Takeda II-SR Portal

Welcome! We are pleased that you are interested in conducting a Takeda Investigator Initiated - Sponsored Research (II-SR) study. We have created this Informational Guide to assist investigators throughout the entire II-SR process. We seek to advance the delivery of quality medical care and make a difference in patient's lives by supporting appropriate scientific research that contributes to the understanding and treatment of specific disease states. Certain resources (i.e. funding and study drug) may be available to investigators who are interested in conducting an acceptable II-SR study. We may provide support (e.g., funding and/or study drug) for Investigator Initiated Sponsored Research (IISR) studies in the following therapeutic areas:

     • Hypertension
          - Mechanism of action studies with azilsartan medoxomil
          - Pleiotropic effects beyond blood pressure control
          - End-organ effects
          - Chlorthalidone + Azilsartan Medoxomil Studies

     • Hyperuricemia/Gout
          - Effects of febuxostat in gout patients with medical comorbidities
               · Cardiometabolic
               · Hypertension
               · Chronic Kidney Disease (especially CKD 3-4)
               · Transplant patients
          - Effects of febuxostat on disease progression with related mechanisms
               · Hypertension
               · Renal Function
               · Nephrolithiasis
               · Atherosclerosis
          - Effects of febuxostat in special populations
          - Febuxostat in Tumor Lysis Syndrome
          - Febuxostat in Lesch-Nyhan Syndrome
               · Inborn errors of metabolism
           Hyperuricemia Studies
          - Clinical correlates of specific sUA levels
          - Clinical correlates of hyperuricemia
               · Cardiometabolic disease
               · Hypertension
               · Chronic Kidney Disease
           Gout Studies
          - Characterization of hypertension and renal function in gout patients
          - Gout diagnostic/monitoring methods
               · With focus on crystal formation and deposition and joint damage
          - Predictors of gout in patients with hyperuricemia
          - Limitations of current gout medications
           Mechanistic Studies
          - Role of Uric acid in inflammation
          - The benefits of urate lowering via inhibition of xanthine oxidase

     • Gastroenterology
           Upper GI
          - Treatment of Gastroesophageal Reflux Disease (GERD) in Adults
               · Control of nocturnal acidity
               · Dosing flexibility
               · Alternative acid index measures (novel)
               · Special patient populations (e.g. obesity, diabetes, etc.)
          - Treatment of the Following
               · Barrett's Esophagitis
               · Eosinophilic Esophagitis
               · Extraesophageal effects (asthma, chronic cough, dental, NCCP)
           Lower GI
          - Chronic Constipation and Irritable Bowel Syndrome with Constipation in Adults
          - Special populations (e.g. IBS-M, diabetes)
          - Effects of lubiprostone on:
               · Sensory function
               · Mucosal barrier function
               · Fluid secretion
               · Bacterial overgrowth and intestinal microflora

Please be aware that support is awarded strictly based on research merit criteria. Support of a study in no way implies any obligation toward or is any way connected to the recommendation or prescribing of products.

We appreciate your interest in the Takeda II-SR program. If you are an existing user, please log below, or if you are a new user you may register for access to the site.