Nemolizumab

Nemolizumab-ilto is a humanized IgG2 monoclonal antibody that inhibits IL-31 signaling by binding selectively to IL-31 RA. IL-31 is a naturally occurring cytokine that is involved in pruritus, inflammation, epidermal dysregulation, and fibrosis.

• NEMLUVIO is an interleukin-31 receptor antagonist indicated for: Prurigo Nodularis The treatment of adults with prurigo nodularis. ( 1.1 ) Atopic Dermatitis The treatment of adults and pediatric patients 12 years of age and older with moderate-to-severe atopic dermatitis in combination with topical corticosteroids and/or calcineurin inhibitors when the disease is not adequately controlled with topical prescription therapies.ICD-10: L20.9

• NEMLUVIO is contraindicated in patients who have known hypersensitivity to nemolizumab-ilto or to any of the excipients in NEMLUVIO [ see Warnings and Precautions (5.1) ]. Known hypersensitivity to nemolizumab-ilto or to any of the excipients in NEMLUVIO.contraindicated

Complete all age-appropriate vaccinations as recommended by current immunization guidelines prior to treatment with NEMLUVIO. ( 2.1 ) Prurigo Nodularis: Adult Patients Weighing Less Than 90kg: The recommended subcutaneous dosage is an initial dose of 60 mg (two 30 mg injections), followed by 30 mg given every 4 weeks. ( 2.2 ) Adult Patients Weighing 90kg or More: The recommended subcutaneous dosage is an initial dose of 60 mg (two 30 mg injections), followed by 60 mg given every 4 weeks. ( 2.2 ) Atopic Dermatitis: The recommended subcutaneous dosage is an initial dose of 60 mg (two 30 mg injections), followed by 30 mg given every 4 weeks. ( 2.3 ) After 16 weeks of treatment, for patients who achieve clear or almost clear skin, a dosage of 30 mg every 8 weeks is recommended. ( 2.3 ) Use NEMLUVIO with topical corticosteroids and/or topical calcineurin inhibitors. When the disease has sufficiently improved, discontinue use of topical therapies. ( 2.3 ) Administer NEMLUVIO by subcutaneous injection. ( 2.5 ) NEMLUVIO must be reconstituted prior to administration. ( 2.6 ) 2.1 Vaccination Prior to Treatment Complete all age-appropriate vaccinations as recommended by current immunization guidelines prior to treatment with NEMLUVIO [ see Warnings and Precautions (5.2) ]. 2.2 Recommended Dosage for Prurigo Nodularis Adult Patients Weighing Less Than 90 kg: The recommended subcutaneous dosage of NEMLUVIO for adult patients weighing less than 90 kg is an initial dose of 60 mg (two 30 mg injections), followed by 30 mg given every 4 weeks.

Hypersensitivity: Hypersensitivity reactions have been reported with NEMLUVIO use. If a clinically significant hypersensitivity reaction occurs, immediately institute appropriate therapy and discontinue NEMLUVIO. ( 5.1 ) Vaccinations: Avoid use of live vaccines during treatment with NEMLUVIO. ( 5.2 ) 5.1 Hypersensitivity Hypersensitivity reactions, such as facial angioedema, have been reported with use of NEMLUVIO. NEMLUVIO is contraindicated in patients with a known hypersensitivity to nemolizumab-ilto or to any of the excipients in NEMLUVIO. If a clinically significant hypersensitivity reaction occurs, immediately institute appropriate therapy and discontinue NEMLUVIO [ see Contraindications (4) , Adverse Reactions (6.1) ]. 5.2 Vaccinations Complete all age-appropriate vaccinations as recommended by current immunization guidelines prior to treatment with NEMLUVIO. Avoid use of live vaccines in patients during treatment with NEMLUVIO. It is unknown if administration of live vaccines during NEMLUVIO treatment will impact the safety or effectiveness of these vaccines. No data are available on the response to non-live vaccines.

The following clinically significant adverse reactions are described in greater details elsewhere in the labeling: Hypersensitivity [ see Warnings and Precautions (5.1) ] Most common adverse reactions are: Prurigo Nodularis (incidence ≥1%): headache, dermatitis atopic, eczema, and eczema nummular. ( 6.1 ) Atopic Dermatitis (incidence ≥1%): headache (including migraine), arthralgia, urticaria, and myalgia. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Galderma Laboratories, L.P. at 1-866-735-4137 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch . 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. Prurigo Nodularis A total of 508 adult subjects with prurigo nodularis were treated with NEMLUVIO in two placebo-controlled trials and an open label long-term extension trial. Of these, 375 subjects were exposed for at least 1 year in the drug development program for prurigo nodularis. The safety of NEMLUVIO in adult subjects with prurigo nodularis was evaluated in two randomized, doubleblind, placebo-controlled, multicenter trials (OLYMPIA 1 and OLYMPIA 2). Subjects were treated for up to 24 weeks in OLYMPIA 1 and up to 16 weeks in OLYMPIA 2. In these 2 trials, 370 subjects were treated with subcutaneous injections of NEMLUVIO, and 186 subjects received placebo [ see Clinical Studies (14.1 )].

8.1 Pregnancy Risk Summary Available data on NEMLUVIO use in pregnant women exposed during clinical trials are insufficient to evaluate for a drug-associated risk of major birth defects, miscarriage, or other adverse maternal or fetal outcomes. In an enhanced pre- and postnatal development study in cynomolgus monkeys, when nemolizumab-ilto was administered subcutaneously during organogenesis to parturition, an increase in early postnatal death was observed at a dose 36 times the maximum recommended human dose (MRHD) for PN and 50 times for AD (see Data). The clinical significance of this nonclinical finding is unknown. The background risk of major birth defects and miscarriage for the indicated populations are unknown. All pregnancies have a background risk of birth defects, loss, or other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively. Clinical Considerations Fetal/Neonatal Adverse Reactions Transport of endogenous IgG antibodies across the placenta increases as pregnancy progresses, and peaks during the third trimester. Therefore, NEMLUVIO may be present in infants exposed in utero. The potential impact of infants being exposed in utero to NEMLUVIO should be considered.

Metabolism

After a single-dose, nemolizumab-ilto exposure increased dose proportionally over a dose range of 0.03 and 3 mg/kg following subcutaneous administration. After multiple doses, nemolizumab-ilto systemic exposure increased in an approximately dose-proportional manner across the subcutaneous dose range up to 30 mg.

There is no specific treatment for NEMLUVIO overdosage. In the event of overdosage, contact Poison Control (1-800-222-1222) for the latest recommendations and monitor the patient for any signs or symptoms of adverse reactions and institute appropriate symptomatic treatment immediately.

• Aug 12, 2024BLABLA761390Galderma Labs Lp

1. 1Product Dose Omission Issue3,05631%
2. 2Device Malfunction1,63417%
3. 3Inappropriate Schedule Of Product Administration1,43114%
4. 4Incorrect Dose Administered1,03610%
5. 5Pruritus99410%
6. 6Rash6516.6%
7. 7Drug Ineffective5365.4%
8. 8Headache3453.5%
9. 9Dermatitis Atopic3343.4%
10. 10Device Leakage2912.9%
11. 11Eczema2622.6%
12. 12Device Use Issue2502.5%
13. 13Dry Skin2232.3%
14. 14Neurodermatitis2222.2%
15. 15Arthralgia2162.2%

The 10 most recently updated of 25 ClinicalTrials.gov registrations naming Nemolizumab as an intervention. Registration is not evidence of efficacy or safety — reference crosswalk only.

• Utilization of a Microdevice for Psoriasis and Atopic Dermatitis
  Not yet recruiting · Phase 4 · Interventional · 10 enrolled · University of California, San Francisco
  NCT07352566updated 2026-06-03
• A Study to Assess Immunization Responses in Adult and Adolescent Participants With Moderate-to-Severe Atopic Dermatitis Treated With Nemolizumab
  Completed · Phase 2 · Interventional · 242 enrolled · Galderma R&D
  NCT04365387updated 2026-06-01
• Proof of Concept Study to Assess the Pharmacokinetics/Pharmacodynamics of Nemolizumab in Adults With Chronic Pruritus of Unknown Origin (CPUO)
  Recruiting · Phase 2 · Interventional · 50 enrolled · Galderma R&D
  NCT07074977updated 2026-06-01
• Real-world Experience on Using Nemolizumab in the Treatment of Moderate-to- Severe Prurigo Nodularis in Adults
  Recruiting · Observational · 600 enrolled · Galderma R&D
  NCT06988618updated 2026-06-01
• Pharmacokinetics, Safety and Efficacy of Nemolizumab in Participants With Moderate-to-Severe Atopic Dermatitis
  Completed · Phase 2 · Interventional · 109 enrolled · Galderma R&D
  NCT04921345updated 2026-05-26
• To Evaluate the Efficacy and Safety of Nemolizumab for 12 Weeks in Participants With Chronic Kidney Disease With Associated Moderate to Severe Pruritus
  Completed · Phase 2 · Phase 3 · Interventional · 258 enrolled · Galderma R&D
  NCT05075408updated 2026-05-01
• A Study of Nemolizumab for the Treatment of Adults With Systemic Sclerosis
  Recruiting · Phase 2 · Interventional · 162 enrolled · Galderma R&D
  NCT07047690updated 2026-03-31
• Real-world Experience Using Nemolizumab in the Treatment of Moderate-to-Severe Atopic Dermatitis in Adolescents & Adults
  Recruiting · Observational · 1,000 enrolled · Galderma R&D
  NCT06988605updated 2026-03-13
• An Open-label, Phase 2 Study to Assess the Efficacy and Safety of Nemolizumab in Subjects With Systemic Sclerosis
  Completed · Phase 2 · Interventional · 6 enrolled · Maruho Co., Ltd.
  NCT05214794updated 2026-02-13
• Nemolizumab to Treat Lichen Planopilaris, a Noncontrolled, Prospective, Pilot Study.
  Recruiting · Phase 4 · Interventional · 10 enrolled · The Skin Center Dermatology Group
  NCT07396168updated 2026-02-10

Frequently asked questions

How does Nemolizumab work?

Nemolizumab-ilto is a humanized IgG2 monoclonal antibody that inhibits IL-31 signaling by binding selectively to IL-31 RA. IL-31 is a naturally occurring cytokine that is involved in pruritus, inflammation, epidermal dysregulation, and fibrosis.

What is Nemolizumab used for?

According to FDA labeling, Nemolizumab carries indications including: NEMLUVIO is an interleukin-31 receptor antagonist indicated for: Prurigo Nodularis The treatment of adults with prurigo nodularis. ( 1.1 ) Atopic Dermatitis The treatment of adults and pediatric patients 12 years of age and older with moderate-to-severe atopic dermatitis in combination with topical corticosteroids and/or calcineurin inhibitors when the disease is not adequately controlled with topical prescription therapies.. This is a reference summary of labeled uses, not medical advice or a treatment recommendation.

What class of drug is Nemolizumab?

Nemolizumab is classified as Agents for dermatitis, excluding corticosteroids, Interleukin-31 Receptor alpha Antagonist, Biological Response Modifiers, Interleukin-31 Receptor alpha Antagonists, Decreased Cytokine Activity, Decreased Cytokine Production.

What are the brand names for Nemolizumab?

Nemolizumab is marketed under brand names including Nemluvio.

What are the contraindications for Nemolizumab?

Nemolizumab labeling lists contraindications including: NEMLUVIO is contraindicated in patients who have known hypersensitivity to nemolizumab-ilto or to any of the excipients in NEMLUVIO [ see Warnings and Precautions (5.1) ]. Known hypersensitivity to nemolizumab-ilto or to any of the excipients in NEMLUVIO.. Always consult the full prescribing information and a clinician.