Eptinezumab is under clinical development by H. Lundbeck 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 Eptinezumab’s likelihood of approval (LoA) and phase transition for Cluster Headache Syndrome (Cluster Headache) took place on 25 Aug 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 Eptinezumab Likelihood of Approval (LoA) and Phase Transition Success Rate (PTSR) Report.

Eptinezumab overview

Eptinezumab (Vyepti) is a humanized immunoglobulin G1(IgG1) monoclonal antibody, which is produced in Pichia pastoris yeast cells by recombinant DNA technology. It is formulated as solution, concentrate solution for intravenous route of administration. Vyepti is indicated as preventive treatment of migraine in adults.

Eptinezumab is under development for the treatment of episodic cluster headache (eCH), chronic migraine and frequent episodic migraine in EU and Canada. It is administered as an intramuscular, intravenous infusion and subcutaneous injection. The drug candidate is a genetically engineered monoclonal antibody acts by targeting calcitonin gene related peptide(CGRP). It is based on Antibody Selection (ABS) process and Mab Xpress antibody production system. The production system exploits yeast expression system to make fully functional whole antibodies.

H. Lundbeck overview

H. Lundbeck (Lundbeck), a subsidiary of The Lundbeck Foundation, carries out the research, development, manufacturing, and marketing of pharmaceuticals for the treatment of central nervous system (CNS) diseases including psychiatric and neurological disorders. The company’s products are indicated for the treatment of Alzheimer’s disease, migraine, depression, Parkinson’s disease, schizophrenia, alcohol dependence, anxiety, bipolar I disorder, depression, anxiety, psychosis, and epilepsy, among others. It operates production facilities in Denmark, France, Italy, and China and research centers in China and Denmark. Lundbeck sells its products primarily to pharmaceutical distributors, pharmacies, and hospitals in Italy, China, Spain, Canada, Australia, the US, and other countries. Lundbeck is headquartered in Valby, Denmark.

Quick View Eptinezumab LOA Data

Report Segments
  • Innovator (NME)
Drug Name
  • Eptinezumab
Administration Pathway
  • Intramuscular
  • Intravenous
  • Subcutaneous
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.