Q3 2026 Recap: Dermatology News & Updates

During the third quarter of 2026, dermatology saw a run of regulatory decisions and comparative efficacy data across inflammatory, autoimmune, and oncologic skin disease. US Food and Drug Administration (FDA) approvals expanded treatment options for dermatomyositis, adolescent alopecia areata, and superficial basal cell carcinoma. New phase 3 and indirect comparison data, meanwhile, sharpened the picture within the oral psoriasis treatment class.

Among the most significant Q3 developments was the FDA approval of brepocitinib (Lisraya), the first oral therapy indicated for adults with dermatomyositis. The agency also approved baricitinib (Olumiant) for adolescents with severe alopecia areata and Ameluz photodynamic therapy for superficial basal cell carcinoma. In clinical research, head-to-head phase 3 data comparing zasocitinib with deucravacitinib were presented at the European Academy of Dermatology and Venereology (EADV) Congress. Pfizer also reported topline phase 3 results for ritlecitinib in nonsegmental vitiligo, and a new matching-adjusted indirect comparison weighed risankizumab against icotrokinra in plaque psoriasis.

The following review of the third quarter of 2026 highlights 6 key pieces of the HCPLive team's coverage of dermatology news:

FDA Approves First Oral Treatment of Dermatomyositis in Adult Patients

In one of the most consequential regulatory decisions of Q3 2026, the FDA approved brepocitinib (Lisraya) tablets for adults with dermatomyositis on August 27. Developed by Priovant Therapeutics, brepocitinib is a once-daily oral inhibitor of tyrosine kinase 2 (TYK2) and Janus kinase 1 (JAK1). The decision makes it the first oral drug indicated for the disease.

The approval was based on a randomized, double-blind, placebo-controlled phase 3 trial of 241 adults who received brepocitinib 30 mg, brepocitinib 15 mg, or placebo once daily. At Week 52, patients on the 30-mg dose achieved a higher mean Total Improvement Score (TIS) versus placebo and were more likely to reduce corticosteroid use by Week 48. The 15-mg dose did not significantly improve the primary endpoint.

"For too long, patients with dermatomyositis have faced a significant unmet need for effective treatments, often relying on therapies meant for other diseases," Nikolay Nikolov, MD, director of the Office of Immunology and Inflammation in the FDA Center for Drug Evaluation and Research, said in a statement.

FDA Approves Baricitinib for Adolescents With Severe Alopecia Areata

On September 25, the FDA approved Eli Lilly's baricitinib (Olumiant) for patients aged 12 years and older with severe alopecia areata, expanding the oral JAK inhibitor's 2022 adult indication. The decision was supported by 36-week results from the adolescent cohort of the phase 3 BRAVE-AA-PEDS study. Participants in this cohort were aged 12–17 years and had a median baseline Severity of Alopecia Tool (SALT) score of 100.

At Week 36, 42% of patients on baricitinib 4 mg and 27% on 2 mg achieved a SALT score of 20 or less, compared with 5% on placebo. Rates of SALT 10 or less reached 37% and 21%, respectively, versus 2% with placebo. Lilly reported a safety profile in adolescents consistent with prior adult data, and the drug retains the boxed warning common to JAK inhibitors.

"The evidence supporting Olumiant's approval is particularly meaningful because it comes from a Phase 3 study specifically designed for pediatric patients, helping clinicians and families make more informed decisions when considering advanced therapies," said Brittany Craiglow, MD, adjunct associate professor of dermatology at Yale School of Medicine.

Ameluz Treatment Becomes First FDA-Approved PDT for Skin Cancer

In a September 14 decision, the FDA approved Biofrontera's supplemental New Drug Application (sNDA) for Ameluz. Ameluz is aminolevulinic acid hydrochloride topical gel, 10%, used with the BF-RhodoLED lamp series, and the new indication covers superficial basal cell carcinoma (sBCC) in adults. The approval makes Ameluz the first photodynamic therapy (PDT) regimen approved by the agency for a skin cancer. It is also now the only topical PDT in the US indicated for both actinic keratosis and a skin malignancy.

The decision was supported by a randomized, double-blind, vehicle-controlled phase 3 trial of 187 adults with histologically confirmed sBCC. The composite primary endpoint was clinical and histological complete response at 12 weeks after the final PDT cycle. It was met by 66% (95/145) of patients on Ameluz PDT versus 5% (2/42) on placebo-PDT. Biofrontera plans to launch the sBCC indication between late Q4 2026 and Q1 2027.

"This approval reflects years of disciplined investment in the clinical development of Ameluz, and the latest stage in the ongoing expansion of our PDT platform," Hermann Luebbert, chief executive officer and chairman of Biofrontera, said in a statement.

EADV 2026: Zasocitinib Tops Deucravacitinib for PASI 100 in Plaque Psoriasis

Following topline results reported in Q2, full data from the phase 3 LATITUDE Atlas trial (NCT06973291) were presented at EADV Congress 2026 in Vienna, Austria. The trial enrolled 606 adults with moderate-to-severe plaque psoriasis. At Week 16, 36.5% of patients receiving zasocitinib 30 mg once daily achieved PASI 100, versus 13.9% receiving deucravacitinib 6 mg once daily (P < .001).

Zasocitinib also outperformed deucravacitinib on all key secondary endpoints. These included PASI 90 (62.5% vs 34.0%) and a static Physician Global Assessment (sPGA) score of 0 (43.2% vs 18.5%). The FDA accepted Takeda's New Drug Application for zasocitinib under priority review in September 2026, and the European Medicines Agency is also reviewing the agent.

"The data from the Phase 3 trials provide a more complete picture of once-daily oral zasocitinib, demonstrating rapid, durable and consistent skin clearance alongside meaningful improvements in itch and quality of life," said Linda Stein Gold, MD, director of dermatology clinical research at Henry Ford Health in Detroit and principal investigator for LATITUDE Atlas.

Ritlecitinib Improves Repigmentation in Nonsegmental Vitiligo Phase 3 Data

On July 30, Pfizer announced positive topline results from the phase 3 TRANQUILLO and TRANQUILLO 2 trials of ritlecitinib (Litfulo) in nonsegmental vitiligo (NSV). Ritlecitinib is a once-daily oral inhibitor of JAK3 and TEC family kinases. Combined, the trials enrolled 2,174 patients with active or stable NSV across 271 sites worldwide.

Both trials met their US co-primary endpoints at Week 52. Significantly more patients on ritlecitinib than on placebo achieved at least 75% improvement in the Facial Vitiligo Area Scoring Index (F-VASI75) and at least 50% improvement in the Total Vitiligo Area Scoring Index (T-VASI50). Exact response rates were not disclosed in the topline release, and Pfizer reported no new safety signals. Based on these results, the company plans to pursue global regulatory filings for ritlecitinib in adults with NSV.

"In these trials, ritlecitinib demonstrated significant improvements in both facial and total body repigmentation, reinforcing its potential to help support a new treatment paradigm with systemic therapies for patients whose disease burden warrants more than localized treatment," said Iltefat Hamzavi, MD, senior staff physician in the department of dermatology at Henry Ford Health.

Risankizumab Versus Icotrokinra: New Data on Adults With Moderate-to-Severe Psoriasis

In July, a matching-adjusted indirect comparison (MAIC) published in Dermatology and Therapy evaluated risankizumab against icotrokinra in adults with moderate-to-severe plaque psoriasis. Icotrokinra is an oral targeted peptide blocking the IL-23 receptor. The investigators, including Linda Stein Gold, MD, of Henry Ford Health, matched individual patient data from the UltIMMa-1, UltIMMa-2, and IMMhance trials to published aggregate results from the ICONIC-LEAD, ICONIC-ADVANCE-1, and ICONIC-ADVANCE-2 trials.

At Week 16, risankizumab showed significantly greater placebo-adjusted response rates across all assessed endpoints. These included PASI 90 (71.4% vs 49.9%; P < .001) and PASI 100 (42.3% vs 29.4%; P < .001). Differences emerged by Weeks 4 to 8 and persisted through Week 52 in unanchored analyses, although the investigators noted indirect comparisons cannot replace randomized head-to-head trials.

"In the absence of head-to-head trials, this study uses matching-adjusted indirect comparison (MAIC) to compare [risankizumab] with [icotrokinra] in the treatment of adult patients with moderate-to-severe psoriasis," Stein Gold and coauthors wrote.

Editor’s note: This summary has been edited for grammar and clarity using artificial intelligence tools.