Atopic dermatitis is a chronic, relapsing inflammatory skin disorder characterized by eczematous lesions and intense itchiness, which can substantially impair an individual’s quality of life. Over the past decade, advances in immunological understanding – particularly the central role of type 2 inflammation, an immune response that frequently overreacts to allergens – have driven a therapeutic shift from broad immunosuppression toward more targeted, mechanism-based interventions. While established treatments have significantly improved people’s ability to control their symptoms, many patients remain inadequately treated due to the disease’s persistent nature. This highlights the need for additional options, and, consequently, a diverse pipeline of new atopic dermatitis treatments is currently under investigation, spanning both validated pathways and novel immunological targets.
In this article, we look more closely at some of the emerging treatments in clinical development for atopic dermatitis.
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IL-4/IL-13 pathway inhibitors: An established class of atopic dermatitis therapeutics
Targeting the type 2 helper T-cell inflammatory axis by inhibiting interleukin (IL)-4 and IL-13 has transformed the management of moderate-to-severe atopic dermatitis. These cytokines are central drivers of epidermal barrier dysfunction, IgE production, and chronic inflammation, making them highly validated therapeutic targets.
Sanofi and Regeneron’s monoclonal antibody drug Dupixent (dupilumab) established this class when it was approved for the treatment of atopic dermatitis in 2017, demonstrating robust and sustained improvements in disease severity through its inhibition of both IL-4 and IL-13. It remains a mainstay in atopic dermatitis treatment to this day.
Since then, however, subsequent therapies have sought to refine this approach; for example, Eli Lilly’s Ebglyss (lebrikizumab) and LEO Pharma’s Adbry (tralokinumab) selectively inhibit only IL-13, aiming to preserve efficacy while potentially reducing adverse effects associated with a broader pathway blockade. There are also several other next-generation treatments currently in clinical development targeting these pathways – one of which could even challenge Dupixent.
Connect Biopharma’s rademikibart demonstrates best-in-class potential in phase 3 trial
In March, Connect Biopharma reported that its lead candidate rademikibart achieved positive results in a phase 3 trial conducted by its partner in China, Simcere Pharmaceutical, in patients with moderate‑to‑severe atopic dermatitis.
Rademikibart is a fully human monoclonal antibody that targets IL-4 receptor alpha (IL-4Rα), a common subunit of IL-4 and IL-13. By binding with IL-4Rα, rademikibart can effectively block the functions of both IL-4 and IL-13, in turn blocking the type 2 inflammatory pathway and treating Th2-related inflammatory diseases like atopic dermatitis.
In the phase 3 trial, rademikibart achieved rapid, durable efficacy results across all its key endpoints. At week 52, 96.6% of patients had a 75% or greater reduction from baseline in their Eczema Area and Severity Index (EASI) score. Meanwhile, 85.3% of patients achieved 90% or greater improvement in EASI, and 87.1% had clear or almost clear skin on the Investigator’s Global Assessment (IGA) of Atopic Dermatitis. The treatment was also well tolerated, with a safety profile comparable to placebo.
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Furthermore, in the press release, Barry Quart, chief executive officer (CEO) and director of Connect Biopharma, pointed out that the rate of conjunctivitis, which is one of the most common side effects of similar products, was not differentiated from placebo in the initial 16-week double-blind induction phase and remained low throughout the 52 weeks of treatment.
He concluded: “These data, together with our prior phase 2b 52-week AD [atopic dermatitis] study showing that rademikibart administered via subcutaneous injection every four weeks worked as well as every two weeks, provide an excellent profile for convenient long-term use and create optionality for us or a future partner to target AD as an indication outside of China.”
Although it is difficult to compare across trials, the phase 3 data for rademikibart is extremely impressive, and they position the candidate as a next-generation competitor to Dupixent.
Apogee Therapeutics reports positive phase 2 data for zumilokibart (APG777)
Apogee Therapeutics is developing an atopic dermatitis therapy called zumilokibart (APG777), a subcutaneous extended half-life monoclonal antibody targeting IL-13. The idea here is that the extended half-life of the asset may allow for markedly reduced dosing frequency compared to existing biologics.
In March, Apogee announced positive 52-week maintenance data from part A of a phase 2 trial of zumilokibart. The results demonstrated durable maintenance of response with both the three- and six- month maintenance dosing regimens. Meanwhile, a deepening of response for the full population across all lesional and itch endpoints was also observed, supporting the asset’s potentially differentiated profile, including significantly less frequent dosing than the current standard of care.
Moving forward, 16-week data from part B of the phase 2 study are expected in the second quarter of 2026. Based on part A’s results and anticipated part B induction data, subject to clinical and regulatory outcomes, the company is planning to begin phase 3 trials of zumilokibart in the second half of 2026, which would enable a potential launch in 2029.
Next-generation JAK inhibitors: Improving the safety of new atopic dermatitis treatments
Janus kinase (JAK) inhibitors have been viewed as a major advance in atopic dermatitis treatment by targeting intracellular signalling pathways downstream of multiple cytokine receptors, including IL-4, IL-13, and others. This class of drugs has demonstrated high efficacy in various phase 3 trials in recent years, often showing rapid itch reduction and significant skin clearance compared to placebo. Some of the key oral JAK inhibitors on the market right now are Pfizer’s CIBINQO (abrocitinib) and AbbVie’s RINVOQ (upadacitinib), both of which have shown superior efficacy results to dupilumab in clinical studies.
There are also topical JAK inhibitors; Incyte’s Opzelura (ruxolitinib) is currently the only one that has been approved for use by the U.S. Food and Drug Administration (FDA). Topical formulations are potentially seen as safer, steroid-sparing options, particularly for maintenance therapy and sensitive areas.
Topical JAK inhibitors also aim to retain efficacy while minimising systemic exposure, as oral formulations have produced some concerns regarding their safety, including risks of infection, venous thromboembolism, malignancies, and death. This has influenced prescribing practices and regulatory guidance around JAK inhibitors, leading the FDA to put boxed warnings on product labels.
Nevertheless, next-generation JAK inhibitors currently undergoing clinical development could overcome these issues. One particularly promising candidate that has just produced very promising phase 3 results is Lynk Pharmaceuticals’ asset.
Lynk Pharmaceuticals’ zemprocitinib achieves positive phase 3 results as a potential new treatment for atopic dermatitis
Chinese company Lynk Pharmaceuticals is developing zemprocitinib, a highly selective, next-generation JAK1 inhibitor with best-in-class potential, being developed for the treatment of atopic dermatitis, rheumatoid arthritis, ankylosing spondylitis, and vitiligo.
The drug potently and dose-dependently inhibits multiple inflammation-related signaling pathways mediated by JAK1, and, compared to first-generation, less selective JAK inhibitors, it has demonstrated significantly greater selectivity for JAK1, which may translate into desirable efficacy while minimizing off-target adverse effects.
In March, Lynk Pharmaceuticals announced positive topline results from its phase 3 trial of zemprocitinib in patients with moderate-to-severe atopic dermatitis. The study met all co-primary and key secondary endpoints, with both dose groups demonstrating highly and statistically significant improvements versus placebo.
Crucially, the asset was also found to have a favorable safety and tolerability profile; the incidence of serious adverse events, adverse events of special interest, and discontinuations due to adverse events was low and comparable to placebo, with no new safety signals observed. There were also no serious adverse reactions related to decreases in hemoglobin, neutrophils, or lymphocytes, and there were no safety concerns associated with elevations in ALT or AST (two liver enzymes that leak into the bloodstream when liver cells are damaged).
Still, if it receives approval, only time will tell whether this next-generation JAK inhibitor is truly safer than its predecessors. The company has previously said a filing for approval for atopic dermatitis is planned for the first half of this year.
Emerging intracellular targets: New atopic dermatitis treatments with greater specificity
Beyond IL-4/IL-13 and JAK inhibition, a new generation of therapies is targeting intracellular signalling pathways with greater specificity. These approaches are intended to retain efficacy while reducing the off-target effects associated with broader immunosuppression.
STAT6 degraders: Kymera Therapeutics pushes ahead with KT-621
Kymera Therapeutics’ KT-621 was the first STAT6-directed drug to enter clinical trials. More specifically, it is a once-daily oral degrader of STAT6, which is the transcription factor responsible for IL-4/IL-13 signaling and the central driver of type 2 inflammation. The candidate is currently being investigated in a phase 2b trial in patients with moderate-to-severe atopic dermatitis.
In December 2025, Kymera announced positive phase 1b results for KT-621 in atopic dermatitis. The data showed that the asset significantly reduced the levels of STAT6 in the blood and skin. At day 29, the average reduction of STAT6 in the blood was 98%, and for skin lesions, the average reduction was 94%. Additionally, the EASI score was reduced by 63% for all patients, and the drug was well-tolerated, with no serious adverse events, no treatment-related adverse events, no reported cases of conjunctivitis, and no clinically relevant changes in vital signs, lab tests, or electrocardiograms (ECGs).
Data from the ongoing phase 2b trial is expected by mid-2027. KT-621 also received fast track designation from the FDA for the treatment of atopic dermatitis in December 2025.
LEO Pharma shares positive phase 2b data for its anti-IL-22RA1 blocker temtokibart
In May last year, LEO Pharma announced positive topline results from a phase 2b trial of a new atopic dermatitis treatment, called temtokibart, which the company licensed from argenx. In the study, the top three doses of the candidate beat placebo on the primary endpoint, which tracked the change in EASI over 16 weeks.
The company subsequently presented some more information at the 2025 European Academy of Dermatology and Venereology (EADV) Congress in September, saying that the candidate demonstrated a favorable safety profile, with a low incidence of adverse events and no dose-dependent adverse effects. Furthermore, biomarker data revealed a 97% improvement in immune gene expression and restoration of epidermal barrier-related genes.
Temtokibart is a monoclonal antibody that works by blocking the IL-22RA1 receptor subunit, in turn inhibiting the effect of the IL-22 cytokine, which is known to be elevated in patients with atopic dermatitis.
Enveda’s ENV-294 achieved positive results in phase 1b trial
Enveda’s ENV-294 is a once-daily oral small molecule designed to reset the cellular immune response to chronic inflammation, instead of merely suppressing individual cytokines.
In March, Enveda reported positive results for the asset in a phase 1b trial in patients with moderate-to-severe atopic dermatitis. The molecule demonstrated rapid, deep, and durable clinical responses, with patients achieving a mean 68% reduction in EASI scores by day 28, which deepened to 85% by day 42, 14 days after treatment cessation.
ENV-294 was also well tolerated, with no serious or severe adverse events reported and no treatment-related adverse events or discontinuations. Furthermore, no clinically meaningful changes were observed in laboratory parameters, vital signs, or ECGs, and the therapy showed no safety signals typically associated with existing systemic treatments, including those linked to immunosuppression.
Enveda has now initiated phase 2a trials for the candidate.
Setbacks in the development of new treatments for atopic dermatitis
Despite rapid progress in the therapeutic landscape, the development of new treatments for atopic dermatitis continues to face significant setbacks, underscoring the complexity of tackling this condition.
One of the clearest examples of this is the attempts from biotech and pharma to target the OX40/OX40L pathway. This approach initially generated considerable enthusiasm as a potential disease-modifying target due to its upstream role in T-cell activation and memory formation, with early clinical data suggesting the possibility of sustained responses after treatment cessation. However, subsequent developments have tempered this optimism; shortly after Amgen backed out of its deal with Kyowa Kirin earlier this year, the Japanese pharma said it would be discontinuing clinical trials investigating its anti-OX40 monoclonal antibody rocatinlimab due to two new cancer cases, disrupting the company’s previously stated plan to request FDA approval of the asset in atopic dermatitis in the first half of this year. Meanwhile, Sanofi’s amlitelimab has also raised safety concerns regarding malignancies, despite recently hitting key endpoints across three late-stage studies.
Even within more established and clinically successful pathways, limitations persist. Therapies targeting IL-4 and IL-13 signalling, including agents such as dupilumab, lebrikizumab, and tralokinumab, have transformed the management of moderate-to-severe atopic dermatitis. However, a substantial proportion of patients fail to achieve complete or sustained disease control, and long-term therapy is typically required to maintain response. And, as the number of agents targeting this pathway increases, the field is also encountering diminishing returns in efficacy, with newer therapies often offering incremental rather than transformative improvements. These limitations emphasise that even highly validated targets do not fully address the heterogeneity of atopic dermatitis.
In response to these challenges, there is growing interest in combination therapeutic strategies aimed at addressing the multifactorial nature of the disease. Rather than relying on an individual drug to blockade individual pathways, combination approaches seek to target complementary mechanisms – for example, pairing biologics with small molecule inhibitors or combining systemic and topical therapies. These strategies may offer benefits like improved efficacy, more rapid disease control, and the ability to tailor treatment to individual patients.
Ultimately, as the treatment landscape continues to evolve, it is likely that future advances will depend not only on the development of new atopic dermatitis treatments but also on more sophisticated approaches to combining and sequencing existing therapies.
