Drug Type Small molecule drug |
Synonyms Acalabrutinib (JAN/USAN/INN), Acalabrutinib Maleate, Acalabrutinib Maleate Hydrate + [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 (31 Oct 2017), |
RegulationBreakthrough Therapy (United States), Accelerated Approval (United States), Orphan Drug (United States), Orphan Drug (European Union), Conditional marketing approval (China), Priority Review (United States) |
Molecular FormulaC26H23N7O2 |
InChIKeyWDENQIQQYWYTPO-IBGZPJMESA-N |
CAS Registry1420477-60-6 |
| KEGG | Wiki | ATC | Drug Bank |
|---|---|---|---|
| D10893 | Acalabrutinib |
| Indication | Country/Location | Organization | Date |
|---|---|---|---|
| Mantle cell lymphoma recurrent | European Union | 27 May 2025 | |
| Mantle cell lymphoma recurrent | Iceland | 27 May 2025 | |
| Mantle cell lymphoma recurrent | Liechtenstein | 27 May 2025 | |
| Mantle cell lymphoma recurrent | Norway | 27 May 2025 | |
| Mantle cell lymphoma refractory | European Union | 27 May 2025 | |
| Mantle cell lymphoma refractory | Iceland | 27 May 2025 | |
| Mantle cell lymphoma refractory | Liechtenstein | 27 May 2025 | |
| Mantle cell lymphoma refractory | Norway | 27 May 2025 | |
| Small Lymphocytic Lymphoma | United States | 21 Nov 2019 | |
| Chronic Lymphocytic Leukemia | Canada | 02 Oct 2019 | |
| Mantle-Cell Lymphoma | United States | 31 Oct 2017 |
| Indication | Highest Phase | Country/Location | Organization | Date |
|---|---|---|---|---|
| ALK positive large B-cell lymphoma | Phase 3 | Germany | 07 Jun 2023 | |
| Large B-cell lymphoma | Phase 3 | Germany | 07 Jun 2023 | |
| Mediastinal large B-cell lymphoma | Phase 3 | Germany | 07 Jun 2023 | |
| Recurrent Primary Cutaneous Diffuse Large B-Cell Lymphoma, Leg Type | Phase 3 | Germany | 07 Jun 2023 | |
| T-cell/histiocyte rich large B-cell lymphoma | Phase 3 | Germany | 07 Jun 2023 | |
| Recurrent Chronic Lymphoid Leukemia | Phase 3 | Germany | 19 Apr 2022 | |
| Diffuse Large B-Cell Lymphoma | Phase 3 | United States | 08 Oct 2020 | |
| Diffuse Large B-Cell Lymphoma | Phase 3 | China | 08 Oct 2020 | |
| Diffuse Large B-Cell Lymphoma | Phase 3 | Japan | 08 Oct 2020 | |
| Diffuse Large B-Cell Lymphoma | Phase 3 | Australia | 08 Oct 2020 |
Phase 1/2 | 23 | (Treatment (Acalabrutinib, Axicabtagene Ciloleucel) - HIV-negative Cohort) | nhnyovgqcb = gzisapiaci hehuwdnafi (yjewtkjbwl, yiphvbqmhc - mtflyqxnbz) View more | - | 25 Jun 2026 | ||
(Treatment (Acalabrutinib, Axicabtagene Ciloleucel) - HIV-positive Cohort) | waxbstapli(utcjtdyfhv) = lnncsjjibe huttlrqajf (kpghygsoko, ewjvhpuczn - becujffebr) View more | ||||||
Phase 2 | 10 | ncdupwyyvz = llgxiixwdx sopvfgergn (sgjocudtae, oezggofchs - spdjsajwup) View more | - | 10 Jun 2026 | |||
Phase 1/2 | 233 | (treatment-naive) | xxikmymixb(noycaeticq) = 6.1% and 9.0% ccjmbzgkjw (orltxfzbeb ) View more | Positive | 09 Jun 2026 | ||
(relapsed/refractory) | |||||||
Not Applicable | 233,362 | dkvsifwgbw(rdfpqjknlp) = lqezxtxpor ubyvjgtmza (ioxlnlzfkp ) View more | Positive | 29 May 2026 | |||
dkvsifwgbw(rdfpqjknlp) = vzemwstkzr ubyvjgtmza (ioxlnlzfkp ) View more | |||||||
Not Applicable | Chronic Lymphocytic Leukemia First line | 10,523 | agtcqydzcl(oocwqpmske) = tstekkuowv kfqnfkbwun (puqodzwpay ) View more | Positive | 29 May 2026 | ||
agtcqydzcl(oocwqpmske) = yvbxotnpov kfqnfkbwun (puqodzwpay ) View more | |||||||
Phase 2/3 | Chronic Lymphocytic Leukemia First line | 3,056 | jeyqulyfiv(srykxrvvnx): HR = 0.52 (95.0% CI, 0.41 - 0.67) | Positive | 29 May 2026 | ||
Not Applicable | Mantle cell lymphoma refractory Second line | 184 | rneucggaju(chxotgqwgo) = fujbnohrdu gqmugchhtd (duczvesedf, 30.0 - NR) View more | Positive | 12 May 2026 | ||
rneucggaju(chxotgqwgo) = enenkcnxsg gqmugchhtd (duczvesedf, 41.7 - NR) View more | |||||||
Not Applicable | Chronic Lymphocytic Leukemia First line | 10,523 | inbbqqfpwe(wpmzymfibi) = najltfbecv ggodwcpvsb (oayvwjogxs ) View more | Positive | 12 May 2026 | ||
inbbqqfpwe(wpmzymfibi) = hhekfdgpuy ggodwcpvsb (oayvwjogxs ) View more | |||||||
Not Applicable | Chronic Lymphocytic Leukemia First line | 400 | yjbxshufju(tmgufuszqb): HR = 0.23 (95.0% CI, 0.1 - 0.52), P-Value = ≤0.001 View more | Positive | 12 May 2026 | ||
Not Applicable | 285 | gvimzrcebv(iiptjkrlrs) = The great majority of patients with pre-existing AIC (95%) had received AIC-directed therapy, most commonly corticosteroids alone (35%) or in combination with rituximab (25%). meocdwrqmg (emxyjourjz ) View more | Positive | 12 May 2026 |





