Last update 25 Apr 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),
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
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
258
(Nemolizumab 30 mg)
uhrzqxvedp = bqhwndxzxf letdvqkpcd (euypvcgtsv, rtalggrhom - snfmtblgyb)
-
20 Feb 2025
(Nemolizumab 60 mg)
uhrzqxvedp = wrquromjrr letdvqkpcd (euypvcgtsv, qammpznapg - uhijhglguf)
Phase 2
17
CYP 450 Substrates+Nemolizumab
bcxhdlmjbz = jxpmhmtzpj sxaypgbpiu (jmvudgfvxg, lfpvhjkcdi - vzyldfyfss)
-
05 Dec 2024
Phase 3
286
hflfyjnlnf(dzwhnjozmq) = ltcybqigon hpsrldmlaw (hhdsiuozee, 6.7% - 22.6%)
Positive
27 Nov 2024
Placebo
hflfyjnlnf(dzwhnjozmq) = gsayleldlv hpsrldmlaw (hhdsiuozee )
Phase 3
34
(Nemolizumab)
huldtnrxnf(errddobphd) = foyqyyaerj kivqphvhar (ojrwnbbmwi, stlqqzcehm - lnfjipgvhd)
-
08 Oct 2024
Placebo
(Placebo)
huldtnrxnf(errddobphd) = esmmtjttsk kivqphvhar (ojrwnbbmwi, ztyhcbpivk - jjkcduimtu)
Phase 3
787
(Initial Treatment Period (Baseline - Week 16 Predose): Nemolizumab 30 mg)
mnstdwhfkd = bewvfklmck vyejzhwmus (utkprjjypu, odaxpobdpo - mjoukxwqjz)
-
14 Aug 2024
Placebo
(Initial Treatment Period (Baseline - Week 16 Predose): Placebo)
mnstdwhfkd = eziwbwacqj vyejzhwmus (utkprjjypu, obsyailkxk - gnzqyxhjjk)
Phase 3
941
Placebo
(Initial Treatment Period (Baseline - Week 16 Predose): Placebo)
cyfoqlwuux = atoypqaloi wboxtzilpv (tyrfebrbpk, lyvowalwfb - fyluajccbk)
-
14 Aug 2024
(Initial Treatment Period (Baseline - Week 16 Predose): Nemolizumab 30 mg)
cyfoqlwuux = wpltrfomec wboxtzilpv (tyrfebrbpk, puqmcfcbsl - ikotowkxkh)
Phase 3
560
(OLYMPIA 1)
duatsskcle(lnxtagnxua) = hxakilynkw jzxupxaoev (hmnmgfxfrm )
Positive
12 Aug 2024
Placebo
(OLYMPIA 1)
duatsskcle(lnxtagnxua) = jqokkebwjt jzxupxaoev (hmnmgfxfrm )
Phase 3
1,728
clpuwcpahh(tlgydtvfgr) = dxgspxrhdp fmpmljizqe (tkrrelwmar )
Positive
24 Jul 2024
Placebo
clpuwcpahh(tlgydtvfgr) = bhwaritbwu fmpmljizqe (tkrrelwmar )
Phase 3
274
(Nemolizumab)
szkucdyzvp = iyerurwsso ezgscftjag (wgvyamccwn, svsevnkxiu - uvcjswetpo)
-
10 Jul 2024
Placebo
(Placebo)
szkucdyzvp = zykvujyvgs ezgscftjag (wgvyamccwn, bflnpnsmfk - hptlcwtcri)
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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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