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Vericiguat is an oral soluble bird nucleotide cyclase (sGC) regulator.
patients with heart failure, sGC stimulation is insufficient due to impaired availability of nitric oxide (NO), leading to dysfunction of the heart muscle and blood vessels.
the main basis for the application for listing is the data from the PHASE III VictorIA study.
VICTORIA study used randomized, double-blind, placebo-controlled, multi-center design, more than 600 centers in 42 countries, including Europe, Japan, China and the United States, 5,050 patients who experienced loss of compensation within 12 months of entering the group's left heart cell shot score decreased to 45% of patients with heart failure deterioration, comparing the efficacy and safety differences of vericiguat vs. placebo in other heart failure therapy.
composite endpoint of the study was the time when heart failure first occurred in hospital or cardiovascular death.
secondary endpoints include the time of cardiovascular death, the time of hospitalization for first heart failure, the time of hospitalization for heart failure (including first and recurrence), the time of hospitalization for total death or heart failure, and the time of total death.
VICTORIA study is the first Phase III trial specifically designed for patients with chronic heart failure who have a high risk of cardiovascular death and repeated hospitalization with heart failure, and the results were presented at the 69th Annual Meeting of the American College of Cardiology and the World Congress of Cardiology and published in the New England Journal of Medicine.
patients with HFrEF (lower blood score) are characterized by insufficient pumping function during cardiac contraction.
about 6.5 million heart failure patients in the United States, 40 to 50 percent of whom are HFrEF.
about 30 percent of patients with pre-symptomatic chronic heart failure in the United States experience worsening symptoms or heart failure events each year.
50 percent of chronic HFrEF patients with worsening symptoms need to be hospitalized within 30 days of heart failure, and about 1/5 of patients with worsening HFrEF die within 2 years.
and Bayer established a global development partnership for sGC in 2014.
, developed in collaboration with the two, is the first sGC regulator to go on sale, but the evidence is pulmonary hypertension, with global sales of nearly $1 billion in 2019.
if approved for the market, it would be first in class's sGC conditioner-type heart failure treatment.
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