ENA-001 is under clinical development by Enalare Therapeutics and currently in the Phase I 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 ENA-001’s likelihood of approval (LoA) and phase transition for Respiratory Depression (Hypoventilation) took place on 03 May 2021, which decreased the likelihood that the drug progresses to the next phase in its clinical pathway and decreased the likelihood of final approval for this indication.

GlobalData uses proprietary data and analytics to provide a complete picture of this assessment in their ENA-001 Likelihood of Approval (LoA) and Phase Transition Success Rate (PTSR) Report.

ENA-001 overview

ENA-001 is under development for the treatment or prevention of drug-over dose respiratory depression, post operative respiratory depression, infection related respiratory distress (COVID-19), apnea of prematurity, community drug overdose and infection related hypoxemia. The drug candidate is administered through intravenous, intramuscular and oral route. It is a new chemical entity and acts by targeting calcium activated potassium channel subunit alpha 1 (KCNMA1). It was under development for the treatment or prevention of central/mixed sleep apnea.

Enalare Therapeutics overview

Enalare Therapeutics is a privately owned clinical-stage biopharmaceutical company dedicated to developing novel therapies for patients suffering from acute respiratory conditions. It is headquartered in Delaware, the US.

Quick View ENA-001 LOA Data

Report Segments
  • Innovator
Drug Name
  • ENA-001
Administration Pathway
  • Intramuscular
  • Intravenous
  • Oral
Therapeutic Areas
  • Cardiovascular
  • Infectious Disease
  • Respiratory
  • Toxicology
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.