Nemluvio (nemolizumab-ilto) / Roche, Maruho, Galderma - LARVOL DELTA

The efficacy and safety of nemolizumab in patients with prurigo nodularis: A systematic review and meta-analysis of randomized controlled trials (EADV 2025) - No abstract available

Retrospective data • Review • Immunology • Prurigo Nodularis

The use of Nemolizumab in refractory scrotal dysesthesias (EADV 2025) - No abstract available

Nemolizumab treatment did not impair immune response to vaccination in patients with atopic dermatitis – Results from a randomised, double-blind, placebo-controlled study. (EADV 2025) - No abstract available

Clinical • Atopic Dermatitis • Dermatitis • Dermatology • Immunology

Pooled Safety Analysis of Nemolizumab in moderate-to-severe atopic dermatitis: Results from two phase 3 trials (EADV 2025) - No abstract available

Clinical • P3 data • Atopic Dermatitis • Dermatitis • Dermatology • Immunology

Nemolizumab long-term safety and efficacy up to 104 weeks in ARCADIA open-label extension study in adolescents and adults with moderate-to-severe atopic dermatitis. (EADV 2025) - No abstract available

Clinical • Atopic Dermatitis • Dermatitis • Dermatology • Immunology

Long-term efficacy and safety of nemolizumab in adolescents with moderate-to-severe atopic dermatitis: Post hoc analyses from ARCADIA LTE 1-year cut-off (EADV 2025) - No abstract available

Clinical • Retrospective data • Atopic Dermatitis • Dermatitis • Dermatology • Immunology

Molecular Signatures in Inflammatory Skin Disease (clinicaltrials.gov) - P=N/A | N=300 | Recruiting | Sponsor: Prof. Dr. Stephan Weidinger | Trial completion date: Dec 2028 ➔ Dec 2029 | Trial primary completion date: Dec 2027 ➔ Dec 2028

Trial completion date • Trial primary completion date • Atopic Dermatitis • Dermatitis • Dermatology • Immunology • Inflammation • Oncology • Psoriasis

The Visualization of Nocturnal Scratching Behavior in Pediatric Atopic Dermatitis: Facilitating Shared Decision-Making and Assessing the Efficacy of Treatment. (PubMed, Cureus) - "Ltd., Osaka, Japan), a smartwatch application, in visualizing nocturnal scratching and facilitating shared decision-making (SDM) in two pediatric AD cases treated with nemolizumab. Objective monitoring revealed discrepancies between self-reported itch and actual scratching behavior, leading to appropriate treatment initiation and significant improvements in scratching behavior, Eczema Area and Severity Index (EASI), and numerical rating scale (NRS) scores. These results highlight the clinical value of behavioral visualization in enhancing SDM and optimizing management in pediatric AD."

Journal • Atopic Dermatitis • Dermatitis • Dermatology • Immunology • Pediatrics • Pruritus

Proof of Concept Study to Assess the Pharmacokinetics/Pharmacodynamics of Nemolizumab in Adults With Chronic Pruritus of Unknown Origin (CPUO) (clinicaltrials.gov) - P2 | N=50 | Not yet recruiting | Sponsor: Galderma R&D

New P2 trial • Dermatology • Pruritus

Galderma Delivers Record First Half 2025 Net Sales of 2.448 Billion USD and 12.2% Year-on-Year Growth at Constant Currency, Raises Full-Year Top-Line Guidance (Businesswire) - "Significant progress on the launch of new innovation, including Nemluvio (nemolizumab) which continues to outperform, delivering 131 million USD in sales, the ongoing positive uptake of Relfydess, now launched in 17 markets, and geographic expansion in Fillers & Biostimulators...Therapeutic Dermatology net sales for the first half of 2025 were 489 million USD, with year-on-year growth of 26.9% at constant currency. This accelerated performance was driven by an impressive ramp-up in Nemluvio sales, notably in the second quarter...Nemluvio delivered 131 million USD in net sales, performing ahead of expectations. Sales were primarily driven by the U.S., the majority still from prurigo nodularis, with the contribution from atopic dermatitis quickly increasing."

Commercial • Sales • Atopic Dermatitis • Musculoskeletal Diseases • Prurigo Nodularis

Nemluvio: “Paid NBRx weekly market share trend (new patient starts); ~32% in prurigo nodularis and ~6% in atopic dermatitis” (Galderma) - H1 2025 Results

Commercial • Atopic Dermatitis • Immunology • Prurigo Nodularis

Clinical Characteristics and Risk Factors for Cutaneous Manifestations Associated With Nemolizumab in Atopic Dermatitis: A Multicenter Retrospective Study in Japan. (PubMed, J Dermatol) - "Despite topical corticosteroid treatment, nemolizumab therapy was discontinued in 42% of the patients affected. In conclusion, nemolizumab frequently induces early-onset, morphologically distinct cutaneous eruptions that appear to be independent of baseline disease severity or biomarkers."

Journal • Retrospective data • Atopic Dermatitis • Bullous Pemphigoid • Dermatitis • Dermatology • Dermatopathology • Immunology • Pruritus • IL31RA

Pharmacokinetics, Safety and Efficacy of Nemolizumab in Participants With Moderate-to-Severe Atopic Dermatitis (clinicaltrials.gov) - P2 | N=105 | Completed | Sponsor: Galderma R&D | Recruiting ➔ Completed | Trial primary completion date: Jan 2025 ➔ Apr 2025

Trial completion • Trial primary completion date • Atopic Dermatitis • Dermatitis • Dermatology • Immunology • Pediatrics

RE-UNITE AD: Real-world Experience Using Nemolizumab in the Treatment of Moderate-to-Severe Atopic Dermatitis in Adolescents & Adults (clinicaltrials.gov) - P=N/A | N=1000 | Recruiting | Sponsor: Galderma R&D | Not yet recruiting ➔ Recruiting

Enrollment open • Atopic Dermatitis • Dermatitis • Dermatology • Immunology

A case of acute generalized exanthematous pustulosis following administration of nemolizumab. (PubMed, JAAD Case Rep) - No abstract available

Journal • Immunology

Nemolizumab for the treatment of refractory primary localized cutaneous amyloidosis in a nonatopic patient. (PubMed, JAAD Case Rep) - No abstract available

Journal • Amyloidosis • Atopic Dermatitis • Dermatitis • Dermatology • Dermatopathology • Immunology

Nemolizumab (Nemluvio®) for prurigo nodularis. (PubMed, Trends Pharmacol Sci) - No abstract available

Journal • Immunology • Prurigo Nodularis

A Clinician's Guide to Dupilumab-related Ocular Surface Disease. (PubMed, J Clin Aesthet Dermatol) - "Current biologics approved for AD include dupilumab, an IL-4 receptor alpha inhibitor, tralokinumab, an IL-13 inhibitor, lebrikizumab, an IL-13 inhibitor, and nemolizumab, an IL-31 receptor alpha inhibitor. For practitioners, it is important to be aware that OSD is a relatively common side effect but rarely causes problems severe enough to lead to cessation of treatment. This brief report provides guidance on screening and managment of OSD in patients with AD receiving anti-IL-4 and/or IL-13 treatment."

Journal • Atopic Dermatitis • Conjunctivitis • Dermatitis • Dermatology • Dry Eye Disease • Immunology • Inflammation • Keratitis • Ocular Infections • Ocular Inflammation • Ophthalmology • Pruritus • IL13 • IL4 • IL4R

Four Cases of Prurigo Nodularis Requiring Nemolizumab due to Persistent Pruritus or Lesions after Dupilumab Treatment. (PubMed, Acta Derm Venereol) - No abstract available

Journal • Dermatology • Immunology • Prurigo Nodularis • Pruritus

Use of Nemolizumab in Refractory Scrotal Dysesthesia. (PubMed, JAMA Dermatol) - No abstract available

Journal

Galderma Initiates Two New Clinical Trials Investigating Nemolizumab in Patients With Systemic Sclerosis and Chronic Pruritus of Unknown Origin (Yahoo Finance) - "Galderma...announced the initiation of two new clinical trials to investigate the efficacy and safety of nemolizumab in treating patients living with Systemic Sclerosis (SSc) and Chronic Pruritus of Unknown Origin (CPUO) – two chronic conditions with high unmet need....Galderma’s phase II proof-of-concept study is a multicenter, randomized, double-blind, placebo-controlled study investigating the pharmacokinetics and pharmacodynamics of nemolizumab in adults with SSc. Patient enrollment is planned to begin in H2 2025, with completion anticipated in 2028....Galderma’s new phase II CPUO trial reinforces the company’s commitment to exploring options for patients with chronic skin conditions that significantly impact quality of life. This randomized, double-blind, placebo-controlled proof-of-concept study will explore the pharmacokinetics and pharmacodynamics of nemolizumab in adults. Enrollment is expected to start in H2 2025 in the U.S., with completion anticipated in 2026."

New P2 trial • Prurigo Nodularis • Systemic Sclerosis

Therapeutic Pipeline (CDA 2025) - "New therapeutics in AD (OX40, Nemolizumab, Delgocitinib, and APG777) 2. New therapeutics in PN (Ruxolitinib) 3. New therapeutics in PsO (Icotrokinra) 4. New therapeutics in HS (Bimekizumab) 5. New therapeutics in CSU (Dupilumab)"

Dermatology

A Study of Nemolizumab for the Treatment of Adults With Systemic Sclerosis (clinicaltrials.gov) - P2 | N=162 | Not yet recruiting | Sponsor: Galderma R&D

New P2 trial • Immunology • Scleroderma • Systemic Sclerosis

New Treatments in Atopic Dermatitis Update. (PubMed, Ann Allergy Asthma Immunol) - "Non-steroidal topical treatments, such as roflumilast and tapinarof creams, are approved for adults and children down to 6 and 2 years, respectively. Topical Janus kinase (JAK) inhibitors, including ruxolitinib, leverage inhibition of the JAK1 pathway with low concern for toxicity. The use of biologics targeting the interleukin (IL)-4/IL-13 pathway has expanded; dupilumab is approved for patients 6 months and older and tralokinumab and lebrikizumab are approved for 12 years and above. Most recently, nemolizumab, targeting the IL-31 receptor, which mediates nonhistaminergic itch, has been approved for those 12 years and above. Although baricitinib is approved in Europe and Japan, upadacitinib and abrocitinib remain the only oral JAK inhibitors approved for U.S. patients 12 years and older...These innovations represent a shift toward personalized AD management. As the treatment landscape evolves, ongoing research is essential to assess long-term safety and efficacy, as..."

Journal • Review • Atopic Dermatitis • Dermatitis • Dermatology • Immunology • Pediatrics • IL13 • JAK1 • TNFSF4

New and Emerging Pharmacotherapies for Pruritus: A Systematic Review and Network Meta-Analysis. (PubMed, Dermatitis) - "The strongest improvements in pruritus were seen from ustekinumab (RR 4.30 [2.88; 6.41]) and ixekizumab (RR 4.42 [3.32; 5.88]) for psoriasis and upadacitinib (RR 5.54 [95% CI: 4.53-6.78]), abrocitinib (RR 3.76 [95% CI: 2.97-4.76]), and baricitinib (RR 3.63 [95% CI: 2.36-5.58]) for atopic dermatitis. Nemolizumab (RR 3.06 [95% CI: 1.63-5.74]) and dupilumab (RR 2.11 [95% CI: 1.30-3.41]) were most effective for prurigo nodularis, though fewer studies were available for comparison. Adverse effects were mild and similar between agents; discontinuation rates were low. This review evaluates efficacy of emerging pruritus treatments based on a single standardized measurement, highlighting the role of novel agents in the treatment of chronic pruritus."

Journal • Retrospective data • Review • Atopic Dermatitis • Dermatitis • Dermatology • Immunology • Prurigo Nodularis • Pruritus • Psoriasis