Galderma Group AG (SIX Swiss Exchange: GALD), the Swiss dermatology company, announced on October 14, 2026, new Phase 2 results demonstrating sustained improvements in itching, sleep disturbance and quality of life among children aged two to 11 years receiving nemolizumab for moderate-to-severe atopic dermatitis. The findings, scheduled for presentation at the Pediatric Dermatology Research Alliance Annual Conference on October 15-17, extend the clinical evidence for the interleukin-31 receptor antagonist into an age group not covered by its current United States approval.
The company reported that 56% to 72% of patients across the evaluated cohorts achieved a clinically meaningful improvement in itch severity at Week 16, defined as a reduction of at least four points on the Peak Pruritus Numerical Rating Scale. Sleep disturbance scores improved by approximately 70% to 78% across cohorts during the same period, with benefits maintained or further improved through Week 52. Measures of children’s quality of life also showed substantial improvement during the year-long investigation.
The study, registered as NCT04921345, was a multicenter, open-label Phase 2 investigation with an actual enrollment of 109 children. Participants received age- and weight-adjusted nemolizumab together with topical treatment, allowing researchers to investigate pharmacokinetics, safety and preliminary efficacy in younger patients. However, the absence of a randomized control group means that the reported improvements cannot be attributed exclusively to nemolizumab or used to establish superiority over alternative treatments.
The development is commercially important because nemolizumab, marketed internationally as Nemluvio, is already approved for moderate-to-severe atopic dermatitis in patients aged 12 years and older and for prurigo nodularis in adults. The medicine generated $433 million in net sales during the first half of 2026, making it an increasingly important component of Galderma’s therapeutic dermatology business. Extending its approved age range could provide additional growth opportunities, but treatment of children younger than 12 remains investigational under the current United States label.
What do the new Week 16 itching results reveal about nemolizumab in children?
Itching is one of the most troublesome symptoms of atopic dermatitis, particularly in young children who may struggle to control scratching or communicate the severity of their discomfort. Persistent itching can damage the skin barrier, worsen inflammation and interfere with sleep and daily activities. Reducing this symptom is therefore an important treatment objective alongside improving visible eczema lesions.
The Phase 2 study evaluated itch severity using the Peak Pruritus Numerical Rating Scale, which measures the intensity of itching. A reduction of at least four points is commonly used as a threshold for clinically meaningful improvement. According to Galderma, 56% to 72% of participants across the evaluated cohorts achieved that level of improvement at Week 16.
These response rates indicate that a substantial proportion of treated children experienced meaningful relief under the study conditions. Galderma also reported similar or higher response rates at Week 52, suggesting that improvement was maintained during continued treatment. However, the October announcement does not disclose the precise Week 52 response percentage for each cohort.
The findings build on data presented at the American Academy of Dermatology Annual Meeting in March 2026. That earlier analysis reported that 72% of children aged two to six and 59% of children aged seven to 11 achieved the four-point itch improvement threshold at Week 16 in the highlighted cohorts. These results support the consistency of the programme’s reported symptom findings.
However, the absence of placebo or active comparator groups limits the conclusions that can be drawn. Itch severity can change with seasonal conditions, changes in topical treatment, disease fluctuations and other aspects of clinical care. The observed response rates therefore demonstrate improvement during treatment rather than the magnitude of benefit attributable solely to the investigational medicine.
How significant were the improvements in sleep disturbance through Week 52?
Sleep disturbance represents a major component of disease burden in pediatric atopic dermatitis. Itching and inflamed skin can make it difficult for children to fall asleep or remain asleep, potentially affecting concentration, behavior and daily functioning. Caregivers may also experience disrupted sleep and additional stress when managing repeated nighttime symptoms.
Galderma reported reductions of approximately 70% to 78% in Sleep Disturbance Numerical Rating Scale scores across the study cohorts at Week 16. The company said improvements were sustained and increased further by Week 52. These results suggest that reduced symptom burden was accompanied by meaningful changes in sleep-related experience.
However, percentage reductions in a symptom score should not be interpreted as equivalent reductions in the number of nighttime awakenings or hours of lost sleep. The numerical rating scale assesses the reported burden of sleep disturbance, and its relationship with objective sleep measurements may vary. The announcement does not provide polysomnography or other direct sleep-monitoring results.
Another consideration is the relationship between itch relief and sleep improvement. Children experiencing less severe itching may naturally have fewer sleep-related complaints, meaning the two outcomes may be closely connected. The study does not establish that nemolizumab has a direct sleep-promoting effect independent of its influence on skin symptoms.
The findings nevertheless add an important dimension to the clinical assessment. A medicine that improves itching but does not meaningfully affect daily functioning may deliver less practical value than one associated with wider improvements in quality of life. The year-long observations therefore support further investigation of outcomes extending beyond visible skin clearance.
What did the study reveal about children’s quality of life?
The new PeDRA analysis includes patient-reported outcomes and age-appropriate quality-of-life measures. For children aged four years and older, investigators used the Children’s Dermatology Life Quality Index to assess how the skin condition affected daily activities and wellbeing. The instrument captures aspects of the disease burden that may not be fully represented by clinician-assessed skin severity scores.
At Week 52, Galderma reported mean improvements of 10.7, 12.0 and 12.0 points from baseline across the study cohorts. These are changes in quality-of-life scores rather than percentages of children achieving a responder threshold. The reductions indicate less reported disease-related burden during follow-up.
The study also used the Infants’ Dermatitis Quality of Life Index for children younger than four and the Patient-Oriented Eczema Measure for children aged at least four. Improvements were observed in both age-appropriate categories. However, the October announcement does not provide complete numerical results for every instrument and cohort.
These measures matter because children with atopic dermatitis can experience difficulties involving school, social confidence, clothing choices and daily routines. Persistent skin symptoms can also place demands on caregivers who must supervise treatment and help manage scratching and sleep disruption. Measuring patient and family experience can therefore help demonstrate whether observed skin improvements have broader practical significance.
Nevertheless, these outcomes are particularly susceptible to limitations associated with an open-label study. Participants and caregivers knew that active treatment was being administered, potentially influencing subjective assessments. Larger controlled investigations would help determine the amount of improvement attributable to nemolizumab beyond the effects of ongoing care and study participation.
How was the 109-patient pediatric Phase 2 study designed?
The investigation was registered as NCT04921345 and conducted as a multicenter, open-label, single-group Phase 2 study. Its actual enrollment was 109 participants aged two to 11 years with moderate-to-severe atopic dermatitis. The study’s principal objectives included evaluation of pharmacokinetics and safety, with clinical efficacy and patient-reported outcomes assessed as additional measures.
Children entered different cohorts according to age and weight, allowing investigators to evaluate dosing strategies across the pediatric population. The programme involved children aged two to six and seven to 11 years, with weight-adjusted treatment intended to achieve appropriate systemic exposure. Nemolizumab was administered together with topical therapy rather than being investigated as a standalone replacement for all other eczema treatment.
Galderma previously described dosing in selected cohorts involving 5 mg for children weighing at least 10 kg but less than 20 kg, 10 mg for those weighing at least 20 kg but less than 30 kg, and 15 mg for those weighing at least 30 kg. The clinical programme also included different dosing cohorts used to evaluate and refine drug exposure. These investigational regimens should not be confused with an approved dosing schedule for children younger than 12.
The study followed participants for approximately 52 weeks, providing information about treatment experience extending substantially beyond the initial Week 16 assessment. Longer observation is particularly relevant in chronic inflammatory disorders where patients may require continued treatment over many months or years. However, an open-label extension of exposure does not independently establish a comparative efficacy advantage.
The completed registry status also does not mean that regulatory authorization has been granted. The company must determine how the findings fit within its broader pediatric development package and whether additional evidence is required for a label expansion.
Why does blocking interleukin-31 affect itching and skin inflammation?
Nemolizumab is a monoclonal antibody targeting the interleukin-31 receptor alpha subunit. Interleukin-31 is a signaling protein involved in communication between immune cells, sensory nerves and other components of the skin environment. Its activity has been associated with itching and several biological processes contributing to inflammatory skin disease.
By binding to the receptor component, nemolizumab inhibits IL-31 signaling. This can reduce activation of pathways associated with itch and may influence related inflammatory activity. The medicine therefore offers a mechanism distinct from treatments that primarily block interleukin-4, interleukin-13 or Janus kinase signaling.
The mechanism may be particularly relevant when severe itching is a central complaint. Nevertheless, atopic dermatitis involves multiple immune pathways and abnormalities in the skin barrier, meaning that IL-31 is not the sole driver of disease. Blocking the receptor may improve important symptoms without eliminating every underlying cause of eczema.
The pediatric study’s combination with topical treatment also reflects the need to address several aspects of the condition. Moisturizers, topical corticosteroids and topical calcineurin inhibitors can contribute to managing skin inflammation and barrier dysfunction. Nemolizumab’s proposed role must therefore be considered within a treatment strategy rather than as an automatic replacement for conventional skin care.
The early and sustained itch responses observed in the study are consistent with the medicine’s known mechanism. However, the relationship between IL-31 inhibition and long-term changes in skin structure or disease progression remains an area requiring further investigation.
How does the evidence compare with nemolizumab’s approved use in older patients?
The FDA approved Nemluvio for adults with prurigo nodularis in August 2024. In December of the same year, it authorized the medicine for patients aged 12 years and older with moderate-to-severe atopic dermatitis when topical prescription treatments do not adequately control the disease or are not advisable. The approved atopic dermatitis regimen includes combination treatment with topical corticosteroids and/or calcineurin inhibitors.
Those decisions were supported by randomized Phase 3 clinical evidence, including the ARCADIA programme in adolescents and adults with atopic dermatitis. The studies demonstrated improvements in skin lesions and itch compared with placebo under controlled conditions. This represents a different level of evidence from the open-label Phase 2 pediatric investigation.
Galderma has continued generating longer-term data in the approved population. In September 2026, the company reported analyses from the ARCADIA long-term extension programme showing that many patients maintained favorable skin and itch outcomes for up to three years. These observations provide additional evidence about treatment experience in older patients, although extension analyses have their own methodological limitations.
The existing results may help inform development in younger children, particularly when comparing pharmacokinetic exposure and potential safety concerns. However, clinical findings in adolescents and adults cannot automatically establish efficacy or safety in two-year-old children. Age-related differences in physiology, immune development and dosing require specific assessment.
The current pediatric programme helps address that gap by studying younger patients directly. Its value lies partly in determining whether the mechanism remains biologically relevant and clinically tolerable across a broader age range.
What does the safety evidence establish for children aged two to 11?
Galderma reported that nemolizumab was generally well tolerated throughout the pediatric Phase 2 programme, with no new safety signals identified. The company described the findings as consistent with the established experience in adults and adolescents. However, the October announcement did not provide a complete breakdown of adverse events, serious adverse reactions or treatment discontinuations.
The approved United States prescribing information identifies risks including hypersensitivity reactions and advises avoidance of live vaccines during treatment. Common adverse reactions reported in the approved atopic dermatitis population include headache, joint pain, urticaria and muscle pain. These established safety considerations are relevant to ongoing development but should not be presented as the frequencies observed in the new pediatric cohorts.
Younger children may differ from older patients in body weight, immune development and exposure to medicines. The clinical study’s weight-adjusted dosing reflects the importance of selecting an appropriate regimen. Pharmacokinetic comparisons can help identify suitable exposures, but they do not independently establish that all long-term safety risks have been characterized.
A study enrolling 109 children can provide useful initial tolerability information, particularly over one year. However, it is not large enough to reliably exclude uncommon adverse events. Broader clinical experience and continued pharmacovigilance would remain necessary if an expanded pediatric indication receives authorization.
The absence of a randomized comparator also limits direct assessment of whether the treatment changes the overall rate of adverse events relative to standard topical care. Additional information from complete study results and regulatory review will be important when evaluating the benefit-risk profile in younger children.
How does nemolizumab compete with other pediatric atopic dermatitis treatments?
The treatment landscape for younger children already includes several therapeutic options, and the available choices vary according to age and disease severity. Dupixent, containing dupilumab, is approved in the United States for moderate-to-severe atopic dermatitis in children aged six months and older under the relevant prescribing conditions. This makes it an established biological treatment option within the age range Galderma is investigating.
Other medicines, including selected topical anti-inflammatory treatments, are also available for pediatric eczema. Their suitability depends on factors such as age, affected skin areas, disease severity and previous treatment response. The presence of approved options means the commercial opportunity for nemolizumab is not based on a complete absence of therapy.
Instead, Galderma may seek differentiation through its IL-31-targeting mechanism and evidence concerning itching, sleep and quality of life. These outcomes are important because patients with similar visible eczema severity can experience different levels of itch-related burden. A medicine addressing that burden effectively could provide an additional choice for physicians.
However, no head-to-head randomized trial has established that nemolizumab is superior to dupilumab or another approved pediatric therapy in children aged two to 11. Response percentages from different trials should not be directly compared because study populations, background treatments, endpoint definitions and observation periods may differ. Comparative effectiveness remains unresolved.
The practical value of any new pediatric authorization would also depend on dosing frequency, injection burden, safety and reimbursement. Families and clinicians may prioritize different aspects of treatment according to the child’s symptoms and circumstances. These considerations will become more important if Galderma pursues formal expansion of the label.
What does pediatric expansion mean for Galderma’s growing Nemluvio franchise?
Nemluvio has already become a major commercial growth driver for Galderma. The company reported $433 million in first-half 2026 net sales for the medicine, compared with approximately $131 million during the corresponding period in 2025. This represents an increase of approximately 230%, calculated from the company’s disclosed figures.
The broader Therapeutic Dermatology business generated $848 million in revenue during the first six months of 2026, increasing 67.9% at constant currency. Nemluvio therefore accounted for slightly more than half of the division’s reported revenue during the period. Its commercial success is increasingly important to Galderma’s overall pharmaceutical portfolio.
The United States contributes the vast majority of current Nemluvio sales, with atopic dermatitis generating a larger contribution than prurigo nodularis. Galderma has also continued expanding international availability, with approvals in more than 40 countries covering relevant existing indications. Commercial adoption is therefore no longer dependent solely on the initial United States launch.
Extending treatment to younger children could broaden the addressable patient population and strengthen the medicine’s lifecycle management strategy. However, Galderma has not disclosed a specific revenue forecast for a potential under-12 indication or announced that the new Phase 2 findings have resulted in FDA approval. Any financial contribution remains conditional on regulatory progress and subsequent prescribing.
The scientific and commercial issues are also distinct. Positive patient-reported outcomes may support continued development, but their contribution to future revenue will depend on the final authorized indication, payer coverage and physician confidence in the available evidence.
What must happen before nemolizumab can be approved for younger children?
The principal outstanding question is whether the full pediatric evidence package provides sufficient support for extending the approved indication below age 12. Regulators will need to evaluate pharmacokinetics, safety, dosing and clinically relevant outcomes in the intended population. Additional controlled evidence may be required depending on the regulatory strategy and the agency’s assessment.
The completed Phase 2 study provides an important foundation because it includes 109 children and approximately one year of observation. Its results suggest that nemolizumab can be administered at weight-adjusted doses and is associated with sustained improvements in symptoms. However, the lack of a control group limits its ability to isolate the treatment effect.
Future regulatory discussions may also consider the existing randomized evidence from adolescents and adults. Comparability of drug exposure and biological mechanism can contribute to pediatric development strategies, but the extent to which older-patient evidence may be extrapolated is a decision for regulators. No new United States authorization for children younger than 12 was announced alongside the PeDRA findings.
Further evaluation of age-specific quality-of-life measures will also matter. Younger children may rely more heavily on caregiver observations, while older participants can describe their own symptoms with greater detail. Understanding these differences can improve both clinical trial interpretation and routine treatment monitoring.
Galderma’s October 2026 results provide encouraging evidence that nemolizumab may reduce itching, improve sleep and lessen the everyday burden of moderate-to-severe atopic dermatitis in children aged two to 11. The findings are consistent with the medicine’s established IL-31 mechanism and extend observation of treatment-related improvements through one year.
The next meaningful milestone will be clarification of the company’s regulatory pathway for younger children and whether the available evidence supports an expanded indication. Until then, the treatment remains investigational for this United States age group. The opportunity is to establish another effective option for pediatric eczema, but the scale of its clinical advantage will require stronger comparative evidence than the current open-label study can provide.
