Overview
No overview information available.
Indication
No indication information available.
Associated Conditions
No associated conditions information available.
Research Report
SYN-818: An Investigational DNA Polymerase Theta (Polθ) Inhibitor for Precision Oncology
I. Introduction to SYN-818
A. Overview of SYN-818
SYN-818 is an orally available, investigational novel small molecule inhibitor specifically designed to target DNA Polymerase Theta (Polθ).[1] Its development is centered on the principles of precision oncology, aiming to exploit vulnerabilities within the DNA damage repair (DDR) mechanisms of cancer cells.[1] A core concept underpinning its therapeutic strategy is synthetic lethality, particularly in tumors characterized by deficiencies in homologous recombination (HR) repair pathways, such as those with BRCA1 or BRCA2 mutations.[1]
B. Developer: SynRx Therapeutics
SYN-818 is an asset independently developed by SynRx Therapeutics Co., Ltd..[1] Founded in 2021 and headquartered in Hangzhou, China, SynRx Therapeutics is a biopharmaceutical company specializing in precision oncology, with a particular focus on DDR pathways and synthetic lethality.[1] The company successfully secured $14.2 million in seed funding to support its research and development endeavors.[6] SYN-818 represents a significant milestone for the company, being its first internally developed innovative drug candidate to progress into the clinical development stage.[1]
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
|---|---|---|---|---|---|
2024/10/30 | Phase 1 | Recruiting | Hangzhou SynRx Therapeutics Biomedical Technology Co., Ltd |
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.