This is a feasibility study to assess the use of a Digital Medicine Program (consisting of an FDA-approved ingestible sensor co-encapsulated with oxycodone/acetaminophen (5 mg/325 mg), a small wearable patch, and a mobile application) in cancer patients with metastatic disease experiencing uncontrolled pain.

Start Date22 Jan 2020

Sponsor / Collaborator

Proteus Digital Health, Inc.

NCT04088955 / Unknown statusNot Applicable

A Pragmatic, Non-Interventional Study of DigiMeds™ in Combination With Standard of Care for Treatment of Patients With Cancer

DigiMeds™ are medications with FDA-approved ingestible sensors (IS), a wearable sensor patch (patch), and a mobile app, which records time-stamped medication type and dose alongside biometric activity.
The aim of this registry is to collect and analyze data on the use of DigiMeds™ and a digital feedback system on medication adherence, patient-provider communication, and data-driven optimization of therapy for cancer patients.

Start Date06 Sep 2019

Sponsor / Collaborator

Proteus Digital Health, Inc.

NCT03418675 / CompletedPhase 2IIT

A Double-Blind, Placebo-Controlled Study of Brexpiprazole in the Treatment of Borderline Personality Disorder.

The primary objective of the proposed study is to evaluate the safety and efficacy of Brexpiprazole in adults with borderline personality disorder (BPD). The hypothesis to be tested is that brexpiprazole will be more effective and well tolerated in adults with BPD compared to placebo. The proposed study will provide needed data on the treatment of a disabling disorder.

Start Date26 Nov 2018

Sponsor / Collaborator

The University of Chicago

[+1]

100 Clinical Results associated with Otsuka America Pharmaceutical, Inc.

0 Patents (Medical) associated with Otsuka America Pharmaceutical, Inc.

138

Literatures (Medical) associated with Otsuka America Pharmaceutical, Inc.

01 Jul 2024·Influenza and Other Respiratory Viruses

Economic Burden of Medically Attended Respiratory Syncytial Virus Infections Among Privately Insured Children Under 5 Years of Age in the USA

Article

Author: Tran, Phuong T ; Wang, Yanning ; Diaby, Vakaramoko ; Finelli, Lynn ; Nduaguba, Sabina O ; Winterstein, Almut G ; Choi, Yoonyoung

ABSTRACT:

Background:

The cost of medically attended RSV LRI (lower respiratory infection) is critical in determining the economic value of new RSV immunoprophylaxes. However, most studies have focused on intermittent RSV encounters, not the episode of care that captures the entirety of RSV illness.

Methods:

We created age‐ and condition‐specific cohorts of children under 5 years of age using MarketScan® data (2015–2019). We contrasted aggregating healthcare costs over RSV‐LRTI episodes to ascertaining costs based on RSV‐specific encounters only. Economic burden was estimated by multiplying costs per encounter or per episode by their respective incidence rates.

Results:

Average cost was higher per episode than per encounter regardless of settings (inpatient: $28,586 vs. $18,056 and outpatient/ED: $2099 vs. $407 for infants). Across ages, the economic burden was highest for infants and RSV‐LRTI requiring inpatient care, but the burden in outpatient/ED settings was disproportionately higher than costs due to higher incidence rates (for inpatient vs. outpatient episodes: $226,403 vs. $101,269; for inpatient vs. outpatient encounters: $151,878 vs. $38,819 per 1000 infant‐years). For high‐risk children, cost and burden were up to 3–10 times higher, respectively.

Conclusions:

With a comprehensive stratification by settings and risk condition, the encounter‐ versus episode‐based estimates provide a robust range for policymakers' economic appraisal of new RSV immunoprophylaxes.

01 Sep 2022·JAMA Oncology

Log-Rank Test vs MaxCombo and Difference in Restricted Mean Survival Time Tests for Comparing Survival Under Nonproportional Hazards in Immuno-oncology Trials: A Systematic Review and Meta-analysis.

Review

Author: Rubin, Eric H ; Chappell, Richard J ; Ye, Jiabu ; Halabi, Susan ; Anderson, Keaven M ; Roychoudhury, Satrajit ; Mukhopadhyay, Pralay

Importance:

The log-rank test is considered the criterion standard for comparing 2 survival curves in pivotal registrational trials. However, with novel immunotherapies that often violate the proportional hazards assumptions over time, log-rank can lose power and may fail to detect treatment benefit. The MaxCombo test, a combination of weighted log-rank tests, retains power under different types of nonproportional hazards. The difference in restricted mean survival time (dRMST) test is frequently proposed as an alternative to the log-rank under nonproportional hazard scenarios.

Objective:

To compare the log-rank with the MaxCombo and dRMST in immuno-oncology trials to evaluate their performance in practice.

Data Sources:

Comprehensive literature review using Google Scholar, PubMed, and other sources for randomized clinical trials published in peer-reviewed journals or presented at major clinical conferences before December 2019 assessing efficacy of anti-programmed cell death protein-1 or anti-programmed death/ligand 1 monoclonal antibodies.

Study Selection:

Pivotal studies with overall survival or progression-free survival as the primary or key secondary end point with a planned statistical comparison in the protocol. Sixty-three studies on anti-programmed cell death protein-1 or anti-programmed death/ligand 1 monoclonal antibodies used as monotherapy or in combination with other agents in 35 902 patients across multiple solid tumor types were identified.

Data Extraction and Synthesis:

Statistical comparisons (n = 150) were made between the 3 tests using the analysis populations as defined in the original protocol of each trial.

Main Outcomes and Measures:

Nominal significance based on a 2-sided .05-level test was used to evaluate concordance. Case studies featuring different types of nonproportional hazards were used to discuss more robust ways of characterizing treatment benefit instead of sole reliance on hazard ratios.

Results:

In this systematic review and meta-analysis of 63 studies including 35 902 patients, between the log-rank and MaxCombo, 135 of 150 comparisons (90%) were concordant; MaxCombo achieved nominal significance in 15 of 15 discordant cases, while log-rank did not. Several cases appeared to have clinically meaningful benefits that would not have been detected using log-rank. Between the log-rank and dRMST tests, 137 of 150 comparisons (91%) were concordant; log-rank was nominally significant in 5 of 13 cases, while dRMST was significant in 8 of 13. Among all 3 tests, 127 comparisons (85%) were concordant.

Conclusions and Relevance:

The findings of this review show that MaxCombo may provide a pragmatic alternative to log-rank when departure from proportional hazards is anticipated. Both tests resulted in the same statistical decision in most comparisons. Discordant studies had modest to meaningful improvements in treatment effect. The dRMST test provided no added sensitivity for detecting treatment differences over log-rank.

01 Jan 2021·Nephrology nursing journal : journal of the American Nephrology Nurses' AssociationQ4 · MEDICINE

Mental Health and Health-Related Quality of Life Among Nephrology Nurses: A Survey-Based Cross-Sectional Study

Q4 · MEDICINE

Article

Author: Donnini, Katie ; Dutka, Paula ; Cloutier, Martin ; Kurzman, Alissa ; Voegel, Arthur ; Pryor, Lillian ; Gauthier-Loiselle, Marjolaine ; Guérin, Annie ; Montoya, Vicki ; Maitland, Jessica ; Hoffmann, Mark ; Kear, Tamara ; Sanon, Myrlene ; Thomas-Hawkins, Charlotte ; Savin, Samuel

Nephrology nurses face health and wellness challenges due to significant work-related stressors. This survey, conducted online between July 24 and August 17, 2020, assessed the psychological well-being of nephrology nurses in the United States during the COVID-19 pandemic (n = 393). Respondents reported feeling burned out from work (62%), symptoms of anxiety (47% with Generalized Anxiety Disorder-7 [GAD-7] scores ≥ 5), and major depressive episodes (16% with Patient Health Questionnaire-2 [PHQ-2] scores ≥ 3). Fifty-six percent (56%) of survey respondents reported caring for COVID-19 patients, and 62% were somewhat or very worried about COVID-19. Factors, including high workload, age, race, and the COVID-19 pandemic, may partially explain the high proportion of nephrology nurses who reported symptoms of burnout, anxiety, and depression.

136

News (Medical) associated with Otsuka America Pharmaceutical, Inc.

03 Dec 2024

·www.prnewswire.com

The National Hispanic Health Foundation (NHHF) Hosts Scholarship Gala in Washington, DC to Honor Leaders and Students Advancing Health Equity

WASHINGTON, Dec. 3, 2024 /PRNewswire/ -- The National Hispanic Health Foundation (NHHF) is proud to announce the awarding of 18 new scholarships with the support of the United Health Foundation (up to $20,000) to graduate students from the Western United States on their journeys to become doctors, nurses, dentists, pharmacists, and physician assistants in our communities. "We are deeply grateful to our leaders and sponsors whose support strengthens the path toward a more diverse and equitable health sector," said Dr. Elena Rios, President of NHHF. The Washington DC Awards Gala will be held on December 4th from 6:30-10:30 p.m. Eastern Time at the Hilton Washington DC, National Mall, The Wharf. The National Hispanic Health Foundation thanks the following health leaders for their work in transforming government programs, academic institutions, private sector organizations, and local communities to increase access to health care. Washington DC Hispanic Health Leadership Honorees include: Congresswoman Nanette Barragán; Congressman Adriano Espaillat; Congressman Joaquin Castro; Congresswoman Linda T. Sánchez; David J. Skorton, MD (President & CEO of the Association of American Medical Colleges); Cristina Antelo (CEO of Feroz Strategies); and Sindy Escobar Alvarez, PhD, (Medical Research Program Director at the Doris Duke Foundation). With immense gratitude, NHHF thanks all our scholarship gala sponsors across sectors for their generosity and dedication to supporting our mission to empower and diversify the next generation of health professionals. Platinum Sponsors include: United Health Foundation. Gold Sponsors include: Centene Corporation. Silver Sponsors include: Bristol-Myers Squibb-Pfizer Alliance, Eli Lilly, Otsuka Pharmaceuticals. Media Partners include: El Tiempo Latino, Latina Publishers, Latina Style Magazine, Latino Leaders, and Rolli. It is with great pleasure that the National Hispanic Health Foundation announces the following 2024 scholarship award recipients for the Eastern United States: Natalia Perez Baez University of Illinois College of Medicine Jhoely Duque-Jimenez Weill Cornell Medical College Angela Teresa Perez Villalobos Georgetown University School of Medicine Elyse Manzo Martin Tufts University School of Medicine Yanilka Rodriguez SUNY Downstate Health Sciences University College Devin Barzallo Case Western Reserve University of Medicine Dariana Gil Hernandez Yale University School of Medicine Ronald Arguete Howard University College of Medicine Jessica Schlaen Nova Southern University College of Dental Medicine Margarita Nino University of Pittsburgh School of Dental Medicine Adele Shepin Saint Elizabeth University Physician Associate School Maria C Arevalo City of University of New York School of Medicine Physician Associate Melanie Kapelson Rivier University School of Nursing and Health Professions Eliam Aguilar Rollero University of Puerto Rico- Medical Sciences Campus Angela Gates Virginia Commonwealth University School of Pharmacy Megan Rebollar Mercer University College of Pharmacy Bernardo Lopez Samayoa Johns Hopkins Bloomberg School of Public Health Sebastian Cota Columbia University Mailman School of Public Health Visit nhhfx.org for additional information about the gala and NHHF SOURCE National Hispanic Health Foundation WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

19 Nov 2024

·pipelinereview.com

Otsuka Provides Update on Sibeprenlimab, an Investigational Monoclonal Antibody for the Treatment of IgA Nephropathy in Adults

PRINCETON, NJ, USA & TOKYO, Japan I November 19, 2024 I Otsuka Pharmaceutical Development & Commercialization, Inc. (OPDC) and Otsuka Pharmaceutical, Co. Ltd. (Otsuka) announce the decision to submit a Biologics License Application (BLA) in the U.S. for sibeprenlimab, an investigational drug for the treatment of immunoglobulin A nephropathy (IgA nephropathy) in adults, in the first half of 2025. The update follows a recent meeting with the U.S. Food & Drug Administration to discuss the positive interim analysis results from the Phase 3 VISIONARY study (NCT05248646). Sibeprenlimab is an investigational, anti-APRIL monoclonal antibody ( A PR oliferation- I nducing L igand) that blocks a key initiating step in the immune pathogenic cascade of IgA nephropathy by limiting aberrant IgA1 (Gd-IgA1) production and immune complex formation. IgA nephropathy is a progressive, autoimmune, chronic kidney disease that can lead to end-stage kidney disease (ESKD) over the lifetime of most patients. 1,2,3,4 Otsuka was previously granted Breakthrough Therapy designation for sibeprenlimab following favorable results of the Phase 2 ENVISION clinical trial. 3 “We greatly appreciated the opportunity to discuss the positive interim data from the Phase 3 sibeprenlimab trial with the FDA and plan to incorporate the Agency’s feedback as we prepare the BLA filing,” said John Kraus, M.D., Ph.D., executive vice president and chief medical officer, Otsuka Pharmaceutical Development & Commercialization, Inc. “Otsuka is committed to the nephrology community and looks forward to bringing this innovative targeted therapy to people living with IgA nephropathy. We want to thank the patients, caregivers and healthcare professionals who continue to be such an important part of this process.” In October, Otsuka announced positive interim results from the Phase 3 sibeprenlimab trial. The ongoing Phase 3 study continues in a blinded manner to evaluate the change in kidney function over 24 months as measured by estimated glomerular filtration rate (eGFR) and is expected to be completed in early 2026. Further prespecified and exploratory analyses of the data will be conducted to determine the full potential of sibeprenlimab for the treatment of IgA nephropathy and will be shared. About Sibeprenlimab Sibeprenlimab (formerly VIS649) was designed and engineered by Visterra, Inc., a wholly owned subsidiary of Otsuka. Pre-clinical and early-stage trials of sibeprenlimab were also conducted by Visterra. Sibeprenlimab is an investigational monoclonal antibody that blocks the action of APRIL (A PR oliferation- I nducing L igand), that plays a key role in IgA nephropathy’s four-hit pathogenic cascade. APRIL is an important sustaining factor in IgA nephropathy progression by promoting the production of pathogenic Gd-IgA1 and immune complex formation. By binding and neutralizing APRIL, sibeprenlimab may help reduce the amount of immunoglobulin A (IgA) and Gd-IgA1. Lower levels of Gd-IgA1 may then result in reduced auto-antibody production, which in turn may result in fewer immune complexes, decreased immune complex deposits in the kidney, and reduced proteinuria and kidney inflammation. By reducing the production of Gd-IgA1, sibeprenlimab is expected to slow kidney damage and progression toward ESKD. 1,2,3,5 By blocking APRIL, sibeprenlimab may help address one of the IgA nephropathy-specific drivers for nephron loss. About Immunoglobulin A Nephropathy (IgAN) and APRIL IgA nephropathy also known as Berger’s disease, is a progressive, autoimmune, chronic kidney disease that typically manifests in adults aged 20-40 years and may lead to ESKD over the lifetime of most patients. 4, 6, 7 IgA nephropathy is characterized by the accumulation of IgA in the kidneys – a type of antibody that plays a critical role in the immune system.IgA nephropathy can lead to progressive kidney dysfunction and, eventually, ESKD, imposing a significant burden on patients. 6 Despite supportive care, including therapies that focus on treating the symptoms of IgA nephropathy, continued research in the disease remains crucial to uncovering opportunities for advancement in our understanding and treatment of patients. 6 About Otsuka Otsuka Pharmaceutical Co., Ltd. is a global healthcare company with the corporate philosophy: Otsuka–people creating new products for better health worldwide . Otsuka researches, develops, manufactures, and markets innovative products, with a focus on pharmaceutical products to meet unmet medical needs and nutraceutical products for the maintenance of everyday health. In pharmaceuticals, Otsuka is a leader in the challenging areas of mental, renal, and cardiovascular health and has additional research programs in oncology and on several under-addressed diseases including tuberculosis, a significant global public health issue. These commitments illustrate how Otsuka is a “big venture” company at heart, applying a youthful spirit of creativity in everything it does. Otsuka established a presence in the U.S. in 1973 and today its U.S. affiliates include Otsuka Pharmaceutical Development & Commercialization, Inc. (OPDC) and Otsuka America Pharmaceutical, Inc. (OAPI). These two companies’ 2,250 employees in the U.S. develop and commercialize medicines in the areas of mental health and nephrology, using cutting-edge technology to address unmet healthcare needs. OPDC and OAPI are indirect subsidiaries of Otsuka Pharmaceutical Co., Ltd., which is a subsidiary of Otsuka Holdings Co., Ltd. headquartered in Tokyo, Japan. The Otsuka group of companies employed 34,400 people worldwide and had consolidated sales of approximately USD 14.2 billion in 2023. All Otsuka stories start by taking the road less traveled. Learn more about Otsuka in the U.S. at www.otsuka-us.com and connect with us on LinkedIn and Twitter at @OtsukaUS . Otsuka Pharmaceutical Co., Ltd.’s global website is accessible at https://www.otsuka.co.jp/en/. References 1. Mathur M, Barratt J, Chacko B, et al. A Phase 2 Trial of Sibeprenlimab in Immunoglobulin A Nephropathy Patients. NEJM. 2023 https://www.nejm.org/doi/full/10.1056/NEJMoa2305635 2. Chang S, Li XK. The Role of Immune Modulation in Pathogenesis of IgA Nephropathy (nih.gov) 3. Mathur M, Barratt J, Suzuki Y, et al. Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of VIS649 (Sibeprenlimab), an APRIL-Neutralizing IgG2 Monoclonal Antibody, in Healthy Volunteers. Kidney Int Rep. 2022;7(5):993-1003. 4. Pitcher, D. Braddon, et. al Long-term outcomes in IGA nephropathy. Clinical journal of the American Society of Nephrology : CJASN. https://pubmed.ncbi.nlm.nih.gov/37055195/ . 5. Otsuka Pharmaceutical Development & Commercialization, Inc.Visionary Study: Phase 3 Trial of Sibeprenlimab in Immunoglobulin A Nephropathy (IgAN). Clinicaltrials.gov. 6. Cheung CK, Barratt J, Liew A, Zhang H, Tesar V, Lafayette R. The role of BAFF and April in IGA nephropathy: Pathogenic mechanisms and targeted therapies. Frontiers in nephrology. February 1, 2024. 7. Lai K. Iga nephropathy. Nature reviews. Disease primers. 2016. https://pubmed.ncbi.nlm.nih.gov/27189177/ . 8. Yeo SC et al. Is immunoglobulin A nephropathy different in different ethnic populations? April 2019. https://onlinelibrary.wiley.com/doi/full/10.1111/nep.13592 . SOURCE: Otsuka Pharmaceutical

Phase 2Phase 3Breakthrough Therapy

19 Nov 2024

·www.businesswire.com

Otsuka Provides Update on Sibeprenlimab, an Investigational Monoclonal Antibody for the Treatment of IgA Nephropathy in Adults

PRINCETON, N.J. & TOKYO--( BUSINESS WIRE )--Otsuka Pharmaceutical Development & Commercialization, Inc. (OPDC) and Otsuka Pharmaceutical, Co. Ltd. (Otsuka) announce the decision to submit a Biologics License Application (BLA) in the U.S. for sibeprenlimab, an investigational drug for the treatment of immunoglobulin A nephropathy (IgA nephropathy) in adults, in the first half of 2025. The update follows a recent meeting with the U.S. Food & Drug Administration to discuss the positive interim analysis results from the Phase 3 VISIONARY study (NCT05248646). Sibeprenlimab is an investigational, anti-APRIL monoclonal antibody ( A PR oliferation- I nducing L igand) that blocks a key initiating step in the immune pathogenic cascade of IgA nephropathy by limiting aberrant IgA1 (Gd-IgA1) production and immune complex formation. IgA nephropathy is a progressive, autoimmune, chronic kidney disease that can lead to end-stage kidney disease (ESKD) over the lifetime of most patients. 1,2,3,4 Otsuka was previously granted Breakthrough Therapy designation for sibeprenlimab following favorable results of the Phase 2 ENVISION clinical trial. 3 “We greatly appreciated the opportunity to discuss the positive interim data from the Phase 3 sibeprenlimab trial with the FDA and plan to incorporate the Agency's feedback as we prepare the BLA filing,” said John Kraus, M.D., Ph.D., executive vice president and chief medical officer, Otsuka Pharmaceutical Development & Commercialization, Inc. “Otsuka is committed to the nephrology community and looks forward to bringing this innovative targeted therapy to people living with IgA nephropathy. We want to thank the patients, caregivers and healthcare professionals who continue to be such an important part of this process.” In October, Otsuka announced positive interim results from the Phase 3 sibeprenlimab trial. The ongoing Phase 3 study continues in a blinded manner to evaluate the change in kidney function over 24 months as measured by estimated glomerular filtration rate (eGFR) and is expected to be completed in early 2026. Further prespecified and exploratory analyses of the data will be conducted to determine the full potential of sibeprenlimab for the treatment of IgA nephropathy and will be shared. About Sibeprenlimab Sibeprenlimab (formerly VIS649) was designed and engineered by Visterra, Inc., a wholly owned subsidiary of Otsuka. Pre-clinical and early-stage trials of sibeprenlimab were also conducted by Visterra. Sibeprenlimab is an investigational monoclonal antibody that blocks the action of APRIL (A PR oliferation- I nducing L igand), that plays a key role in IgA nephropathy’s four-hit pathogenic cascade. APRIL is an important sustaining factor in IgA nephropathy progression by promoting the production of pathogenic Gd-IgA1 and immune complex formation. By binding and neutralizing APRIL, sibeprenlimab may help reduce the amount of immunoglobulin A (IgA) and Gd-IgA1. Lower levels of Gd-IgA1 may then result in reduced auto-antibody production, which in turn may result in fewer immune complexes, decreased immune complex deposits in the kidney, and reduced proteinuria and kidney inflammation. By reducing the production of Gd-IgA1, sibeprenlimab is expected to slow kidney damage and progression toward ESKD. 1,2,3,5 By blocking APRIL, sibeprenlimab may help address one of the IgA nephropathy-specific drivers for nephron loss. About Immunoglobulin A Nephropathy (IgAN) and APRIL IgA nephropathy also known as Berger’s disease, is a progressive, autoimmune, chronic kidney disease that typically manifests in adults aged 20-40 years and may lead to ESKD over the lifetime of most patients. 4, 6, 7 IgA nephropathy is characterized by the accumulation of IgA in the kidneys – a type of antibody that plays a critical role in the immune system. IgA nephropathy can lead to progressive kidney dysfunction and, eventually, ESKD, imposing a significant burden on patients. 6 Despite supportive care, including therapies that focus on treating the symptoms of IgA nephropathy, continued research in the disease remains crucial to uncovering opportunities for advancement in our understanding and treatment of patients. 6 About Otsuka Otsuka Pharmaceutical Co., Ltd. is a global healthcare company with the corporate philosophy: Otsuka–people creating new products for better health worldwide . Otsuka researches, develops, manufactures, and markets innovative products, with a focus on pharmaceutical products to meet unmet medical needs and nutraceutical products for the maintenance of everyday health. In pharmaceuticals, Otsuka is a leader in the challenging areas of mental, renal, and cardiovascular health and has additional research programs in oncology and on several under-addressed diseases including tuberculosis, a significant global public health issue. These commitments illustrate how Otsuka is a “big venture” company at heart, applying a youthful spirit of creativity in everything it does. Otsuka established a presence in the U.S. in 1973 and today its U.S. affiliates include Otsuka Pharmaceutical Development & Commercialization, Inc. (OPDC) and Otsuka America Pharmaceutical, Inc. (OAPI). These two companies’ 2,250 employees in the U.S. develop and commercialize medicines in the areas of mental health and nephrology, using cutting-edge technology to address unmet healthcare needs. OPDC and OAPI are indirect subsidiaries of Otsuka Pharmaceutical Co., Ltd., which is a subsidiary of Otsuka Holdings Co., Ltd. headquartered in Tokyo, Japan. The Otsuka group of companies employed 34,400 people worldwide and had consolidated sales of approximately USD 14.2 billion in 2023. All Otsuka stories start by taking the road less traveled. Learn more about Otsuka in the U.S. at www.otsuka-us.com and connect with us on LinkedIn and Twitter at @OtsukaUS . Otsuka Pharmaceutical Co., Ltd.’s global website is accessible at https://www.otsuka.co.jp/en/. References 1. Mathur M, Barratt J, Chacko B, et al. A Phase 2 Trial of Sibeprenlimab in Immunoglobulin A Nephropathy Patients. NEJM. 2023 https://www.nejm.org/doi/full/10.1056/NEJMoa2305635 2. Chang S, Li XK. The Role of Immune Modulation in Pathogenesis of IgA Nephropathy (nih.gov) 3. Mathur M, Barratt J, Suzuki Y, et al. Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of VIS649 (Sibeprenlimab), an APRIL-Neutralizing IgG2 Monoclonal Antibody, in Healthy Volunteers. Kidney Int Rep. 2022;7(5):993-1003. 4. Pitcher, D. Braddon, et. al Long-term outcomes in IGA nephropathy. Clinical journal of the American Society of Nephrology : CJASN. https://pubmed.ncbi.nlm.nih.gov/37055195/ . 5. Otsuka Pharmaceutical Development & Commercialization, Inc.Visionary Study: Phase 3 Trial of Sibeprenlimab in Immunoglobulin A Nephropathy (IgAN). Clinicaltrials.gov. 6. Cheung CK, Barratt J, Liew A, Zhang H, Tesar V, Lafayette R. The role of BAFF and April in IGA nephropathy: Pathogenic mechanisms and targeted therapies. Frontiers in nephrology. February 1, 2024. 7. Lai K. Iga nephropathy. Nature reviews. Disease primers. 2016. https://pubmed.ncbi.nlm.nih.gov/27189177/ . 8. Yeo SC et al. Is immunoglobulin A nephropathy different in different ethnic populations? April 2019. https://onlinelibrary.wiley.com/doi/full/10.1111/nep.13592 .

Phase 2Phase 3Breakthrough Therapy

100 Deals associated with Otsuka America Pharmaceutical, Inc.

100 Translational Medicine associated with Otsuka America Pharmaceutical, Inc.

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Pipeline Snapshot as of 21 Dec 2024

The statistics for drugs in the Pipeline is the current organization and its subsidiaries are counted as organizations,Early Phase 1 is incorporated into Phase 1, Phase 1/2 is incorporated into phase 2, and phase 2/3 is incorporated into phase 3

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Drug(Targets)	Indications	Global Highest Phase

OPB-111077 ( STAT3 )	Relapsing acute myeloid leukemia More	Phase 1
Venetoclax ( Bcl-2 )	Refractory acute myeloid leukemia More	Phase 1
Decitabine ( DNMT1 )	Refractory acute myeloid leukemia More	Phase 1
MSP-1009	Central Nervous System Diseases More	Preclinical
Urea-13C	Helicobacter pylori infection More	Withdrawn

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