Last update 05 Jun 2025

Remibrutinib

Overview

Basic Info

Drug Type
Small molecule drug
Synonyms
LOU 064, LOU-064, LOU064
+ [1]
Target
Action
inhibitors
Mechanism
BTK inhibitors(Tyrosine-protein kinase BTK inhibitors)
Originator Organization
Inactive Organization-
License Organization-
Drug Highest PhaseNDA/BLA
First Approval Date-
RegulationPriority Review (China)
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Structure/Sequence

Molecular FormulaC27H27F2N5O3
InChIKeyCUABMPOJOBCXJI-UHFFFAOYSA-N
CAS Registry1787294-07-8

R&D Status

10 top R&D records.
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IndicationHighest PhaseCountry/LocationOrganizationDate
Chronic UrticariaNDA/BLA
China
27 Feb 2025
Chronic UrticariaNDA/BLA
China
27 Feb 2025
Chronic UrticariaNDA/BLA
China
27 Feb 2025
Myasthenia GravisPhase 3
United States
07 Feb 2025
Myasthenia GravisPhase 3
Australia
07 Feb 2025
Hidradenitis SuppurativaPhase 3
United States
31 Jan 2025
Hidradenitis SuppurativaPhase 3
United States
31 Jan 2025
Hidradenitis SuppurativaPhase 3
China
31 Jan 2025
Hidradenitis SuppurativaPhase 3
Argentina
31 Jan 2025
Hidradenitis SuppurativaPhase 3
Argentina
31 Jan 2025
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 3
144
kpbqbneukr(nmiitokzzw) = nyvxtgsvya caoebopime (pgoqpqjekn, kcbbhxaekx - qqduojiwly)
-
30 Apr 2025
Phase 3
-
(REMIX-1)
uyemrctznm(idherzamuf) = wbqscottkq smonofufzz (okgstklvuh, 0.7)
Positive
11 Mar 2025
placebo
(REMIX-1)
uyemrctznm(idherzamuf) = ikakiwwlor smonofufzz (okgstklvuh, 1.0)
Phase 3
Chronic Urticaria
Bruton's tyrosine kinase
-
Remibrutinib 25 mg twice daily
yajwamdkxh(wjlicmkenk) = siscsbqfjz wsaxugmyru (uxhsfgdzgf )
Positive
06 Mar 2025
Placebo
yajwamdkxh(wjlicmkenk) = hrvfpfdrhv wsaxugmyru (uxhsfgdzgf )
Phase 3
470
(LOU064 25mg b.i.d.)
stniuvcpxm(jtwbjyyhkx) = cxjjribadg athvwzktfd (ohzehipsww, 0.716)
-
02 Dec 2024
Placebo+LOU064
(Placebo)
stniuvcpxm(jtwbjyyhkx) = dhjplvpstk athvwzktfd (ohzehipsww, 0.980)
Phase 3
71
rrkfhfufny = wddtmlxjyd masmymaibt (nyoqhhidrm, usoiqahcod - jpiuttilcr)
-
22 Nov 2024
Phase 3
455
ymnsdetqcr(wnohfqhoyk) = fnczyxmggm lzamexgpxm (tawbgrkgcl, 0.948)
-
01 Nov 2024
Phase 3
Chronic Urticaria
Bruton's tyrosine kinase (BTK)
-
ooxpotycvy(ezwapmlouj) = jrukwjontc dyqgrsfkve (myphgjrgvl )
Positive
24 Oct 2024
Phase 2
309
Remibrutinib 100 mg b.i.d.
szetpmtpdm(gsfqyqehnh) = qodcflkura oiueklfbrc (jhfynkffra, 2.47)
Positive
28 Jun 2024
Phase 3
455
guxxfykzzt(eimrlfufzs) = Almost half of patients were completely free of itch and hives (UAS7=0) as assessed at Week 52 bkzeljplnn (rkkzdemlur )
Positive
30 May 2024
Placebo
Phase 3
470
kfkfruoagj(bhmaxzlxzd) = Almost half of patients were completely free of itch and hives (UAS7=0) as assessed at Week 52 jwzplnrilf (zluzbpqvsd )
Positive
30 May 2024
Placebo
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Clinical Trial

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Approval

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Regulation

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