to 5 Years

Biologic agents continue to benefit from evolving clinical evidence. IL‑23 inhibitors such as guselkumab (Tremfya; Johnson & Johnson) remain foundational for moderate to severe plaque psoriasis and psoriatic arthritis, with late‑breaking data from the phase 3b APEX study showing significant inhibition of structural joint damage in active psoriatic arthritis alongside improvements in joint and skin endpoints at week 24. These results further reinforce the role of IL‑23 blockade in systemic disease manifestations.

FDA Approves Guselkumab for Pediatric Plaque Psoriasis and Psoriatic Arthritis

In parallel, oral small molecules have entrenched themselves in practice. Deucravacitinib (Sotyktu; Bristol Myers Squibb), a selective TYK2 inhibitor, is widely utilized for adult plaque psoriasis and, as of 2025, is moving towards regulatory acceptance for active psoriatic arthritis, offering an oral alternative for patients who prefer non‑injectable therapy or who have comorbid joint involvement.

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Late‑Stage Clinical Trial Findings: Efficacy, Safety, and Durability

Among late‑phase investigational therapies, several developments in 2025 have considerable clinical relevance:

Zasocitinib (TAK‑279; Takada) has emerged as a promising oral TYK2 inhibitor with robust phase 3 evidence positioning it as a potential new option for moderate to severe plaque psoriasis. Recent Dermatology Times coverage reports that in pivotal trials, over half of treated patients achieved PASI 90 and a meaningful proportion achieved complete skin clearance (PASI 100) by week 16, with safety outcomes comparable to existing therapies and superior efficacy to apremilast. These data signal a notable advance in orally administered systemic therapy that may rival biologic results while offering the convenience of simple daily dosing.

Phase 3 Data Position Zasocitinib as a Potential New Oral Option for Psoriasis

Icotrokinra (JNJ‑2113; Johnson & Johnson) represents another innovative strategy: an oral IL‑23 receptor blocker designed to mimic the efficacy of injectable IL‑23 inhibitors. Longitudinal data from phase 2b/long‑term extension studies demonstrate sustained PASI 75, PASI 90, and PASI 100 responses through 52 weeks, suggesting durable skin clearance with an acceptable safety profile. Head‑to‑head phase 3 data have shown superiority against existing oral therapy (Sotyktu) at key time points, and an NDA is under active review for plaque psoriasis in adults and adolescents.

Second Generation TYK2 Inhibitors Transform Psoriasis Management

Established biologics such as bimekizumab, ustekinumab, secukinumab, ixekizumab, and risankizumab continue to demonstrate high levels of skin clearance and favorable safety profiles in long‑term follow‑up, with bimekizumab’s dual IL‑17A/F blockade delivering rapid onset of effect and deep responses in trials and real‑world cohorts alike. Notably, the convenience of a single‑injection formulation of bimekizumab has been launched, reinforcing adherence and flexibility in management.

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Investigational Therapies in Phase 2 and Beyond

Beyond late‑stage assets nearing approval, additional investigational therapies with innovative mechanisms are under exploration:

Next‑generation TYK2 inhibitors continue to be evaluated for both skin and joint disease with the goal of maximizing selectivity and minimizing off‑target effects relative to earlier TYK2 compounds. Phase 2b findings for oral TYK2 agents show encouraging PASI and ACR endpoints, which may further diversify oral systemic options.

Topical agents like roflumilast and other next‑generation formulations seek to fill niches in mild to moderate psoriasis or localized disease, providing efficacious non‑systemic alternatives with favorable tolerability.

Rare forms of psoriasis, particularly generalized pustular psoriasis (GPP), are seeing attention through therapies such as imsidolimab (IL‑36 receptor antagonist), for which a BLA has recently been submitted with priority review in 2026 based on phase 3 GEMINI program results demonstrating rapid and maintained clearance with reassuring safety.

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Emerging biologics and novel small molecules remain in earlier development stages, with continued exploration of IL‑17 family blockade, JAK/STAT modulation, and other immune signaling targets that may ultimately add to clinician choices.

Conclusion

In 2025, psoriasis care reflects a broadening and deepening therapeutic armamentarium. Expanded indications for both topical and systemic therapies, advances in oral treatment options that rival biologic efficacy, and targeted approaches for rare variants such as GPP exemplify progress. At the same time, unmet needs persist in optimizing long‑term safety monitoring, refining predictive biomarkers for treatment response, and improving access and adherence across diverse patient populations.

Looking forward, the convergence of novel mechanisms, improved delivery platforms, and personalized care models suggests a future in which treatment choice is increasingly tailored to individual disease biology, comorbid conditions, and patient priorities—with the goal of durable remission and improved quality of life for people living with psoriasis.