October 2026 dermatology approvals and pipeline advances

By Tom Whitfield

Two FDA approvals and five pipeline or regulatory advances marked October 2026, including the first treatment approved specifically for symptomatic dermographism. The month combined late-stage data in hidradenitis suppurativa, protoporphyrias and plaque psoriasis with regulatory moves in actinic keratoses and vitiligo.

Clinical updates also came from EADV 2026 and the Fall Clinical Dermatology Conference. Together, these events placed the month's regulatory actions alongside active trial readouts.

What changed in urticaria and HSV?

On October 7, the FDA approved remibrutinib (Rhapsido, Novartis), an oral Bruton tyrosine kinase inhibitor, for adults with symptomatic dermographism inadequately controlled by H1 antihistamines. It is the first FDA-approved treatment with that specific indication; remibrutinib already holds approval for chronic spontaneous urticaria. Symptomatic dermographism is a common form of chronic inducible urticaria.

In the phase 3 RemIND trial, 29.3% of remibrutinib recipients achieved complete response from hives at week 12, versus 14.0% with placebo (P = .0229). The result adds an oral option for persistent symptoms despite antihistamine therapy.

On October 15, the FDA approved pritelivir for refractory mucocutaneous herpes simplex virus infections in immunocompromised adults. The oral helicase-primase inhibitor produced significantly higher complete lesion-healing rates than investigator's choice in the phase 3 PRIOH-1 trial. The October results did not specify numerical response percentages.

Unlike nucleoside analogues, pritelivir targets the viral helicase-primase complex. That mechanism offers an option for difficult-to-treat HSV in immunocompromised patients.

Where did photodynamic therapy advance?

Biofrontera filed a supplemental New Drug Application on October 8 seeking to expand aminolevulinic acid hydrochloride gel (Ameluz) with red light photodynamic therapy. The proposed label would cover actinic keratoses on the extremities, neck and trunk, beyond the current face-and-scalp use; FDA approval remains pending.

The sponsor says broader coverage could give clinicians more flexibility for patients with extensive sun damage. The filing also follows September FDA approval of Ameluz with RhodoLED for superficial basal cell carcinoma. The sequence reflects continued regulatory development of photodynamic therapy in dermatology.

What did the phase 3 hidradenitis suppurativa trial show?

On October 22, AbbVie reported positive topline results from the phase 3 INTREPID trial of lutikizumab (ABT-981), a dual IL-1α and IL-1β antagonist. The study evaluated adolescents and adults with moderate to severe hidradenitis suppurativa.

At week 16, 31.4% of lutikizumab-treated patients achieved Hidradenitis Suppurativa Clinical Response 75, or HiSCR75, versus 23.4% on placebo (P ≤ .001). The drug also met all eight ranked secondary endpoints, including skin pain, disease flares and quality of life.

HS flares affected 18.4% of lutikizumab recipients and 28.1% of placebo recipients during the first 16 weeks. Investigators identified no new safety signals. AbbVie expects additional trial results in 2027 and plans regulatory submissions in the second half of that year.

Did the protoporphyria trial meet its endpoints?

On October 19, Disc Medicine reported that oral glycine transporter 1 inhibitor bitopertin met both co-primary and all secondary endpoints in the phase 3 APOLLO trial. The study evaluated patients with erythropoietic protoporphyria and X-linked protoporphyria.

Bitopertin reduced whole-blood metal-free protoporphyrin IX by 41.4% relative to placebo (P < .0001). At month 6, treated patients gained an average 12.2 hours per month of light exposure without pain (P = .0010). Disc Medicine also reported improvements in phototoxic reactions, sunlight tolerance and patient-reported outcomes, with no new safety signals.

The company said inhibiting glycine transporter 1 may offer a disease-modifying approach by targeting protoporphyrin accumulation. It plans to resubmit its New Drug Application by the end of 2026, with a potential FDA decision anticipated in 2027.

What does the EB06 IND permit?

On October 16, the FDA cleared an Investigational New Drug application for phase 2 investigation of EB06 in vitiligo. The clearance permits further evaluation of an investigational therapy as researchers explore approaches to autoimmune mechanisms underlying depigmentation.

IND clearance authorizes a study; it neither establishes efficacy nor authorizes marketing. The decision advances the program, but any clinical benefit remains unproven.

How did zasocitinib compare with deucravacitinib?

On October 2, phase 3 LATITUDE Atlas findings presented at EADV 2026 showed superior skin clearance with oral TYK2 inhibitor zasocitinib versus deucravacitinib. The head-to-head trial involved adults with moderate to severe plaque psoriasis.

Zasocitinib produced higher rates of complete and near-complete clearance, although the October review supplied no numerical response rates. The findings followed the FDA's September grant of Priority Review to zasocitinib, which remains investigational. They add to competition among targeted oral treatments seeking biologic-like efficacy without injections.

What should clinicians watch next?

AbbVie plans another lutikizumab readout in 2027 before submitting to regulators in the second half of the year. Disc Medicine aims to resubmit bitopertin's NDA by year-end, with an FDA decision possible in 2027.

The next decisions will test whether broader photodynamic therapy indications and early investigational programs translate into approvals. Until then, remibrutinib and pritelivir have FDA approval, while five other programs remain in development or review. Those results and decisions will show whether October's advances become approved options beyond the two new authorizations.