Takeda has submitted the NDA for the compound on the basis of the results from four Phase 3 clinical trials conducted in Japan.
In those trials, Takeda has evaluated the safety and efficacy of TAK-536 in comparison with Blopress (candesartan cilexetil); another angiotensin II receptor blocker (ARB) discovered and marketed by Takeda in Japan.
The trial involved slightly more than 1,000 patients, out of all four trials; one trial evaluated around 636 patients in Japan.
The trial which involved 636 patients demonstrated that TAK-536 was statistically superior to Blopress in lowering the change from baseline in sitting diastolic blood pressure, which is the primary endpoint.
TAK-536 was found to be safe and well tolerated, with the safety profile comparable to Blopress.
Takeda Pharmaceutical Development Division general manager Nancy Joseph-Ridge said if approved, they expect that TAK-536 will provide a valuable, new treatment option for hypertensive patients and the health care providers who treat them, and at the same time, enhance their presence in hypertension drug market in Japan.