RegulationBreakthrough Therapy (United States), Fast Track (United States), Accelerated Approval (United States), Orphan Drug (United States), Orphan Drug (European Union), Special Review Project (China), Orphan Drug (Japan), Orphan Drug (South Korea), Priority Review (China)

Structure/Sequence

Molecular FormulaC25H24N6O2

InChIKeyXYFPWWZEPKGCCK-GOSISDBHSA-N

CAS Registry936563-96-1

406

Clinical Trials associated with Ibrutinib

NCT07474961

/ Not yet recruitingPhase 4IIT

A Multicentre, Adaptive, Randomised, Multidomain, Platform Trial for Dose Optimization in the Treatment of Adult Patients With Haematological Diseases (BLOOD-dose): Core Protocol

BLOOD-dose is a multicentre, adaptive, randomized, multidomain platform trial designed to optimize treatment dosing strategies in adult patients with haematological diseases.
The BLOOD-dose core protocol outlines the overall clinical trial design that applies to all included interventions, while domain-specific appendices (DSA) detail the unique characteristics of each domain and specify domain-specific interventions.
New domains will be incorporated over time to address distinct dose-optimization research questions across different haematological conditions and interventions.

Start Date01 Mar 2027

Sponsor / Collaborator

Rigshospitalet

CTR20261712

/ Active, not recruitingNot Applicable

伊布替尼胶囊生物等效性试验

[Translation] Ibrutinib capsule bioequivalence study

主要研究目的评价中国健康成年试验参与者空腹条件下单次单剂量口服伊布替尼胶囊受试制剂（规格：0.14g，申办者：金鸿药业股份有限公司）和参比制剂（商品名：亿珂®，规格：140mg，持证商：Janssen-Cilag International NV）后的药代动力学特点和生物等效性。次要研究目的研究伊布替尼胶囊受试制剂（规格：0.14g）和参比制剂（商品名：亿珂®，规格：140mg）在中国健康成年试验参与者中的安全性。

[Translation]

Primary Study Objective: To evaluate the pharmacokinetic characteristics and bioequivalence of a single oral dose of ibrutinib capsules (0.14 g, sponsor: Jinhong Pharmaceutical Co., Ltd.) and the reference formulation (Ibrutinib®, 140 mg, licensee: Janssen-Cilag International NV) administered under fasting conditions to healthy adult participants in China. Secondary Study Objective: To investigate the safety of ibrutinib capsules (0.14 g, reference formulation: Ibrutinib®, 140 mg) in healthy adult participants in China.

Start Date25 May 2026

Sponsor / Collaborator

Zhuhai Kinhoo Pharmaceutical Co. Ltd.

ChiCTR2600121895

/ Not yet recruitingNot ApplicableIIT

Exploration of Converting Bruton’s Tyrosine Kinase Inhibitor Continuous Therapy in Chronic Lymphocytic Leukemia to a Time-Limited Treatment Model Through MRD-Guided Bridging Therapy with Lisaftoclax: A Prospective, Single-Arm, Phase 2 Study

Start Date01 Apr 2026

Sponsor / Collaborator-

100 Clinical Results associated with Ibrutinib

100 Translational Medicine associated with Ibrutinib

100 Patents (Medical) associated with Ibrutinib

4,788

Literatures (Medical) associated with Ibrutinib

31 Dec 2026·JOURNAL OF MEDICAL ECONOMICS

Prolonged progression-free survival with zanubrutinib in relapsed/refractory CLL: an indirect treatment comparison versus other BTK inhibitors using multilevel network meta-regression

Article

Author: Xu, Sheng ; Yang, Keri ; Bouwmeester, Walter ; Mohseninejad, Leyla ; Shadman, Mazyar ; Jevdjevic, Milica ; Jansen, Jeroen P. ; Williams, Rhys

BACKGROUND:

Bruton tyrosine kinase inhibitors (BTKis) are therapeutic agents for relapsed/refractory chronic lymphocytic leukemia (R/R CLL). Previous indirect treatment comparisons are limited in simultaneously comparing multiple interventions and adjusting for population differences. This study aimed to use a more rigorous approach called multilevel network meta-regression (ML-NMR) to estimate the relative treatment effects of zanubrutinib compared to acalabrutinib and ibrutinib in two target populations: a general R/R CLL population similar to the phase 3 ALPINE trial's intention-to-treat (ITT) population, and a high-risk population with del(17p) and/or del(11q), similar to the ITT population of the phase 3 ELEVATE-RR trial.

METHODS:

The ML-NMR was conducted using data from three phase 3 randomized controlled trials: ALPINE (N = 652), ELEVATE-RR (N = 533), and ASCEND (N = 310). Progression-free survival (PFS) and overall survival (OS) were the outcomes of interest. The ML-NMR integrated individual patient data from ALPINE with aggregate data from the other trials, incorporating important effect modifiers to estimate relative treatment effects for the target populations.

RESULTS:

In the general R/R CLL population, zanubrutinib showed an improved PFS compared to ibrutinib (HR = 0.67, 95% Credible Interval [CrI] = 0.52-0.87) and acalabrutinib (HR = 0.57, 95% CrI = 0.34-0.95). In the high-risk population, zanubrutinib maintained its PFS advantage over ibrutinib and acalabrutinib. OS was similar across BTKis in both populations, with wide CrIs that included an estimate of no difference between treatments.

CONCLUSION:

This ML-NMR suggests that zanubrutinib offers improved PFS compared to ibrutinib and acalabrutinib in both general and high-risk R/R CLL populations. OS results were uncertain due to limited follow-up.

31 Dec 2026·Gut Microbes

Longitudinal gut microbiome dynamics are associated with clinical outcome and toxicity during ibrutinib therapy

Article

Author: Montassier, Emmanuel ; Le Gouill, Steven ; Roquilly, Antoine ; Guimard, Thomas ; Morineau, Nadine ; Papin, Mathilde ; Tessoulin, Benoît

Accumulating evidence indicates that the gut microbiome influences therapeutic efficacy and toxicity across cancer treatments; however, its longitudinal dynamics during targeted therapies remain poorly characterized. Here, we performed whole-genome shotgun metagenomic sequencing of 291 longitudinal stool samples collected over one year from 30 patients with hematologic malignancies treated with ibrutinib. Overall gut microbial diversity remained stable at the population level but exhibited markedly divergent temporal trajectories according to clinical outcome, with progressive recovery in responders and blunted or delayed restoration in non-responders. Longitudinal modeling revealed distinct species- and pathway-level microbial dynamics between patients with treatment response or nonresponse, including enrichment of saccharolytic, short-chain fatty acid-associated taxa and metabolic pathways in responders, and expansion of bile acid-modifying, proteolytic, and inflammation-associated microbial features in non-responders. Functional profiling further demonstrated opposing temporal trends in pathways related to carbohydrate fermentation, amino-acid metabolism, and secondary bile acid synthesis. In addition, both baseline microbiome composition and longitudinal remodeling were associated with the development of ibrutinib-associated diarrhea. Together, these findings reveal coordinated, outcome-specific remodeling of the gut microbiome during ibrutinib therapy and highlight longitudinal microbiome trajectories, rather than static baseline features, as potential biomarkers of treatment response and toxicity, as well as targets for microbiome-directed interventions. In conclusion, our findings highlight a potential role of gut microbiome dynamics in modulating response to BTK inhibition and support the need for larger, prospective studies to validate these observations.

01 Aug 2026·EUROPEAN JOURNAL OF PHARMACEUTICS AND BIOPHARMACEUTICS

QbD-based intranasal pH-sensitive Ibrutinib liposomes for glioblastoma management: in vitro, ex vivo, and in vivo pharmacokinetics and brain distribution assessment

Article

Author: Dikundwar, Amol G ; Phatale, Vivek ; Naresh Katarpawar, Shraddha ; Pandey, Giriraj ; Kumar, Rahul ; Amulya, Etikala ; Sikder, Anupama ; Sharma, Abhishek ; Vambhurkar, Ganesh ; Khairnar, Pooja ; Wagh, Suraj ; Srivastava, Saurabh

Ibrutinib (IBR), a potent Bruton's tyrosine kinase (BTK) inhibitor, has demonstrated promising anticancer potential; however, its poor solubility, limited bioavailability and restricted permeability across the blood-brain barrier (BBB) significantly constrain its therapeutic application in glioblastoma (GBM). For GBM therapy, overcoming the formidable BBB remains a major obstacle. In the current research, a pH-sensitive liposomal formulation encapsulating IBR (IBR-LIPO) was developed to facilitate direct nose-to-brain (N2B) delivery and enhance brain targeting. The optimized IBR-LIPO depicted a spherical morphology with a mean particle size below 200 nm, as confirmed by transmission electron microscopy (TEM) and dynamic light scattering (DLS). The optimized formulation depicted a zeta potential of -31.8 ± 0.95 indicating good stability. The formulation depicted an entrapment efficiency and drug loading of 85.46 ± 1.35% and 4.5 ± 0.34% respectively. The incorporation of cholesteryl hemisuccinate (CHS) conferred pH-responsive behavior, resulting in controlled yet initial-burst release profile in acidic conditions. Ex vivo nasal permeation and toxicity studies revealed a 2.54-fold enhancement in the nasal permeation with no signs of toxicity. In vitro evaluation using 2D and 3D cell culture revealed significantly improved cytotoxicity of IBR-LIPO compared to the free drug. In vivo pharmacokinetic analysis depicted enhanced brain delivery with a 2.30-fold enhancement in drug targeting efficiency (%DTE) and a 2.39-fold increase in direct transport percentage (%DTP) and a higher drug targeting index (DTI) over free IBR following intranasal (IN) administration. Collectively, these findings highlight IBR-LIPO as a promising nanocarrier for efficient N2B delivery and targeted GBM therapy.

806

News (Medical) associated with Ibrutinib

06 Jul 2026

·www.prnewswire.com

Curis Consents First Six Patients in TakeAim CLL Study

LEXINGTON, Mass., July 6, 2026 /PRNewswire/ -- Curis, Inc. (NASDAQ: CRIS), a biotechnology company focused on the development of emavusertib (CA-4948), an orally available, small molecule IRAK4 and FLT3 inhibitor, today announced an important enrollment milestone in its TakeAim CLL study. On June 26, 2026, Curis announced that eleven clinical sites had opened for enrollment in the TakeAim CLL study. Today, Curis is announcing that it has consented the first six patients in that study – and reaffirmed its guidance for the dosing of five CLL patients by the end of July 2026, with initial CLL data expected in December 2026. "We are encouraged by the strong interest among clinical sites and key opinion leaders in our TakeAim CLL study that has enabled us to exceed expectations for site activation and enrollment," said James Dentzer, Chief Executive Officer of Curis. "It reflects the clear unmet need in CLL and the excitement for the potential of emavusertib to fundamentally change the treatment paradigm in CLL." In CLL, disease is driven by NF-kB dysregulation, which is in turn driven by two biologic pathways: BCR and TLR1. The goal of combining emavusertib with a BTK inhibitor (BTKi) in the TakeAim CLL Study is to enable a dual blockade of NF-kB, by inhibiting both the BCR and TLR pathways. BTK inhibitors (BTKi) block the BCR pathway; emavusertib blocks the TLR pathway. BTKi is the current standard of care in CLL. In the registrational study for the BTKi zanubrutinib, 93% of patients were able to achieve an objective response, but only 7% achieved complete response2. More recent clinical studies have demonstrated that adding emavusertib to a BTKi regimen, blocking both the TLR and BCR pathways, can enable patients with NHL to achieve deeper responses, including complete responses or undetectable minimal residual disease (MRD). About the TakeAim CLL Study The TakeAim CLL Study is an open label phase 2 study of emavusertib in combination with zanubrutinib in patients with CLL (CA-4948-203, NCT07271667). Participants in the study must be in a partial response (PR) or partial response with lymphocytosis (PR-L), with measurable residual disease (MRD+) as determined by the clonoSEQ assay and actively taking zanubrutinib for at least 12 months. Curis expects to announce the dosing of the initial 5 patients in the TakeAim CLL study by the end of July, with initial data expected in December 2026. About Curis, Inc. Curis is a biotechnology company focused on the development of emavusertib, an orally available, small molecule IRAK4 and FLT3 inhibitor. Emavusertib is currently being evaluated in the TakeAim Lymphoma Phase 1/2 study (CA-4948-101) of emavusertib in combination with the BTK inhibitor, ibrutinib, in patients with relapsed/refractory primary central nervous system lymphoma (PCNSL) and in the TakeAim CLL Phase 2 study (CA-4948-203) of emavusertib in combination with the BTK inhibitor, zanubrutinib, in chronic lymphocytic leukemia (CLL). The Company's monotherapy and combination studies in acute myeloid leukemia (AML) are substantially complete, with additional funding the Company plans to continue development of emavusertib in AML. Emavusertib has received Orphan Drug Designation from the U.S. Food and Drug Administration for the treatment of PCNSL, AML and MDS and from the European Commission for the treatment of PCNSL. Curis, through its 2015 collaboration with Aurigene Discovery Technologies Limited, has the exclusive license to emavusertib (CA-4948). For more information, visit Curis's website at . Cautionary Note Regarding Forward-Looking Statements: This press release contains forward-looking statements within the meaning of the U.S. Private Securities Litigation Reform Act of 1995, including, without limitation, statements concerning Curis's expectations with respect to the dosing of the first five patients and initial data from the TakeAim CLL study. Forward-looking statements may contain the words "believes," "expects," "anticipates," "plans," "intends," "seeks," "estimates," "assumes," "predicts," "projects," "targets," "will," "may," "would," "could," "should," "likelihood", "continue," "potential," "opportunity," "focus," "strategy," "mission," or similar expressions. These forward-looking statements are not guarantees of future performance and involve risks, uncertainties, assumptions and other important factors that may cause actual results to be materially different from those indicated by such forward-looking statements. Curis may experience adverse results, delays and/or failures in its drug development programs and may not be able to successfully advance the development of its drug candidates in the time frames it projects, if at all. Curis's drug candidates may cause unexpected toxicities, fail to demonstrate sufficient safety and efficacy in clinical studies and/or may never achieve the requisite regulatory approvals needed for commercialization. Favorable results seen in preclinical studies and early clinical trials of Curis's drug candidates may not be replicated in later trials. Curis is dependent on the success of emavusertib and any delays in the development of emavusertib could have a material adverse effect on its business. There can be no guarantee that the collaboration agreement with Aurigene or the CRADA with NCI will continue for their full terms, that Curis or its collaborators will each maintain the financial and other resources necessary to continue financing its portion of the research, development and commercialization costs, or that the parties will successfully discover, develop or commercialize drug candidates under the collaboration. Curis will require substantial additional capital to fund its business. Based on its available cash resources, it does not have sufficient cash on hand to support current operations within the next 12 months from the date of this press release. Curis will require substantial additional funding to fund the development of emavusertib through regulatory approval and commercialization, and to support its continued operations. If it is not able to obtain sufficient funding, it will be forced to delay, reduce in scope or eliminate the development of emavusertib, including related clinical trials and operating expenses, potentially delaying the time to market for, or preventing the marketing of, emavusertib, which could adversely affect its business prospects and its ability to continue operations, and would have a negative impact on its financial condition and its ability to pursue its business strategies. Curis faces substantial competition. Curis and its collaborators face the risk of potential adverse decisions made by the FDA, EMA and other regulatory authorities, investigational review boards, and publication review bodies. Curis may not obtain or maintain necessary patent protection and could become involved in expensive and time-consuming patent litigation and interference proceedings. Unstable market and economic conditions, natural disasters, public health crises, political crises and other events outside of Curis's control, including its ability to regain and maintain its listing on the Nasdaq Capital Market, could significantly disrupt its operations or the operations of third parties on which Curis depends and could adversely impact Curis's operating results and its ability to raise capital. Other important factors that may cause or contribute to actual results being materially different from those indicated by forward-looking statements include the factors set forth under the captions "Risk Factor Summary" and "Risk Factors" in our most recent Form 10-K, and the factors that are discussed in other filings that Curis periodically makes with the Securities and Exchange Commission. In addition, any forward-looking statements represent the views of Curis only as of today and should not be relied upon as representing Curis's views as of any subsequent date. Curis disclaims any intention or obligation to update any of the forward-looking statements after the date of this press release whether as a result of new information, future events or otherwise, except as may be required by law. __________________________ 1 Bennett, Curr Opin Hematol. 2022 2 Zanubrutinib USPI. SOURCE Curis, Inc. 21% more press release views with Request a Demo

Phase 2Orphan DrugLicense out/in

02 Jul 2026

·www.prnewswire.com

Lilly's Jaypirca (pirtobrutinib) recommended by CHMP for approval in the European Union for adults with chronic lymphocytic leukemia (CLL) across all lines of therapy

The positive opinion is based on results from the Phase 3 BRUIN CLL-313 and BRUIN CLL-314 trials, previously presented at the 2025 American Society of Hematology Annual Meeting and published in The Journal of Clinical Oncology BRUIN CLL-313 is the first Phase 3 study to evaluate a non-covalent BTK inhibitor exclusively in patients with treatment-naïve CLL and BRUIN CLL-314 is the first Phase 3 CLL trial to compare non-covalent and covalent BTK inhibitors, as well as the first to compare any BTK inhibitors in the treatment-naïve setting If granted marketing authorization, this would expand pirtobrutinib's indication as a treatment option for patients with CLL in the European Union across all lines of therapy June 26, 2026 -- Eli Lilly and Company (NYSE: LLY) today announced that the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) has issued a positive opinion for Jaypirca (pirtobrutinib), a non-covalent Bruton tyrosine kinase (BTK) inhibitor, for the treatment of adults with chronic lymphocytic leukemia (CLL) across all lines of therapy and regardless of prior BTK inhibitor treatment. Following this positive opinion, the application is now referred to the European Commission for final action. The European Commission's decision is expected in the next one to two months. "Results from BRUIN CLL-313 and BRUIN CLL-314 provide compelling evidence that pirtobrutinib can make a meaningful difference for people living with CLL across multiple lines of therapy," said Paolo Ghia, M.D., professor, medical oncology, Università Vita-Salute San Raffaele and IRCCS Ospedale San Raffaele, Milano, Italy. "The strong efficacy and tolerability demonstrated in these trials underscores the clinical value pirtobrutinib may offer patients. This positive opinion from the CHMP is an exciting and significant milestone, bringing us closer to a future where pirtobrutinib is an option for more people with CLL across the European Union." Results from BRUIN CLL-313 and BRUIN CLL-314 were presented at the American Society of Hematology (ASH) Annual Meeting and Exposition in December 2025 and published in The Journal of Clinical Oncology. "Based on the strong results from the BRUIN CLL-313 and CLL-314 studies, we believe Jaypirca has the potential to serve as a meaningful new option for newly diagnosed patients and those who have not yet received a BTK inhibitor," said Jacob Van Naarden, executive vice president and president of Lilly Oncology. "Thanks to the impact of contemporary CLL treatments, many patients may receive fewer lines of therapy over their lifetime, making treatment choices in earlier lines profoundly important. This CHMP opinion represents a step toward an important global approval for Jaypirca in this indication and reflects our ambition to make Jaypirca available to every CLL patient who may benefit, at any line of therapy. Today, we are on the brink of making that a reality across the European Union as we await the European Commission's final decision." Lilly has also submitted these results to the U.S. Food and Drug Administration (FDA) for approval for adult patients with CLL, with a decision expected in the second half of 2026. BRUIN CLL-313 is a Phase 3, global, randomized, open-label study of pirtobrutinib versus chemoimmunotherapy (BR) in people with CLL/SLL without 17p deletions who have not been previously treated. The trial enrolled 282 patients who were randomized 1:1 to receive pirtobrutinib (200 mg orally, once daily) or BR per labeled doses. BR is a chemoimmunotherapy regimen used in the treatment of CLL. The primary endpoint is PFS as assessed by blinded IRC. Secondary endpoints include investigator and IRC assessed ORR, duration of response (DoR), and PFS, OS, time to next treatment (TTNT), safety and tolerability and patient-reported outcomes (PRO). BRUIN CLL-314 is a Phase 3, randomized, open-label study of Jaypirca (pirtobrutinib) versus Imbruvica (ibrutinib) in patients with CLL/SLL who were either treatment-naïve, or who were previously treated and were BTK inhibitor-naïve. The trial enrolled 662 patients who were randomized 1:1 to receive pirtobrutinib (200 mg orally, once daily) or ibrutinib (420 mg orally, once daily). The primary endpoint is ORR as assessed by blinded IRC. Secondary endpoints include investigator and IRC-assessed PFS, duration of response (DoR) and event-free survival (EFS), and time to next treatment (TTNT), OS, safety and tolerability, and patient-reported outcomes (PRO). Jaypirca (pirtobrutinib, formerly known as LOXO-305) (pronounced jay-pihr-kaa) is a highly selective (300 times more selective for BTK versus 98% of other kinases tested in preclinical studies), non-covalent inhibitor of the enzyme BTK.1 BTK is a validated molecular target found across numerous B-cell leukemias and lymphomas including mantle cell lymphoma (MCL) and chronic lymphocytic leukemia (CLL).2,3 Jaypirca is a U.S. FDA-approved oral prescription medicine, 100 mg or 50 mg tablets taken as a once-daily 200 mg dose with or without food until disease progression or unacceptable toxicity. CLL is a form of slow-growing non-Hodgkin lymphoma that develops from white blood cells known as lymphocytes.4,5 CLL is one of the most common types of leukemia in adults.6 There are roughly 100,000 new cases of CLL globally each year, and the overall incidence of CLL in Europe is approximately 4.92 cases per 100,000 persons per year.6,7 In CLL, the cancer cells are present in the blood.6 Lilly is a medicine company turning science into healing to make life better for people around the world. We've been pioneering life-changing discoveries for 150 years, and today our medicines help tens of millions of people across the globe. Harnessing the power of biotechnology, chemistry and genetic medicine, our scientists are urgently advancing new discoveries to solve some of the world's most significant health challenges: redefining diabetes care; treating obesity and curtailing its most devastating long-term effects; advancing the fight against Alzheimer's disease; providing solutions to some of the most debilitating immune system disorders; and transforming the most difficult-to-treat cancers into manageable diseases. With each step toward a healthier world, we're motivated by one thing: making life better for millions more people. That includes delivering innovative clinical trials that reflect the diversity of our world and working to ensure our medicines are accessible and affordable. Endnotes & References Mato AR, Shah NN, Jurczak W, et al. Pirtobrutinib in relapsed or refractory B-cell malignancies (BRUIN): a phase 1/2 study. Lancet. 2021;397(10277):892-901. doi:10.1016/S0140-6736(21)00224-5 Hanel W, Epperla N. Emerging therapies in mantle cell lymphoma. J Hematol Oncol. 2020;13(1):79. Published 2020 Jun 17. doi:10.1186/s13045-020-00914-1 Gu D, Tang H, Wu J, Li J, Miao Y. Targeting Bruton tyrosine kinase using non-covalent inhibitors in B cell malignancies. J Hematol Oncol. 2021;14(1):40. Published 2021 Mar 6. doi:10.1186/s13045-021-01049-7 Mukkamalla SKR, Taneja A, Malipeddi D, et al. Chronic Lymphocytic Leukemia. [Updated 2023 Feb 18]. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2023 Jan. Available from: https://www.ncbi.nlm.nih.gov/books/NBK470433/ The Leukemia and Lymphoma Society. NHL Subtypes. Access here: https://www.lls.org/lymphoma/non-hodgkin-lymphoma/nhl-subtypes. Accessed on October 25, 2023. Ou Y, Long Y, Ji L, et al. Trends in Disease Burden of Chronic Lymphocytic Leukemia at the Global, Regional, and National Levels From 1990 to 2019, and Projections Until 2030: A Population-Based Epidemiologic Study. Front Oncol. 2022;12:840616. Published 2022 Mar 10. doi:10.3389/fonc.2022.840616 Sant M, et al. Incidence of hematologic malignancies in Europe by morphologic subtype: results of the HAEMACARE project. Blood. 2010. 116:3724–34. https://pubmed.ncbi.nlm.nih.gov/20664057/ The content above comes from the network. if any infringement, please contact us to modify.

Clinical ResultASHDrug ApprovalASCO

29 Jun 2026

·www.fiercepharma.com

BeOne’s Brukinsa hits goal in mantle cell lymphoma confirmatory trial

A Brukinsa regimen has delivered a large progression-free survival (PFS) benefit in what BeOne Medicines called a “new chemotherapy-free standard” in first-line mantle cell lymphoma. The BTK inhibitor, combined with rituximab, reduced the risk of progression or death by 43% compared with bendamustine and rituximab (BR) in the phase 3 Mangrove study, BeOne announced Tuesday. Overall survival (OS), a key secondary endpoint, remained immature but showed a “strong trend” in favor of the Brukinsa regimen, the company said. The Mangrove study, also known as BGB-3111-306, is meant to serve as the confirmatory trial for Brukinsa’s accelerated approval in previously treated MCL. Granted in 2019, that FDA nod kicked off Brukinsa’s blockbuster journey. BeOne said it’s in discussions with regulatory authorities on planned submissions in 2026. OS outcomes will likely be key in BeOne’s approval bid with the FDA. Previously, AbbVie and Johnson & Johnson withdrew Imbruvica’s MCL indication in the U.S. after the phase 3 Shine study showed a statistically significant reduction in the risk of disease progression or death, but a negative OS trend, for the addition of Imbruvica to bendamustine and rituximab. In early 2025, the FDA greenlighted AstraZeneca’s rival BTK drug Calquence, used in tandem with bendamustine and rituximab, in first-line MCL patients who are ineligible for autologous stem cell transplant. In the phase 3 Echo study, the Calquence regimen cut the risk of disease progression or death by 27% versus bendamustine and rituximab. At the time of the PFS analysis, OS data remained immature but favored the Calquence regimen, with patient deaths reported in 32% of the Calquence arm versus 35% in the control arm. Then, in July 2025, based on the phase 3 Triangle study conducted in Europe, J&J convinced the European Commission to approve Imbruvica as part of a multi-drug combination, which involves the R-CHOP combo, for first-line MCL patients who would be eligible for an autologous stem cell transplant. In that study, Imbruvica plus chemoimmunotherapy with or without transplant significantly reduced the risk of death by 47.8% versus transplant and chemoimmunotherapy. Now, without bendamustine and rituximab maintenance, Brukinsa plus rituximab has shown “unprecedented improvements” in PFS, “potentially redefining the treatment paradigm globally,” BeOne’s chief medical officer of hematology, Amit Agarwal, M.D., Ph.D., said in a June 30 statement. “We believe it would be very meaningful for patients to be free from the burden of frequent infusions,” he added. Sparing patients the toxicity burden of upfront chemotherapy could be beneficial in MCL, as the non-Hodgkin lymphoma subtype predominantly affects older adults, according to BeOne. An approval in first-line MCL could help Brukinsa pull further ahead of Calquence in revenue as the two drugs eat away at Imbruvica’s market share. In the first quarter, Brukinsa global sales reached $1.1 billion, versus $923 million for Calquence.

Clinical ResultPhase 3Drug ApprovalImmunotherapyAccelerated Approval

100 Deals associated with Ibrutinib

External Link

KEGG	Wiki	ATC	Drug Bank
D10223	Ibrutinib	L01XE27	DB09053

R&D Status

Approved

10 top approved records.

to view more data

Indication	Country/Location	Organization	Date
Lymphoplasmacytic Lymphoma	Japan	Janssen Pharmaceutical KK	23 Dec 2022
Marginal Zone B-Cell Lymphoma	United States	Pharmacyclics LLC	18 Jan 2017
Chronic graft-versus-host disease	Mexico	Janssen-Cilag SA de CV	01 Mar 2015
Small Lymphocytic Lymphoma	Mexico	Janssen-Cilag SA de CV	01 Mar 2015
Mantle cell lymphoma recurrent	European Union	Janssen-Cilag International NV	21 Oct 2014
Mantle cell lymphoma recurrent	Iceland	Janssen-Cilag International NV	21 Oct 2014
Mantle cell lymphoma recurrent	Liechtenstein	Janssen-Cilag International NV	21 Oct 2014
Mantle cell lymphoma recurrent	Norway	Janssen-Cilag International NV	21 Oct 2014
Mantle cell lymphoma refractory	European Union	Janssen-Cilag International NV	21 Oct 2014
Mantle cell lymphoma refractory	Iceland	Janssen-Cilag International NV	21 Oct 2014
Mantle cell lymphoma refractory	Liechtenstein	Janssen-Cilag International NV	21 Oct 2014
Mantle cell lymphoma refractory	Norway	Janssen-Cilag International NV	21 Oct 2014
Waldenstrom Macroglobulinemia	South Korea	Janssen Korea Ltd.	08 Aug 2014
Chronic Lymphocytic Leukemia	United States	Pharmacyclics LLC	12 Feb 2014
Mantle-Cell Lymphoma	United States	Pharmacyclics LLC	13 Nov 2013

Developing

10 top R&D records.

to view more data

Indication	Highest Phase	Country/Location	Organization	Date
Waldenstrom's macroglobulinaemia recurrent	Phase 3	United Kingdom	Janssen-Cilag Ltd.	03 Feb 2020
Hepatitis B, Chronic	Phase 3	Hong Kong	Janssen LP	01 Nov 2016
Refractory Mature B-Cell Non-Hodgkin Lymphoma	Phase 3	United States	Janssen Research & Development LLC	01 Jul 2016
Refractory Mature B-Cell Non-Hodgkin Lymphoma	Phase 3	United States	Pharmacyclics LLC	01 Jul 2016
Refractory Mature B-Cell Non-Hodgkin Lymphoma	Phase 3	Belgium	Janssen Research & Development LLC	01 Jul 2016
Refractory Mature B-Cell Non-Hodgkin Lymphoma	Phase 3	Belgium	Pharmacyclics LLC	01 Jul 2016
Refractory Mature B-Cell Non-Hodgkin Lymphoma	Phase 3	Brazil	Janssen Research & Development LLC	01 Jul 2016
Refractory Mature B-Cell Non-Hodgkin Lymphoma	Phase 3	Brazil	Pharmacyclics LLC	01 Jul 2016
Refractory Mature B-Cell Non-Hodgkin Lymphoma	Phase 3	Bulgaria	Janssen Research & Development LLC	01 Jul 2016
Refractory Mature B-Cell Non-Hodgkin Lymphoma	Phase 3	Bulgaria	Pharmacyclics LLC	01 Jul 2016

Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT02997761 (CTgov)	Phase 2	Refractory B Acute Lymphoblastic Leukemia	19	Ibrutinib+Blinatumomab	ruarwkkayn = hdcnguvnye vvfeeyejyk (roknbfwkoz, csqkitnoxc - aeotukgytj) View more	-	09 Jun 2026
ASCO2026	Phase 1	AIDS-Related Lymphoma CD4 <100 \| asymptomatic leptomeningeal disease	37	Ibrutinib + R-da-EPOCH	vcpxzyzyca(fnbezkejvx) = 105, 50% clepvadwve (nvbfyygfzd ) View more	Positive	29 May 2026
ASCO2026	Phase 2/3	Chronic Lymphocytic Leukemia First line	3,056	Venetoclax plus ibrutinib	peuhxripst(urdansgtnf): HR = 0.52 (95.0% CI, 0.41 - 0.67)	Positive	29 May 2026
				Acalabrutinib plus obinutuzumab
ASCO2026	Not Applicable	Chronic Lymphocytic Leukemia First line	10,523	Zanubrutinib	rvnkjcmyil(mzyhimugap) = fhjexbshho nkiyyijnni (gtttdasmgk ) View more	Positive	29 May 2026
				Ibrutinib	rvnkjcmyil(mzyhimugap) = acajwyerhm nkiyyijnni (gtttdasmgk ) View more
ASCO2026	Not Applicable	Chronic Lymphocytic Leukemia	233,362	zanubrutinib	xdnyqwduyj(lmwspssfbo) = tggusudoao vmowrvxcyy (dschjkhlct ) View more	Positive	29 May 2026
				Acalabrutinib	xdnyqwduyj(lmwspssfbo) = tlyacpefwl vmowrvxcyy (dschjkhlct ) View more
NCT03646461 (CTgov)	Phase 2	Recurrent Squamous Cell Carcinoma of the Head and Neck	5	Ibrutinib 560mg PO daily (Imbruvica)+Cetuximab (Arm A: Ibrutinib + Cetuximab)	mzizvxqqtt = ggkfaljnjs uiyslvqxyz (whjlbgthdt, ulufkipciy - pgvfeomqow) View more	-	22 May 2026
				Ibrutinib 560mg PO daily (Imbruvica)+Nivolumab (Arm B: Ibrutinib + Nivolumab)	mzizvxqqtt = yiovxblajk uiyslvqxyz (whjlbgthdt, jbqftwgjiy - qsabryauaq) View more
EHA2026	Not Applicable	Chronic Lymphocytic Leukemia First line	200	Ibrutinib+Venetoclax	skmxmxpplw(kyleucdxta) = nabqqijplt mlkkwjnpjl (ixbcrtduih, 86.3 - 95.9) View more	Positive	12 May 2026
EHA2026	Not Applicable	Chronic Lymphocytic Leukemia First line	1,707	Ibrutinib continuous monotherapy	sgcjhcdxan(woyfdiynzg) = xnvhjzprzz sucsaxkswt (trnquoudkm ) View more	Positive	12 May 2026
				triplet (ibrutinib, venetoclax + obinutuzumab)	sgcjhcdxan(woyfdiynzg) = afwjjmixfl sucsaxkswt (trnquoudkm ) View more
PTL-2022 (EHA2026)	Not Applicable	Testicular Neoplasms	12	R-mNHL-BFM-90 regimen with ibrutinib and lenalidomide followed by autologous HSCT	qzscunkwqy(iorhigmkdb) = ufvvjwilge bnxhwrslsl (ypffellvjh )	Positive	12 May 2026
EHA2026	Not Applicable	Chronic Lymphocytic Leukemia First line	144	Ibrutinib-Venetoclax (IV)	ggmxzaewig(fehljdomap) = thafczdyvm vrhkttkufs (vpfvchlljg ) View more	Positive	12 May 2026
				Venetoclax-Obinutuzumab (VO)	ggmxzaewig(fehljdomap) = jgmjjljlri vrhkttkufs (vpfvchlljg )

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