News|Articles|November 12, 2026

Dermatology Times Monthly FDA and Pipeline Review: October 2026

Author(s)Shannon Heaning, Content Associate

October brought FDA approvals in urticaria and HSV, new regulatory filings, and phase 3 advances in HS, psoriasis, and rare diseases.

October delivered several notable developments across the dermatology treatment landscape, including new FDA approvals, regulatory submissions, and promising late-stage clinical trial results. Advances in chronic inducible urticaria, hidradenitis suppurativa (HS), psoriasis, and rare genetic disorders highlighted continued progress toward more targeted and individualized treatment options.

The month also brought new clinical data from the European Academy of Dermatology and Venereology (EADV) Congress and the Fall Clinical Dermatology Conference, alongside regulatory developments in photodynamic therapy and vitiligo.

This installment of the Dermatology Times Monthly FDA and Pipeline Review examines selected October milestones and their potential implications for clinical practice.

FDA Approves Remibrutinib for Symptomatic Dermographism

October 7, 2026

The FDA approved remibrutinib (Rhapsido; Novartis), an oral Bruton tyrosine kinase (BTK) inhibitor, for adults with symptomatic dermographism inadequately controlled by H1 antihistamines. The decision marks the first FDA-approved treatment specifically indicated for symptomatic dermographism, a common form of chronic inducible urticaria.

Approval was supported by results from the phase 3 RemIND trial, in which 29.3% of remibrutinib-treated patients achieved complete response from hives at week 12 compared with 14.0% receiving placebo (P = .0229).

The expanded indication builds on remibrutinib's existing approval for chronic spontaneous urticaria and introduces an additional targeted oral treatment option for patients with persistent symptoms despite antihistamine therapy.

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FDA Approves Pritelivir for Refractory Mucocutaneous HSV

October 15, 2026

The FDA approved pritelivir, an oral helicase-primase inhibitor, for refractory mucocutaneous herpes simplex virus (HSV) infections in immunocompromised adults.

The decision was supported by findings from the phase 3 PRIOH-1 trial, which demonstrated significantly higher rates of complete lesion healing with pritelivir compared with investigator's choice treatment.

Unlike conventional nucleoside analogues, pritelivir targets the viral helicase-primase complex, offering a distinct mechanism of action for patients with difficult-to-treat infections.

The approval represents an important development for immunocompromised patients whose HSV infections remain refractory to existing antiviral therapies.

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Biofrontera Submits sNDA to Expand Ameluz Photodynamic Therapy

October 8, 2026

Biofrontera submitted a supplemental New Drug Application (sNDA) to the FDA seeking to expand the indication for aminolevulinic acid hydrochloride gel (Ameluz) used with red light photodynamic therapy (PDT).

The proposed expansion would extend treatment of actinic keratoses beyond the face and scalp to include lesions on the extremities, neck, and trunk.

If approved, the expanded indication could provide clinicians with additional flexibility in managing actinic keratoses across multiple anatomical locations, particularly in patients with extensive sun damage.

The submission follows the September FDA approval of Ameluz with RhodoLED for superficial basal cell carcinoma, reflecting continued regulatory development of PDT in dermatology.

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Lutikizumab Meets Primary and Secondary End Points in Phase 3 HS Trial

October 22, 2026

AbbVie announced positive topline results from the phase 3 INTREPID trial evaluating lutikizumab (ABT-981), an investigational dual interleukin (IL)-1α and IL-1β antagonist, in adults and adolescents with moderate to severe HS.

At week 16, 31.4% of patients receiving lutikizumab achieved Hidradenitis Suppurativa Clinical Response 75 (HiSCR75), compared with 23.4% receiving placebo (P ≤ .001). The trial also met all 8 ranked secondary end points, including measures of skin pain, disease flares, and quality of life.

HS flares occurred in 18.4% of lutikizumab-treated patients compared with 28.1% of placebo-treated patients during the first 16 weeks. No new safety signals were identified.

The findings support dual IL-1α/IL-1β inhibition as a potential treatment strategy in HS. AbbVie anticipates additional trial results in 2027, with regulatory submissions planned for the second half of that year.

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Bitopertin Meets All End Points in Phase 3 APOLLO Trial

October 19, 2026

Disc Medicine reported positive topline findings from the phase 3 APOLLO trial evaluating bitopertin in erythropoietic protoporphyria (EPP) and X-linked protoporphyria (XLP).

The investigational oral glycine transporter 1 inhibitor met both co-primary end points and all secondary end points. Treatment reduced whole-blood metal-free protoporphyrin IX by 41.4% relative to placebo (P < .0001) and increased average monthly time in light without pain by 12.2 hours at month 6 (P = .0010).

Additional improvements were observed in phototoxic reactions, sunlight tolerance, and patient-reported outcomes. The company reported no new safety signals.

Bitopertin targets the underlying biochemical pathway responsible for protoporphyrin accumulation, potentially offering a disease-modifying approach to these rare phototoxic disorders.

Disc Medicine plans to resubmit its New Drug Application by the end of 2026, with a potential FDA decision anticipated in 2027.

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FDA Clears Phase 2 Investigation of EB06 for Vitiligo

October 16, 2026

The FDA granted Investigational New Drug (IND) clearance for the phase 2 clinical investigation of EB06 in vitiligo.

The regulatory clearance enables further clinical evaluation of the investigational therapy as researchers explore additional approaches to treating the autoimmune mechanisms underlying depigmentation.

Although IND clearance does not establish efficacy or constitute marketing approval, it represents an important regulatory milestone that allows the clinical development program to advance.

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Zasocitinib Demonstrates Superior Skin Clearance in Phase 3 Psoriasis Trial

October 2, 2026

Phase 3 LATITUDE Atlas findings presented at EADV 2026 demonstrated superior skin clearance with investigational oral TYK2 inhibitor zasocitinib compared with deucravacitinib in adults with moderate to severe plaque psoriasis.

The head-to-head results demonstrated higher rates of complete and near-complete skin clearance with zasocitinib, adding to evidence supporting its potential role in the evolving oral psoriasis treatment landscape.

The findings follow the FDA's September decision to grant Priority Review to zasocitinib, positioning the investigational agent as a potential future option for patients seeking effective oral systemic therapy.

The results also highlight increasing competition among targeted oral treatments as developers seek to achieve biologic-like efficacy without injectable administration.

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Looking Ahead

October's regulatory decisions and clinical readouts reflected continued momentum across inflammatory, infectious, and rare dermatologic diseases. New approvals expanded options for patients with symptomatic dermographism and refractory HSV, while late-stage findings in HS and EPP advanced investigational therapies toward potential future regulatory submissions.

As the year approaches its close, attention will turn to additional clinical readouts, pending regulatory filings, and anticipated FDA decisions that could further shape dermatology treatment options in 2027.

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