Atopic Dermatitis Clinical Trials 2025: Incyte Announces Additional FDA Approval of OPZELURA Cream in Children Ages 2-11 with Atopic Dermatitis, While 120+ Pipeline Drugs Drive Innovation

DelveInsight's "Atopic Dermatitis - Clinical Trials, 2025" reviews 90+ therapies currently in development for atopic dermatitis, a chronic inflammatory skin condition that imposes a high disease burden across both pediatric and adult populations. The landscape has seen rapid evolution, marked by Incyte's recent FDA approval (2025) of Opzelura® (ruxolitinib) cream for children ages 2-11, expanding treatment options for younger patients and highlighting the growing role of JAK inhibitors in disease management.

The clinical trial pipeline is dominated by biologics and small molecules targeting key immunological pathways, including IL-4, IL-13, IL-31, and JAK/STAT signaling. Companies such as Sanofi, Regeneron, AbbVie, LEO Pharma, and Eli Lilly are advancing next-generation therapies, with candidates like dupilumab, lebrikizumab, tralokinumab, and nemolizumab leading late-stage development. These agents aim to improve disease control, reduce flare frequency, and offer more durable symptom relief compared to topical corticosteroids and calcineurin inhibitors.

Beyond biologics, novel topical agents and oral JAK inhibitors are being tested to address varying disease severities and patient age groups. Combination regimens and precision-driven strategies are also emerging to overcome limitations of monotherapy and improve long-term outcomes.

With multiple Phase II and Phase III trials underway, the atopic dermatitis treatment landscape is shifting toward targeted, mechanism-driven therapies that promise improved efficacy, safety, and quality of life. As late-stage candidates advance and new approvals like Opzelura's pediatric expansion take hold, the market is poised for significant transformation, offering hope for more personalized and comprehensive disease management in the years ahead.

Interested in learning more about the current treatment landscape and the key drivers shaping the Atopic Dermatitis pipeline? Click here: https://www.delveinsight.com/report-store/atopic-dermatitis-ad-pipeline-insight?utm_source=openpr&utm_medium=pressrelease&utm_campaign=jpr

Key Takeaways from the Atopic Dermatitis Pipeline Report
• DelveInsight's atopic dermatitis pipeline analysis depicts a strong space with 100+ active players working to develop 120+ pipeline drugs for atopic dermatitis treatment.
• The leading atopic dermatitis companies include Vanda Pharmaceuticals, TechnoDerma Medicines, Asana BioSciences, Artax Biopharma, Corvus Pharmaceuticals, Yuhan, BioVersys, Rubedo Life Sciences, Innocare Pharma, Apogee Therapeutics, Celldex Therapeutics, Aclaris Therapeutics, Astria Therapeutics, and others are evaluating their lead assets to improve the atopic dermatitis treatment landscape.
• Key atopic dermatitis pipeline therapies in various stages of development include Tradipitant, TDM 180935, ASN002, AX 158, Soquelitinib, YH 35324, BV-200, RLS 1496, ICP-332, APG777, Barzolvolimab, ATI-2138, STAR-0310, and others.
• In September 2025, the FDA approved Incyte's OPZELURA (ruxolitinib) cream 1.5% for short-term and non-continuous treatment of mild to moderate atopic dermatitis in non-immunocompromised children aged 2 and older, when other topical therapies are ineffective or unsuitable.
• In June 2025, Nektar Therapeutics (Nasdaq: NKTR), a clinical-stage biotech focused on novel immunology therapies, announced an investor call and live webcast on June 24, 2025, at 8:15 a.m. ET to review top-line data from the 16-week induction period of the ongoing global Phase 2b REZOLVE-AD trial of rezpegaldesleukin, a regulatory T-cell (Treg) proliferator, for moderate-to-severe atopic dermatitis.
• In June 2025, the FDA extended the review of Incyte's sNDA for ruxolitinib cream (Opzelura®) to treat mild to moderate atopic dermatitis in children aged 2-11, moving the PDUFA date to September 19, 2025.
• In May 2025, Teva Pharmaceutical and Biolojic Design announced that Teva had begun IND-enabling studies for BD9, a dual-specific multibody targeting TSLP and IL-13. Teva holds exclusive rights to develop BD9 for TH2-driven inflammatory diseases like atopic dermatitis and asthma.
• In May 2025, Corvus Pharmaceuticals (Nasdaq: CRVS) reported Q1 2025 results and provided a business update. Phase I trial data for soquelitinib in atopic dermatitis showed strong safety and efficacy, with cohort 3 demonstrating earlier, deeper responses. A Phase 3 trial in peripheral T cell lymphoma is actively enrolling. The company also raised ~$31.3 million from early warrant exercises. Key data will be discussed in a webcast today at 4:30 p.m. ET.

Request a sample and discover the recent breakthroughs happening in the atopic dermatitis pipeline landscape at https://www.delveinsight.com/report-store/atopic-dermatitis-ad-pipeline-insight?utm_source=openpr&utm_medium=pressrelease&utm_campaign=jpr

Atopic Dermatitis Overview
Atopic dermatitis (AD) is a chronic inflammatory skin condition characterized by dry, itchy, and inflamed skin. It commonly begins in childhood but can persist into or develop in adulthood. AD is associated with a defective skin barrier and immune dysregulation, often linked to other atopic conditions like asthma or allergic rhinitis. Allergens, irritants, stress, or climate may trigger flare-ups. While not contagious, AD significantly impacts quality of life. Treatment focuses on moisturizing, avoiding triggers, and using topical or systemic therapies to manage inflammation and itch.

Find out more about atopic dermatitis medication at https://www.delveinsight.com/report-store/atopic-dermatitis-ad-pipeline-insight?utm_source=openpr&utm_medium=pressrelease&utm_campaign=jpr

Atopic Dermatitis Treatment Analysis: Drug Profile
ICP-332: Innocare Pharma
ICP-332 is a selective TYK2 inhibitor in Phase III development for atopic dermatitis (AD) and other T-cell-mediated autoimmune diseases like vitiligo and inflammatory bowel disease. TYK2, part of the JAK-STAT signaling pathway, plays a key role in inflammatory disease mechanisms, making it a promising therapeutic target.

APG777: Apogee Therapeutics
APG777 is a long-acting, subcutaneous monoclonal antibody targeting IL-13 for the treatment of AD, currently in Phase II trials. Preclinical studies showed it matches or exceeds the potency of lebrikizumab, and Phase I data demonstrated a 77-day half-life and sustained biomarker suppression for up to 12 months after a single dose.

Barzolvolimab: Celldex Therapeutics
Barzolvolimab is a humanized monoclonal antibody targeting KIT, a receptor involved in mast cell function. Inhibiting KIT signaling may reduce inflammatory responses associated with mast cell activation in conditions like AD. It is currently in Phase II trials for atopic dermatitis.

Learn more about the novel and emerging atopic dermatitis pipeline therapies at https://www.delveinsight.com/report-store/atopic-dermatitis-ad-pipeline-insight?utm_source=openpr&utm_medium=pressrelease&utm_campaign=jpr

Atopic Dermatitis Therapeutics Assessment
By Product Type
• Mono
• Combination
• Mono/Combination.

By Stage
• Late-stage products (Phase III)
• Mid-stage products (Phase II)
• Early-stage product (Phase I) along with the details of
• Pre-clinical and Discovery stage candidates
• Discontinued & Inactive candidates

By Route of Administration
• Oral
• Intravenous
• Subcutaneous
• Parenteral
• Topical

By Molecule Type
• Recombinant fusion proteins
• Small molecule
• Monoclonal antibody
• Peptide
• Polymer
• Gene therapy

Scope of the Atopic Dermatitis Pipeline Report
• Coverage: Global
• Key Atopic Dermatitis Companies: Vanda Pharmaceuticals, TechnoDerma Medicines, Asana BioSciences, Artax Biopharma, Corvus Pharmaceuticals, Yuhan, BioVersys, Rubedo Life Sciences, Innocare Pharma, Apogee Therapeutics, Celldex Therapeutics, Aclaris Therapeutics, Astria Therapeutics, and others.
• Key Atopic Dermatitis Pipeline Therapies: Tradipitant, TDM 180935, ASN002, AX 158, Soquelitinib, YH 35324, BV-200, RLS 1496, ICP-332, APG777, Barzolvolimab, ATI-2138, STAR-0310, and others.

To dive deep into rich insights for drugs used for atopic dermatitis treatment, visit: https://www.delveinsight.com/report-store/atopic-dermatitis-ad-pipeline-insight?utm_source=openpr&utm_medium=pressrelease&utm_campaign=jpr

Table of Contents
1. Introduction
2. Executive Summary
3. Atopic Dermatitis Pipeline: Overview
4. Analytical Perspective In-depth Commercial Assessment
5. Atopic Dermatitis Pipeline Therapeutics
6. Atopic Dermatitis Pipeline: Late-Stage Products (Phase III)
7. Atopic Dermatitis Pipeline: Mid-Stage Products (Phase II)
8. Atopic Dermatitis Pipeline: Early Stage Products (Phase I)
9. Therapeutic Assessment
10. Inactive Products
11. Company-University Collaborations (Licensing/Partnering) Analysis
12. Key Companies
13. Key Products
14. Unmet Needs
15. Market Drivers and Barriers
16. Future Perspectives and Conclusion
17. Analyst Views
18. Appendix

Contact Us:
Jatin Vimal
jvimal@delveinsight.com
+14699457679
Healthcare Consulting
https://www.delveinsight.com/consulting-services

About DelveInsight
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This release was published on openPR.