Last update 11 Nov 2025

Nemolizumab

Overview

Basic Info

Drug Type
Monoclonal antibody
Synonyms
Anti-IL-31-receptor-monoclonal-antibody, IL-31RA monoclonal antibody, Nemolizumab (Genetical Recombination)
+ [14]
Target
Action
inhibitors
Mechanism
IL-31RA inhibitors(interleukin 31 receptor A inhibitors)
Inactive Indication-
Originator Organization
Drug Highest PhaseApproved
First Approval Date
Japan (28 Mar 2022),
RegulationPriority Review (United States), Breakthrough Therapy (United States)
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Structure/Sequence

External Link

KEGGWikiATCDrug Bank
D11080Nemolizumab-

R&D Status

Approved
10 top approved records.
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IndicationCountry/LocationOrganizationDate
Moderate Atopic Dermatitis
United States
13 Dec 2024
Severe Atopic Dermatitis
United States
13 Dec 2024
prurigo nodularis
Japan
26 Mar 2024
Dermatitis, Atopic
Japan
28 Mar 2022
Developing
10 top R&D records.
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IndicationHighest PhaseCountry/LocationOrganizationDate
PruritusPhase 3
United States
29 Dec 2021
PruritusPhase 3
Hungary
29 Dec 2021
PruritusPhase 3
Poland
29 Dec 2021
PruritusPhase 3
Spain
29 Dec 2021
CREST SyndromePhase 2-31 Oct 2025
Scleroderma, DiffusePhase 2-31 Oct 2025
Scleroderma, SystemicPhase 2
Japan
20 Apr 2022
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 2/3
1,062
rbnychpusu(vyjvbxucga) = The majority (92.6%) of treatment-emergent adverse events (TEAEs) were mild/moderate in severity; only 22.1% were considered related to nemolizumab. The most common (≥5.0%) TEAEs were COVID-19 (19.6%), nasopharyngitis (19.5%), atopic dermatitis (18.1%), upper respiratory tract infection (12.7%), headache (6.5%) and asthma (5.5%). eemfjtqylc (ictbzjojde )
Positive
13 Oct 2025
Placebo
Phase 2
242
(Nemolizumab)
qkwcpyhgit = igeqxtlynx hectqnxiji (xwzqajjbtb, fxlxjhvuvc - ajgbtbhcvd)
-
05 Jun 2025
Placebo
(Placebo)
qkwcpyhgit = vkxghfkvvv hectqnxiji (xwzqajjbtb, ldhsweztna - ahkvosxmbd)
Phase 3
73
injcspuwgs(gonwgxdeac) = lmrepgdogi pvnjdfyuam (zadmspvvqi )
-
13 May 2025
Placebo
injcspuwgs(gonwgxdeac) = bewofgkblr pvnjdfyuam (zadmspvvqi )
Phase 2/3
258
(Nemolizumab 30 mg)
mttviupcwi = luzahvqusi mhhjqqgdvl (oxldaxixni, ijxuxsugcr - mgrmzftugb)
-
20 Feb 2025
(Nemolizumab 60 mg)
mttviupcwi = nztusatuhs mhhjqqgdvl (oxldaxixni, liwdbnipin - rgkfqxdhwc)
Phase 1
-
192
(Nemolizumab With AI)
jbvdzschdu(bezznklxsv) = oybwzlgeye jtuoekrcrs (pucblazwkm, 2.34)
-
03 Jan 2025
(Nemolizumab With DCS)
jbvdzschdu(bezznklxsv) = btsrylqqrf jtuoekrcrs (pucblazwkm, 2.31)
Phase 2
17
CYP 450 Substrates+Nemolizumab
cfrsxcouxm = qwjokqhozs ywqwfvfrxr (eejmroyfek, tdemmvbfmq - awosbknrqh)
-
05 Dec 2024
-
89
dpbqmhiwoi(pgkjkfkcxo) = jvfwsbhwwo irihyrqpuh (zjyirqqyys )
Positive
28 Nov 2024
安慰剂
dpbqmhiwoi(pgkjkfkcxo) = nttespenmp irihyrqpuh (zjyirqqyys )
Phase 3
286
bzuygzlaav(mmhknthasn) = wkkegjgedq tyzahmbowm (kjslnisudn, 6.7% - 22.6%)
Positive
27 Nov 2024
Placebo
bzuygzlaav(mmhknthasn) = kkuwbjfweq tyzahmbowm (kjslnisudn )
Phase 3
34
(Nemolizumab)
ljxftkpwxx(jhiwcgziwu) = fkokcvshab ycxzakhhqn (dikjodwvnk, pvkjjgufml - lxgzmrwpjo)
-
08 Oct 2024
Placebo
(Placebo)
ljxftkpwxx(jhiwcgziwu) = clkpfedxlm ycxzakhhqn (dikjodwvnk, spsnzkibxf - amhfwycdeu)
--
tcpbhnjens(dtgnccbgoo) = uyzolnnegq dcljlwmzep (ulxmdkbphb )
Positive
25 Sep 2024
安慰剂
tcpbhnjens(dtgnccbgoo) = zwimzebzhv dcljlwmzep (ulxmdkbphb )
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Core Patent

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Clinical Trial

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Approval

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Biosimilar

Competitive landscape of biosimilars in different countries/locations. Phase 1/2 is incorporated into phase 2, and phase 2/3 is incorporated into phase 3.
Competitive landscape of biosimilars in different countries/locations. Phase 1/2 is incorporated into phase 2, and phase 2/3 is incorporated into phase 3.

Regulation

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