EXXUA™ (gepirone ER)
Major Depressive Disorder (MDD)
Key Facts
About Aytu BioPharma
Aytu BioPharma is a publicly traded, commercial-stage company with a mission to become a leading CNS-focused specialty pharma by commercializing novel therapeutics and ensuring broad patient access. Its core strategy leverages a dual-portfolio approach: a high-growth CNS franchise anchored by the recently launched EXXUA™ for MDD and an ADHD portfolio, alongside a legacy non-CNS business that provides stable cash flow. The company differentiates itself through its integrated commercial engine, particularly the Aytu RxConnect patient support program, aiming to overcome market access barriers in complex CNS markets.
View full company profileAbout Aytu BioScience
Aytu BioPharma is a publicly traded, commercial-stage biopharmaceutical company with a distinct focus on complex CNS conditions, including MDD and ADHD. Its strategy centers on acquiring, in-licensing, and commercializing novel therapeutics, supported by a best-in-class patient access platform, Aytu RxConnect. The company has built a portfolio of FDA-approved products, most notably the recently launched antidepressant EXXUA™ (gepirone), while managing a legacy portfolio of pediatric and other specialty products. Aytu's hybrid model generates revenue from commercial sales to fund operations and strategic growth initiatives.
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 |
| INV-202 (Oral & LAI) | Indivior | Preclinical |
| Gepirone ER | Fabre-Kramer Pharmaceuticals | NDA Submitted |
| 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 |
| Flow tDCS Headset & App | Flow Neuroscience | Approved |
| Mood Disorders Biomarker Services | The Siesta Group | Service Offering |