Prescription medicine
Nemolizumab Brand names: Nemluvio
Nemolizumab (Nemluvio) is a prescription medicine. No generic is listed in FDA's NDC Directory.
- No generic listed
Check it at the source: the nemolizumab FDA label on DailyMed (effective June 26, 2025); every nemolizumab label on DailyMed.
Highlights of the record
FDA label of June 26, 2025; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026
Used for
From the label: indications and usageNEMLUVIO is an interleukin-31 receptor antagonist indicated for: Prurigo Nodularis The treatment of adults with prurigo nodularis.
Forms and strengths
- 30 mg
Injection (powder) (lyophilized) for solution.
On the market
- Generic approvals
- No generic approved
- Labelers listed (NDC)
- 1 of which 0 under generic applications, 1 under brand applications, repackagers included
Supply and safety
- Pharmacy cost (NADAC)
- Not in the survey
- Shortage (FDA)
- No current entry
- Recalls by its makers (FDA)
- No recall recorded
- FAERS reports
- 12,636 through July 30, 2026
What is nemolizumab used for?
From the label: indications and usageNEMLUVIO 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. […]
Conditions named in the indications of nemolizumab's FDA labels, with every medicine labeled for each:
FDA pharmacologic class: Interleukin-31 Receptor alpha Antagonist.
Source: FDA drug label (NEMLUVIO), Galderma Laboratories, L.P., effective June 26, 2025 (SPL set e9229ef1-ac60-4c24-afb6-009d3c781687), via openFDA; the full label on DailyMed
Is there a generic for nemolizumab (Nemluvio)?
No generic nemolizumab is approved (Drugs@FDA, October 8, 2026).
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
What do FAERS reports show for nemolizumab?
The FDA Adverse Event Reporting System holds 12,636 reports that list nemolizumab among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 117 are coded as a death and 346 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is. Reports rose sharply in 2025 (7,272, against a median of 0 a year): FAERS counts follow reporting, which news, litigation and label changes can drive, not how often a reaction happens.
Reports received each year
The most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026
What else is labeled for the same conditions as nemolizumab?
3 other medicines are given the same way (subcutaneous) and in the same FDA class as nemolizumab or labeled mainly for the same use (eczema (atopic dermatitis)), the same class first. Eczema (atopic dermatitis) lists all 26 medicines labeled for it, by any route. They are listed as records, not as substitutes: whether one can replace another is a prescriber's decision.
| Medicine | Shared indication | Generic labelers (subcutaneous) | Pharmacy cost | Shortage |
|---|---|---|---|---|
| Dupilumab | Eczema (atopic dermatitis) | none listed | $1,773.74 per mL 200 mg/1.14 mL syring | No current entry |
| Lebrikizumab | Eczema (atopic dermatitis) | none listed | $1,783.52 per mL 250 mg/2 mL pen | No current entry |
| Tralokinumab | Eczema (atopic dermatitis) | none listed | n/a | No current entry |
Every medicine labeled for the same conditions as nemolizumab
Source: FDA drug labels (indications), NDC Directory, NADAC of October 7, 2026, FDA shortages (October 8, 2026)
What next?
- Alternatives to nemolizumab
- 3 medicines for the same use
- Nemolizumab side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other