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) |
Therapeutic Areas |
Inactive Indication |
Originator Organization |
Active 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) |
Molecular FormulaC36H40FN9O3 |
InChIKeyLCFFREMLXLZNHE-GBOLQPHISA-N |
CAS Registry1575596-29-0 |
| KEGG | Wiki | ATC | Drug Bank |
|---|---|---|---|
| D11873 | - | - | - |
| Indication | Country/Location | Organization | Date |
|---|---|---|---|
| Purpura, Thrombocytopenic, Idiopathic | United States | 29 Aug 2025 |
| Indication | Highest Phase | Country/Location | Organization | Date |
|---|---|---|---|---|
| Immunoglobulin G4-Related Disease | Phase 3 | United States | 26 Sep 2025 | |
| Immunoglobulin G4-Related Disease | Phase 3 | China | 26 Sep 2025 | |
| Immunoglobulin G4-Related Disease | Phase 3 | Japan | 26 Sep 2025 | |
| Immunoglobulin G4-Related Disease | Phase 3 | Japan | 26 Sep 2025 | |
| Immunoglobulin G4-Related Disease | Phase 3 | Argentina | 26 Sep 2025 | |
| Immunoglobulin G4-Related Disease | Phase 3 | Argentina | 26 Sep 2025 | |
| Immunoglobulin G4-Related Disease | Phase 3 | Belgium | 26 Sep 2025 | |
| Immunoglobulin G4-Related Disease | Phase 3 | Belgium | 26 Sep 2025 | |
| Immunoglobulin G4-Related Disease | Phase 3 | Canada | 26 Sep 2025 | |
| Immunoglobulin G4-Related Disease | Phase 3 | Chile | 26 Sep 2025 |
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 ) View more | Positive | 06 Dec 2025 | |||
Phase 3 | 202 | jpdnalgqvh(sptbimnkeq) = Two pts (3%) had grade ≥2 related TEAE of infection zktykblvcl (qrgzkwpajy ) View more | Positive | 06 Dec 2025 | |||
Phase 3 | 180 | cfrqfhutbp(jbeqtautwc) = gynmuwmpmy nnkqdvjuwd (fnqtrddsfo ) View more | Positive | 06 Dec 2025 | |||
Placebo | ovxwurezxd(iqzxhssakj) = eqkslxkpug xfbttggrlw (pofpojrrpm ) View more | ||||||
Phase 2 | 27 | ppnegxeaof(strsdwuiwp) = oxmhihnphp guihnegjxl (hqptgbkdbo ) View more | 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 ) View more | Positive | 14 May 2025 | |||
Phase 3 | 174 | fqniafvstb(xwxnldvjgx) = kuxxdgjdvq vqwcovagcp (teubteubsf ) View more | 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 ) View more | Positive | 23 Apr 2025 | |||
placebo | ttqvdqfmmk(cmradjqazr) = xfyowcihmo aivishoqvh (brxsuglpuz ) View more |





