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

Structure/Sequence

Molecular FormulaC25H24N6O2

InChIKeyXYFPWWZEPKGCCK-GOSISDBHSA-N

CAS Registry936563-96-1

401

Clinical Trials associated with Ibrutinib

NCT06649812

/ RecruitingPhase 2IIT

A Phase 2 Study of Venetoclax, Ibrutinib, Prednisone, Obinutuzumab, and Revlimid (ViPOR) in Relapsed or Refractory CD10-Negative Diffuse-Large B-Cell Lymphoma (DLBCL) and High-Grade B-Cell Lymphoma With MYC and BCL2 Rearrangements (HGBCL-DH-BCL2)

This phase II trial tests how well venetoclax, ibrutinib, prednisone, obinutuzumab, and Revlimid? (ViPOR) works in treating patients with CD10 negative diffuse large B-cell lymphoma (DLBCL) and high-grade lymphoma with MYC and BCL2 rearrangements that has come back after a period of improvement (relapsed) and/or that has not responded to previous treatment (refractory). Venetoclax is in a class of medications called B-cell lymphoma-2 (BCL-2) inhibitors. It may stop the growth of cancer cells by blocking Bcl-2, a protein needed for cancer cell survival. Ibrutinib is in a class of medications called kinase inhibitors. It blocks a protein called BTK, which is present on B-cell (a type of white blood cells) cancers at abnormal levels. This may help keep cancer cells from growing and spreading. Anti-inflammatory drugs, such as prednisone lower the body's immune response and are used with other drugs in the treatment of some types of cancer. Obinutuzumab, a monoclonal antibody, binds to a protein called CD20, which is found on B cells and some types of leukemia and lymphoma cells. Obinutuzumab may block CD20 and help the immune system kill cancer cells. Revlimid, a type of anti-angiogenesis agent and a type of immunomodulating agent, may help the immune system kill abnormal blood cells or cancer cells. It may also prevent the growth of new blood vessels that cancers need to grow. ViPOR may be an effective treatment option for patients with relapsed and/or refractory CD10 negative DLBCL and high-grade B-cell lymphoma with MYC and BCL2 rearrangements.

Start Date21 Mar 2026

Sponsor / Collaborator

National Cancer Institute

NCT07082868

/ Not yet recruitingPhase 1IIT

A Phase Ib Trial With Dose Expansion of Epcoritamab in Combination With Ibrutinib in Refractory/Recurrent CNS Lymphoma (EIFEL-Trial)

The purpose of this study is to find out whether the combination of epcoritamab and ibrutinib is a safe treatment approach that causes few or mild side effects in people with relapsed/refractory primary central nervous system lymphoma (PCNSL) or secondary central nervous system lymphoma (SCNSL).

Start Date18 Aug 2025

Sponsor / Collaborator

Memorial Sloan Kettering Cancer Center

NCT07052695

/ Not yet recruitingPhase 1/2IIT

A Pilot Study Evaluating Mosunetuzumab for Clearance of Detectable Minimal Residual Disease in Chronic Lymphocytic Leukemia

The goal of this study is to test mosunetuzumab given alone or in combination with a Bruton tyrosine kinase inhibitor (BTKi, such as ibrutinib, acalabrutinib, zanubrutinib, or pirtobrutinib) in participants with CLL (chronic lymphocytic leukemia) or small lymphocytic lymphoma (SLL).
The names of the study drugs in this research study are:
* Mosunetuzumab
* BTK inhibitor: Ibrutinib, acalabrutinib, zanubrutinib, or pirtobrutinib

Start Date01 Aug 2025

Sponsor / Collaborator

Dana-Farber Cancer Institute, Inc.

[+1]

100 Clinical Results associated with Ibrutinib

100 Translational Medicine associated with Ibrutinib

100 Patents (Medical) associated with Ibrutinib

5,480

Literatures (Medical) associated with Ibrutinib

01 Dec 2025·CANCER CHEMOTHERAPY AND PHARMACOLOGY

Evaluation of Bruton’s Tyrosine Kinase (BTK) inhibition with alternative doses of ibrutinib in subjects with Chronic Lymphocytic Leukemia (CLL)

Article

Author: Smith, Emma ; Valenzuela, Belén ; Desphande, Sanjay ; Haddish-Berhane, Nahor ; Perez Ruixo, Juan José ; Srinivasan, Srimathi ; Treijtel, Nicoline ; Ouerdani, Aziz

Abstract:

Purpose:

To evaluate alternative ibrutinib dosing regimens that maintain Bruton’s tyrosine kinase (BTK) receptor occupancy over the entire dosing interval for CLL patients using a model-based approach.

Methods:

Ibrutinib inhibits B-cell proliferation via irreversible binding of BTK. As IC50 is not an appropriate parameter to describe the potency of the inhibition in the presence of a covalent binding inhibitor. A BTK covalent binding model was developed using kinact/KI as key parameter to account for covalent binding. The ibrutinib-BTK covalent binding model was used to describe the effect of daily doses of 140, 280, 420 and 560 mg on the proportion of subjects with more than 90% BTK inhibition at steady state trough concentrations. Predictive performance of the model was assessed using the available ibrutinib BTK inhibition data following QD dosing. Model-based predictions were used to identify the minimum ibrutinib QD dose that provides more than 90% inhibition in more than 90% of the subjects.

Results:

The covalent binding model was able to describe the data and predicted that ibrutinib QD dose reduced from 420 mg to 280 mg or 140 mg may inhibit de novo synthetized BTK efficiently in a CLL population.

Conclusion:

Using a model-based approach showed that reducing the ibrutinib dosing regimen to 280 mg QD or even 140 mg in case of adverse events could maintain BTK inhibition over the entire dosing interval.

01 Dec 2025·JOURNAL OF CLINICAL IMMUNOLOGY

Disseminated Aspergillosis in X-linked Agammaglobulinemia: Beyond the norm

Letter

Author: Rawat, Amit ; Vignesh, Pandiarajan ; Jindal, Ankur Kumar ; Thangaraj, Abarna ; Goel, Sumit ; Sil, Archan

X-linked agammaglobulinemia (XLA) due to a mutation in Bruton's tyrosine kinase (BTK), leads to the arrested development of B cells at the pro-B cell stage. This results in absent B cells and severe hypogammaglobulinemia. XLA patients usually present with recurrent sinopulmonary infection. Bacterial infections are the commonest [2], fungal infections like Pneumocystis jirovecii, Aspergillus and Candida species are rarely reported and they are associated with mortality in XLA [3]. We report a 3.5-year-old boy with disseminated aspergillosis, an uncommon presentation of XLA. Despite treatment with antifungals, including voriconazole and amphotericin B, the patient succumbed to the illness. Genetic analysis revealed a pathogenic variant in the BTK gene (R28H), confirming XLA diagnosis. This case highlights the potential for severe fungal infections in XLA patients and suggests broader immune system dysregulation beyond B-cell defects.

01 Dec 2025·Blood Research

Relative efficacy of systemic treatments for patients with relapsed/refractory chronic lymphocytic leukemia: a network meta-analysis according to 17p deletion/TP53 mutations

Article

Author: Lim, Joo Han ; Kim, Jinchul ; Lee, Moon Hee ; Cho, Jinhyun

Abstract:

Purpose:

This network meta-analysis aimed to evaluate the relative efficacy of systemic treatments in patients with relapsed/refractory chronic lymphocytic leukemia (R/R CLL), focusing on key genetic mutations, specifically the 17p deletion and TP53 mutations.

Methods:

We conducted a systematic literature review to identify all publicly available randomized controlled trials (RCTs) using PubMed, EMBASE, the Cochrane database, and meeting abstracts published through December 2023. A Bayesian network meta-analysis was performed to estimate the hazard ratios (HRs) for progression-free survival (PFS) with 95% confidence intervals (CIs) and to determine the ranking of the included regimens.

Results:

Twelve trials involving 4,437 patients and 13 treatment options were included in the meta-analysis. Venetoclax plus rituximab and zanubrutinib emerged as the most effective treatments for the overall R/R CLL population, showing the lowest PFS HR (HR 0.62, 95% CI 0.32–1.20 and HR 0.65, 95% CI 0.49–0.86, respectively) versus ibrutinib, and were ranked as the best agent (surface under the cumulative ranking curve [SUCRA] value of both 90%, respectively) among the included drugs. In the 17p deletion/TP53 mutation subgroup, zanubrutinib demonstrated the most favorable efficacy (HR 0.52, 95% CI 0.31–0.88 versus ibrutinib) with the highest SUCRA value (97%). In patients without these mutations, venetoclax plus rituximab was the most effective (HR 0.49, 95% CI 0.26–0.94 versus ibrutinib) with a SUCRA value of 94%.

Conclusion:

Our findings highlight the superior efficacy of venetoclax plus rituximab and zanubrutinib for treating R/R CLL and confirm that the role of each regimen may vary depending on the clinically significant mutations.

714

News (Medical) associated with Ibrutinib

31 Jul 2025

·news.abbvie.com

AbbVie Reports Second-Quarter 2025 Financial Results

Corporate News Reports Second-Quarter Diluted EPS of $0.52 on a GAAP Basis, a Decrease of 32.5 Percent; Adjusted Diluted EPS of $2.97, an Increase of 12.1 Percent; These Results Include an Unfavorable Impact of $0.42 Per Share Related to Acquired IPR&D and Milestones Expense Delivers Second-Quarter Net Revenues of $15.423 Billion, an Increase of 6.6 Percent on a Reported Basis or 6.5 Percent on an Operational Basis Second-Quarter Global Net Revenues from the Immunology Portfolio Were $7.631 Billion, an Increase of 9.5 Percent on a Reported Basis, or 9.2 Percent on an Operational Basis; Global Skyrizi Net Revenues Were $4.423 Billion; Global Rinvoq Net Revenues Were $2.028 Billion; Global Humira Net Revenues Were $1.180 Billion Second-Quarter Global Net Revenues from the Neuroscience Portfolio Were $2.683 Billion, an Increase of 24.2 Percent on a Reported Basis, or 24.0 Percent on an Operational Basis; Global Vraylar Net Revenues Were $900 Million; Global Botox Therapeutic Net Revenues Were $928 Million; Combined Global Ubrelvy and Qulipta Net Revenues Were $605 Million Second-Quarter Global Net Revenues from the Oncology Portfolio Were $1.676 Billion, an Increase of 2.6 Percent on a Reported Basis, or 2.4 Percent on an Operational Basis; Global Imbruvica Net Revenues Were $754 Million; Global Venclexta Net Revenues Were $691 Million; Global Elahere Net Revenues Were $159 Million Second-Quarter Global Net Revenues from the Aesthetics Portfolio Were $1.279 Billion, a Decrease of 8.1 Percent on a Reported Basis, or 8.0 Percent on an Operational Basis; Global Botox Cosmetic Net Revenues Were $692 Million; Global Juvederm Net Revenues Were $260 Million Raises 2025 Adjusted Diluted EPS Guidance Range from $11.67 - $11.87 to $11.88 - $12.08, which Includes an Unfavorable Impact of $0.55 Per Share Related to Acquired IPR&D and Milestones Expense Incurred Year-To-Date Through the Second Quarter 2025 NORTH CHICAGO, Ill., July 31, 2025 /PRNewswire/ -- AbbVie (NYSE:ABBV) announced financial results for the second quarter ended June 30, 2025. "AbbVie delivered another outstanding quarter with strong performance from our diversified growth platform. We also made meaningful pipeline progress with several regulatory approvals, encouraging clinical data and strategic investments in promising external innovation," said Robert A. Michael, chairman and chief executive officer, AbbVie. "We're entering the second half of the year with substantial momentum and are once again raising our full-year outlook." Second-Quarter Results Worldwide net revenues were $15.423 billion, an increase of 6.6 percent on a reported basis, or 6.5 percent on an operational basis. Global net revenues from the immunology portfolio were $7.631 billion, an increase of 9.5 percent on a reported basis, or 9.2 percent on an operational basis. Global Skyrizi net revenues were $4.423 billion, an increase of 62.2 percent on a reported basis, or 61.8 percent on an operational basis. Global Rinvoq net revenues were $2.028 billion, an increase of 41.8 percent on a reported basis, or 41.2 percent on an operational basis. Global Humira net revenues were $1.180 billion, a decrease of 58.1 percent on a reported basis, or 58.2 percent on an operational basis. Global net revenues from the neuroscience portfolio were $2.683 billion, an increase of 24.2 percent on a reported basis, or 24.0 percent on an operational basis. Global Vraylar net revenues were $900 million, an increase of 16.3 percent. Global Botox Therapeutic net revenues were $928 million, an increase of 14.1 percent on a reported basis, or 14.2 percent on an operational basis. Global Ubrelvy net revenues were $338 million, an increase of 47.1 percent on a reported basis, or 47.2 percent on an operational basis. Global Qulipta net revenues were $267 million, an increase of 77.5 percent on a reported basis, or 76.9 percent on an operational basis. Global net revenues from the oncology portfolio were $1.676 billion, an increase of 2.6 percent on a reported basis, or 2.4 percent on an operational basis. Global Imbruvica net revenues were $754 million, a decrease of 9.5 percent. Global Venclexta net revenues were $691 million, an increase of 8.5 percent on a reported basis, or 8.3 percent on an operational basis. Global Elahere net revenues were $159 million, an increase of 24.2 percent on a reported basis, or 23.7 percent on an operational basis. Global net revenues from the aesthetics portfolio were $1.279 billion, a decrease of 8.1 percent on a reported basis, or 8.0 percent on an operational basis. Global Botox Cosmetic net revenues were $692 million, a decrease of 5.0 percent on a reported basis, or 4.9 percent on an operational basis. Global Juvederm net revenues were $260 million, a decrease of 24.0 percent. On a GAAP basis, gross margin in the second quarter was 71.8 percent. The adjusted gross margin was 84.4 percent. On a GAAP basis, selling, general and administrative (SG&A) expense was 21.1 percent of net revenues. The adjusted SG&A expense was 21.0 percent of net revenues. On a GAAP basis, research and development (R&D) expense was 13.8 percent of net revenues. The adjusted R&D expense was 13.7 percent of net revenues. Acquired IPR&D and milestones expense was 5.3 percent of net revenues. On a GAAP basis, operating margin in the second quarter was 31.7 percent. The adjusted operating margin was 44.3 percent. Net interest expense was $678 million. On a GAAP basis, the tax rate in the quarter was 39.4 percent. The adjusted tax rate was 16.2 percent. Diluted EPS in the second quarter was $0.52 on a GAAP basis. Adjusted diluted EPS, excluding specified items, was $2.97. These results include an unfavorable impact of $0.42 per share related to acquired IPR&D and milestones expense. Global Skyrizi net revenues were $4.423 billion, an increase of 62.2 percent on a reported basis, or 61.8 percent on an operational basis. Global Rinvoq net revenues were $2.028 billion, an increase of 41.8 percent on a reported basis, or 41.2 percent on an operational basis. Global Humira net revenues were $1.180 billion, a decrease of 58.1 percent on a reported basis, or 58.2 percent on an operational basis. Global Vraylar net revenues were $900 million, an increase of 16.3 percent. Global Botox Therapeutic net revenues were $928 million, an increase of 14.1 percent on a reported basis, or 14.2 percent on an operational basis. Global Ubrelvy net revenues were $338 million, an increase of 47.1 percent on a reported basis, or 47.2 percent on an operational basis. Global Qulipta net revenues were $267 million, an increase of 77.5 percent on a reported basis, or 76.9 percent on an operational basis. Global Imbruvica net revenues were $754 million, a decrease of 9.5 percent. Global Venclexta net revenues were $691 million, an increase of 8.5 percent on a reported basis, or 8.3 percent on an operational basis. Global Elahere net revenues were $159 million, an increase of 24.2 percent on a reported basis, or 23.7 percent on an operational basis. Global Botox Cosmetic net revenues were $692 million, a decrease of 5.0 percent on a reported basis, or 4.9 percent on an operational basis. Global Juvederm net revenues were $260 million, a decrease of 24.0 percent. Note: "Operational" comparisons are presented at constant currency rates that reflect comparative local currency net revenues at the prior year's foreign exchange rates. Recent Events AbbVie announced the U.S. Food and Drug Administration (FDA) approved Rinvoq (upadacitinib) as the first oral Janus Kinase (JAK) inhibitor approved for the treatment of adults with giant cell arteritis (GCA). The approval was supported by data from the pivotal Phase 3 SELECT-GCA trial, which met the primary endpoint of sustained remission and key secondary endpoints. This marks the ninth approved indication for Rinvoq in the U.S., across rheumatology, gastroenterology and dermatology. AbbVie announced positive topline results from the first of two pivotal studies in the Phase 3 UP-AA clinical program evaluating the safety and efficacy of Rinvoq in adult and adolescent patients with severe alopecia areata (AA). In the study, Rinvoq achieved the primary endpoint, demonstrating that 44.6% and 54.3% of patients with severe AA treated with Rinvoq 15mg and 30mg, respectively, reached 80% or more scalp hair coverage at week 24 as defined by the severity of alopecia tool (SALT) score ≤20. Key secondary endpoints, including improvements in eyebrows and eyelashes, as well as the percentage of subjects with 90% or more scalp coverage (SALT ≤10) and complete scalp hair coverage (SALT=0) at Week 24, were also met. Rinvoq's safety profile in AA was generally consistent with that in approved indications, and no new safety signals were identified in this study. AbbVie and Capstan Therapeutics, a clinical-stage biotechnology company dedicated to advancing in vivo engineering of cells through RNA delivery using targeted lipid nanoparticles (tLNPs), announced a definitive agreement under which AbbVie will acquire Capstan. The transaction includes CPTX2309, a potential first-in-class in vivo tLNP anti-CD19 CAR-T therapy candidate, currently in Phase 1 development for the treatment of B cell-mediated autoimmune diseases. Additionally, AbbVie will acquire Capstan's proprietary tLNP platform technology designed to deliver RNA payloads, such as mRNA, capable of engineering specific cell types in vivo. AbbVie announced new data from its Phase 3 TEMPLE head-to-head study evaluating the tolerability, safety and efficacy of Qulipta (atogepant) compared to topiramate for the preventive treatment of migraine in adult patients with a history of four or more migraine days per month. In the study, Qulipta met the primary endpoint of fewer treatment discontinuations attributed to adverse events versus topiramate, and all six secondary endpoints achieved statistical significance for superiority versus topiramate, demonstrating clinical efficacy. Full results from the TEMPLE study will be presented at an upcoming medical meeting. AbbVie announced that Emrelis (telisotuzumab vedotin-tllv) was granted accelerated approval by the FDA for the treatment of adult patients with locally advanced or metastatic, non-squamous non-small cell lung cancer (NSCLC) with high c-Met protein overexpression who have received a prior systemic therapy. Emrelis is the first treatment approved for previously treated advanced NSCLC patients with high c-Met protein overexpression, a population that often faces poor prognosis and has limited treatment options. AbbVie announced the submission of a supplemental New Drug Application (sNDA) to the FDA for Venclexta (venetoclax) and acalabrutinib combination therapy for the treatment of chronic lymphocytic leukemia (CLL). This combination therapy has potential to be the first all oral, fixed-duration regimen for previously untreated patients with CLL. The submission is supported by data from the Phase 3 AMPLIFY trial which demonstrated that the combination regimen of Venclexta and acalabrutinib improved progression-free survival (PFS) compared to standard chemoimmunotherapy in previously untreated patients with CLL. At the American Society of Clinical Oncology (ASCO) Annual Meeting, AbbVie presented key data that showcased significant progress across AbbVie's robust oncology pipeline, in a range of difficult-to-treat solid tumors and blood cancers. Highlights included new data from AbbVie's novel investigational antibody-drug conjugates (ADCs) telisotuzumab adizutecan (ABBV-400, Temab-A) in advanced NSCLC, ABBV-706 in high-grade neuroendocrine neoplasms (NENs) and pivekimab sunirine (PVEK) in blastic plasmacytoid dendritic cell neoplasm (BPDCN). AbbVie announced the global Phase 3 VERONA trial evaluating Venclexta (venetoclax) in combination with azacitidine in the treatment of newly diagnosed higher-risk myelodysplastic syndrome (MDS) did not meet the primary endpoint of overall survival. No new safety signals were observed and results from the trial will be available in a future medical congress and/or publication. AbbVie and Ichnos Glenmark Innovation (IGI) announced an exclusive licensing agreement for IGI's lead investigational asset, ISB 2001, which is being investigated for the treatment of oncology and autoimmune diseases. ISB 2001 is a first-in-class trispecific T-cell engager currently in Phase 1 development for relapsed/refractory (r/r) multiple myeloma (MM). AbbVie announced the FDA approved a label expansion for Mavyret (glecaprevir/pibrentasvir), an oral pangenotypic direct acting antiviral (DAA) therapy. Mavyret is the first oral eight-week pangenotypic treatment option approved for people with acute or chronic hepatitis C virus (HCV). With this approval, providers can now treat HCV patients immediately at the time of diagnosis. AbbVie and ADARx Pharmaceuticals, a late clinical-stage biotechnology company developing next-generation RNA therapeutics, announced a collaboration and license option agreement to develop small interfering RNA (siRNA) therapeutics across multiple disease areas. The collaboration will leverage AbbVie's expertise in biotherapeutic drug development and commercialization with ADARx's proprietary RNA technology to advance next-generation siRNA therapies across neuroscience, immunology and oncology. Full-Year 2025 Outlook AbbVie is raising its adjusted diluted EPS guidance for the full year 2025 from $11.67 - $11.87 to $11.88 - $12.08, which includes an unfavorable impact of $0.55 per share related to acquired IPR&D and milestones expense incurred year-to-date through the second quarter 2025. The company's 2025 adjusted diluted EPS guidance excludes any impact from acquired IPR&D and milestones that may be incurred beyond the second quarter of 2025, as both cannot be reliably forecasted. About AbbVie AbbVie's mission is to discover and deliver innovative medicines that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas: immunology, neuroscience, oncology, and eye care - and products and services across our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on X (formerly Twitter), Facebook, Instagram, YouTube or LinkedIn. Conference Call AbbVie will host an investor conference call today at 8:00 a.m. Central Time to discuss our second-quarter performance. The call will be webcast through AbbVie's Investor Relations website at investors.abbvie.com. An archived edition of the call will be available after 11:00 a.m. Central Time. Non-GAAP Financial Results Financial results for 2025 and 2024 are presented on both a reported and a non-GAAP basis. Reported results were prepared in accordance with GAAP and include all revenue and expenses recognized during the period. Non-GAAP results adjust for certain non-cash items and for factors that are unusual or unpredictable, and exclude those costs, expenses, and other specified items presented in the reconciliation tables later in this release. AbbVie's management believes non-GAAP financial measures provide useful information to investors regarding AbbVie's results of operations and assist management, analysts and investors in evaluating the performance of the business. Non-GAAP financial measures should be considered in addition to, and not as a substitute for, measures of financial performance prepared in accordance with GAAP. Forward-Looking Statements Some statements in this news release are, or may be considered, forward-looking statements for purposes of the Private Securities Litigation Reform Act of 1995. The words "believe," "expect," "anticipate," "project" and similar expressions and uses of future or conditional verbs, generally identify forward-looking statements. AbbVie cautions that these forward-looking statements are subject to risks and uncertainties that may cause actual results to differ materially from those expressed or implied in the forward-looking statements. Such risks and uncertainties include, but are not limited to, challenges to intellectual property, competition from other products, difficulties inherent in the research and development process, adverse litigation or government action, changes to laws and regulations applicable to our industry, the impact of global macroeconomic factors, such as economic downturns or uncertainty, international conflict, trade disputes and tariffs, and other uncertainties and risks associated with global business operations. Additional information about the economic, competitive, governmental, technological and other factors that may affect AbbVie's operations is set forth in Item 1A, "Risk Factors," of AbbVie's 2024 Annual Report on Form 10-K, which has been filed with the Securities and Exchange Commission, as updated by its Quarterly Reports on Form 10-Q and in other documents that AbbVie subsequently files with the Securities and Exchange Commission that update, supplement or supersede such information. AbbVie undertakes no obligation, and specifically declines, to release publicly any revisions to forward-looking statements as a result of subsequent events or developments, except as required by law. Media: Investors: Gabby Tarbert Liz Shea (224) 244-0111 (847) 935-2211 Todd Bosse (847) 936-1182 Jeffrey Byrne (847) 938-2923 AbbVie Inc. Key Product Revenues Quarter Ended June 30, 2025 (Unaudited) % Change vs. 2Q24 Net Revenues (in millions) Reported Operationala U.S. Int'l. Total U.S. Int'l. Total Int'l. Total NET REVENUES $11,762 $3,661 $15,423 5.9 % 9.1 % 6.6 % 8.4 % 6.5 % Immunology 6,097 1,534 7,631 6.7 22.3 9.5 20.7 9.2 Skyrizi 3,843 580 4,423 64.3 49.7 62.2 47.2 61.8 Rinvoq 1,452 576 2,028 42.7 39.6 41.8 37.5 41.2 Humira 802 378 1,180 (66.0) (16.8) (58.1) (17.2) (58.2) Neuroscience 2,333 350 2,683 23.2 30.6 24.2 28.7 24.0 Vraylar 898 2 900 16.2 72.8 16.3 76.8 16.3 Botox Therapeutic 775 153 928 15.9 5.7 14.1 6.0 14.2 Ubrelvy 330 8 338 46.5 73.9 47.1 76.7 47.2 Qulipta 237 30 267 62.8 >100.0 77.5 >100.0 76.9 Vyalev 22 76 98 n/m >100.0 >100.0 >100.0 >100.0 Duodopa 20 77 97 (13.6) (13.7) (13.7) (16.3) (15.7) Other Neuroscience 51 4 55 (11.4) (23.3) (12.3) (21.3) (12.2) Oncology 1,026 650 1,676 (1.0) 8.7 2.6 8.3 2.4 Imbruvicab 543 211 754 (8.9) (11.2) (9.5) (11.2) (9.5) Venclexta 321 370 691 7.4 9.5 8.5 9.1 8.3 Elahere 138 21 159 8.0 n/m 24.2 n/m 23.7 Epkinlyc 22 48 70 57.4 >100.0 93.9 >100.0 92.3 Other Oncology 2 — 2 n/m n/m n/m n/m n/m Aesthetics 797 482 1,279 (7.8) (8.5) (8.1) (8.3) (8.0) Botox Cosmetic 410 282 692 (8.7) 0.9 (5.0) 1.2 (4.9) Juvederm Collection 105 155 260 (23.6) (24.4) (24.0) (24.4) (24.0) Other Aesthetics 282 45 327 1.6 5.8 2.2 6.4 2.3 Eye Care 226 288 514 (5.7) (2.4) (3.9) (1.5) (3.4) Ozurdex 30 95 125 (12.6) 5.8 0.6 4.4 (0.4) Lumigan/Ganfort 52 51 103 19.9 (15.4) (0.8) (15.2) (0.7) Alphagan/Combigan — 36 36 (91.6) (3.1) (25.6) (0.2) (23.5) Other Eye Care 144 106 250 (4.3) (1.7) (3.2) 0.9 (2.1) Other Key Products 835 202 1,037 11.2 (4.4) 7.8 (5.8) 7.5 Mavyret 184 191 375 9.7 (5.1) 1.6 (6.5) 0.8 Creon 404 — 404 8.4 n/m 8.4 n/m 8.4 Linzess/Constella 247 11 258 17.4 10.8 17.1 10.3 17.1 a "Operational" comparisons are presented at constant currency rates that reflect comparative local currency net revenues at the prior year's foreign exchange rates. b Reflects profit sharing for Imbruvica international revenues. c Epkinly U.S. revenues reflect profit sharing. International revenues reflect product revenues as well as profit sharing from certain international territories. n/m = not meaningful AbbVie Inc. Key Product Revenues Six Months Ended June 30, 2025 (Unaudited) % Change vs. 6M24 Net Revenues (in millions) Reported Operationala U.S. Int'l. Total U.S. Int'l. Total Int'l. Total NET REVENUES $21,741 $7,025 $28,766 7.9 % 6.0 % 7.4 % 8.3 % 8.0 % Immunology 10,980 2,915 13,895 11.3 17.9 12.6 20.4 13.1 Skyrizi 6,762 1,086 7,848 69.2 46.9 65.8 49.6 66.2 Rinvoq 2,672 1,074 3,746 53.3 37.6 48.5 40.1 49.3 Humira 1,546 755 2,301 (62.6) (20.8) (54.7) (18.4) (54.3) Neuroscience 4,305 660 4,965 19.3 27.4 20.3 29.8 20.6 Vraylar 1,661 4 1,665 13.4 41.8 13.5 47.4 13.5 Botox Therapeutic 1,498 296 1,794 17.0 5.2 14.9 8.6 15.5 Ubrelvy 563 15 578 33.0 46.7 33.3 51.2 33.4 Qulipta 409 51 460 49.5 >100.0 63.6 >100.0 63.6 Vyalev 28 133 161 n/m >100.0 >100.0 >100.0 >100.0 Duodopa 40 153 193 (16.6) (14.9) (15.2) (14.0) (14.5) Other Neuroscience 106 8 114 (10.4) (12.7) (10.5) (8.1) (10.2) Oncology 2,053 1,256 3,309 2.4 7.1 4.2 9.1 5.0 Imbruvicab 1,072 420 1,492 (11.1) (9.7) (10.7) (9.7) (10.7) Venclexta 633 723 1,356 9.1 7.8 8.4 11.3 10.3 Elahere 303 35 338 57.5 n/m 75.5 n/m 75.5 Epkinlyc 43 78 121 61.8 >100.0 92.1 >100.0 93.3 Other Oncology 2 — 2 n/m n/m n/m n/m n/m Aesthetics 1,437 944 2,381 (12.3) (5.6) (9.8) (3.6) (9.0) Botox Cosmetic 705 543 1,248 (15.9) 3.7 (8.4) 5.8 (7.6) Juvederm Collection 180 311 491 (25.9) (21.5) (23.2) (19.8) (22.2) Other Aesthetics 552 90 642 (1.0) 11.7 0.6 14.5 0.9 Eye Care 447 573 1,020 (4.2) (5.3) (4.8) (1.8) (2.8) Ozurdex 60 188 248 (12.4) 0.8 (2.8) 2.7 (1.4) Lumigan/Ganfort 100 109 209 39.4 (11.0) 7.5 (7.7) 9.6 Alphagan/Combigan 26 70 96 (3.6) (13.1) (10.6) (8.5) (7.2) Other Eye Care 261 206 467 (12.8) (4.4) (9.3) 0.3 (7.3) Other Key Products 1,471 375 1,846 2.5 (12.0) (0.8) (10.4) (0.4) Mavyret 326 355 681 4.9 (12.8) (5.1) (11.2) (4.2) Creon 759 — 759 15.4 n/m 15.4 n/m 15.4 Linzess/Constella 386 20 406 (17.4) 7.0 (16.5) 9.7 (16.4) a "Operational" comparisons are presented at constant currency rates that reflect comparative local currency net revenues at the prior year's foreign exchange rates. b Reflects profit sharing for Imbruvica international revenues. c Epkinly U.S. revenues reflect profit sharing. International revenues reflect product revenues as well as profit sharing from certain international territories. n/m = not meaningful AbbVie Inc. Consolidated Statements of Earnings (Unaudited) (in millions, except per share data) Second Quarter Ended June 30 Six Months Ended June 30 2025 2024 2025 2024 Net revenues $ 15,423 $ 14,462 $ 28,766 $ 26,772 Cost of products sold 4,346 4,202 8,348 8,296 Selling, general and administrative 3,253 3,377 6,546 6,692 Research and development 2,131 1,948 4,198 3,887 Acquired IPR&D and milestones 823 937 1,071 1,101 Other operating income (24) — (24) — Total operating costs and expenses 10,529 10,464 20,139 19,976 Operating earnings 4,894 3,998 8,627 6,796 Interest expense, net 678 506 1,305 959 Net foreign exchange loss 23 1 27 5 Other expense, net 2,639 1,345 4,080 1,931 Earnings before income tax expense 1,554 2,146 3,215 3,901 Income tax expense 613 773 985 1,156 Net earnings 941 1,373 2,230 2,745 Net earnings attributable to noncontrolling interest 3 3 6 6 Net earnings attributable to AbbVie Inc. $ 938 $ 1,370 $ 2,224 $ 2,739 Diluted earnings per share attributable to AbbVie Inc. $ 0.52 $ 0.77 $ 1.24 $ 1.53 Adjusted diluted earnings per sharea $ 2.97 $ 2.65 $ 5.43 $ 4.96 Weighted-average diluted shares outstanding 1,771 1,771 1,772 1,772 a Refer to the Reconciliation of GAAP Reported to Non-GAAP Adjusted Information for further details. AbbVie Inc. Reconciliation of GAAP Reported to Non-GAAP Adjusted Information (Unaudited) 1. Specified items impacted results as follows: Quarter Ended June 30, 2025 (in millions, except per share data) Earnings Diluted Pre-tax After-taxa EPS As reported (GAAP) $ 1,554 $ 938 $ 0.52 Adjusted for specified items: Intangible asset amortization 1,864 1,571 0.89 Change in fair value of contingent consideration 2,795 2,709 1.53 Other 91 60 0.03 As adjusted (non-GAAP) $ 6,304 $ 5,278 $ 2.97 a Represents net earnings attributable to AbbVie Inc. Specified items reflect the impact of applicable statutory tax rates. Reported GAAP earnings and adjusted non-GAAP earnings for the three months ended June 30, 2025 included acquired IPR&Dand milestone expense of $823 million on a pre-tax and $737 million on an after-tax basis, representing an unfavorable impact of $0.42 to both diluted EPS and adjusted diluted EPS. 2. The impact of the specified items by line item was as follows: Quarter Ended June 30, 2025 (in millions) Cost ofproducts sold SG&A R&D Other operatingincome Other expense,net As reported (GAAP) $ 4,346 $ 3,253 $ 2,131 $ (24) $ 2,639 Adjusted for specified items: Intangible asset amortization (1,864) — — — — Change in fair value of contingent consideration — — — — (2,795) Other (69) (14) (16) 24 (16) As adjusted (non-GAAP) $ 2,413 $ 3,239 $ 2,115 $ — $ (172) 3. The adjusted tax rate for the second quarter of 2025 was 16.2 percent, as detailed below: Quarter Ended June 30, 2025 (dollars in millions) Pre-tax earnings Income taxes Tax rate As reported (GAAP) $ 1,554 $ 613 39.4 % Specified items 4,750 410 8.6 % As adjusted (non-GAAP) $ 6,304 $ 1,023 16.2 % AbbVie Inc. Reconciliation of GAAP Reported to Non-GAAP Adjusted Information (Unaudited) 1. Specified items impacted results as follows: Quarter Ended June 30, 2024 (in millions, except per share data) Earnings Diluted Pre-tax After-taxa EPS As reported (GAAP) $ 2,146 $ 1,370 $ 0.77 Adjusted for specified items: Intangible asset amortization 1,947 1,651 0.93 Acquisition and integration costs 145 125 0.07 Change in fair value of contingent consideration 1,476 1,438 0.81 Other 90 126 0.07 As adjusted (non-GAAP) $ 5,804 $ 4,710 $ 2.65 a Represents net earnings attributable to AbbVie Inc. Specified items reflect the impact of applicable statutory tax rates. Acquisition and integration costs primarily reflect costs related to the ImmunoGen acquisition. Reported GAAP earnings and adjusted non-GAAP earnings for the three months ended June 30, 2024 included acquired IPR&Dand milestone expense of $937 million on a pre-tax and $924 million on an after-tax basis, representing an unfavorable impactof $0.52 to both diluted EPS and adjusted diluted EPS. 2. The impact of the specified items by line item was as follows: Quarter Ended June 30, 2024 (in millions) Cost of products sold SG&A R&D Other expense,net As reported (GAAP) $ 4,202 $ 3,377 $ 1,948 $ 1,345 Adjusted for specified items: Intangible asset amortization (1,947) — — — Acquisition and integration costs (79) (35) (31) — Change in fair value of contingent consideration — — — (1,476) Other (41) (27) — (22) As adjusted (non-GAAP) $ 2,135 $ 3,315 $ 1,917 $ (153) 3. The adjusted tax rate for the second quarter of 2024 was 18.8 percent, as detailed below: Quarter Ended June 30, 2024 (dollars in millions) Pre-tax earnings Income taxes Tax rate As reported (GAAP) $ 2,146 $ 773 36.0 % Specified items 3,658 318 8.7 % As adjusted(non-GAAP) $ 5,804 $ 1,091 18.8 % AbbVie Inc. Reconciliation of GAAP Reported to Non-GAAP Adjusted Information (Unaudited) 1. Specified items impacted results as follows: Six Months Ended June 30, 2025 (in millions, except per share data) Earnings Diluted Pre-tax After-taxa EPS As reported (GAAP) $ 3,215 $ 2,224 $ 1.24 Adjusted for specified items: Intangible asset amortization 3,722 3,145 1.78 Change in fair value of contingent consideration 4,313 4,186 2.36 Other 153 93 0.05 As adjusted (non-GAAP) $ 11,403 $ 9,648 $ 5.43 a Represents net earnings attributable to AbbVie Inc. Specified items reflect the impact of applicable statutory tax rates. Reported GAAP earnings and adjusted non-GAAP earnings for the six months ended June 30, 2025 included acquired IPR&D and milestones expense of $1.1 billion on a pre-tax and $975 million on an after-tax basis, representing an unfavorable impactof $0.55 to both diluted EPS and adjusted diluted EPS. 2. The impact of the specified items by line item was as follows: Six Months Ended June 30, 2025 (in millions) Cost of products sold SG&A R&D Otheroperating income Other expense,net As reported (GAAP) $ 8,348 $ 6,546 $ 4,198 $ (24) $ 4,080 Adjusted for specified items: Intangible asset amortization (3,722) — — — — Change in fair value of contingent consideration — — — — (4,313) Other (97) (27) (32) 24 (21) As adjusted (non-GAAP) $ 4,529 $ 6,519 $ 4,166 $ — $ (254) 3. The adjusted tax rate for the first six months of 2025 was 15.3 percent, as detailed below: Six Months Ended June 30, 2025 (dollars in millions) Pre-tax earnings Income taxes Tax rate As reported (GAAP) $ 3,215 $ 985 30.6 % Specified items 8,188 764 9.3 % As adjusted (non-GAAP) $ 11,403 $ 1,749 15.3 % AbbVie Inc. Reconciliation of GAAP Reported to Non-GAAP Adjusted Information (Unaudited) 1. Specified items impacted results as follows: Six Months Ended June 30, 2024 (in millions, except per share data) Earnings Diluted Pre-tax After-taxa EPS As reported (GAAP) $ 3,901 $ 2,739 $ 1.53 Adjusted for specified items: Intangible asset amortization 3,838 3,254 1.84 Acquisition and integration costs 656 611 0.34 Change in fair value of contingent consideration 2,136 2,081 1.17 Other 111 145 0.08 As adjusted (non-GAAP) $ 10,642 $ 8,830 $ 4.96 a Represents net earnings attributable to AbbVie Inc. Specified items reflect the impact of applicable statutory tax rates. Acquisition and integration costs primarily reflect costs related to the ImmunoGen acquisition. Reported GAAP earnings and adjusted non-GAAP earnings for the six months ended June 30, 2024 included acquired IPR&Dand milestones expense of $1.1 billion on a pre-tax and after-tax basis, representing an unfavorable impact of $0.60 to bothdiluted EPS and adjusted diluted EPS. 2. The impact of the specified items by line item was as follows: Six Months Ended June 30, 2024 (in millions) Cost of productssold SG&A R&D Interestexpense, net Otherexpense, net As reported (GAAP) $ 8,296 $ 6,692 $ 3,887 $ 959 $ 1,931 Adjusted for specified items: Intangible asset amortization (3,838) — — — — Acquisition and integration costs (158) (315) (159) (24) — Change in fair value of contingent consideration — — — — (2,136) Other (57) (30) — — (24) As adjusted (non-GAAP) $ 4,243 $ 6,347 $ 3,728 $ 935 $ (229) 3. The adjusted tax rate for the first six months of 2024 was 17.0 percent, as detailed below: Six Months Ended June 30, 2024 (dollars in millions) Pre-tax earnings Income taxes Tax rate As reported (GAAP) $ 3,901 $ 1,156 29.6 % Specified items 6,741 650 9.6 % As adjusted (non-GAAP) $ 10,642 $ 1,806 17.0 % SOURCE AbbVie For more information Contact us » Subscribe for email alerts Sign up Subscription management We also welcome the opportunity to hear from you in these social channels, but remember we work in a highly-regulated industry with unique legal considerations. Before engaging, please read and adhere to our established community guidelines for each channel. View our social media channel guidelines » AbbVie.com | Site Map | Terms of Use | Privacy Notice | Consumer Health Data Privacy Notice | Cookies Settings | Your Privacy Choices Copyright © 2025 AbbVie Inc. North Chicago, Illinois, U.S.A. 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Clinical ResultPhase 3Phase 1Drug ApprovalLicense out/in

29 Jul 2025

·www.fiercepharma.com

In BTK clash, Lilly upstart Jaypirca measures up to warhorse Imbruvica

In a phase 3 trial, Eli Lilly's non-covalent BTK inhibitor Jaypirca has matched up to AbbVie and Johnson & Johnson's covalent BTK inhibitor Imbruvica on overall response rate. The newest BTK inhibitor on the market, Eli Lilly’s Jaypirca, has shown its chops in a head-to-head battle against the oldest treatment in the class, AbbVie and Johnson & Johnson’s Imbruvica.A phase 3 trial of Jaypirca has met its primary endpoint in patients with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) who were newly diagnosed or had never received BTK inhibitors.Lilly’s drug hit its mark, demonstrating that it matched up to Imbruvica in overall response rate (ORR) for both subpopulations in the study. The comparison also showed a nominal superiority for Jaypirca, although this analysis was not part of the trial's statistical plan. Data for progression-free survival (PFS) were not mature, but Lilly said they were trending in favor of Jaypirca. The trial, coded Bruin CLL-314, will undergo a formal PFS analysis with the goal of showing superiority in the future, the company added.“We launched the [Jaypirca] randomized development program with an ambitious suite of clinical trials, including head-to-head studies against modern standards of care and examinations of patient populations that reflect real world use, such as BTK inhibitor-pretreated patients,” Jacob Van Naarden, Lilly’s oncology chief, said in a statement. Jaypirca’s overall safety profile remained consistent with previously reported trials, and no detriment to patients' life expectancy was observed, according to Lilly. Detailed results from the study will be presented at a medical conference later this year, the company said.The company is waiting for results from another trial of Jaypirca, coded Bruin CLL-313, in CLL/SLL patients to apply for global approvals in the indication. That study, which pits Jaypirca against chemoimmunotherapy in treatment-naïve patients and uses PFS as the primary endpoint, is expected to read out later this year.In 2023, Jaypirca scored accelerated FDA nods to treat CLL, SLL and mantle cell lymphoma after at least two prior lines of therapy, including one with another BTK inhibitor. Jaypirca is unique in that it is a non-covalent, or reversible, BTK inhibitor, which can be used after treatment with the other three options in the class. Those BTKs—Imbruvica, AstraZeneca’s Calquence and BeOne Medicines' Brukinsa—are covalent and can’t be use sequentially.Jaypirca generated sales of $337 million in 2024, compared to $3.1 billion for Calquence, which reached the market in 2017, and $2.6 billion for Brukinsa, which was approved in 2019. Imbruvica, which scored its original FDA nod in 2013, generated $6.4 billion last year. Its sales peaked in 2021 at $9.8 billion.

Phase 3Clinical ResultDrug ApprovalImmunotherapyAccelerated Approval

29 Jul 2025

·pipelinereview.com

Lilly's Jaypirca (pirtobrutinib), the first and only approved non-covalent (reversible) BTK inhibitor, met its primary endpoint in a head-to-head Phase 3 trial versus Imbruvica (ibrutinib) in CLL/SLL

Pirtobrutinib met the primary endpoint of response rate non-inferiority, favoring pirtobrutinib with a nominal P-value for superiority < 0.05 Progression-free survival data was immature, but trending in favor of pirtobrutinib BRUIN CLL-314 is the first-ever head-to-head Phase 3 study versus a covalent BTK inhibitor to include treatment-naïve patients INDIANAPOLIS, IN, USA I July 29, 2025 I Eli Lilly and Company (NYSE: LLY ) today announced positive topline results from the Phase 3 BRUIN CLL-314 clinical trial of Jaypirca (pirtobrutinib), a non-covalent (reversible) Bruton’s tyrosine kinase (BTK) inhibitor, versus Imbruvica (ibrutinib), a covalent BTK inhibitor, in patients with chronic lymphocytic leukemia or small lymphocytic lymphoma (CLL/SLL). This study enrolled patients with treatment-naïve CLL/SLL and those who had been previously treated but were BTK inhibitor-naïve. The study met its primary endpoint of non-inferiority on overall response rate (ORR) as assessed by an independent review committee (IRC) in both the pre-treated and intent-to-treat populations. ORR favored pirtobrutinib with a nominal P-value for superiority 1 (p <0.05). Progression free survival (PFS), a key secondary endpoint, was not yet mature at this analysis, but was trending in favor of pirtobrutinib. A formal PFS analysis testing for superiority is planned at a future analysis. No detriment was observed for overall survival (OS). BRUIN CLL-314 is the first ever head-to-head trial versus ibrutinib in CLL to include treatment-naïve patients. This important subpopulation (n=225) had the longest follow-up and a particularly pronounced PFS effect size in favor of pirtobrutinib. The overall safety profile of pirtobrutinib in BRUIN CLL-314 was similar to previously reported trials. Detailed results will be presented at a medical congress later in 2025. “We launched the pirtobrutinib randomized development program with an ambitious suite of clinical trials, including head-to-head studies against modern standards of care and examinations of patient populations that reflect real world use, such as BTK inhibitor-pretreated patients,” said Jacob Van Naarden, executive vice president and president of Lilly Oncology. “These data mark the second positive Phase 3 study in the program, as we continue to build evidence supporting the potential role of pirtobrutinib in treating people with CLL/SLL and hopefully enabling future regulatory approvals that allow physicians to use the medicine in various disease settings, whether treatment-naïve or BTK inhibitor-pretreated.” These data build on the previously reported positive results from the BRUIN Phase 1/2 trial and the Phase 3 BRUIN CLL-321 trial, the first randomized, controlled study ever conducted in an exclusively post-covalent BTK inhibitor population. The BRUIN CLL-313 Phase 3 study of pirtobrutinib versus chemoimmunotherapy in treatment naïve CLL/SLL is expected to read out later in 2025 and combined with the results of BRUIN CLL-314, will form the basis of regulatory submissions globally. For more information on the BRUIN Phase 3 clinical trial program, please visit clinicaltrials.gov . About BRUIN CLL-314 BRUIN CLL-314 is a Phase 3, randomized, open-label study of pirtobrutinib versus ibrutinib in patients with chronic lymphocytic leukemia or small lymphocytic lymphoma (CLL/SLL) who were either treatment-naïve, or who were previously treated and were BTK inhibitor-naïve. The trial planned to enroll 650 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 overall response rate (ORR) as assessed by blinded independent review committee (IRC). Secondary endpoints include investigator and IRC assessed progression-free survival (PFS), duration of response (DoR) and event-free survival (EFS), and time to next treatment (TTNT), overall survival (OS), safety and tolerability, and patient-reported outcomes (PRO). About Jaypirca (pirtobrutinib) 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 (reversible) inhibitor of the enzyme BTK. 2 BTK is a validated molecular target found across numerous B-cell leukemias and lymphomas including mantle cell lymphoma (MCL) and chronic lymphocytic leukemia (CLL). 3,4 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. INDICATIONS FOR JAYPIRCA (pirtobrutinib) Jaypirca is a kinase inhibitor indicated for the treatment of These indications are approved under accelerated approval based on response rate. Continued approval for these indications may be contingent upon verification and description of clinical benefit in a confirmatory trial. Please see Prescribing Information and Patient Information for Jaypirca. About Lilly 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 nearly 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. To learn more, visit Lilly.com and Lilly.com/news , or follow us on Facebook , Instagram , and LinkedIn . P-LLY Trademarks and Trade Names All trademarks or trade names referred to in this press release are the property of the company, or, to the extent trademarks or trade names belonging to other companies are references in this press release, the property of their respective owners. Solely for convenience, the trademarks and trade names in this press release are referred to without the ® and ™ symbols, but such references should not be construed as any indicator that the company or, to the extent applicable, their respective owners will not assert, to the fullest extent under applicable law, the company’s or their rights thereto. We do not intend the use or display of other companies’ trademarks and trade names to imply a relationship with, or endorsement or sponsorship of us by, any other companies. Endnotes and References: SOURCE: Eli Lilly

Clinical ResultPhase 3Drug ApprovalAccelerated ApprovalImmunotherapy

100 Deals associated with Ibrutinib

External Link

KEGG	Wiki	ATC	Drug Bank
D10223	Ibrutinib	L01XE27	DB09053

R&D Status

Approved

10 top approved records.

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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.

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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	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	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

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT02649387 (MERIT, CTgov)	Phase 2	Chronic Lymphocytic Leukemia \| Residual Neoplasm	35	Laboratory Biomarker Analysis+Ibrutinib	kovrzdcedh = wapqkqfokj qxfgtgfzhv (daanbgpgsi, pkfyllqqsd - bmhucavqzt) View more	-	24 Jul 2025
NCT04230304 (CTgov)	Phase 2	Recurrent Chronic Lymphoid Leukemia \| Chronic lymphocytic leukaemia refractory \| Refractory Small Lymphocytic Lymphoma	8	Ibrutinib+Daratumumab	xoayoycdzc = iswtxooymi voqytbglln (rbqfoiguem, ovbugsmlmv - lwubfktmhp) View more	-	01 Jul 2025
NCT02910583 (CAPTIVATE, ASCO2025)	Phase 2	Small Lymphocytic Lymphoma First line del(17p) \| unmutated IGHV \| mutated IGHV ... View more	202	Ibrutinib + Venetoclax	pjlyuuohji(rmnnzrqkrd) = occurred in 24 pts across the entire study period, including 12 initial treatment and 4 retreatment TEAEs twsjnpaeuj (pmotpfjmfx )	Positive	30 May 2025
RESONATE-2; ELEVATE-TN; SEQUOIA (ASCO2025)	Phase 3	Chronic Lymphocytic Leukemia First line	537	Ibrutinib	hgobyjcbrn(ureqavuadq) = eoslcukepx jppbazbjud (ihfqkyxvsj, 75.6 - 92.1) View more	Positive	30 May 2025
RESONATE-2; ELEVATE-TN; SEQUOIA (ASCO2025)	Phase 3	Chronic Lymphocytic Leukemia First line	537	Acalabrutinib	hgobyjcbrn(ureqavuadq) = dzurewinur jppbazbjud (ihfqkyxvsj, 67.5 - 81.1) View more	Positive	30 May 2025
NCT03112174 (SYMPATICO, ASCO2025)	Phase 3	Mantle-Cell Lymphoma First line	78	Ibrutinib 560 mg + Venetoclax 400 mg	bjnovggohp(uuoatjvpoi) = wwarkwqrtj hrqlwvvrza (gjstdexfzu, 87 - 99) View more	Positive	30 May 2025
NCT04802590 (OASIS II, ASCO2025)	Phase 2	Mantle-Cell Lymphoma	102	Ibrutinib/CD20mAb	iciwityrbr(bxuymirdmx) = xtbuvbqjax ihpeakhsya (otoqckbjcr, 42.4% - 65%) View more	Positive	30 May 2025
NCT04802590 (OASIS II, ASCO2025)	Phase 2	Mantle-Cell Lymphoma	102	Ibrutinib/CD20mAb/Venetoclax	iciwityrbr(bxuymirdmx) = fwammlinvp ihpeakhsya (otoqckbjcr, 71.7% - 89.7%) View more	Positive	30 May 2025
RESONATE-2, ELEVATE-TN, SEQUOIA (EHA2025)	Phase 3	Chronic Lymphocytic Leukemia First line	537	Ibrutinib	frootulyso(vkdbhwdukn) = avzphsxyjq sfkuudsnqc (xzqbgwzaax, 75.6 - 92.1) View more	Positive	22 May 2025
RESONATE-2, ELEVATE-TN, SEQUOIA (EHA2025)	Phase 3	Chronic Lymphocytic Leukemia First line	537	Acalabrutinib	frootulyso(vkdbhwdukn) = slvbstmmlx sfkuudsnqc (xzqbgwzaax, 67.5 - 81.1) View more	Positive	22 May 2025
CAPTIVATE (EHA2025)	Phase 2	Chronic Lymphocytic Leukemia \| Small Lymphocytic Lymphoma First line unmutated IGHV \| mutated IGHV \| uMRD4	202	Ibrutinib + Venetoclax	reyclzzrol(eyavafpgpo) = 24 patients across the entire study period, including 12 initial treatment and 4 retreatment treatment-emergent adverse events aarktepxtb (paherbxjjp )	Positive	22 May 2025
SYMPATICO (EHA2025)	Phase 3	Mantle-Cell Lymphoma First line TP53 mutation	78	Ibrutinib 560 mg + Venetoclax 400 mg	wmuszwiwnd(tbouhdluoy) = grkyigwgyo zpdlnxbarl (akmfaeseyw ) View more	Positive	22 May 2025
REDOT_MCL (EHA2025)	Not Applicable	Mantle-Cell Lymphoma	226	Ibrutinib full dose	tgfcagjlzv(wwbmwtnnjz) = ylwpuazkfs cjgxyrsbhg (nytauqgfmt ) View more	Positive	14 May 2025
REDOT_MCL (EHA2025)	Not Applicable	Mantle-Cell Lymphoma	226	Ibrutinib reduced dose	tgfcagjlzv(wwbmwtnnjz) = sprkrzpoay cjgxyrsbhg (nytauqgfmt ) View more	Positive	14 May 2025

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