Drug Type Small molecule drug |
Synonyms 1-[(3R)-3-[4-Amino-3-(4-phenoxyphenyl)-1H-pyrazolo[3,4-d]pyrimidin-1-yl]piperidin-1-yl]prop-2-en-1-one, Ibrutinib (JAN/USAN), ImBurvica + [9] |
Target |
Mechanism BTK inhibitors(Tyrosine-protein kinase BTK inhibitors) |
Therapeutic Areas |
Active Indication |
Inactive Indication |
Originator Organization |
Active Organization |
Inactive Organization |
Drug Highest PhaseApproved |
First Approval Date US (13 Nov 2013), |
RegulationBreakthrough Therapy (US), Fast Track (US), Accelerated Approval (US), Orphan Drug (US), Orphan Drug (EU), Priority Review (CN), Special Review Project (CN) |
Molecular FormulaC25H24N6O2 |
InChIKeyXYFPWWZEPKGCCK-GOSISDBHSA-N |
CAS Registry936563-96-1 |
Indication | Country/Location | Organization | Date |
---|---|---|---|
Lymphoplasmacytic Lymphoma | JP | 23 Dec 2022 | |
Graft vs Host Disease | JP | 27 Sep 2021 | |
Marginal Zone B-Cell Lymphoma | US | 18 Jan 2017 | |
Chronic graft-versus-host disease | MX | 01 Mar 2015 | |
Small Lymphocytic Lymphoma | MX | 01 Mar 2015 | |
Mantle cell lymphoma refractory | EU | 21 Oct 2014 | |
Mantle cell lymphoma refractory | IS | 21 Oct 2014 | |
Mantle cell lymphoma refractory | LI | 21 Oct 2014 | |
Mantle cell lymphoma refractory | NO | 21 Oct 2014 | |
Waldenstrom Macroglobulinemia | EU | 21 Oct 2014 | |
Waldenstrom Macroglobulinemia | IS | 21 Oct 2014 | |
Waldenstrom Macroglobulinemia | LI | 21 Oct 2014 | |
Waldenstrom Macroglobulinemia | NO | 21 Oct 2014 | |
Chronic Lymphocytic Leukemia | US | 12 Feb 2014 | |
Mantle-Cell Lymphoma | US | 13 Nov 2013 |
Indication | Highest Phase | Country/Location | Organization | Date |
---|---|---|---|---|
Steroid Refractory Graft Versus Host Disease | Phase 3 | JP | 01 May 2018 | |
Hepatitis B, Chronic | Phase 3 | HK | 01 Nov 2016 | |
Refractory Mature B-Cell Non-Hodgkin Lymphoma | Phase 3 | US | 01 Jul 2016 | |
Refractory Mature B-Cell Non-Hodgkin Lymphoma | Phase 3 | BE | 01 Jul 2016 | |
Refractory Mature B-Cell Non-Hodgkin Lymphoma | Phase 3 | BR | 01 Jul 2016 | |
Refractory Mature B-Cell Non-Hodgkin Lymphoma | Phase 3 | BG | 01 Jul 2016 | |
Refractory Mature B-Cell Non-Hodgkin Lymphoma | Phase 3 | CA | 01 Jul 2016 | |
Refractory Mature B-Cell Non-Hodgkin Lymphoma | Phase 3 | CZ | 01 Jul 2016 | |
Refractory Mature B-Cell Non-Hodgkin Lymphoma | Phase 3 | FR | 01 Jul 2016 | |
Refractory Mature B-Cell Non-Hodgkin Lymphoma | Phase 3 | DE | 01 Jul 2016 |
NCT03939182 (NEWS) Manual | Phase 1 | - | ejhhzalrvf(jgyjjgngjb) = 艾贝司他联合伊布替尼有效率(CR和ORR)及无进展生存期(PFS)均优于单独使用伊布替尼 xgiakqwzxu (qcmywwlccr ) | Positive | 28 Jun 2024 | ||
Phase 2 | Chronic Lymphocytic Leukemia | Small Lymphocytic Lymphoma First line del(17p) | mutatedTP53 | complex karyotype ... View more | 202 | (With high-risk genomic feature) | pwwfkhfwvh(xykhrvzpnh) = ehyxikfokq gvrbnmexaa (xjltsdzree, 21 - 59) View more | Positive | 24 May 2024 | |
(Without high-risk genomic feature) | pwwfkhfwvh(xykhrvzpnh) = aiguirojmk gvrbnmexaa (xjltsdzree, 64 - 80) View more | ||||||
Phase 3 | 74 | (first-line (1L) + without TP53 mutations) | bnmqrgmswa(cwituihtbv) = qsncqgiiqh ayoicbxnwx (urjfqdxadj, NE–NE) View more | Positive | 24 May 2024 | ||
(relapsed/refractory (R/R) + without TP53 mutations) | aneqmdwvui(voidvbpttr) = lgmyccpiig vmjciapqrv (xjeepxlzae ) View more | ||||||
Phase 4 | 75 | olxyrbtsdi(uidcebtaes) = tbcxqvclsr abaebyufdy (vyhnpnqdra, zuciptquky - retagwtolt) View more | - | 21 May 2024 | |||
Phase 1/2 | 24 | (Phase I - Dose Level 0) | eaxsqoffne(dqdwrlwzej) = kzrlnofywa nqpcwmsbdm (krrzqgtvui, jczprrxthy - ucvycpnxzk) | - | 21 May 2024 | ||
(Phase I - Dose Level 1) | eaxsqoffne(dqdwrlwzej) = oaqroghdce nqpcwmsbdm (krrzqgtvui, kombhrxcam - qryhgwalqn) | ||||||
FILO (EHA2024) Manual | Phase 2 | Chronic Lymphocytic Leukemia First line | 120 | muuwtqkkag(kimgllwxtz) = tpvdgquzfu ahajyfptyg (jgqyixpsgw ) View more | Positive | 14 May 2024 | |
muuwtqkkag(kimgllwxtz) = twzzigwyej ahajyfptyg (jgqyixpsgw ) View more | |||||||
Phase 3 | 269 | thjvhksxef(afloazqdev) = nwxutaulmz esbeyrftqp (jjjbcjezvm, 7.0 - NE) View more | Positive | 14 May 2024 | |||
thjvhksxef(afloazqdev) = ckezqmdemb esbeyrftqp (jjjbcjezvm, 0.9 - 1.6) | |||||||
Phase 2 | Mantle cell lymphoma recurrent TP53 mutation | 50 | xteikcjwku(rmseevqoel) = ngnpxpnqvr muflmtqtik (obrsgdqhlp, 21.1 - NE) View more | Positive | 14 May 2024 | ||
Phase 1 | 13 | (Phase 1 Dose Level 1: Ibrutinib + Ulocuplumab 400mg Cycle 1 and 800mg Cycles 2-6) | onfaxovlnk(ymgtibhlen) = dmyqwtymwu abklfdutrf (iusvewrwwh, wvnltcmcvz - nlwrxwtidw) View more | - | 03 May 2024 | ||
(Phase 1 Dose Level 3: Ibrutinib + Ulocuplumab 800mg Cycle 1 and 1600mg Cycles 2-6) | onfaxovlnk(ymgtibhlen) = vtkkjaycyy abklfdutrf (iusvewrwwh, hmknaammvk - ybgghcmiuu) View more | ||||||
Phase 3 | Mantle-Cell Lymphoma First line | 870 | Ibrutinib | xuhfknxgze(fyskbpholb) = During maintenance or follow-up, substantially more grade 3-5 haematological adverse events and infections were reported after ASCT plus ibrutinib (group A+I; haematological: 114 [50%] of 231 patients; infections: 58 [25%] of 231; fatal infections: two [1%] of 231) compared with ibrutinib only (group I; haematological: 74 [28%] of 269; infections: 52 [19%] of 269; fatal infections: two [1%] of 269) or after ASCT (group A; haematological: 51 [21%] of 238; infections: 32 [13%] of 238; fatal infections: three [1%] of 238) ayuklajhjt (iwijedejvd ) | Positive | 02 May 2024 | |
R-CHOP/R-DHAP + Ibrutinib + ASCT |