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10 Diseases |  |
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0 Trials |  |
21 News |  |
- | imarikiren (TAK-272) / Takeda
Preclinical, Journal: Development of a novel murine heart failure model overexpressing human renin and angiotensinogen. (Pubmed Central) - Jul 11, 2021
Triple-tg mice treated with 10 mg/kg of TAK-272 (imarikiren / SCO-272), an orally active direct renin inhibitor, exhibited improvements in heart failure phenotypes, such as cardiac hypertrophy and survival rate; however, a dose of 300 mg/kg was required to improve symptoms in CSQ-tg mice. Our results suggest that this newly generated triple-tg heart failure model is useful to evaluate the cardioprotective effects of human renin inhibitors at clinically relevant doses, thereby minimizing the concerns of off-target effects related to much higher drug exposure than that achieved in clinical study.
- | imarikiren (TAK-272) / Takeda
Journal: Benchmarking renin suppression and blood pressure reduction of direct renin inhibitor imarikiren through quantitative systems pharmacology modeling. (Pubmed Central) - May 9, 2020
Our analysis indicates that low doses (5-10 mg) of imarikiren are comparable to current RAAS therapies, and at higher doses (25-200 mg), RAAS suppression may be equivalent to existing dual-RAAS combinations (at registered doses). This study illustrates application of QSP modeling to predict phase II endpoints from phase I data.
- || imarikiren (TAK-272) / Takeda
Clinical, Journal: Efficacy and Safety of Imarikiren in Patients with Type 2 Diabetes and Microalbuminuria: A Randomized, Controlled Trial. (Pubmed Central) - Apr 1, 2020
This study illustrates application of QSP modeling to predict phase II endpoints from phase I data. Imarikiren resulted in a dose-dependent improvement in albuminuria compared with placebo, and it was well tolerated in patients with type 2 diabetes mellitus and microalbuminuria.
- || imarikiren (TAK-272) / Takeda
Clinical, P1 data, PK/PD data, Journal: A Randomized, Single-Center, Double-Blind, Placebo-Controlled Multiple-Dose Phase 1 Study to Evaluate the Safety, Pharmacokinetics, and Pharmacodynamics of Imarikiren in Healthy Adult Nonelderly and Elderly Male Subjects. (Pubmed Central) - Dec 6, 2019
Treatment-emergent adverse events were reported in 33.3% (elderly) and 22.2% (nonelderly) of imarikiren subjects. Multiple oral administrations of imarikiren for 7 days were safe and well tolerated with no drug accumulation and strong and sustained suppression of plasma renin activity.
- | imarikiren (TAK-272) / Takeda
PK/PD data, Preclinical, Journal: The effect of elevated α-acid glycoprotein on the pharmacokinetics of TAK-272 (SCO-272), an orally active renin inhibitor, in rats. (Pubmed Central) - Apr 26, 2019
3. These results strongly suggested that the pharmacokinetic of TAK-272 in humans would also be affected by the variation in the plasma AGP levels and should be discussed with not only the total concentrations but also the unbound concentrations in the clinical trial for patients with elevated plasma AGP levels.
- |||| imarikiren (TAK-272) / Takeda
Trial completion: A Phase 2 Dose-finding Study of TAK-272 in Participants With Type 2 Diabetes Mellitus and Microalbuminuria (clinicaltrials.gov) - Sep 9, 2016
P2, N=415, Completed, Sponsor: Takeda
These results strongly suggested that the pharmacokinetic of TAK-272 in humans would also be affected by the variation in the plasma AGP levels and should be discussed with not only the total concentrations but also the unbound concentrations in the clinical trial for patients with elevated plasma AGP levels. Recruiting --> Completed
- | imarikiren (TAK-272) / Takeda
Trial completion: Phase I Open-label Study to Evaluate Pharmacokinetics of TAK-272 in Participants With Renal or Hepatic Impairment (clinicaltrials.gov) - Jul 15, 2016
P1, N=48, Completed, Sponsor: Takeda
Recruiting --> Completed Active, not recruiting --> Completed
- imarikiren (TAK-272) / Takeda
Enrollment closed: Phase I Open-label Study to Evaluate Pharmacokinetics of TAK-272 in Participants With Renal or Hepatic Impairment (clinicaltrials.gov) - Jun 30, 2016
P1, N=48, Active, not recruiting, Sponsor: Takeda
Active, not recruiting --> Completed Recruiting --> Active, not recruiting
- | imarikiren (TAK-272) / Takeda
Trial completion, Trial primary completion date: Drug-Drug Interaction Study Between TAK-272 and Itraconazole, Digoxin or Midazolam (clinicaltrials.gov) - Aug 1, 2015
P1, N=34, Completed, Sponsor: Takeda
Recruiting --> Active, not recruiting Recruiting --> Completed | Trial primary completion date: Apr 2016 --> Apr 2015
- imarikiren (TAK-272) / Takeda
Enrollment open, Trial primary completion date: Drug-Drug Interaction Study Between TAK-272 and Itraconazole, Digoxin or Midazolam (clinicaltrials.gov) - Jun 9, 2015
P1, N=34, Recruiting, Sponsor: Takeda
Recruiting --> Completed | Trial primary completion date: Apr 2016 --> Apr 2015 Not yet recruiting --> Recruiting | Trial primary completion date: Apr 2015 --> Apr 2016
- imarikiren (TAK-272) / Takeda
Enrollment open: Phase I Open-label Study to Evaluate Pharmacokinetics of TAK-272 in Participants With Renal or Hepatic Impairment (clinicaltrials.gov) - Mar 23, 2015
P1, N=48, Recruiting, Sponsor: Takeda
Not yet recruiting --> Recruiting | Trial primary completion date: Apr 2015 --> Apr 2016 Not yet recruiting --> Recruiting
- | imarikiren (TAK-272) / Takeda
New P1 trial: Drug-Drug Interaction Study Between TAK-272 and Itraconazole, Digoxin or Midazolam (clinicaltrials.gov) - Feb 26, 2015
P1, N=34, Not yet recruiting, Sponsor: Takeda
- | imarikiren (TAK-272) / Takeda
New P1 trial: Phase I Open-label Study to Evaluate Pharmacokinetics of TAK-272 in Participants With Renal or Hepatic Impairment (clinicaltrials.gov) - Feb 20, 2015
P1, N=48, Not yet recruiting, Sponsor: Takeda
- ||||| imarikiren (TAK-272) / Takeda
New P2 trial: A Phase 2 Dose-finding Study of TAK-272 in Participants With Type 2 Diabetes Mellitus and Microalbuminuria (clinicaltrials.gov) - Jan 7, 2015
P2, N=408, Recruiting, Sponsor: Takeda