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Details:

AXS-12 (reboxetine) is a highly selective and potent norepinephrine reuptake inhibitor and cortical dopamine modulator. It is being evaluated for the treatment of Narcolepsy.


Lead Product(s): Reboxetine Mesylate

Therapeutic Area: Sleep Product Name: AXS-12

Highest Development Status: Phase IIIProduct Type: Small molecule

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable March 25, 2024

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Apnimed’s lead product candidate, AD109, targets the neurologic control and facilitates the activation of the upper airway dilator muscles to maintain an open airway during sleep.


Lead Product(s): Reboxetine Mesylate,Oxybutynin

Therapeutic Area: Sleep Product Name: AD128

Highest Development Status: Phase II/ Phase IIIProduct Type: Small molecule

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable May 17, 2021

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The expedited development plan includes one Phase 3 efficacy trial, which, along with the previously completed Phase 2 CONCERT trial, will be used to support the filing of an NDA (New Drug Application) for approval of AXS-12 for the treatment of cataplexy in narcolepsy.


Lead Product(s): Reboxetine Mesylate

Therapeutic Area: Sleep Product Name: AXS-12

Highest Development Status: Phase IIProduct Type: Small molecule

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable September 21, 2020

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Axsome will present efficacy & safety data from the CONCERT Ph 2 trial of AXS-12 in the treatment of narcolepsy at the 34th Annual SLEEP Meeting of the APSS. AXS-12 is a novel, oral, highly selective and potent norepinephrine reuptake inhibitor for the treatment of narcolepsy.


Lead Product(s): Reboxetine Mesylate

Therapeutic Area: Sleep Product Name: AXS-12

Highest Development Status: Phase IIProduct Type: Small molecule

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable August 28, 2020

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AXS-12 is a novel, oral, highly selective and potent norepinephrine reuptake inhibitor. Axsome previously received Orphan Drug Designation from the FDA for AXS-12 for the treatment of narcolepsy.


Lead Product(s): Reboxetine Mesylate

Therapeutic Area: Sleep Product Name: AXS-12

Highest Development Status: Phase IIProduct Type: Small molecule

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable August 05, 2020

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Agreement accelerates ongoing clinical development of AXS-12 (reboxetine) in narcolepsy which expands Axsome’s pipeline with new Phase 3-stage esreboxetine product candidate for fibromyalgia


Lead Product(s): Reboxetine Mesylate

Therapeutic Area: Sleep Product Name: Undisclosed

Highest Development Status: Phase IIProduct Type: Small molecule

Partner/Sponsor/Collaborator: Axsome Therapeutics

Deal Size: $331.0 million Upfront Cash: $3.0 million

Deal Type: Licensing Agreement January 13, 2020

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