The Ministry of Food and Drug Safety Thursday approved Boryung Pharmaceutical’s phase 1 clinical trials for FAH Tab, a combination of its existing high-blood pressure drug Dukarb and a diuretic called hydrochlorothiazide.

The phase 1 clinical trial will begin at Inje University Busan Baik Hospital in 36 males, to investigate drug interactions between three ingredients (fimasartan, amlodipine, and hydrochlorothiazide) in an open-label, randomized, single-dose, and cross-design trial.

These efforts are strategically aligned with the company’s plan to expand the “Kanarb (ingredient: fimasartan) family,” Boryung_보령제약 said. Since the launching of the first domestically developed high blood pressure drug Kanarb, the company had added Kanarb Plus, Dukarb, and Tuvero to its product line.

In tandem with the ministry’s approval, the company celebrated the first anniversary of Dukarb (ingredients: fimasartan, amlodipine) which was launched in July last year.

Dukarb has recorded accumulated sales of 6 billion won ($5.25 million), and Boryung expects next month’s sales will exceed 1 billion won. The company hopes the drug’s sales will surpass 10 billion won making it a blockbuster drug.

“By strengthening Dukarb’s marketing alongside Kanarb’s – recognized by prescribers and patients for their clinically proven effects – we will improve patient’s quality of life and achieve commercial success at home and abroad,” Boryung CEO Choi Tae-hong_최태홍 said.

Boryung is also developing other fimasartan combination products along with a hypertension-diabetes combination therapy that combines Kanarb and Trajenta tab, he said.

Dukarb showed a maximum systolic blood pressure reduction effect of 34.5mmHg and an "excellent" response rate of 89.4 percent in domestic clinical trials. Currently, it is prescribed by more than 100 general hospitals in Korea.