Q1 Dermatology Drug & Device Report: FDA Approvals & Pipeline Updates

The first quarter of 2025 saw significant developments in the dermatology specialty, with key decisions from the US FDA and a flurry of submissions, trial advancements, and regulatory actions from various organizations driving the pipeline forward.

With a wealth of advancements, Dermatology Times has been diligently tracking all relevant updates to ensure you stay informed. To help you catch up on the latest developments from January to March, we have compiled a comprehensive summary of FDA approvals, new submissions, designations, and other pivotal regulatory movements in dermatology.

FDA Approvals and Clearances

FDA Approves Collagen-Based DermiSphere Hydrogel

In January: The FDA granted 510(k) clearance to Fesarius Therapeutics Inc. for its DermiSphere hydrogel Dermal Regeneration Template (DermiSphere hDRT).¹ This novel collagen-based dermal matrix is designed to support tissue integration, revascularization, and wound healing, with applications in advanced wound care, reconstructive surgery, and regenerative medicine. Unlike conventional fibrillar collagen products, DermiSphere hDRT’s hydrogel composition mimics the extracellular matrix to promote cellular infiltration and regeneration.

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FDA Clears Zabalafin Hydrogel’s Investigational New Drug Application for AD

In February: The FDA cleared Alphyn Biologics’ IND application for Zabalafin hydrogel, a novel treatment for mild to moderate atopic dermatitis that targets inflammation, itch, and bacterial complications.² A phase 2a trial demonstrated significant improvements in symptoms, including itch reduction and skin infection clearance, with minimal side effects. Alphyn highlighted Zabalafin’s potential as a long-term, well-tolerated therapy addressing key disease aspects. Global phase 2b trials are set to begin later this year.

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Regulations, Recommendations, Designations, and Submissions

Rezpegaldesleukin Receives Fast Track Designation for Moderate to Severe AD

In February: The FDA granted fast track designation to rezpegaldesleukin for moderate to severe atopic dermatitis in patients 12 years and older whose condition is inadequately controlled with topical treatments.³ This investigational biologic targets the IL-2 receptor complex to enhance regulatory T cell activity, aiming to restore immune balance. In a 12-week induction phase and for at least 36 weeks post-treatment, rezpegaldesleukin showed promising improvements in exploratory disease outcomes. The phase 2b REZOLVE-AD study is ongoing, with topline data expected in Q2 2025. Additionally, rezpegaldesleukin is being studied for severe alopecia areata in the REZOLVE-AA trial.

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FDA Accepts sBLA for Dupilumab as Potential BP Treatment

In February: The FDA accepted the supplemental Biologics License Application for dupilumab (Dupixent) for priority review as a potential treatment for bullous pemphigoid, with a decision expected by June 20, 2025.⁴ A phase 2/3 trial showed a 5-fold improvement in sustained disease remission with dupilumab compared to placebo, along with reductions in disease severity, itch, and corticosteroid use. While some adverse events were noted, dupilumab’s targeted mechanism offers a potential alternative to traditional immunosuppressive therapies. If approved, it would be the first targeted treatment for BP in the US.

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FDA Accepts Supplemental New Drug Application for Arcutis’ Roflumilast in Children with AD

In February: The FDA accepted Arcutis Biotherapeutics’ sNDA for Zoryve (roflumilast) cream 0.05% to treat mild to moderate atopic dermatitis in children aged 2 to 5.⁵ The submission was supported by positive results from the INTEGUMENT-PED phase 3 trial, which showed significant symptom improvement by week 4. The treatment demonstrated a favorable safety profile and reduced itch severity in young patients. If approved, Zoryve would offer a steroid-free, once-daily topical option for this pediatric population. The FDA set a PDUFA target action date for October 13, 2025.

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FDA Alerts

FDA Alerts of New Independent Testing for Benzoyl Peroxide Acne Products, Additional Voluntary Recalls

In March: The FDA issued an alert on potential benzene contamination in benzoyl peroxide products after independent testing of 95 acne treatments, prompted by third-party reports.⁶ While over 90% had undetectable or low benzene levels, 6 products exceeded safety limits, leading to voluntary recalls, including L’Oréal’s Effaclar Duo.

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Clinical Trial Advancement

VYNE Completes Phase 2b Enrollment for Vitiligo Gel

In January: VYNE Therapeutics completed enrollment in its phase 2b trial evaluating repibresib (VYN201) gel for nonsegmental vitiligo, with top-line results expected in mid-2025.⁷ This randomized, double-blind, vehicle-controlled study includes approximately 180 participants receiving once-daily treatment with repibresib in 1%, 2%, or 3% concentrations. The trial’s primary endpoint is achieving F-VASI50 at week 24, with additional outcomes assessed at weeks 24 and 52. Repibresib, a pan-BET inhibitor, targets inflammatory pathways while minimizing systemic exposure.

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Nektar Therapeutics Completes Enrollment for Phase 2b REZOLVE-AD Trial of Rezpegaldesleukin

In January: Nektar Therapeutics completed target enrollment for its phase 2b REZOLVE-AD study, evaluating the efficacy and safety of rezpegaldesleukin, an interleukin-2 receptor agonist, in patients with moderate to severe atopic dermatitis.⁸ Previous trials have shown its potential to improve atopic dermatitis symptoms for up to 36 weeks after treatment. The study, involving 396 patients across 110 sites, will measure improvement in the Eczema Area and Severity Index score and other key endpoints. Topline data from the trial are expected in mid-2025.

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Phase 2 Trial of Qtorin 3.9% Rapamycin Anhydrous Gel Underway in Patients With Cutaneous Venous Malformations

In January: Palvella Therapeutics initiated dosing in the phase 2 TOIVA trial evaluating Qtorin 3.9% rapamycin anhydrous gel for cutaneous venous malformations, a rare genetic skin condition with no approved treatments in the US.⁹ Qtorin rapamycin, a topical mTOR inhibitor, aims to provide localized therapeutic effects while minimizing systemic exposure. The single-arm, open-label TOIVA trial will assess safety, tolerability, and efficacy in approximately 15 participants over 12 weeks. Qtorin rapamycin has also received FDA fast track designation and is in phase 3 development for microcystic lymphatic malformations.

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VYNE Therapeutics Advances VYN202 with Phase 1b Trial in Moderate to Severe Plaque Psoriasis

In February: VYNE Therapeutics Inc. initiated a phase 1b clinical trial to assess the safety and preliminary efficacy of VYN202, an oral BD2-selective BET inhibitor, in patients with moderate to severe plaque psoriasis.¹⁰ The decision followed promising phase 1a results, which demonstrated favorable safety, tolerability, and no serious adverse events in healthy volunteers. Top-line data is expected by late 2025, with potential phase 2 progression if results are favorable.

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References

1. Fesarius Therapeutics inc announces FDA 510(k) clearance for dermisphere hydrogel dermal regeneration template. News Release. PR Newswire. January 8, 2025. Accessed March 28, 2025. https://www.prnewswire.com/news-releases/fesariustherapeutics-inc-announces-fda-510k-clearance-for-dermisphere-hydrogel-dermal-regeneration-template-302346137.html

2. Alphyn secures FDA clearance of investigational new drug application for atopic dermatitis treatment. News release. PR Newswire. February 19, 2025. Accessed March 28, 2025. https://www.prnewswire.com/news-releases/alphyn-secures-fda-clearance-of-investigational-new-drug-application-for-atopic-dermatitis-treatment-302379675.html

3. Nektar Therapeutics receives fast track designation for rezpegaldesleukin for the treatment of moderate-to-severe atopic dermatitis. News release. PRNewswire. February 10, 2025. Accessed March 28, 2025. https://www.prnewswire.com/news-releases/nektar-therapeutics-receives-fast-track-designation-for-rezpegaldesleukin-for-the-treatment-of-moderate-to-severe-atopic-dermatitis-302371995.html

4. Dupixent sBLA accepted for FDA priority review for the targeted treatment of bullous pemphigoid. News Release. Sanofi. February 18, 2025. Accessed March 28, 2025. https://www.sanofi.com/en/media-room/press-releases/2025/2025-02-18-06-00-00-3027482

5. U.S. FDA accepts supplemental new drug application for Arcutis’ ZORYVE® (roflumilast) cream 0.05% for the treatment of children aged 2 to 5 with mild to moderate atopic dermatitis. News release. Arcutis Biotherapeutics. February 26, 2025. Accessed March 28, 2025. https://www.arcutis.com/u-s-fda-accepts-supplemental-new-drug-application-for-arcutis-zoryve-roflumilast-cream-0-05-for-the-treatment-of-children-aged-2-to-5-with-mild-to-moderate-atopic-dermatitis/

6. Limited number of voluntary recalls initiated after FDA testing of acne products for benzene; findings show a small number of products with elevated levels of benzene contamination. News Release. US FDA. March 11, 2025. Accessed March 28, 2025. https://www.fda.gov/drugs/drug-safety-and-availability/limited-number-voluntary-recalls-initiated-after-fda-testing-acne-products-benzene-findings-show

7. VYNE therapeutics completes enrollment in phase 2b trial evaluating VYN201 for the treatment of nonsegmental vitiligo. News Release. VYNE Therapeutics. January 6, 2025. Accessed March 28, 2025. https://vynetherapeutics.com/uncategorized/vyne-therapeutics-completes-enrollment-in-phase-2b-trial-evaluating-vyn201-for-the-treatment-of-nonsegmental-vitiligo/

8. Nektar Therapeutics announces completion of target enrollment in REZOLVE-AD phase 2b clinical trial of rezpegaldesleukin in patients with moderate-to-severe atopic dermatitis. News release. Nektar Therapeutics. January 10, 2025. Accessed March 28, 2025. https://ir.nektar.com/news-releases/news-release-details/nektar-therapeutics-announces-completion-target-enrollment

9. VYNE Therapeutics initiates phase 1b trial of VYN202, a novel BD2-selective oral BET inhibitor, in plaque psoriasis. News release. Globe Newswire. February 19, 2025. Accessed March 28, 2025. https://www.globenewswire.com/news-release/2025/02/19/3028700/0/en/VYNE-Therapeutics-Initiates-Phase-1b-Trial-of-VYN202-a-Novel-BD2-Selective-Oral-BET-Inhibitor-in-Plaque-Psoriasis.html

10. Palvella Therapeutics announces first patients dosed in phase 2 TOIVA clinical trial of Qtorin 3.9% rapamycin anhydrous gel (Qtorin rapamycin) for the treatment of cutaneous venous malformations. News release. Palvella Therapeutics. January 8, 2025. Accessed March 28, 2025. https://www.globenewswire.com/news-release/2025/01/08/3006228/0/en/Palvella-Therapeutics-Announces-First-Patients-Dosed-in-Phase-2-TOIVA-Clinical-Trial-of-QTORIN-3-9-Rapamycin-Anhydrous-Gel-QTORIN-rapamycin-for-the-Treatment-of-Cutaneous-Venous-Ma.html