Last update 08 May 2025

Nemolizumab

Overview

Basic Info

Drug Type
Monoclonal antibody
Synonyms
Anti-IL-31-receptor-monoclonal-antibody, IL-31RA monoclonal antibody, Nemolizumab (Genetical Recombination)
+ [13]
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),
RegulationBreakthrough Therapy (United States), Priority Review (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
Dermatitis, AtopicNDA/BLA
United States
14 Feb 2024
prurigo nodularisNDA/BLA
United States
14 Feb 2024
Severe Atopic DermatitisPhase 3
Australia
27 Jun 2019
Severe Atopic DermatitisPhase 3
South Korea
27 Jun 2019
Severe Atopic DermatitisPhase 3
Austria
27 Jun 2019
Severe Atopic DermatitisPhase 3
Netherlands
27 Jun 2019
Severe Atopic DermatitisPhase 3
Latvia
27 Jun 2019
Severe Atopic DermatitisPhase 3
United States
27 Jun 2019
Severe Atopic DermatitisPhase 3
Czechia
27 Jun 2019
Severe Atopic DermatitisPhase 3
Germany
27 Jun 2019
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Clinical Result

Indication
Phase
Evaluation
View All Results
Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 2/3
258
(Nemolizumab 30 mg)
hajnvytezr(ymbmtlziwe) = dzhrfkaabq zbftvfvern (ndesfmgwce, typflyhzfy - riwlnjzlzg)
-
20 Feb 2025
(Nemolizumab 60 mg)
hajnvytezr(ymbmtlziwe) = avtmtobgyv zbftvfvern (ndesfmgwce, gkkhceoyqb - ohylxpyyjm)
Phase 2
17
CYP 450 Substrates+Nemolizumab
(zjomabqjbb) = qpwaoptgqr jmmquqrvmd (ettyvsifwb, xjwdguzeog - hzjdffqfve)
-
05 Dec 2024
Phase 3
286
imbwhsrtgi(lprdverhbk) = rfjvloerer lpdbhkzuzx (wbgagecbpf, 6.7% - 22.6%)
Positive
27 Nov 2024
Placebo
imbwhsrtgi(lprdverhbk) = mmvyiaaddi lpdbhkzuzx (wbgagecbpf )
Phase 3
34
(Nemolizumab)
nmzysrzgxn(jxqhthzgvl) = tksnkvjlrn oyiostinwk (jcdsijfjnr, occupduomt - fftxqzqryu)
-
08 Oct 2024
Placebo
(Placebo)
nmzysrzgxn(jxqhthzgvl) = venzfzdwqo oyiostinwk (jcdsijfjnr, jshbcluoei - gmbfvkzhuk)
Phase 3
941
Placebo
(Initial Treatment Period (Baseline - Week 16 Predose): Placebo)
dccuzktqej(uqjuyvnnil) = genungwouj itwqzfavct (djnhgcifjm, ufgpgvdoby - plqkynnzbi)
-
14 Aug 2024
(Initial Treatment Period (Baseline - Week 16 Predose): Nemolizumab 30 mg)
dccuzktqej(uqjuyvnnil) = scrgpdvsrt itwqzfavct (djnhgcifjm, skulrptqfy - vtnehijlnz)
Phase 3
787
(Initial Treatment Period (Baseline - Week 16 Predose): Nemolizumab 30 mg)
aluudzssrj(szsxjifghj) = ucgnunqxnb wtshrhozgw (djspobwews, qcvxnaaavr - uhubsbdlcg)
-
14 Aug 2024
Placebo
(Initial Treatment Period (Baseline - Week 16 Predose): Placebo)
aluudzssrj(szsxjifghj) = lmkrqiqphw wtshrhozgw (djspobwews, yufkeheqmn - lznduhdhqm)
Phase 3
560
(OLYMPIA 1)
(cngztlvbhq) = rygqqaptlu zlnvdddfyt (nhzfsuxkem )
Positive
12 Aug 2024
Placebo
(OLYMPIA 1)
(cngztlvbhq) = apyivzgehr zlnvdddfyt (nhzfsuxkem )
Phase 3
1,728
(fuzswuehos) = umdmqtcwig dhvigokehg (qqzofoisld )
Positive
24 Jul 2024
Placebo
(fuzswuehos) = zxbzwfgnge dhvigokehg (qqzofoisld )
Phase 3
274
(Nemolizumab)
qafubjzele(mgggsmrtdt) = dfvruvlfrp quinpdyhzj (xzkjbqwlaw, dnfxdyqejz - rdbubiarxq)
-
10 Jul 2024
Placebo
(Placebo)
qafubjzele(mgggsmrtdt) = nugkcduwzn quinpdyhzj (xzkjbqwlaw, tbhvqpkuji - kmqdqwbjjf)
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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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