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Dermatology

What's next in dermatology — October 26, 2026

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This edition brings together five dermatology milestones expected between late 2026 and the first quarter of 2027, each with an official date or a company estimate: three FDA decisions, one approval expected in the EU and US, and two phase 3 readouts. None changes practice yet; any of them may slip or come back negative.

1. Imsidolimab for generalized pustular psoriasis

[Regulatory decision pending] [United States] [Confirmed date: December 12, 2026]
What it is: A fully human IgG4 monoclonal antibody against the IL-36 receptor (Vanda). The FDA accepted the Biologics License Application (BLA) with a PDUFA target date of December 12, 2026. In GEMINI-1 (NCT05352893; randomized, double-blind, 45 patients, 15 per arm), a single 750 mg IV dose achieved GPPPGA 0/1 at week 4 in 53% vs 13% with placebo (p = 0.0131); GEMINI-2 (NCT05366855) assessed maintenance with monthly subcutaneous dosing in patients rolled over from GEMINI-1, including those who required rescue.
What problem it solves: Generalized pustular psoriasis is rare and potentially severe; today the only approved targeted therapy is spesolimab (same mechanism), and the rest are conventional systemic drugs of limited efficacy.
Critical take: Small trials funded by the developer, with no comparison against spesolimab; practical value will depend on price and access, the main barrier in our setting.

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2. Oral zasocitinib for moderate-to-severe plaque psoriasis

[Regulatory decision pending] [United States and EU] [Estimated date: first quarter of 2027 for the FDA, per Takeda]
What it is: An oral TYK2 inhibitor (Takeda). The FDA accepted the NDA under priority review on September 14, 2026, with a target action date in the first quarter of 2027; the EMA has also accepted the marketing authorization application. In LATITUDE PsO 3001 (n = 693) and 3002 (n = 1,108), randomized and double-blind, versus placebo and apremilast, week-16 PASI 75 was 76% and 71% (placebo 12%; apremilast 37% and 33%; p < 0.001 for all comparisons).
What problem it solves: An oral route with efficacy approaching some biologics; current targeted oral options are apremilast, deucravacitinib and icotrokinra (FDA-approved in March 2026).
Critical take: In the head-to-head phase 3 LATITUDE Atlas trial (randomized, double-blind, n = 606, presented at EADV 2026), zasocitinib outperformed deucravacitinib on week-16 PASI 100 (36.5% vs 13.9%), but there are no head-to-head trials against icotrokinra or biologics; the efficacy data cited come from Takeda's release and a congress presentation.

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3. Oral povorcitinib for hidradenitis suppurativa

[Regulatory decision pending] [EU and United States] [Estimated date: late 2026 in the EU and first quarter of 2027 in the US, per Incyte]
What it is: An oral JAK1 inhibitor (45 and 75 mg once daily). In STOP-HS1 (608 randomized) and STOP-HS2 (619 randomized), both randomized and double-blind, week-12 HiSCR50 was 40% and 41% vs 30% with placebo in STOP-HS1 and 42% with both doses vs 29% in STOP-HS2; at week 54, HiSCR50 ranged from 57.3% to 71.4% across trials and doses (observed cases; 48.6% to 60.3% with modified non-responder imputation).
What problem it solves: Moderate-to-severe HS has only injectable biologics approved (adalimumab, secukinumab, bimekizumab) and many responses are partial; povorcitinib would offer a targeted oral option.
Critical take: The week-12 benefit over placebo was modest (about 10 to 13 percentage points); through week 54 there were 4 major cardiovascular or venous thromboembolic events (1 MACE and 3 thromboembolic). JAK class safety will require careful patient selection, and comparisons with biologics are lacking. The trials were funded by Incyte.

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4. Roflumilast cream 0.05% for infants with atopic dermatitis

[Regulatory decision pending] [United States] [Confirmed date: February 23, 2027]
What it is: A label expansion of Zoryve cream 0.05% (Arcutis) to mild-to-moderate atopic dermatitis in infants aged 3 to 24 months; the FDA accepted the supplemental application with a PDUFA target date of February 23, 2027. This strength is currently approved for children aged 2 to 5 years. In INTEGUMENT-INFANT (phase 2, open-label, 101 infants enrolled, 96 completed 4 weeks), 34.4% of completers achieved vIGA-AD success and 58.3% achieved EASI-75 at week 4.
What problem it solves: Under age 2, topical steroids and emollients are standard options, with concern about adverse effects on sensitive areas; in the US a steroid-free topical PDE4 inhibitor, crisaborole (Eucrisa), is already FDA-approved from 3 months of age for mild-to-moderate atopic dermatitis, and roflumilast would widen steroid-free options if approved.
Critical take: Open-label, uncontrolled and only 4 weeks long; efficacy is exploratory and long-term safety in infants is not established.

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5. Phase 3 readouts: ruxolitinib cream in HS and povorcitinib in prurigo nodularis

[Ongoing trial] [International] [Estimated date: fourth quarter of 2026, per Incyte]
What it is: Topline results from TRuE-HS1 and TRuE-HS2 (ruxolitinib cream in mild-to-moderate hidradenitis suppurativa) and STOP-PN1 and STOP-PN2 (oral povorcitinib in prurigo nodularis).
What problem it solves: HS has no approved topical treatment (topical clindamycin and local measures are used today); in prurigo nodularis the approved options are injectable biologics (dupilumab, nemolizumab).
Critical take: Timing is the company's estimate and results may be negative; in prurigo, the benefit of an oral JAK will have to be weighed against already approved biologics with more safety experience.

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