TheraRadar
Data updated: Jul 17, 2026

IBRUTINIB · ZYDUS WORLDWIDE DMCC

Generic · see IMBRUVICA
Oncology Approved 2013-11-13

IBRUTINIB is FDA-approved to treat 5 conditions (same as IMBRUVICA).

Source: FDA Label
Jump to: Indications Approvals Trials Competitors Safety Patents
1
Indication
--
Phase 3 Trials
12
Years on Market

Details

Status
Prescription
First Approved
2013-11-13
Routes
ORAL
Dosage Forms
TABLET, CAPSULE

Companies

ZYDUS WORLDWIDE DMCC Novartis ZYDUS LIFESCIENCES Teva ALVOGEN PINE BROOK ALVOGEN
Active Ingredient: IBRUTINIB

IBRUTINIB Approval History

2022
2023
2024
2025
2026
Original
New Indication
New Form
Label Update
4 FDA actions from 2021 to 2025
Feb 2025 SUPPL
Label · Labeling
Mar 2021 ORIGINAL
Update
FDA Letter

What IBRUTINIB Treats

5 indications

IBRUTINIB is approved for 5 conditions since its original approval in 2021. These indications span multiple therapeutic areas including oncology, immunology, and more.

Same approved indications as IMBRUVICA (same active ingredient).

Source: FDA Label
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Clinical Trial Registry

258 trials
Trial Sponsor ID Phase Status Title
NCT06649812 NCI-2024-08642 NCI-2024-08642, EA4231 Ph 2 recruiting Testing the Effectiveness of a Combination Targeted Therapy (ViPOR) for Patients With Relapsed and/or Refractory Aggressive B-cell Lymphoma
NCT04840602 NCI-2021-02851 NCI-2021-02851, S2005 Ph 2 recruiting Testing the Combination of Venetoclax and Rituximab, in Comparison to the Usual Treatment (Ibrutinib Plus Rituximab or Zanubrutinib Alone) for Waldenstrom's Macroglobulinemia/Lymphoplasmacytic Lymphoma
NCT03701282 NCI-2018-02127 NCI-2018-02127, EA9161 Ph 3 active not recruiting Assessing the Ability of Combination Treatment With Venetoclax to Permit Time Limited Therapy in Chronic Lymphocytic Leukemia
NCT02160015 NCI-2014-01157 NCI-2014-01157, 2015-00531 Ph 1 active not recruiting Lenalidomide, Ibrutinib, and Rituximab in Treating Patients With Relapsed or Refractory Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma That Is Metastatic or Cannot Be Removed by Surgery
NCT01841723 NCI-2013-00826 NCI-2013-00826, 2012C0139 Ph 2 active not recruiting Ibrutinib in Treating Patients With Relapsed Hairy Cell Leukemia
NCT01955499 NCI-2013-01810 NCI-2013-01810, OSU 13022 Ph 1 active not recruiting Lenalidomide and Ibrutinib in Treating Patients With Relapsed or Refractory B-Cell Non-Hodgkin Lymphoma
NCT04263480 CZAR-1 CZAR-1 Ph 2 active not recruiting Efficacy and Safety of Carfilzomib in Combination With Ibrutinib vs Ibrutinib in Waldenström's Macroglobulinemia
NCT06136559 1026-011 2022-501697-19-00, U1111-1281-7895 Ph 3 recruiting A Study of Nemtabrutinib (MK-1026) Versus Comparator (Investigator's Choice of Ibrutinib or Acalabrutinib) in First Line (1L) Chronic Lymphocytic Leukemia (CLL)/ Small Lymphocytic Lymphoma (SLL) (MK-1026-011/BELLWAVE-011)
NCT04273139 results posted 19-651 Ph 2 active not recruiting Ibrutinib + Venetoclax in Untreated WM
NCT03462719 GLOW results posted CR108428 2017-004699-77, 54179060CLL3011 Ph 3 active not recruiting A Study of the Combination of Ibrutinib Plus Venetoclax Versus Chlorambucil Plus Obinutuzumab for the First-line Treatment of Participants With Chronic Lymphocytic Leukemia (CLL)/Small Lymphocytic Lymphoma (SLL)
NCT01804686 CAN3001 CR100955 PCI-32765CAN3001, 2012-004225-24 Ph 3 recruiting A Long-term Extension Study of PCI-32765 (Ibrutinib)
NCT05963074 TAILOR 54179060CLL2032 54179060CLL2032, 2023-504044-34-00 Ph 2 recruiting A Study to Customize Ibrutinib Treatment Regimens for Participants With Previously Untreated Chronic Lymphocytic Leukemia
NCT05283720 M22-132 2023-505347-38, 2023-505347-38-00 Ph 2 active not recruiting A Study to Evaluate Adverse Events and Change in Disease Activity of Subcutaneous (SC) Epcoritamab in Combination With Oral and Intravenous Anti-Neoplastic Agents in Adult Participants With Non-Hodgkin Lymphoma
NCT07082868 25-032 Ph 1 recruiting A Study of Epcoritamab and Ibrutinib in People With Central Nervous System Lymphoma (CNSL)
NCT03506373 results posted MC178B 18-000580 Ph 2 terminated Ibrutinib and Ixazomib Citrate in Treating Newly Diagnosed, Relapsed or Refractory Waldenstrom Macroglobulinemia
NCT02443077 results posted NCI-2015-00668 NCI-2015-00668, BMT CTN 1201 Ph 3 active not recruiting Ibrutinib Before and After Stem Cell Transplant in Treating Patients With Relapsed or Refractory Diffuse Large B-cell Lymphoma
NCT01886872 results posted NCI-2013-01220 NCI-2013-01220, ALLIANCE A041202 Ph 3 active not recruiting Rituximab and Bendamustine Hydrochloride, Rituximab and Ibrutinib, or Ibrutinib Alone in Treating Older Patients With Previously Untreated Chronic Lymphocytic Leukemia
NCT03737981 results posted NCI-2018-02485 NCI-2018-02485, A041702 Ph 3 active not recruiting Testing the Addition of a New Anti-cancer Drug, Venetoclax, to the Usual Treatment (Ibrutinib and Obinutuzumab) in Untreated, Older Patients With Chronic Lymphocytic Leukemia
NCT02048813 results posted NCI-2014-00118 NCI-2014-00118, E1912 Ph 3 active not recruiting Ibrutinib and Rituximab Compared With Fludarabine Phosphate, Cyclophosphamide, and Rituximab in Treating Patients With Untreated Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma
NCT02581930 results posted NCI-2015-01744 NCI-2015-01744, NCI9922 Ph 2 active not recruiting Ibrutinib in Treating Patients With Refractory Metastatic Cutaneous Melanoma
NCT04608318 CLL17 CLL17 2022-500439-35-00, 2019-003854-99 Ph 3 active not recruiting Ibrutinib Monotherapy Versus Fixed-duration Venetoclax Plus Obinutuzumab Versus Fixed-duration Ibrutinib Plus Venetoclax in Patients With Previously Untreated Chronic Lymphocytic Leukaemia (CLL)
NCT03964090 190103 19-C-0103 Ph 2 active not recruiting Temozolomide, Etoposide, Doxil, Dexamethasone, Ibrutinib, and Rituximab (TEDDI-R) in Aggressive B-cell Lymphomas With Secondary Involvement of the Central Nervous System (CNS)
NCT01849263 results posted NCI-2013-00887 NCI-2013-00887, MC1282 Ph 2 active not recruiting Ibrutinib in Treating Patients With Relapsed or Refractory Follicular Lymphoma
NCT04739813 210014 21-C-0014 Ph 1 active not recruiting Venetoclax, Ibrutinib, Prednisone, Obinutuzumab, and Revlimid in Combination With Polatuzumab (ViPOR-P) in Relapsed/Refractory B-cell Lymphoma
NCT03479268 19565 NCI-2018-00315, STUDY00017005 Ph 1 active not recruiting Pevonedistat and Ibrutinib in Treating Participants With Relapsed or Refractory CLL or Non-Hodgkin Lymphoma
NCT02436707 LY17 Ph 2 active not recruiting Novel Combination Therapy in the Treatment of Relapsed and Refractory Aggressive B-Cell Lymphoma
NCT03223610 170127 17-C-0127 Ph 1, Ph 2 recruiting Venetoclax, Ibrutinib, Prednisone, Obinutuzumab, and Revlimid (ViPOR) in Relapsed/Refractory B-cell Lymphoma
NCT05254743 BRUIN-CLL-314 18281 J2N-OX-JZNU, LOXO-BTK-20030 Ph 3 recruiting A Study of Pirtobrutinib (LOXO-305) Versus Ibrutinib in Participants With Chronic Lymphocytic Leukemia (CLL)/Small Lymphocytic Lymphoma (SLL)
NCT03960840 CYTB323A12101 Ph 1, Ph 2 active not recruiting Phase I/II Study of Rapcabtagene Autoleucel in CLL, 3L+ DLBCL, r/r ALL and 1L HR LBCL
NCT03328078 CA-4948-101 2024-513312-95-00, 2022-000891-20 Ph 1, Ph 2 recruiting CA-4948-101: Open-Label, Dose Escalation and Expansion Trial of Emavusertib (CA-4948) in Relapsed or Refractory Primary Central Nervous System Lymphoma (R/R PCNSL)
NCT05998642 I244 Ph 2 recruiting Ibrutinib Combination Therapy in Transplant Ineligible Individuals With Newly Diagnosed Primary CNS Lymphoma
NCT02514083 results posted 150172 15-H-0172 Ph 2 active not recruiting A Phase II Study Using Ibrutinib and Short-Course Fludarabine in Treatment-Naive CLL
NCT01829568 NCI-2013-00792 NCI-2013-00792, CALGB-A051103 Ph 1 active not recruiting Rituximab, Lenalidomide, and Ibrutinib in Treating Patients With Previously Untreated Stage II-IV Follicular Lymphoma
NCT01589302 results posted OSU-11133 NCI-2012-00560 Ph 2 active not recruiting PCI-32765 (Ibrutinib) in Treating Patients With Relapsed or Refractory Chronic Lymphocytic Leukemia, Small Lymphocytic Lymphoma, or B-cell Prolymphocytic Leukemia
NCT04450173 UCDCC#275 NCI-2020-01372, UCDCC#275 Ph 2 active not recruiting Obinutuzumab, Ibrutinib, and Venetoclax for the Treatment of Previously Untreated Stage II-IV Follicular Lymphoma
NCT02159755 NCI-2014-01202 NCI-2014-01202, 1403014853 Ph 1 active not recruiting Ibrutinib and Palbociclib in Treating Patients With Previously Treated Mantle Cell Lymphoma
NCT03220022 results posted NCI-2017-01240 NCI-2017-01240, AMC-101 Ph 1 active not recruiting Ibrutinib, Rituximab, Etoposide, Prednisone, Vincristine Sulfate, Cyclophosphamide, and Doxorubicin Hydrochloride in Treating Patients With HIV-Positive Stage II-IV Diffuse Large B-Cell Lymphomas
NCT03478514 AFT-32 Ph 2 active not recruiting Phase II Palbociclib +Ibrutinib in Mantle Cell Lymphoma
NCT03697512 MALIBU IELSG47 2018-002364-44 Ph 2 active not recruiting MALIBU Trial - Combination of Ibrutinib and Rituximab in Untreated Marginal Zone Lymphomas
NCT02997761 results posted 945122 UCDCC#266, UCDCC#266 Ph 2 completed Ibrutinib and Blinatumomab in Treating Patients With Relapsed or Refractory B Acute Lymphoblastic Leukemia
NCT02518555 OSU-15012 NCI-2015-00932 Ph 2 completed Ibrutinib as an Immune Modulating Agent for Patients With Asymptomatic, High-risk CLL/SLL Risk Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma
NCT02537613 15-283 Ph 1 active not recruiting A Study of Ibrutinib + Obinutuzumab in Patients With Relapsed or Refractory Chronic Lymphocytic Leukemia
NCT02477696 results posted ACE-CL-006 2023-509347-27-00, 2014-005530-64 Ph 3 active not recruiting Study of Acalabrutinib (ACP-196) Versus Ibrutinib in Previously Treated Participants With High Risk Chronic Lymphocytic Leukemia (CLL)
NCT02682641 GELTAMO-IMCL-2015 2015-004158-17 Ph 2 active not recruiting Ibrutinib in Combination With Rituximab in Patients With Indolent Clinical Forms of MCL
NCT02446236 results posted Pro00005444 Ph 1 active not recruiting Dose Finding Study of Ibrutinib Plus Lenalidomide / Rituximab in Relapsed or Refractory Mantle Cell Lymphoma
NCT03282396 2016-0914 NCI-2018-01045, 2016-0914 Ph 2 active not recruiting Ibrutinib in Treating Participants With Untreated High Risk Smoldering Mantle Cell Lymphoma
NCT03359460 1043625 UCDCC#265, UCDCC#265 Ph 1 completed Ibrutinib and Lenalidomide in Treating Patients With Myelodysplastic Syndrome
NCT02629809 2015-0281 NCI-2016-00016, 2015-0281 Ph 2 active not recruiting Ibrutinib, Fludarabine Phosphate, Cyclophosphamide, and Obinutuzumab in Treating Patients With Chronic Lymphocytic Leukemia
NCT03514017 results posted MCC-19199 Ph 2 terminated Ibrutinib and PD-1 Blockade in High Risk Lymphocytic Leukemia
NCT04421560 20-144 Ph 1, Ph 2 recruiting Pembrolizumab, Ibrutinib and Rituximab in PCNSL

Showing 50 of 258 trials

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Active Pipeline

Pro

Ongoing clinical trials by development phase

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Key Completed Trials

Pro

Completed studies with published results, ranked by significance

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Trial Timeline

ClinicalTrials.gov ↗ Pro

Full development history with FDA approval milestones

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Understanding FDA Approval Types
Count Type What it means
- ORIG Original approval - drug first enters market
- SUPPL - Efficacy New indication (new disease/condition approved)
- SUPPL - Labeling Label text changes (warnings, dosing updates)
- SUPPL - Manufacturing Production changes (new facility)
- SUPPL - Chemistry Formulation changes (new dosage strength)

Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.

IBRUTINIB FDA Label Details

Indications & Usage

IBRUTINIB is FDA-approved to treat 5 conditions — same approved indications as IMBRUVICA.

Looking for the branded version?

IMBRUVICA

Full clinical data, patents, trials, and competitive landscape for ibrutinib.

See IMBRUVICA

Data Sources

FDA Approval: ANDA214296 → Trials: ClinicalTrials.gov →

Data sourced from official FDA and NIH databases. Click links to verify on original sources.