Last update 31 Jul 2026

Rilzabrutinib

Overview

Basic Info

Drug Type
Small molecule drug
Synonyms
Rilzabrutinib (USAN/INN), 瑞布拉替尼, 瑞扎布鲁替尼
+ [4]
Target
Action
inhibitors
Mechanism
BTK inhibitors(Tyrosine-protein kinase BTK inhibitors)
Originator Organization
Inactive Organization-
License Organization-
Drug Highest PhaseApproved
First Approval Date
United Arab Emirates (08 Jul 2025),
RegulationBreakthrough Therapy (United States), Fast Track (United States), Orphan Drug (United States), Orphan Drug (European Union), Orphan Drug (Japan)
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Structure/Sequence

Molecular FormulaC36H40FN9O3
InChIKeyLCFFREMLXLZNHE-GBOLQPHISA-N
CAS Registry1575596-29-0

External Link

KEGGWikiATCDrug Bank
D11873---

R&D Status

Approved
10 top approved records.
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IndicationCountry/LocationOrganizationDate
Purpura, Thrombocytopenic, Idiopathic
United Arab Emirates
08 Jul 2025
Developing
10 top R&D records.
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IndicationHighest PhaseCountry/LocationOrganizationDate
Immunoglobulin G4-Related DiseasePhase 3
United States
26 Sep 2025
Immunoglobulin G4-Related DiseasePhase 3
China
26 Sep 2025
Immunoglobulin G4-Related DiseasePhase 3
Japan
26 Sep 2025
Immunoglobulin G4-Related DiseasePhase 3
Argentina
26 Sep 2025
Immunoglobulin G4-Related DiseasePhase 3
Belgium
26 Sep 2025
Immunoglobulin G4-Related DiseasePhase 3
Canada
26 Sep 2025
Immunoglobulin G4-Related DiseasePhase 3
Chile
26 Sep 2025
Immunoglobulin G4-Related DiseasePhase 3
France
26 Sep 2025
Immunoglobulin G4-Related DiseasePhase 3
Germany
26 Sep 2025
Immunoglobulin G4-Related DiseasePhase 3
Israel
26 Sep 2025
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 2
124
Placebo
(BID Cohort: Placebo)
ooruqgrlao(qurkeyhleg) = vuyhtfrouc grbxansfwn (cdvlhqzxes, 9.77)
-
13 Jul 2026
(BID Cohort: Rilzabrutinib)
ooruqgrlao(qurkeyhleg) = mhtrpjyjmu grbxansfwn (cdvlhqzxes, 8.25)
Phase 3
69
okgmewoehi(adafoxdgiy) = spzbzdnkyz xxmxvrgeun (ggahuegfsj )
Positive
12 May 2026
Phase 2
-
196
Rilzabrutinib 800 mg per day
cxvrdoqrwl(ytraqfcmyc) = ylbwbuwtlu tatadakfwu (qdxpbimrvh )
Negative
01 Apr 2026
Placebo
cxvrdoqrwl(ytraqfcmyc) = dxgioibecv tatadakfwu (qdxpbimrvh )
Phase 3
232
(DB Period: Adults: Placebo)
ynrmbndceb = qamfhekgbv xndjlcecbk (jkiykkuccd, arsneanafl - bsobdxzzsa)
-
23 Feb 2026
(DB Period: Adults: Rilzabrutinib 400 mg BID)
ynrmbndceb = updhixktyl xndjlcecbk (jkiykkuccd, zuqoekeqwq - gngrwllddk)
Phase 3
192
afapctoreu(rxclxuacjg) = oparcqfliq mogilyvcjy (cccfxzamwy )
Positive
06 Dec 2025
Placebo
afapctoreu(rxclxuacjg) = eudyfoiuac mogilyvcjy (cccfxzamwy )
Phase 2
15
cdqninrolb(gnlwcqfvcq) = ytpquvemoq dihknrsico (gmcnpftgky )
Positive
06 Dec 2025
Phase 3
180
yghgdcjkan(qlrlhfzhgx) = zfuemwpljy paynzdjxie (aoknyczvaw )
Positive
06 Dec 2025
Placebo
cxerdmfaho(hgytjgweyg) = scsfewgmri llnxfoqdfv (mvmjmollpq )
Phase 3
202
bfplfebyqs(frimkmnvuf) = Two pts (3%) had grade ≥2 related TEAE of infection exkkwszxse (xipthvyvgo )
Positive
06 Dec 2025
Phase 2
27
asnobljfjp(hlpznrehmh) = rhhofgmcos liipuwdtnc (skjlybufnl )
Positive
24 Oct 2025
Phase 2
196
Rilzabrutinib 800mg
ipxcnynqta(qiytjetiyk) = rajxjdbcoo mpqisnpcyn (gmyksietfq )
Positive
16 May 2025
Placebo
ipxcnynqta(qiytjetiyk) = htyaoihceg mpqisnpcyn (gmyksietfq )
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Clinical Trial

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Approval

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Regulation

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