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Molecule

Nemolizumab

Interleukin-31 Receptor alpha Antagonist
Available on requestBiologicCold chainDermatology
Presentations
1
Brands
1
Manufacturers
1
Available from stock
0

Nemolizumab is an interleukin-31 receptor alpha antagonist indicated for prurigo Nodularis The treatment of adults with prurigo nodularis, among other approved uses. It is available as powder for injection for subcutaneous use. MedsAcross supplies Nemolizumab for export from India to licensed hospitals, importers and physicians acting for named patients, with the documents each country requires.

Information from the US FDA prescribing information, retrieved 12 November 2026. Not yet medically reviewed.How we review

Key facts

Pharmacological class
Interleukin-31 Receptor alpha Antagonist, Interleukin-31 Receptor alpha Antagonists
ATC classification
D11AH12 Nemolizumab · Other skin treatments, subgroup D11A, subgroup D11AH
US FDA first approval
12 August 2024
EU status
Authorised
Orphan designation
No
WHO essential medicine
Not recorded
India (CDSCO)
Not yet confirmed against CDSCO approval lists
Routes
Subcutaneous
Dosage forms
Powder for injection
Biologic
Yes
Identifiers
UNII GN465U8B72Q30314619

Clinical information

From the regulator-approved product information. Each section names its source.

Uses

NEMLUVIO is an interleukin-31 receptor antagonist indicated for: Prurigo Nodularis The treatment of adults with prurigo nodularis. 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.

Source: US FDA prescribing information

How it works

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. Nemolizumab-ilto inhibited IL-31-induced responses including the release of proinflammatory cytokines and chemokines.

Source: US FDA prescribing information

Dosing overview

Complete all age-appropriate vaccinations as recommended by current immunization guidelines prior to treatment with NEMLUVIO. 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. 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. 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. After 16 weeks of treatment, for patients who achieve clear or almost clear skin, a dosage of 30 mg every 8 weeks is recommended. Use NEMLUVIO with topical corticosteroids and/or topical calcineurin inhibitors.

Source: US FDA prescribing information

Contraindications

NEMLUVIO is contraindicated in patients who have known hypersensitivity to nemolizumab-ilto or to any of the excipients in NEMLUVIO. Known hypersensitivity to nemolizumab-ilto or to any of the excipients in NEMLUVIO.

Source: US FDA prescribing information

Warnings and precautions

Hypersensitivity: Hypersensitivity reactions have been reported with NEMLUVIO use. If a clinically significant hypersensitivity reaction occurs, immediately institute appropriate therapy and discontinue NEMLUVIO. Vaccinations: Avoid use of live vaccines during treatment with NEMLUVIO.

Source: US FDA prescribing information

Side effects

The following clinically significant adverse reactions are described in greater details elsewhere in the labeling: Hypersensitivity Most common adverse reactions are: Prurigo Nodularis (incidence ≥1%): headache, dermatitis atopic, eczema, and eczema nummular. Atopic Dermatitis (incidence ≥1%): headache (including migraine), arthralgia, urticaria, and myalgia.

Source: US FDA prescribing information

Storage

Store the NEMLUVIO dual-chamber, prefilled pen in a refrigerator at 36°F to 46°F (2°C to 8°C) in the original carton to protect from light until the expiration date. Do not freeze. Alternatively, the NEMLUVIO carton containing the unused dual-chamber, prefilled pen may be stored at room temperature [up to 77°F (25°C)] for up to 90 days. Write the date the NEMLUVIO dual-chamber, prefilled pen is first removed from the refrigerator in the space provided on the inner partition for the pen. Do not use the NEMLUVIO dual-chamber, prefilled pen beyond the expiration date or 90 days after the date it was first removed from the refrigerator (whichever is earlier).

Source: US FDA prescribing information

For healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.

All presentations

1 presentations of Nemolizumab, sorted by availability.

MedicineManufacturerRegisterAvailability
Nemluvio 30 mg/100 mg powder for injectionSubcutaneous Cold chainGalderma LaboratoriesUS FDAAvailable on request

Brands by market

1 brand names across 1 markets.

Brand names by country

United States

Manufacturers

Regulatory status

Approval facts from US FDA, EMA and CDSCO data, and registration status by country where we hold register data.

RegisterStatusSource
US FDAFirst approved 12 August 2024Drugs@FDA
EU (EMA)AuthorisedEMA medicines data
India (CDSCO)Not yet confirmed against CDSCO approval lists—
AustriaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
BelgiumRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
BulgariaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
CroatiaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
CyprusRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
CzechiaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
DenmarkRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
EstoniaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
FinlandRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
FranceRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
GermanyRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
GreeceRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
HungaryRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
IcelandRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
IrelandRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
ItalyRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
LatviaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
LiechtensteinRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
LithuaniaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
LuxembourgRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
MaltaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
NetherlandsRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
NorwayRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
PolandRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
PortugalRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
RomaniaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
SlovakiaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
SloveniaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
SpainRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
SwedenRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
United StatesRegisteredUS FDA (NDC directory, openFDA)Checked 12 November 2026

Questions and answers

Is Nemolizumab available for export from India?

Yes, on request. MedsAcross lists 1 presentations of Nemolizumab and sources them for licensed hospitals, importers and physicians against valid import documents.

What brand names does Nemolizumab have?

The catalogue lists 1 brand names for Nemolizumab, including Nemluvio.

Is Nemolizumab approved by the US FDA?

Yes. The US FDA first approved Nemolizumab on 12 August 2024, according to Drugs@FDA.

Is Nemolizumab authorised in the European Union?

Yes. Nemolizumab has a central EU marketing authorisation (status: authorised), according to European Medicines Agency data.

Does Nemolizumab need cold chain shipping?

At least one listed presentation of Nemolizumab must be kept cold, so it is shipped in temperature-controlled packaging. Check the storage line on each presentation.

Which ATC class is Nemolizumab in?

Nemolizumab is classified under ATC code D11AH12 (Nemolizumab).

References

  1. NEMLUVIO prescribing information (Galderma Laboratories). U.S. National Library of Medicine, DailyMed. Retrieved 26 June 2025
  2. Nemluvio: European public assessment report (EPAR). European Medicines Agency. Retrieved 14 October 2026

Request Nemolizumab for export supply

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