Overview
Troriluzole is under investigation in clinical trial NCT03701399 (Troriluzole in Adult Subjects With Spinocerebellar Ataxia).
Indication
No indication information available.
Associated Conditions
No associated conditions information available.
Research Report
Troriluzole (DB15079): A Comprehensive Monograph on a Novel Glutamate Modulator from Prodrug Design to Clinical Application
Executive Summary
Troriluzole (DB15079) is an investigational small molecule therapeutic representing a sophisticated application of prodrug chemistry. It is a third-generation tripeptide prodrug of riluzole, a medication approved for amyotrophic lateral sclerosis.[1] The primary rationale for its development was to engineer a molecule that retains the glutamate-modulating activity of riluzole while systematically overcoming the parent compound's significant clinical liabilities, which include poor and variable bioavailability, a negative food effect, and dose-dependent hepatotoxicity.[4]
The principal mechanism of action of Troriluzole, mediated through its active metabolite riluzole, is the normalization of synaptic glutamate levels. This is achieved through a dual action: enhancing the uptake and clearance of glutamate from the synapse by augmenting the function of glial excitatory amino acid transporters (EAATs) and inhibiting the presynaptic release of glutamate.[7] This central mechanism is complemented by ancillary actions, including the inactivation of voltage-dependent sodium channels.[10]
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
|---|---|---|---|---|---|
2024/08/13 | Early Phase 1 | Recruiting | Ugonma Chukwueke | ||
2024/07/31 | N/A | Active, not recruiting | |||
2023/09/13 | N/A | AVAILABLE | |||
2021/05/25 | Phase 2 | Terminated | |||
2021/01/14 | Phase 3 | ENROLLING_BY_INVITATION | |||
2021/01/05 | Phase 3 | Completed | |||
2020/11/23 | Phase 3 | Active, not recruiting | |||
2019/05/31 | Phase 2 | Recruiting | Global Coalition for Adaptive Research | ||
2019/02/04 | Phase 3 | Completed | |||
2018/10/10 | Phase 3 | Active, not recruiting |
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. | |||||
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