The main purpose of the study is to investigate the efficacy on cutaneous thickness and the safety of Nemolizumab in adult patients with systemic sclerosis after a 52-week treatment period and to select the optimal dose for this target population.

Start Date20 Feb 2026

Sponsor / Collaborator

GALDERMA PHARMA SA

NCT07396168

/ RecruitingPhase 4

Nemolizumab to Treat Lichen Planopilaris, a Noncontrolled, Prospective, Pilot Study.

Lichen planopilaris (LPP) is a primary lymphocytic cicatricial alopecia characterized by progressive, permanent hair loss and scalp symptoms such as pruritus and burning. Current treatments-including topical and intralesional corticosteroids, hydroxychloroquine, and immunosuppressants-are often inadequate, with limited evidence for efficacy and frequent treatment switching or discontinuation due to side effects or lack of response.1,2 Recent systematic reviews and meta-analyses highlight the need for new, targeted therapies. 3,4 Nemolizumab, an IL-31 receptor antagonist, FDA-approved for prurigo nodularis and atopic dermatitis, has demonstrated efficacy in pruritic and fibrosing dermatoses, making it a rational candidate for LPP.

Start Date01 Feb 2026

Sponsor / Collaborator

The Skin Center Dermatology Group

NCT07352566

/ Not yet recruitingPhase 4IIT

Utilization of a Cutaneous Therapy In Situ Microdevice

This study is being done to test a microdevice, which is a small device designed to test drugs directly on skin conditions like atopic dermatitis (eczema) and psoriasis.
The small device, about the size of a grain of rice, has up to 20 tiny reservoirs that hold medications that are approved by the Food and Drug Administration (FDA) for atopic dermatitis and psoriasis. Very small amounts of these medications will be released into the skin (at levels in your body much lower than are typically used). In this study, the device will be tested to see if it's safe and works well for predicting how the skin will react to standard treatments. We will also look at how these reactions are connected to genetic information and overall treatment results.

Start Date01 Jan 2026

Sponsor / Collaborator

The University of California, San Francisco

100 Clinical Results associated with Nemolizumab

100 Translational Medicine associated with Nemolizumab

100 Patents (Medical) associated with Nemolizumab

197

Literatures (Medical) associated with Nemolizumab

31 Dec 2026·JOURNAL OF DERMATOLOGICAL TREATMENT

Nemolizumab for chronic pruritus beyond atopic dermatitis and prurigo nodularis: a systematic review and synthesis of emerging evidence

Review

Author: Shanshal, Mohammed ; Uthayakumar, Aarthy

BACKGROUND:

Nemolizumab, an anti-IL-31 receptor A antibody, is licensed for atopic dermatitis and prurigo nodularis; its role in other chronic pruritus (CP) syndromes is uncertain.

OBJECTIVE:

To synthesize efficacy, safety and strength of evidence for nemolizumab in CP beyond these indications. Methods: We conducted a PROSPERO-registered systematic review (CRD420251207054) of databases and trial registries to November 2025 for nemolizumab studies in CP outside AD/PN. Eligible reports were extracted and patients grouped as systemic, neurologic/neurogenic, dermatologic (non-AD) or primary CP/CP of unknown origin.

RESULTS:

Seventeen reports (one randomized trial, two cohorts, 14 case series/reports) describing 114 patients were included. In chronic kidney disease-associated pruritus, a phase II hemodialysis trial showed modest, statistically uncertain benefit versus placebo, contrasting with rapid, near-complete relief in dialysis and cholestatic case reports. Uncontrolled data in neuropathic itch/pain syndromes, non-AD inflammatory and papular dermatoses (notably amyloidosis and perforating disorders) and long-standing primary CP/CPUO described complete itch clearance. Across indications, nemolizumab was well tolerated, but certainty was low for CKD-aP and very low for other groups.

CONCLUSIONS:

Nemolizumab shows plausible antipruritic activity across CP phenotypes, yet the evidence base remains fragile; these signals justify cautious experimental use and prioritize etiology-specific IL-31 receptor blockade trials beyond AD/PN.

31 Dec 2026·JOURNAL OF DERMATOLOGICAL TREATMENT

24-week real world outcomes of nemolizumab in patients with prurigo nodularis

Article

Author: Iozumi, Ken ; Mima, Yoshihito ; Yamamoto, Masako

BACKGROUNDS:

Prurigo nodularis (PN) is a chronic pruritic inflammatory disease associated with immune and neural dysregulation. Although nemolizumab has demonstrated efficacy in clinical trials, real-world post-marketing data remain limited.

OBJECTIVE:

To evaluate the real-world efficacy, safety, and drug survival of nemolizumab in patients with PN.

MATERIALS AND METHODS:

We retrospectively analyzed 38 patients with PN treated with nemolizumab at a single center. Peak Pruritus Numerical Rating Scale (PP-NRS) and Prurigo Nodularis Investigator's Global Assessment (PN-IGA) were assessed up to Week 24. Treatment-emergent adverse events (TEAEs) and drug survival were evaluated.

RESULTS:

Mean PP-NRS rapidly improved from 8.1 at baseline to 1.8 at Week 8 and remained stable through Week 24 (p < 0.001). PN-IGA scores gradually improved from 3.1 to 1.4 by Week 24 (p < 0.01). At Week 24, ≥4-point PP-NRS improvement and PP-NRS 0/1 were achieved in 90.9% and 59.1% of patients, respectively, while PN-IGA 0/1 was achieved in 50.0%. Early PP-NRS improvement correlated with long-term outcomes. TEAEs occurred in 39.5%, mainly cutaneous reactions, and drug survival was significantly lower in patients with TEAEs.

CONCLUSION:

Nemolizumab provided rapid and sustained itch relief with gradual lesion improvement in real-world PN. Early pruritus response may predict long-term efficacy, while adverse events affect treatment persistence.

01 Dec 2026·MOLECULAR BIOLOGY REPORTS

Construction of genetically modified lactic acid bacteria producing an Anti-Interleukin-31 receptor A Single-chain variable fragment

Article

Author: Murakami, Aito ; Ikeda, Hotaru ; Sato, Takashi ; Namai, Fu ; Yoda, Masahiro ; Shimosato, Takeshi

BACKGROUND:

Nemolizumab, which targets the receptor for interleukin-31 (IL-31R), was approved in Japan in 2022 as a therapeutic antibody agent for atopic dermatitis. IL-31 is a cytokine involved in skin inflammation and pruritus, and recent studies have shown that it is also involved in pulmonary and respiratory diseases. Although antibody therapies such as nemolizumab have proven effective, their drug delivery methods remain suboptimal. Thus, in this study, we attempted to establish a novel local delivery system for IL-31Ra single-chain variable fragment (scFv) using recombinant lactic acid bacteria with the goal of enhancing the value of nemolizumab for future application to respiratory diseases.

METHODS AND RESULTS:

The genetically modified lactic acid bacteria (gmLAB) constructed by electroporation was confirmed by Western blotting to produce recombinant scFv in a nisin-dependent manner. The binding of the recombinant scFv to its target protein, human IL-31Ra, was verified by ELISA. Furthermore, in vitro assay using A549 cells, the purified recombinant scFv was found to significantly inhibit signal transducer and activator of transcription (STAT3) phosphorylation induced by IL-31 stimulation.

CONCLUSIONS:

We successfully constructed a novel tool for expressing IL-31Ra scFv designed based on nemolizumab using gmLAB. The scFv produced by gmLAB specifically bound human IL-31Ra and suggesting that it inhibits IL-31/IL-31Ra signaling. Taken together, our results suggest that the gmLAB established in this study may represent an efficient and convenient new tool for administering IL-31Ra scFv, with potential application to pulmonary and respiratory diseases.

105

News (Medical) associated with Nemolizumab

23 Apr 2026

·www.galderma.com

Galderma reports strong start to the year, delivering first quarter 2026 net sales of 1.473 billion USD, growing 25.5% at constant currency

Ad hoc announcement pursuant to Art. 53 LR Zug, Switzerland, April 23, 2026 – Galderma Group AG (SIX:GALD), the pure-play dermatology category leader, today announced its sales performance for the first quarter of 2026. Strong start to the year delivering net sales of 1,473 million USD, predominantly driven by volume and complemented by positive price and mix effects, underscoring the continued execution of its unique, growth-driven integrated dermatology strategy. Widespread net sales growth of 25.5% year-on-year at constant currency1, aligned with strong growth performance across geographies and product categories, including Injectable Aesthetics (+13.1%), Dermatological Skincare (+17.0%) and Therapeutic Dermatology (+71.3%). Continued market outperformance, with broad-based growth momentum across the existing portfolio, complemented by differentiated launches and geographic expansion. Demonstrated scientific leadership with new clinical data presented at major congresses, including positive phase II results for nemolizumab in children with moderate-to-severe atopic dermatitis and new data strengthening the Injectable Aesthetics portfolio to address latest patient needs, with pioneering research on menopause-related skin changes. Strengthened financial profile and shareholder returns through share repurchases, a dividend payment, and a successful Eurobond placement of 500 million EUR in March to fully repay the Term Loan, following the earlier replacement of the Revolving Credit Facility. Completed the transition to a free-float dominated shareholder base, following the full divestment by the EQT-led consortium of investors, marking the largest fully monetized capital gain from a single private equity fund. Confirming 2026 full-year guidance, with net sales growth of 17-20% year-on-year at constant currency and a Core EBITDA margin of approximately 26% at constant currency, with increased confidence to navigate a volatile environment. Strong start to the year delivering net sales of 1,473 million USD, predominantly driven by volume and complemented by positive price and mix effects, underscoring the continued execution of its unique, growth-driven integrated dermatology strategy. Widespread net sales growth of 25.5% year-on-year at constant currency1, aligned with strong growth performance across geographies and product categories, including Injectable Aesthetics (+13.1%), Dermatological Skincare (+17.0%) and Therapeutic Dermatology (+71.3%). Continued market outperformance, with broad-based growth momentum across the existing portfolio, complemented by differentiated launches and geographic expansion. Demonstrated scientific leadership with new clinical data presented at major congresses, including positive phase II results for nemolizumab in children with moderate-to-severe atopic dermatitis and new data strengthening the Injectable Aesthetics portfolio to address latest patient needs, with pioneering research on menopause-related skin changes. Strengthened financial profile and shareholder returns through share repurchases, a dividend payment, and a successful Eurobond placement of 500 million EUR in March to fully repay the Term Loan, following the earlier replacement of the Revolving Credit Facility. Completed the transition to a free-float dominated shareholder base, following the full divestment by the EQT-led consortium of investors, marking the largest fully monetized capital gain from a single private equity fund. Confirming 2026 full-year guidance, with net sales growth of 17-20% year-on-year at constant currency and a Core EBITDA margin of approximately 26% at constant currency, with increased confidence to navigate a volatile environment. “Galderma’s strong first quarter results reflect our commitment to advancing dermatology and delivering innovative solutions for consumers and patients worldwide. This marks a strong start to another year of key launches, sustained execution and scientific momentum, as well as the continued strengthening of our financial profile – all reinforcing our category leadership. Our integrated dermatology strategy continues to drive growth and we are well-positioned to build on this success throughout 2026.” FLEMMING ØRNSKOV, M.D., MPH CHIEF EXECUTIVE OFFICER GALDERMA Galderma expects 2026 to be another year of opportunities as it continues to execute on its proven, growth-driven integrated dermatology strategy. Growth for the year is expected to be broad-based across its existing portfolio, complemented by new launches and geographic expansion. For the first quarter of the year, Galderma achieved net sales of 1,473 million USD, representing year-on-year net sales growth of 25.5% at constant currency. As anticipated, net sales growth was particularly high in the first quarter. This was driven by the strong ramp-up of Nemluvio against a low comparative base, combined with the strong commercial performance across the rest of the portfolio, with Dermatological Skincare in particular delivering ahead of expectations. Growth was widespread across geographies and product categories, outperforming the market in each product category. Growth was driven predominantly by volume, complemented by positive price and mix effects. Injectable Aesthetics Injectable Aesthetics net sales for the first quarter of 2026 were 648 million USD, with year-on-year growth of 13.1% at constant currency. Neuromodulators delivered net sales of 364 million USD, up 12.5% year-on-year at constant currency. Performance was broad-based and particularly high in Europe and Asia Pacific, with the U.S. also benefitting from some favorable phasing. Galderma outpaced the market in Neuromodulators in both reporting geographies, with Dysport continuing to grow and Relfydess on a strong ramp-up trajectory. Galderma continues to progress on the execution of its portfolio strategy, while advancing Relfydess regulatory reviews in additional markets. Fillers & Biostimulators achieved net sales of 284 million USD, up 14.0% year-on-year at constant currency. Fillers & Biostimulators outpaced the market in both reporting geographies, with particularly strong growth in the U.S., which benefitted from favorable phasing. Galderma continues to strengthen its broad Restylane portfolio, delivering growth in a soft market. Key recent highlights include the U.S. FDA approval of Restylane Contour™ for the correction of temple hollowing and the global ‘Wake Up To Restylane’ campaign, positioning Restylane as an everyday natural beauty ally. Sculptra maintains its double-digit growth momentum in both geographies. In addition to strengthening Sculptra’s position in regenerative aesthetics and expanding into body indications in Europe, Galderma launched its ‘We Are All Sculptra’ program, following nine new patients over two years to highlight its real-life regenerative impact. Dermatological Skincare Dermatological Skincare net sales for the first quarter were 441 million USD, with year-on-year growth of 17.0% at constant currency. Both Dermatological Skincare flagship brands, Cetaphil and Alastin, maintained strong growth momentum, also benefitting from a lower comparable base for the period. Growth was positive in both geographies, with particularly strong performance of Cetaphil in fast-growing International markets and of Alastin in the U.S. Outperformance in the category continues to be driven by focused execution, innovation and portfolio synergies. Commercial execution remained strong, with e-commerce continuing as the fastest growing channel, including outstanding growth from Cetaphil in China. Alastin also strengthened partnerships with leading aesthetics clinics in the U.S. through Alastin Signature Practices, a premium in-office experience designed to elevate regenerative, peri-procedural skincare. Galderma continued to support its core portfolio with differentiated innovation. For Cetaphil, this included the introduction of AM/PM Antioxidant Serums, a breakthrough daily system clinically designed to defend skin by day and support accelerated repair by night for sensitive, stressed skin. For Alastin, it included the U.S. launch of Alastin Regenerating Skin Nectar with TriHex+™ technology, a new formulation with our proprietary Octapeptide‑45 which helps reinforce skin structure, restore skin barrier and support long-term skin longevity. Therapeutic Dermatology Therapeutic Dermatology net sales reached 385 million USD for the first quarter of 2026, up 71.3% year-on-year at constant currency. Growth was driven by Nemluvio’s continued strong launch trajectories in both reporting geographies, complemented by anticipated moderate growth from the mature Therapeutic Dermatology portfolio in International markets during the period. This more than offset the decline of the mature portfolio in the U.S. Nemluvio net sales for the quarter were 185 million USD. The vast majority of sales came from the U.S., with a greater contribution from atopic dermatitis than prurigo nodularis. In the U.S., Nemluvio paid new patient starts (NBRx) from the beginning of February to mid-March 2026 was trending at about 39% market share in prurigo nodularis and about 8% in atopic dermatitis. The majority of patients starting treatment continue to be new to biologics. Galderma also continues to expand its healthcare professional engagement, supported by real world experience data to reinforce Nemluvio’s efficacy on skin clearance, complementing its position as the itch relief treatment of choice. In International markets, which represent only a small portion of total Nemluvio sales, the launch trajectory remains even stronger. Meanwhile, Galderma is also advancing regulatory reviews in additional top markets. Galderma reinforced its leadership in dermatology during the first quarter through impactful data presentations and industry-leading medical education at global congresses and company-led platforms. At the 2026 American Academy of Dermatology (AAD) Annual Meeting, Galderma presented 22 abstracts spanning its full portfolio. Highlights included late-breaking data for nemolizumab showing clinically meaningful benefits in children aged 2 to 11 with moderate-to-severe atopic dermatitis. These findings reinforce the previously established safety and efficacy of nemolizumab in adults and adolescents with moderate-to-severe atopic dermatitis, for which it is approved by multiple global regulatory authorities. It also represents a significant opportunity to improve patient lives, with up to 25% of children affected by atopic dermatitis and the currently limited approved treatment options for children living with moderate-to severe atopic dermatitis. At 2026 Winter Clinical™ Miami, interim results from the OLYMPIA long-term extension study showed Nemluvio maintained disease control in prurigo nodularis for up to three years, with clinically meaningful improvements in itch intensity, skin lesions, and quality of life – the longest extension study in prurigo nodularis reported to date. Earlier, at the Aesthetic & Anti-Aging Medicine World Congress 2026 (AMWC) in Monaco, Galderma presented 9 posters across its aesthetics portfolio, highlighting the regenerative benefits of Sculptra, the long-lasting efficacy of Restylane and the advanced clinical performance of Relfydess. The scientific program addressed emerging patient needs and trends, including medication-driven weight loss patients and perimenopausal women. Finally, at the International Master Course on Aging Science (IMCAS) 2026, Galderma extended its aesthetics leadership with findings from a global survey of over 4,300 women revealing a significant knowledge gap around menopause-related skin changes and underscored its commitment to including menopausal status in all injectable aesthetics clinical trials. Galderma also presented new data on Sculptra, Restylane and Relfydess, building on clinical updates from its neuromodulator portfolio highlighted earlier at the TOXINS 2026 International Conference. Galderma demonstrated meaningful progress in further strengthening its financial profile in the first quarter of the year, as evidenced by its investment grade ratings from S&P (BBB, positive) and Fitch (BBB, positive). Galderma replaced in February 2026 its Revolving Credit Facility originally implemented at the time of its 2024 IPO, with significantly improved terms and a size increase from 0.7 to 1 billion USD. In March, Galderma also successfully issued a Eurobond, for a total of 500 million EUR, with proceeds used for full early Term Loan repayment. Galderma also continued to demonstrate its commitment to superior shareholder returns. This included share repurchases of 232 million CHF in the accelerated bookbuild offering of Galderma shares by Sunshine SwissCo GmbH (“EQT”), Abu Dhabi Investment Authority (“ADIA”) and Auba Investment Pte. Ltd. (“Auba”) which took place in March. Funded from existing liquidity on hand, they are to be held in treasury to support Galderma’s employee participation plans, business development activities and/or treasury management. This final accelerated bookbuild offering marks the full divestment by the EQT-led consortium of investors. Emphasizing Galderma’s reliable performance and attractive outlook as a stand-alone company, it is the largest fully monetized capital gain from a single fund in the history of global private equity. At the recent Annual General Meeting, following another record year, a dividend payment of 0.35 CHF (gross) per share was approved out of reserves from capital contributions.2 Galderma is confirming its full-year guidance for 2026, with net sales growth of 17-20% at constant currency and a Core EBITDA margin of approximately 26% at constant currency. Based on the strong start to the year, the guidance is increasingly being de-risked with confidence to navigate a volatile environment. On U.S. tariffs, exposure is expected to remain manageable in the year. In addition to the already assumed 15% U.S. tariff on the import values of Sculptra and Restylane, the confirmed full year guidance now also factors in the expected effects of the recent U.S. administration proclamation on the imports of pharmaceuticals and pharmaceutical ingredients into the U.S. The evolution from February to March of the simulated foreign exchange impact is available in the Appendix, highlighting key foreign exchange currency pairs. 2026 remains a key year to capitalize on opportunities and drive net sales growth. The five key opportunity areas for the year include 1) significant launches, including the strong uptake of Nemluvio and Relfydess, the geographic expansion of Restylane and Sculptra, and ongoing innovation in Dermatological Skincare, 2) further market share gains, 3) a strengthened financial profile, 4) a shift to long-term growth with increasing strategic optionality, and 5) dynamic commercial investments to continue to drive growth. Galderma will host a trading update call today at 15:30 CEST to discuss first quarter 2026 results and respond to questions from financial analysts. Investors and the public may access the webcast by registering on the Galderma Investor Relations website at https://investors.galderma.com/events-presentations. A recording will also be made available after the event. Galderma (SIX: GALD) is the pure-play dermatology category leader, present in approximately 90 countries. We deliver an innovative, science-based portfolio of premium flagship brands and services that span the full spectrum of the fast-growing dermatology market through Injectable Aesthetics, Dermatological Skincare and Therapeutic Dermatology. Since our foundation in 1981, we have dedicated our focus and passion to the human body’s largest organ – the skin – meeting individual consumer and patient needs with superior outcomes in partnership with healthcare professionals. Because we understand that the skin we are in shapes our lives, we are advancing dermatology for every skin story. For more information: www.galderma.com. For further information: Media Christian Marcoux, M.Sc. Chief Communications Officer christian.marcoux@galderma.com +41 76 315 26 50 Investors Emil Ivanov Head of Strategy, Investor Relations and ESG emil.ivanov@galderma.com +41 21 642 78 12 Richard Harbinson Corporate Communications Director richard.harbinson@galderma.com +41 76 210 60 62 Jessica Cohen Investor Relations and Strategy Director jessica.cohen@galderma.com +41 21 642 76 43 Appendix Appendix 1: Q1 2026 net sales by product category and geography Net sales Year-on-year growth Q1 2025 Q1 2026 Constant currency Reported 1,129 1,473 25.5% 30.5% 547 648 13.1% 18.4% 311 364 12.5% 17.1% 236 284 14.0% 20.1% 370 441 17.0% 19.3% 212 385 71.3% 81.4% 39 185 >100% >100% 697 862 16.0% 23.7% 432 610 41.5% 41.5% Appendix 2: Overview of foreign exchange rate exposure FY 2025 average rate February 2026 closing rate (recall) March 2026 closing rate 0.645 0.713 0.685 0.179 0.195 0.190 1.206 1.294 1.252 0.139 0.146 0.145 1.130 1.181 1.147 0.052 0.058 0.055 Net sales +245 bps +105 bps Core EBITDA +144 bps +45 bps Notes and references Note: Due to rounding numbers presented may not add up precisely to the totals provided and percentages may not precisely reflect the absolute figures. All ratios, subtotals and variances are calculated using the underlying amount rather than the presented rounded amount. Forward-looking statements Follow us on Social Media for current news and patients stories

Clinical Result

30 Mar 2026

·allsci.com

Sanofi’s amlitelimab meets Phase III endpoints in atopic dermatitis with extended 12-week dosing interval

Sanofi (NASDAQ: SNY) reported Phase III data from three trials of amlitelimab in moderate-to-severe atopic dermatitis, showing that the anti-OX40L antibody met primary endpoints across monotherapy and combination settings — with efficacy at a dosing interval of once every 12 weeks that matched the every-four-week regimen. The results, presented as late-breaking research at the 2026 American Academy of Dermatology annual meeting in Denver, position amlitelimab as a mechanistically distinct entrant into a treatment landscape that has grown crowded but remains defined by frequent dosing and incomplete responses. The COAST 1 and COAST 2 trials were randomized, double-blind, placebo-controlled Phase III studies evaluating amlitelimab monotherapy in adults and adolescents aged 12 and older with moderate-to-severe atopic dermatitis. SHORE used the same design but tested amlitelimab in combination with topical corticosteroids, with or without topical calcineurin inhibitors. Across the three trials, 1,786 patients were enrolled at sites spanning North America, Europe, Asia, and Latin America. The primary endpoint for all three studies was the proportion of patients achieving a validated Investigator Global Assessment for atopic dermatitis (vIGA-AD) score of 0 or 1 — clear or almost clear skin — with at least a two-point reduction from baseline at Week 24. Both the Q4W and Q12W amlitelimab arms met this endpoint in each trial.For US and US reference countries, the primary endpoint was vIGA-AD 0/1 with a ≥2-point reduction. Of note, for the EU reference countries and Japan, the studies used co-primary endpoints that included the same vIGA-AD measure plus EASI-75. In COAST 1, vIGA-AD 0/1 rates were 21.1% (Q4W) and 22.5% (Q12W) versus 9.2% for placebo. EASI-75 — the proportion of patients achieving at least 75% improvement in the Eczema Area and Severity Index — reached 35.9% and 39.1% in the Q4W and Q12W arms, respectively, compared to 19.1% for placebo. Itch reduction, measured by a four-point or greater decrease in peak pruritus numerical rating scale, was 22.5% (Q4W) and 24.5% (Q12W) versus 12.7% for placebo. All key secondary endpoints in COAST 1 reached statistical significance. COAST 2 showed a similar pattern, with vIGA-AD 0/1 rates of 25.3% (Q4W) and 25.7% (Q12W) versus 14.8% for placebo. EASI-75 and itch endpoints reached nominal significance, though one secondary endpoint — vIGA-AD 0/1 with barely perceptible erythema — did not achieve statistical significance. The distinction between the two monotherapy trials is worth noting: COAST 2’s higher placebo response rate narrowed the treatment delta, a common challenge in atopic dermatitis trials with geographically diverse enrollment. SHORE, the combination study, produced the highest absolute response rates. vIGA-AD 0/1 was achieved by 28.7% (Q4W) and 32.3% (Q12W) of patients versus 16.8% on placebo plus topical therapy alone. EASI-75 reached 48.1% and 46.8% in the active arms versus 32.3% for placebo. All primary and key secondary endpoints were statistically significant. Across all three trials, Sanofi reported that efficacy was progressively increasing at Week 24 with no evidence of plateau, suggesting that longer treatment durations may yield higher response rates — a pattern that will be tested in the ongoing ESTUARY extension study. The safety profile was consistent with earlier-phase data. The most common adverse events across COAST 1, COAST 2, and SHORE were nasopharyngitis, atopic dermatitis flares, and upper respiratory tract infections, occurring at rates generally comparable to or lower than placebo. Malignancy rates were below 1% and similar between active and placebo groups. No severe injection site reactions or serious gastrointestinal ulceration events were reported. Sanofi disclosed a second case of Kaposi’s sarcoma in the amlitelimab development program, identified in the still-blinded ESTUARY Phase III extension study. Both Kaposi’s sarcoma cases occurred in patients with known risk factors, and both patients discontinued treatment and entered recovery. Out of an estimated 3,778 patients exposed to amlitelimab across all indications, no additional cases have been identified. The signal remains numerically small but warrants monitoring given the immunomodulatory mechanism. Sanofi stated that it “believes that amlitelimab continues to have the potential to be a meaningful and convenient option for patients with AD”. Amlitelimab is a fully human, non-T cell depleting monoclonal antibody that blocks OX40 ligand, a costimulatory molecule involved in the activation and survival of effector T cells. By targeting this upstream pathway, the drug aims to modulate pathogenic immune responses without the broad immunosuppression associated with JAK inhibitors or the cytokine-specific blockade of IL-4/IL-13 antibodies. The non-depleting design distinguishes it from therapies that reduce T cell populations, potentially offering a different safety-efficacy tradeoff. The atopic dermatitis treatment landscape in 2026 includes six approved systemic therapies for moderate-to-severe disease: dupilumab and tralokinumab (both anti-IL-4/IL-13 pathway), lebrikizumab (anti-IL-13), nemolizumab (anti-IL-31 receptor), and the oral JAK1 inhibitors abrocitinib and upadacitinib. All approved injectable biologics require dosing every two to four weeks. Amlitelimab’s Q12W regimen — approximately four injections per year — would represent a substantial reduction in treatment burden if the dosing schedule is maintained in regulatory filings. Cross-trial comparisons are limited by differences in study populations, placebo rates, and endpoint definitions, but the absolute vIGA-AD 0/1 and EASI-75 rates observed in the COAST and SHORE trials are numerically lower than those reported for dupilumab and upadacitinib in their respective pivotal programs. Whether the dosing convenience and mechanistic novelty offset the apparent efficacy gap will be a central question for regulators, payers, and prescribers. Rocatinlimab, developed by Amgen, targets the OX40 receptor rather than the ligand and is also in Phase III development for atopic dermatitis. The two drugs represent competing approaches to the same pathway, and their relative clinical profiles will become clearer as more data emerge. A 2024 review in the Journal of Dermatology and Therapy examined both molecules, noting that while they share a pathway target, their binding sites and downstream effects may differ. Results from ESTUARY, evaluating Q12W maintenance dosing and longer-term safety, are anticipated in the second half of 2026. Your email address will not be published. Required fields are marked * Comment * Name * Email * Website

Clinical ResultPhase 3Immunotherapy

28 Mar 2026

·www.businesswire.com

AAD 2026: Late-Breaking Nemolizumab Data Demonstrate Clinically Meaningful Benefits for Children Aged 2 to 11 With Moderate-to-Severe Atopic Dermatitis

Pharmacokinetics, safety and efficacy clinical study data show that nemolizumab achieved clinically meaningful reductions in skin lesions and itch through Week 16, which were sustained up to a year in children aged 2 to 11 with moderate-to-severe atopic dermatitis 1 These findings reinforce the previously established safety and efficacy of nemolizumab in adults and adolescents with moderate-to-severe atopic dermatitis, for which it is approved by multiple global regulatory authorities 2,3 Up to 25% of children are affected by atopic dermatitis, and currently there are limited approved treatment options for children living with moderate-to-severe atopic dermatitis 4,5 ZUG, Switzerland--(BUSINESS WIRE)--Galderma (SIX: GALD) today announced new phase II data showing that nemolizumab was well tolerated and effective in children (aged 2 to 11 years) with moderate-to-severe atopic dermatitis, with a clinically meaningful and sustained reduction in skin lesions and itch for up to a year.1 Results will be presented in a late-breaking session at the 2026 American Academy of Dermatology (AAD) Annual Meeting. Atopic dermatitis is the most common inflammatory skin disorder in children, yet treatment options in the moderate-to-severe pediatric setting are limited.5 The disease can have a significant impact on quality of life for both the patients and their loved ones, with persistent itch and recurrent skin lesions often disrupting sleep, school and relationships.5-8 “Atopic dermatitis can affect many aspects of children’s lives including schoolwork, emotional development, and social confidence. This burden also often extends to caregivers who can experience anxiety, stress, and sleep loss. In our study, nemolizumab demonstrated a clinically meaningful benefit in children with moderate-to-severe atopic dermatitis, helping to reduce skin lesions and itch up to one year, and had a similar safety profile as with adults and adolescents.” LAWRENCE EICHENFIELD, M.D. PROFESSOR OF DERMATOLOGY AND PEDIATRICS AT THE UNIVERSITY OF CALIFORNIA SAN DIEGO SCHOOL OF MEDICINE AND CHIEF OF PEDIATRIC DERMATOLOGY AT RADY CHILDREN'S HOSPITAL SAN DIEGO, UNITED STATES Clinically meaningful reductions in skin lesions and itch in children with atopic dermatitis A phase II study (NCT04921345) was conducted to assess the pharmacokinetics, safety, and efficacy of nemolizumab in children (aged 2 to 11 years) with moderate-to-severe atopic dermatitis.1 Results showed that nemolizumab pediatric doses were associated with similar pharmacokinetic exposure compared to adults and adolescents, and were well tolerated and effective in children, with clinically meaningful reductions in skin lesions and itch through Week 16 and sustained up to Week 52.1 Amongst two of the cohorts evaluated, children aged 7 to 11 and 2 to 6, with nemolizumab doses of 5 mg (for weights ≥10 kg to <20 kg), 10 mg (for ≥20 kg to <30 kg), and 15 mg (for ≥30 kg): Investigator’s Global Assessment of skin lesion improvement to clear (0) or almost clear (1) skin was observed as early as Week 4, with 41-47% of patients achieving it by Week 16 1 A 75% improvement in the Eczema Area and Severity Index score was observed as early as Week 4, with 69-73% of patients achieving it by Week 16 1 Itch relief - defined as a score of ≥4 on the Peak Pruritus Numerical Rating Scale (PP-NRS) - was observed as early as Week 1, with 72% of children aged 2 to 6 and 59% of children aged 7 to 11 achieving it at Week 16 1 Similar or higher response rates were observed at Week 52 for all these clinical endpoints demonstrating sustained efficacy over a year 1 These phase II findings are consistent with the previously established safety and efficacy of nemolizumab in adults and adolescents with moderate-to-severe atopic dermatitis.2,3 “These new data in children below 12 years old build on nemolizumab’s robust and growing clinical evidence base in moderate-to-severe atopic dermatitis. They also demonstrate our commitment to advancing research to address key areas of unmet need in dermatology, such as atopic dermatitis in children, which has such a high prevalence and burden." CHRISTOPHE PIKETTY, M.D., PH.D. GLOBAL PROGRAM HEAD, THERAPEUTIC DERMATOLOGY GALDERMA For adult and adolescent patients with moderate-to-severe atopic dermatitis, nemolizumab is the first approved monoclonal antibody that specifically targets IL-31 receptor alpha, inhibiting the signaling of IL-31.2,3,9 IL-31 is a neuroimmune cytokine that drives itch and is involved in inflammation and skin barrier dysfunction in both atopic dermatitis and prurigo nodularis, and in fibrosis in prurigo nodularis.9-11 It is approved by multiple regulatory authorities around the world for the treatment of adults and adolescent patients with moderate-to-severe atopic dermatitis and adults with prurigo nodularis, including in the U.S. and European Union.2,3 For more information about the impact of atopic dermatitis on children and families, watch this video. Media can find more information and resources on atopic dermatitis in this toolkit. About Galderma Galderma (SIX: GALD) is the pure-play dermatology category leader, present in approximately 90 countries. We deliver an innovative, science-based portfolio of premium flagship brands and services that span the full spectrum of the fast-growing dermatology market through Injectable Aesthetics, Dermatological Skincare and Therapeutic Dermatology. Since our foundation in 1981, we have dedicated our focus and passion to the human body’s largest organ – the skin – meeting individual consumer and patient needs with superior outcomes in partnership with healthcare professionals. Because we understand that the skin we are in shapes our lives, we are advancing dermatology for every skin story. For more information: www.galderma.com. References Eichenfield LF, et al. Pharmacokinetics, safety, and efficacy of nemolizumab in children (aged 2 to 11 years) with moderate-to-severe atopic dermatitis. Late breaking abstract presented at 2026 American Academy of Dermatology (AAD) Annual Meeting; March 27-31, 2026; United States Nemluvio ® U.S. Prescribing Information. Available online . Accessed March 2026 Nemluvio ® European Medicines Agency. Summary of Product Characteristics. Available online . Accessed March 2026 Schoch JJ, et al. Atopic dermatitis: Update on skin-directed management: clinical report. Pediatrics . 2025; 155(6):e2025071812. doi:10.1542/peds.2025-071812 Eichenfield LF, et al. Patient-reported impact of atopic dermatitis on pediatric and adolescent patients with moderate-to-severe disease: results of a real-world, cross-sectional survey. Pediatr Dermatolog y. 2025;42:523-531. doi:10.1111/pde.15940 Vittrup I, et al. The association between atopic dermatitis, cognitive function and school performance in children and young adults. Br J Dermatol . 2023;188(3):341-349. doi: 10.1093/bjd/ljac058 Mostafa N and Smith S D. Improving psychological health outcomes in children with atopic dermatitis. Clin Cosmet Investig Dermatol. 2023;16:2821-2827. doi: 10.2147/CCID.S393254 Kelly K A, et al. Skin disease in children: Effects on quality of life, stigmatization, bullying, and suicide risk in pediatric acne, atopic dermatitis, and psoriasis patients. Children (Basel). 2021;8(11):1057. doi:10.3390/children8111057 Silverberg JI, et al. Phase 2B randomized study of nemolizumab in adults with moderate-to-severe atopic dermatitis and severe pruritus. J Allergy Clin Immunol . 2020;145(1): 173-182. doi: 10.1016/j.jaci.2019.08.013 Bewley A, et al. Prurigo nodularis: A review of IL-31RA blockade and other potential treatments. Dermatol Ther (Heidelb). 2022;12(9):2039–2048. doi: 10.1007/s13555- 022-00782-2 Kwatra SG, Misery L, Clibborn C, Steinhoff M. Molecular and cellular mechanisms of itch and pain in atopic dermatitis and implications for novel therapeutics. Clin Transl Immunology . 2022;11(5):e1390. doi: 10.1002/cti2.1390

Clinical ResultPhase 2Drug Approval

100 Deals associated with Nemolizumab

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KEGG	Wiki	ATC	Drug Bank
D11080	Nemolizumab	-	DB15252

R&D Status

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
Moderate Atopic Dermatitis	United States	Galderma Laboratories LP	13 Dec 2024
Severe Atopic Dermatitis	United States	Galderma Laboratories LP	13 Dec 2024
prurigo nodularis	Japan	Maruho Co., Ltd.	26 Mar 2024
Dermatitis, Atopic	Japan	Maruho Co., Ltd.	28 Mar 2022

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Pruritus	Phase 3	United States	Galderma Holding SA	18 Mar 2022
Pruritus	Phase 3	Hungary	Galderma Holding SA	18 Mar 2022
Pruritus	Phase 3	Poland	Galderma Holding SA	18 Mar 2022
Pruritus	Phase 3	Spain	Galderma Holding SA	18 Mar 2022
CREST Syndrome	Phase 2	United States	GALDERMA PHARMA SA	20 Feb 2026
CREST Syndrome	Phase 2	Switzerland	GALDERMA PHARMA SA	20 Feb 2026
Scleroderma, Diffuse	Phase 2	United States	GALDERMA PHARMA SA	20 Feb 2026
Scleroderma, Diffuse	Phase 2	Switzerland	GALDERMA PHARMA SA	20 Feb 2026
Scleroderma, Systemic	Phase 2	Japan	Maruho Co., Ltd.	20 Apr 2022

Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


AAD2026	Not Applicable	Dermatitis, Atopic	1,092	Lebrikizumab	trdydyfxzn(crxoaccvpj) = wabxrpwynw guvyaygpor (hizhmgxsez ) View more	Positive	27 Mar 2026
				Nemolizumab	trdydyfxzn(crxoaccvpj) = rcjltkezpz guvyaygpor (hizhmgxsez ) View more
NCT03989206 (ARCADIA, AAD2026)	Phase 2/3	Dermatitis, Atopic	618	Nemolizumab 30mg Q4W	pwsocvjvoj(icynbsujqj) = yjcfdrukgf hwwujlehxo (ibswnogqwd ) View more	Positive	27 Mar 2026
NCT03989206 (ARCADIA LTE, AAD2026)	Phase 3	Moderate Atopic Dermatitis	497	Nemolizumab 30mg (EASI 60≥50% but <75% improvement or IGA score 2/3 with ≥1-point improvement + Partial responders)	ukmbiyclmg(tiopajzxep) = mekvwsvaxc orchkpgrqs (anmzxumbmf ) View more	Positive	27 Mar 2026
				Nemolizumab 30mg (Did not achieve EASI-50 with IGA score 3/4 and no improvement + Non-responders)	ukmbiyclmg(tiopajzxep) = zlibbypvkd orchkpgrqs (anmzxumbmf ) View more
AAD2026	Phase 3	prurigo nodularis	859	Nemolizumab (Prurigo Nodularis)	igxnwethdp(ctzhddixkp) = wkvfublwjt vlazctlsgp (ynnqhunyvs ) View more	Positive	27 Mar 2026
NCT03989206 (ARCADIA LTE, AAD2026)	Phase 2/3	Dermatitis, Atopic	254	Nemolizumab 30mgNemolizumab 30mg (Nemolizumab experienced patients)	zadahmgcqt(qlpyzoubvw) = improved over time kyyuyqlptb (mwqbtzynew )	Positive	27 Mar 2026
				Nemolizumab 30mgNemolizumab (New to Nemolizumab)
NCT05214794 (CTgov)	Phase 2	Scleroderma, Systemic	6	nemolizumab	xmtquxxplf(whfrdfdezy) = yjvkpscpdl lwdnswbfef (pmqegxwrrn, xaowodzxnj - gqbluhxvdj) View more	-	13 Feb 2026
NCT04204616 (OLYMPIA LTE, Pubmed \| J Eur Acad Dermatol Venereol)	Phase 3	prurigo nodularis	508	Nemolizumab	ivpwfnzxat(ntsseqxpyw) = gncxuyausv tuohoychmt (zikifbyraz ) View more	Positive	17 Dec 2025
NCT03989206 (ARCADIA LTE, Pubmed \| J Eur Acad Dermatol Venereol)	Phase 2/3	Dermatitis, Atopic	1,062	Nemolizumab	xchvrrxekt(weqsewoejf) = The majority (92.6%) of treatment-emergent adverse events (TEAEs) were mild/moderate in severity; only 22.1% were considered related to nemolizumab. The most common (≥5.0%) TEAEs were COVID-19 (19.6%), nasopharyngitis (19.5%), atopic dermatitis (18.1%), upper respiratory tract infection (12.7%), headache (6.5%) and asthma (5.5%). aeoxafofer (rjhvwobrtt )	Positive	13 Oct 2025
				Placebo
NCT04365387 (CTgov)	Phase 2	Moderate Atopic Dermatitis \| Severe Atopic Dermatitis	242	Nemolizumab (Nemolizumab)	hbhsdakccl = hxkomcfhtl eaqridihaa (rrtakhzfqc, bobxypiimj - altqnipwlb) View more	-	05 Jun 2025
				Placebo (Placebo)	hbhsdakccl = ywufbqmpkk eaqridihaa (rrtakhzfqc, ktkwfzdfvs - kdunybfsvg) View more
NCT03985943 (ARCADIA, Pubmed \| Patient)	Phase 3	Dermatitis, Atopic	73	Nemolizumab	pamdqkmquf(xhddmixycs) = mueetpigzl dahuorvoiu (nriebjawed ) View more	-	13 May 2025
				Placebo	pamdqkmquf(xhddmixycs) = tgrcyfolqd dahuorvoiu (nriebjawed ) View more

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