Overview
Padsevonil is under investigation in clinical trial NCT03695094 (A Study in Participants With Epilepsy, to Evaluate the Pharmacokinetics, Safety and Tolerability of Oxcarbazepine on Padsevonil).
Indication
No indication information available.
Associated Conditions
No associated conditions information available.
Research Report
Padsevonil (UCB-0942): A Comprehensive Review of a Dual-Action Antiseizure Medication from Rational Design to Clinical Discontinuation
Executive Summary
This report provides an exhaustive analysis of Padsevonil (UCB-0942), an investigational small molecule developed by UCB Pharma for drug-resistant focal epilepsy. Padsevonil was rationally designed as a first-in-class agent with a novel dual mechanism of action: high-affinity binding to synaptic vesicle protein 2 (SV2) isoforms (A, B, and C) and partial agonism at the benzodiazepine site of GABAA receptors. This was intended to create a synergistic antiseizure effect superior to existing therapies.
Initial preclinical data and a Phase 2a proof-of-concept trial (EP0069) showed clinically meaningful efficacy signals in a highly treatment-refractory patient population, generating significant optimism for the program. However, two large-scale pivotal trials, the Phase 2b ARISE (EP0091) and Phase 3 DUET (EP0092) studies, failed to meet their primary efficacy endpoints. Padsevonil did not demonstrate a statistically significant reduction in seizure frequency compared to placebo across any tested dose.
Consequently, UCB terminated the entire clinical development program in 2020. This report deconstructs the complete trajectory of Padsevonil, from its compelling scientific rationale to its ultimate clinical failure. It analyzes the detailed trial results, explores the strategic impact on UCB, and contextualizes this outcome within the broader challenges of the "translational gap" in epilepsy drug development. The failure of Padsevonil serves as a critical case study on the difficulties of treating drug-resistant epilepsy and offers important lessons for the future of neurotherapeutic research.
1.0 Introduction: The Unmet Need in Drug-Resistant Epilepsy and the Rationale for Padsevonil
1.1 The Persistent Challenge of Drug-Resistant Epilepsy (DRE)
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
|---|---|---|---|---|---|
2020/02/25 | Phase 1 | Withdrawn | |||
2019/10/23 | Phase 1 | Terminated | UCB Biopharma S.P.R.L. | ||
2019/10/18 | Phase 1 | Terminated | |||
2019/10/15 | Phase 1 | Terminated | UCB Biopharma S.P.R.L. | ||
2019/08/30 | Phase 1 | Completed | UCB Biopharma S.P.R.L. | ||
2019/07/31 | Phase 1 | Terminated | UCB Biopharma S.P.R.L. | ||
2019/07/09 | Phase 1 | Completed | UCB Biopharma S.P.R.L. | ||
2018/11/14 | Phase 3 | Terminated | |||
2018/10/03 | Phase 1 | Completed | UCB Biopharma S.P.R.L. | ||
2018/03/29 | Phase 1 | Completed | UCB Biopharma S.P.R.L. |
FDA Drug Approvals
Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
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| No FDA approvals found for this drug. | |||||
EMA Drug Approvals
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| No EMA approvals found for this drug. | |||
HSA Drug Approvals
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| No HSA approvals found for this drug. | |||||
NMPA Drug Approvals
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| No NMPA approvals found for this drug. | |||||
PPB Drug Approvals
Approved Product | Registration No. | Company | Licence No. | Strength | Registration Date |
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| No PPB approvals found for this drug. | |||||
TGA Drug Approvals
Approved Product | ARTG ID | Sponsor | Registration Type | Status | Registration Date |
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| No TGA approvals found for this drug. | |||||
Health Canada Drug Approvals
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| No Health Canada approvals found for this drug. | |||||
CIMA AEMPS Drug Approvals
Approved Product | Company | Registration Number | Pharmaceutical Form | Prescription Type | Status |
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| No CIMA AEMPS (Spain) approvals found for this drug. | |||||
Philippines FDA Drug Approvals
Approved Product | Company | License Number | Dosage Form | Strength | Approval Date |
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| No Philippines FDA approvals found for this drug. | |||||
Saudi SFDA Drug Approvals
Approved Product | Company | License Number | Dosage Form | Strength | Approval Date |
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| No Saudi SFDA approvals found for this drug. | |||||
Malaysia NPRA Drug Approvals
Approved Product | Company | Registration Number | Dosage Form | Strength | Approval Date |
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| No Malaysia NPRA approvals found for this drug. | |||||
UK EMC Drug Information
Medicine Name | MA Holder | MA Number | Pharmaceutical Form | Active Ingredient | Authorization Date |
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| No UK EMC drug information found for this drug. | |||||
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