Mirabegron ER is under clinical development by Astellas Pharma and currently in the Phase I and Phase II in clinical pathway. The characteristics of the clinical trial as well as other attributes related to the drug, regulations, and company play a fundamental role in ensuring the likelihood of transition that the drug moves from its current development stage to next.

According to GlobalData, the latest event to affect Mirabegron ER’s likelihood of approval (LoA) and phase transition for Erectile Dysfunction took place on 17 Nov 2020, which increased the likelihood that the drug progresses to the next phase in its clinical pathway and increased the likelihood of final approval for this indication.

GlobalData uses proprietary data and analytics to provide a complete picture of this assessment in their Mirabegron ER Likelihood of Approval (LoA) and Phase Transition Success Rate (PTSR) Report.

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, erectile dysfunction 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 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, infectious diseases, cancer, nephrology, and metabolic diseases, immunodeficiency diseases, and transplantation. Its pipeline possesses drug candidates for the treatment of urothelial cancer; gastric cancer; gastroesophageal junction cancer; anemia associated with chronic kidney disease (CKD) in dialysis; Rheumatoid arthritis and non-dialysis patients; menopause-related vasomotor symptoms (MR-VMS) such as hot flashes and night sweats; 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 Tokyo, Japan.

Quick View Mirabegron ER LOA Data

Report Segments
  • Innovator (NME)
Drug Name
  • Mirabegron ER
Administration Pathway
  • Oral
Therapeutic Areas
  • Gastrointestinal
  • Genito Urinary System And Sex Hormones
  • Male Health
Key Developers
Highest Development Stage
  • Marketed

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.