Overview
No overview information available.
Indication
No indication information available.
Associated Conditions
No associated conditions information available.
Research Report
Oveporexton (TAK-861): A First-in-Class Orexin Receptor 2 Agonist Poised to Revolutionize the Treatment of Narcolepsy Type 1
Executive Summary
Oveporexton, also known by its developmental code TAK-861, is an investigational, orally administered, first-in-class selective orexin receptor 2 (OX2R) agonist developed by Takeda Pharmaceuticals. It represents a paradigm shift in the therapeutic strategy for Narcolepsy Type 1 (NT1), a debilitating chronic neurological disorder characterized by a profound deficiency of the neuropeptide orexin. Unlike current standard-of-care treatments, which offer only symptomatic relief by modulating downstream neurotransmitter systems, oveporexton is designed to address the root pathophysiological cause of the disease by directly replacing the missing orexin signal.
The clinical development program for oveporexton has yielded exceptionally robust and consistent results. Across a comprehensive series of studies, including two pivotal, global Phase 3 trials (FirstLight and RadiantLight), the agent demonstrated statistically significant and clinically meaningful improvements across the full spectrum of NT1 symptoms. Treatment with oveporexton resulted in profound enhancements in objective and subjective measures of wakefulness, a marked reduction in cataplexy events, and significant improvements in patient-reported quality of life and daily functioning. Notably, a substantial proportion of treated participants achieved levels of wakefulness and sleepiness within the normative range for healthy individuals.
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
|---|---|---|---|---|---|
2024/07/17 | Phase 3 | Completed | |||
2024/06/24 | Phase 3 | Completed | |||
2023/04/18 | Phase 2 | Recruiting | |||
2023/01/18 | Phase 2 | Completed |
FDA Drug Approvals
Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
|---|---|---|---|---|---|
| No FDA approvals found for this drug. | |||||
EMA Drug Approvals
Approved Product | Authorization Holder | Status | Issued Date |
|---|---|---|---|
| No EMA approvals found for this drug. | |||
HSA Drug Approvals
Approved Product | Manufacturer | Approval Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| No HSA approvals found for this drug. | |||||
NMPA Drug Approvals
Approved Product | Company | Approval Number | Drug Type | Dosage Form | Approval Date |
|---|---|---|---|---|---|
| No NMPA approvals found for this drug. | |||||
PPB Drug Approvals
Approved Product | Registration No. | Company | Licence No. | Strength | Registration Date |
|---|---|---|---|---|---|
| No PPB approvals found for this drug. | |||||
TGA Drug Approvals
Approved Product | ARTG ID | Sponsor | Registration Type | Status | Registration Date |
|---|---|---|---|---|---|
| No TGA approvals found for this drug. | |||||
Health Canada Drug Approvals
Approved Product | Company | DIN | Dosage Form | Strength | Market Date |
|---|---|---|---|---|---|
| No Health Canada approvals found for this drug. | |||||
CIMA AEMPS Drug Approvals
Approved Product | Company | Registration Number | Pharmaceutical Form | Prescription Type | Status |
|---|---|---|---|---|---|
| No CIMA AEMPS (Spain) approvals found for this drug. | |||||
Philippines FDA Drug Approvals
Approved Product | Company | License Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| No Philippines FDA approvals found for this drug. | |||||
Saudi SFDA Drug Approvals
Approved Product | Company | License Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| No Saudi SFDA approvals found for this drug. | |||||
Malaysia NPRA Drug Approvals
Approved Product | Company | Registration Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| No Malaysia NPRA approvals found for this drug. | |||||
UK EMC Drug Information
Medicine Name | MA Holder | MA Number | Pharmaceutical Form | Active Ingredient | Authorization Date |
|---|---|---|---|---|---|
| No UK EMC drug information found for this drug. | |||||
Help Us Improve
Your feedback helps us provide better drug information and insights.