Esreboxetine - Axsome Therapeutics
Alternative Names: [S,S]-Reboxetine; AXS-14; PNU-165442GLatest Information Update: 23 Jan 2026
At a glance
- Originator Pfizer
- Developer Axsome Therapeutics; Pfizer
- Class Antidepressants; Morpholines; Small molecules; Urologics
- Mechanism of Action Adrenergic uptake inhibitors
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Orphan Drug Status
No
Orphan designation is assigned by a regulatory body to encourage companies to develop drugs for rare diseases.
- New Molecular Entity Yes
Highest Development Phases
- Preregistration Fibromyalgia
- Discontinued Diabetic neuropathies; Major depressive disorder; Postherpetic neuralgia; Urinary-Stress-Incontinence
Most Recent Events
- 15 Jan 2026 Axsome Therapeutics initiates the phase III FORWARD trial in Fibromyalgia in USA (PO)
- 04 Aug 2025 Axsome Therapeutics plans a phase III trial for Fibromyalgia in USA in fourth quarter of 2025 (PO)
- 09 Jun 2025 Axsome Therapeutics receives Refusal to File letter from the US FDA for Esreboxetine in Fibromyalgia