Gepirone ER
Major Depressive Disorder (MDD)
NDA SubmittedActive
Key Facts
Indication
Major Depressive Disorder (MDD)
Phase
NDA Submitted
Status
Active
Company
About Fabre-Kramer Pharmaceuticals
Fabre-Kramer Pharmaceuticals is a private, development-stage biotech company with a three-decade legacy in CNS drug development. Its strategy centers on advancing a pipeline of small molecule candidates, primarily for psychiatric indications such as major depressive disorder (MDD) and generalized anxiety disorder (GAD). The company appears to operate with a lean structure, leveraging its deep expertise in CNS pharmacology to navigate clinical development and seek regulatory approvals and/or partnerships. Its success is contingent on positive late-stage clinical data and the ability to secure commercialization pathways.
View full company profileTherapeutic Areas
Other Major Depressive Disorder (MDD) Drugs
| Drug | Company | Phase |
|---|---|---|
| AL001 | Alzamend Neuro | Preclinical |
| Deep TMS (H1 Coil) | BrainsWay | FDA Cleared |
| EXXUA™ (gepirone ER) | Aytu BioPharma | Commercial |
| ZZ6398 | Zhongze Therapeutics | Phase 1/2 |
| INV-202 (Oral & LAI) | Indivior | Preclinical |
| NeuroStar Advanced Therapy | Neuronetics | FDA Cleared |
| Exablate Neuro | Insightec | Clinical Trial |
| BrightKaire Platform for Depression | NeuroKaire | Pre-clinical |
| Tyemvers (CKDB-501) | Healis Therapeutics | Pre-clinical |
| VENTURA-7 | New Hope Clinical Research | Phase 2/3 |
| DT-101 | Draig Therapeutics | Phase 2 |
| Major Depressive Disorder Program | Actipulse Neuroscience | Phase 3 |