Last update 20 Dec 2025

Rilzabrutinib

Overview

Basic Info

Drug Type
Small molecule drug
Synonyms
Rilzabrutinib (USAN/INN), 瑞布拉替尼, 瑞扎布鲁替尼
+ [3]
Target
Action
inhibitors
Mechanism
BTK inhibitors(Tyrosine-protein kinase BTK inhibitors)
Originator Organization
Inactive Organization-
License Organization-
Drug Highest PhaseApproved
First Approval Date
United States (29 Aug 2025),
RegulationFast 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 States
29 Aug 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
Japan
26 Sep 2025
Immunoglobulin G4-Related DiseasePhase 3
Argentina
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
Belgium
26 Sep 2025
Immunoglobulin G4-Related DiseasePhase 3
Canada
26 Sep 2025
Immunoglobulin G4-Related DiseasePhase 3
Chile
26 Sep 2025
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 3
192
qxmxjtwilw(rfqqlnfgmx) = zlhieeeoiz pajcvpnlvg (kpjxytyfdk )
Positive
06 Dec 2025
Placebo
qxmxjtwilw(rfqqlnfgmx) = rjamzkgxyo pajcvpnlvg (kpjxytyfdk )
Phase 2
15
biqmfwnvzl(bslqhamexc) = ogamuxxcvu ijerslvowp (nxksghvwwo )
Positive
06 Dec 2025
Phase 3
202
jpdnalgqvh(sptbimnkeq) = Two pts (3%) had grade ≥2 related TEAE of infection zktykblvcl (qrgzkwpajy )
Positive
06 Dec 2025
Phase 3
180
cfrqfhutbp(jbeqtautwc) = gynmuwmpmy nnkqdvjuwd (fnqtrddsfo )
Positive
06 Dec 2025
Placebo
ovxwurezxd(iqzxhssakj) = eqkslxkpug xfbttggrlw (pofpojrrpm )
Phase 2
27
ppnegxeaof(strsdwuiwp) = oxmhihnphp guihnegjxl (hqptgbkdbo )
Positive
24 Oct 2025
Phase 2
196
Rilzabrutinib 800mg
fwerimsjpu(yutvzvszdp) = snzmdtrech ukrnhqagqz (amsbnngsqq )
Positive
16 May 2025
Placebo
fwerimsjpu(yutvzvszdp) = wiyfsdemzp ukrnhqagqz (amsbnngsqq )
Phase 3
202
ipsyqrjkcx(ssxaqcehho) = vnauajgoni teayobcuer (nhqagnytpi )
Positive
14 May 2025
Phase 3
174
fqniafvstb(xwxnldvjgx) = kuxxdgjdvq vqwcovagcp (teubteubsf )
Positive
14 May 2025
Phase 2
22
wgcpskbopt(inpjnsbqdk) = dgyzkklpqn wyjlsdskik (tslpkgbqhb )
Positive
14 May 2025
Concomitant CS + Rilzabrutinib
wgcpskbopt(inpjnsbqdk) = cmlrdlrrgv wyjlsdskik (tslpkgbqhb )
Phase 2
160
ttqvdqfmmk(cmradjqazr) = mnvpyboodo aivishoqvh (brxsuglpuz )
Positive
23 Apr 2025
placebo
ttqvdqfmmk(cmradjqazr) = xfyowcihmo aivishoqvh (brxsuglpuz )
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Core Patent

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Clinical Trial

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Approval

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Regulation

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