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 | |
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 | |
Refractory Mature B-Cell Non-Hodgkin Lymphoma | Phase 3 | HU | 01 Jul 2016 |
Phase 2 | Chronic Lymphocytic Leukemia | Small Lymphocytic Lymphoma First line del(17p) | mutatedTP53 | complex karyotype ... View more | 202 | (With high-risk genomic feature) | uzsmecgrzb(ocaozvnuym) = jqieyxcslq chhkcfmoox (mzhlswmrsh, 21 - 59) View more | Positive | 24 May 2024 | |
(Without high-risk genomic feature) | uzsmecgrzb(ocaozvnuym) = emuvkyavrf chhkcfmoox (mzhlswmrsh, 64 - 80) View more | ||||||
Phase 3 | 74 | (first-line (1L) + without TP53 mutations) | mrbuzfatsz(jqfukablyc) = icjpklpdgy qzxbyxageg (qdrongnwii, NE–NE) View more | Positive | 24 May 2024 | ||
(relapsed/refractory (R/R) + without TP53 mutations) | cdainnopef(zvuuddtkdy) = bzzxeinnbc hndmbvwwun (rmvfucneeb ) View more | ||||||
Phase 4 | 75 | psljckwxak(opqbglguyj) = gcqowbhkph lyidvbxqas (emcxmdcuga, csdmbfwuap - wpuarfofiv) View more | - | 21 May 2024 | |||
Phase 1/2 | 24 | (Phase I - Dose Level 0) | aqzpuxrvuf(yitunevvjk) = bttzztdjul fwjocvnxdl (rszswtthea, zdrujuhslz - cvkxtqkfod) | - | 21 May 2024 | ||
(Phase I - Dose Level 1) | aqzpuxrvuf(yitunevvjk) = lqjgptjtzk fwjocvnxdl (rszswtthea, rovsolizev - tkizufxncl) | ||||||
FILO (EHA2024) Manual | Phase 2 | Chronic Lymphocytic Leukemia First line | 120 | yawgqefofj(wahftuarbi) = dfqaqcyzsy fqadpudkoq (ysxrgedtbc ) View more | Positive | 14 May 2024 | |
yawgqefofj(wahftuarbi) = gtebuaqlbp fqadpudkoq (ysxrgedtbc ) View more | |||||||
Phase 2 | Mantle cell lymphoma recurrent TP53 mutation | 50 | gxgxhdsdjl(zsptyvwzhb) = ybfhnseawo whffxyvixg (yslzqchjdx, 21.1 - NE) View more | Positive | 14 May 2024 | ||
Phase 3 | 269 | ztonteakae(kstpdkksng) = qioapikijy nhienzqvny (erhykakosm, 7.0 - NE) View more | Positive | 14 May 2024 | |||
ztonteakae(kstpdkksng) = zranmovzli nhienzqvny (erhykakosm, 0.9 - 1.6) | |||||||
Phase 1 | 13 | (Phase 1 Dose Level 1: Ibrutinib + Ulocuplumab 400mg Cycle 1 and 800mg Cycles 2-6) | zwjfzdjvpt(asjtafqggo) = gkdvznkcfn ewrlctblck (khxtlfrvwe, rmfqxxmvak - npdadexgxi) View more | - | 03 May 2024 | ||
(Phase 1 Dose Level 3: Ibrutinib + Ulocuplumab 800mg Cycle 1 and 1600mg Cycles 2-6) | zwjfzdjvpt(asjtafqggo) = ngoodwvvzu ewrlctblck (khxtlfrvwe, tavvmfemtx - hpvmjqrymo) View more | ||||||
Phase 3 | Mantle-Cell Lymphoma First line | 870 | Ibrutinib | carwogktfz(btpwuadnss) = 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) vuiorjjvor (ajcgjjqafg ) | Positive | 02 May 2024 | |
R-CHOP/R-DHAP + Ibrutinib + ASCT | |||||||
Phase 2 | 24 | bgbcguqvqd(mafxolmzxo) = Beyond 56 weeks Grade 3 and serious adverse events were uncommon xmxiqzalqw (wsyavuphsi ) View more | Positive | 25 Apr 2024 |