(Mirabegron + tamsulosin hydrochloride) is under clinical development by DongKoo Bio & Pharma and currently in Phase II for Benign Prostatic Hyperplasia. According to GlobalData, Phase II drugs for Benign Prostatic Hyperplasia have a 45% phase transition success rate (PTSR) indication benchmark for progressing into Phase III. GlobalData’s report assesses how (Mirabegron + tamsulosin hydrochloride)’s drug-specific PTSR and Likelihood of Approval (LoA) scores compare to the indication benchmarks. Buy the report here.

GlobalData tracks drug-specific phase transition and likelihood of approval scores, in addition to indication benchmarks based off 18 years of historical drug development data. Attributes of the drug, company and its clinical trials play a fundamental role in drug-specific PTSR and likelihood of approval.

(Mirabegron + tamsulosin hydrochloride) overview

DKB-17001 is a fixed dose combination of mirabegron and tamsulosin hydrochloride is under development for the treatment of overactive bladder and benign prostatic hyperplasia. It is an incrementally modified drug. Mirabegron acts by targeting beta adrenergic receptor and tamsulosin hydrochloride acts by targets alpha-1 adrenergic receptor.

DongKoo Bio & Pharma overview

DongKoo Bio & Pharma (DongKoo) develops, manufactures, and exports generic drugs and provides contract manufacturing services. The company’s product portfolio includes prescribed medicines, including digestants; antiplatelet agents, allergics; nonsteroidal anti-inflammatory drugs decongestants and nasal preparation products; and oral hypoglycemic agents, non-medical products, CMO products, medical apparatus such as smart X, a stem-cell extraction kit, and cosmetics. It offers products in various forms, such as soft gelatin capsules, hard capsules, tablets, powders or granules, externals and liquids. The company has its presence across Vietnam, New Zealand, Thailand, Hong Kong, and Singapore. DongKoo is headquartered in Seoul, South Korea.

For a complete picture of (Mirabegron + tamsulosin hydrochloride)’s drug-specific PTSR and LoA scores, buy the report here.


GlobalData, the leading provider of industry intelligence, provided the underlying data, research, and analysis used to produce this article.

GlobalData’s Likelihood of Approval analytics tool dynamically assesses and predicts how likely a drug will move to the next stage in its clinical pathway (PTSR), as well as how likely the drug will be approved (LoA). This is based on a proprietary algorithm built from the drugs’ sales forecast, regulatory milestones, cost forecasts, WACC rate and other proprietary data sources found on GlobalData’s Pharmaceutical Intelligence Center.