Liafensine
- Generic Name
- Liafensine
- Drug Type
- Small Molecule
- Chemical Formula
- C24H22N4
- CAS Number
- 1198790-53-2
- Unique Ingredient Identifier
- R34ID086Z6
- Background
Liafensine is under investigation in clinical trial NCT00892840 (Multiple-Ascending Dose Study).
FDA Grants Fast Track Designation to Denovo Biopharma's Liafensine for Treatment-Resistant Depression
• The FDA has granted Fast Track designation to Denovo Biopharma's liafensine (DB104) for treatment-resistant depression (TRD), potentially expediting its review process.
• Liafensine, a first-in-class triple reuptake inhibitor, targets serotonin, norepinephrine, and dopamine transporters, offering a novel approach to TRD treatment.
• A biomarker-guided Phase 2b trial (ENLIGHTEN) demonstrated significant improvement in depressive symptoms in DGM4-positive patients treated with liafensine (p=0.0056).
• The Fast Track designation underscores the urgent need for new TRD therapies and recognizes the potential of Denovo's precision medicine approach using the DGM4 biomarker.
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