API Suppliers
US DMFs Filed
0
CEP/COS Certifications
0
JDMFs Filed
0
Other Certificates
0
Other Suppliers
0
0
USA (Orange Book)
0
Europe
Canada
0
Australia
South Africa
Uploaded Dossiers
0
U.S. Medicaid
0
Annual Reports
0
0
USFDA Orange Book Patents
0
USFDA Exclusivities
0
Blog #PharmaFlow
0
News
EDQM
0
USP
0
JP
0
Other Listed Suppliers
0
0
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
Details:
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
Details:
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
Details:
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
Details:
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
Details:
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