Midazolam hydrochloride is under clinical development by Neuraxpharm France and currently in the 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 Midazolam hydrochloride’s likelihood of approval (LoA) and phase transition for Status Epilepticus took place on 06 Jun 2022, 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 Midazolam hydrochloride Likelihood of Approval (LoA) and Phase Transition Success Rate (PTSR) Report.

Midazolam hydrochloride overview

Midazolam (Buccolam) is a benzodiazepine derivative acts as anti-epileptic agent.  Buccolam is formulated as a solution for the buccal route of administration. Buccolam is indicated for the treatment of prolonged, acute, convulsive seizures in infants, toddlers, children and adolescents in the patients diagnosed with epilepsy. It is also indicated for the treatment of status epilepticus.

Midazolam (Buccolam/ TAK-815/SHP-615) is under development for the treatment of status epilepticus in the U.S.

Quick View Midazolam hydrochloride LOA Data

Report Segments
  • Innovator (Non-NME)
Drug Name
  • Midazolam hydrochloride
Administration Pathway
  • Buccal
Therapeutic Areas
  • Central Nervous System
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.