Glyburide is under clinical development by Biogen and currently in the Phase II and Phase III 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 Glyburide’s likelihood of approval (LoA) and phase transition for Acute Ischemic Stroke took place on 16 Mar 2021, 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 Glyburide Likelihood of Approval (LoA) and Phase Transition Success Rate (PTSR) Report.

Glyburide overview

Glyburide (RP-1127) is under development for the treatment of brain edema (cerebral edema) following large hemispheric infarction (acute ischemic stroke) and traumatic brain injury (brain contusion). The drug candidate is administered intravenously. Glyburide acts on the sulfonylurea receptor 1 (Sur1)-regulated NCCa-ATP cation channel. The drug candidate is based on MPD technology.

The drug candidate was also under development for acute traumatic cervical spinal cord injury and acute subarachnoid hemorrhage.

Biogen overview

Biogen is a biopharmaceutical company that discovers, develops, and delivers drugs and biosimilars for the treatment of various neurological and neurodegenerative diseases. The company’s marketed products include Avonex (interferon beta-1a), Tysabri (natalizumab), Tecfidera (dimethyl fumarate), Fampyra (prolonged-release fampridine tablets), and Plegridy (peginterferon beta-1a) for the treatment of multiple sclerosis (MS); Spinraza (nusinersen) for spinal muscular atrophy (SMA); and Fumaderm (fumaric acid esters) for severe plaque psoriasis. It has several product candidates targeting various indications such as MS, Parkinson’s disease, CNS and neuromuscular disorders, Alzheimer’s disease, and idiopathic pulmonary fibrosis and stroke. The company sells its products through direct sales force, marketing groups, and distributors in the Americas, Europe, Asia, and other territories. Biogen is headquartered in Cambridge, Massachusetts, the US.

Quick View Glyburide LOA Data

Report Segments
  • Innovator
Drug Name
  • Glyburide
Administration Pathway
  • Intravenous
Therapeutic Areas
  • Cardiovascular
  • Central Nervous System
Key Developers
Highest Development Stage
  • Phase III

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.