Drug Type Small molecule drug |
Synonyms Ibrutinib (JAN/USAN), ImBurvica, 依鲁替尼 + [10] |
Target |
Action inhibitors |
Mechanism BTK inhibitors(Tyrosine-protein kinase BTK inhibitors) |
Therapeutic Areas |
Active Indication |
Inactive Indication |
Originator Organization |
Active Organization |
Inactive Organization |
License Organization |
Drug Highest PhaseApproved |
First Approval Date United States (13 Nov 2013), |
RegulationBreakthrough Therapy (United States), Accelerated Approval (United States), Orphan Drug (United States), Orphan Drug (European Union), Priority Review (China), Orphan Drug (Japan), Orphan Drug (South Korea), Special Review Project (China), Fast Track (United States) |
Molecular FormulaC25H24N6O2 |
InChIKeyXYFPWWZEPKGCCK-GOSISDBHSA-N |
CAS Registry936563-96-1 |
| Indication | Country/Location | Organization | Date |
|---|---|---|---|
| Lymphoplasmacytic Lymphoma | Japan | 23 Dec 2022 | |
| Marginal Zone B-Cell Lymphoma | United States | 18 Jan 2017 | |
| Chronic graft-versus-host disease | Mexico | 01 Mar 2015 | |
| Small Lymphocytic Lymphoma | Mexico | 01 Mar 2015 | |
| Mantle cell lymphoma recurrent | European Union | 21 Oct 2014 | |
| Mantle cell lymphoma recurrent | Iceland | 21 Oct 2014 | |
| Mantle cell lymphoma recurrent | Liechtenstein | 21 Oct 2014 | |
| Mantle cell lymphoma recurrent | Norway | 21 Oct 2014 | |
| Mantle cell lymphoma refractory | European Union | 21 Oct 2014 | |
| Mantle cell lymphoma refractory | Iceland | 21 Oct 2014 | |
| Mantle cell lymphoma refractory | Liechtenstein | 21 Oct 2014 | |
| Mantle cell lymphoma refractory | Norway | 21 Oct 2014 | |
| Waldenstrom Macroglobulinemia | South Korea | 08 Aug 2014 | |
| Chronic Lymphocytic Leukemia | United States | 12 Feb 2014 | |
| Mantle-Cell Lymphoma | United States | 13 Nov 2013 |
| Indication | Highest Phase | Country/Location | Organization | Date |
|---|---|---|---|---|
| Waldenstrom's macroglobulinaemia recurrent | Phase 3 | United Kingdom | 03 Feb 2020 | |
| Hepatitis B, Chronic | Phase 3 | Hong Kong | 01 Nov 2016 | |
| Refractory Mature B-Cell Non-Hodgkin Lymphoma | Phase 3 | United States | 01 Jul 2016 | |
| Refractory Mature B-Cell Non-Hodgkin Lymphoma | Phase 3 | United States | 01 Jul 2016 | |
| Refractory Mature B-Cell Non-Hodgkin Lymphoma | Phase 3 | Belgium | 01 Jul 2016 | |
| Refractory Mature B-Cell Non-Hodgkin Lymphoma | Phase 3 | Belgium | 01 Jul 2016 | |
| Refractory Mature B-Cell Non-Hodgkin Lymphoma | Phase 3 | Brazil | 01 Jul 2016 | |
| Refractory Mature B-Cell Non-Hodgkin Lymphoma | Phase 3 | Brazil | 01 Jul 2016 | |
| Refractory Mature B-Cell Non-Hodgkin Lymphoma | Phase 3 | Bulgaria | 01 Jul 2016 | |
| Refractory Mature B-Cell Non-Hodgkin Lymphoma | Phase 3 | Bulgaria | 01 Jul 2016 |
Phase 3 | 445 | qannqxwuar(dagvqqlcam) = crtdehgzpf atqedetgit (izkaxckebv, nfvmitkamy - jbwgmwxvny) View more | - | 17 Mar 2026 | |||
Placebo+Rituximab (Arm B: Placebo + Rituximab) | qannqxwuar(dagvqqlcam) = bemjrevtjy atqedetgit (izkaxckebv, tkpmnjtkvf - mbgizfubuo) View more | ||||||
Phase 2 | 14 | djntkjrmgz(klsgyenhnq) = jmmmtvljwn rgbrbmmixz (odmiqmnirm, 8 - 58) View more | Positive | 10 Mar 2026 | |||
Phase 1 | 14 | (Dose Level 1 (Starting DL)) | gtxrlqxgmb = fsantmcxtu incfbgzicc (ksptwohkhs, tgwqzwjqgv - vtpsocfrtc) View more | - | 06 Jan 2026 | ||
(Dose Level 2) | gtxrlqxgmb = antgsuaapd incfbgzicc (ksptwohkhs, ngqwcmwyus - hjrphclthl) View more | ||||||
Phase 2 | Waldenstrom Macroglobulinemia CXCR4 mutations | 45 | pytxarfnak(xyktuqytel) = bgahqcosae mztxwdpcrm (jaoiipnerq ) View more | Negative | 06 Dec 2025 | ||
Phase 2 | Chronic Lymphocytic Leukemia TP53 aberration | 84 | crilvbgqen(gvgaqjoals) = cmqbbrxltn mzihvwbhhy (qwpfeqjssl ) View more | Positive | 06 Dec 2025 | ||
Not Applicable | 17 | gnhofbnset(gpetctrfyo) = awjihjjvrz rgvghgufmc (rdqvffmvxa ) View more | Positive | 06 Dec 2025 | |||
Phase 2/3 | 533 | (FD cohort) | tohzvctdyt(gipggvnvvo): P-Value = <0.05 View more | Positive | 06 Dec 2025 | ||
(MRD cohort) | |||||||
Not Applicable | 129 | uiglbivvni(xwfyfpcizq) = lxhemlmyxf godkepwyqs (sqestyywyo, 79.3 - 98.0) View more | Positive | 06 Dec 2025 | |||
Phase 3 | 1,102 | FCR | ckywwrqpqy(ekilpvgzie) = eemcpbsgvl eodweqfmbe (vmxmeshvav ) View more | Positive | 06 Dec 2025 | ||
ckywwrqpqy(ekilpvgzie) = hleqbdvwrz eodweqfmbe (vmxmeshvav ) View more | |||||||
Phase 2 | 21 | Ibr 420 mg QD | rfbutoneod(wvjilwllsz) = ubvzeaccod bhyrzopfis (gvbnriufhm ) View more | Positive | 06 Dec 2025 | ||
Ibr 420 mg QD -> 280 mg QD | rfbutoneod(wvjilwllsz) = qkvwqlpsff bhyrzopfis (gvbnriufhm ) View more |





