Mirabegron ER is under clinical development by Astellas Pharma and currently in Phase I for Esophageal Achalasia. According to GlobalData, Phase I drugs for Esophageal Achalasia does not have sufficient historical data to build an indication benchmark PTSR for Phase I. GlobalData uses proprietary data and analytics to create drugs-specific PTSR and LoA in the Mirabegron ER LoA Report. 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 ER overview

Mirabegron (Betanis, Myrbetriq, Myrbetric, YM178) is a smooth muscle relaxant, formulated as extended-release/prolonged release tablets, film coated tablets and granules for suspension for oral route of administration. Mirabegron is indicated for the treatment of urgency, increased micturition frequency and/or urgency incontinence as may occur in adult patients with overactive bladder (OAB) syndrome. Myrbetriq granules is indicated for the treatment of neurogenic detrusor overactivity (NDO) in pediatric patients aged 3 years and older and tablets are indicated for the treatment of neurogenic detrusor overactivity (NDO) in pediatric patients aged 3 years and older and weighing 35 kg or more. Myrbetric is indicated for the treatment of overactive bladder syndrome.

Mirabegron is under development for the treatment of achalasia and idiopathic overactive bladder in pediatric patients. It was also under development for the treatment of overactive bladder associated with symptoms of urgency, urinary frequency, erectile dysfunction and urge urinary incontinence.

Astellas Pharma overview

Astellas Pharma (Astellas) discovers, develops, manufactures, and commercializes a wide range of pharmaceuticals. The company’s product portfolio comprises marketed products for the treatment of a wide range of urological diseases, cancer, nephrology, infectious diseases, and metabolic diseases, immunodeficiency, and transplantation. The company strives to develop new drugs to address high unmet medical needs with focus on biology and modality. Its pipeline consists of drug candidates for the treatment of urothelial cancer; gastric cancer; gastroesophageal junction cancer; anemia associated with chronic kidney disease (CKD) in dialysis; and acute myeloid leukemia (AML), among others. It operates in the Americas, Australia, Europe, and Asia and Oceania through a network of subsidiaries and affiliates. Astellas is headquartered in Chuo-Ku, Tokyo, Japan.

For a complete picture of Mirabegron ER’s drug-specific PTSR and LoA scores, buy the report here.

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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 clinical development (PTSR), as well as how likely the drug will be approved (LoA). This is based on a combination of machine learning and a proprietary algorithm to process data points from various databases found on GlobalData’s Pharmaceutical Intelligence Center.