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Find Clinical Drug Pipelines for Sleep

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            Lead Product(s): Reboxetine

            Therapeutic Area: Sleep Product Name: Undisclosed

            Highest Development Status: Phase II Product 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

            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

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            Lead Product(s): Mazindol

            Therapeutic Area: Sleep Product Name: Undisclosed

            Highest Development Status: Phase II Product Type: Small molecule

            Partner/Sponsor/Collaborator: NLS Pharmaceutics

            Deal Size: Undisclosed Upfront Cash: Undisclosed

            Deal Type: Collaboration January 13, 2020

            Details:

            NLS Pharmaceutics entered a collaboration to develop mazindol (MZD) CR product candidates for the treatment of narcolepsy and ADHD utilizing Adare’s proprietary modified release technologies.

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            Lead Product(s): Calcium,Magnesium,Potassium

            Therapeutic Area: Sleep Product Name: Xywav

            Highest Development Status: Approved Product Type: Small molecule

            Partner/Sponsor/Collaborator: Not Applicable

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable October 08, 2020

            Details:

            All patients were treated with Xywav during the open-label titration period and clinically meaningful improvements in the Epworth Sleepiness Scale (ESS) were observed.

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            Lead Product(s): Melatonin,Apigenin

            Therapeutic Area: Sleep Product Name: Kinderlyte Sleep

            Highest Development Status: Approved Product Type: Peptide

            Partner/Sponsor/Collaborator: Not Applicable

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable September 30, 2020

            Details:

            Kinderlyte's Herbal Sleep Supplement is a doctor-formulated, drug-free sleep aid that uses a proprietary blend of melatonin and calming botanicals such as chamomile, passionflower, and lemon balm to support sleep.

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            Lead Product(s): Reboxetine

            Therapeutic Area: Sleep Product Name: AXS-12

            Highest Development Status: Phase II Product Type: Small molecule

            Partner/Sponsor/Collaborator: Not Applicable

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable September 21, 2020

            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.

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            Lead Product(s): XW10172

            Therapeutic Area: Sleep Product Name: XW10172

            Highest Development Status: Phase I Product Type: Small molecule

            Partner/Sponsor/Collaborator: Panacea Venture

            Deal Size: $40.0 million Upfront Cash: Undisclosed

            Deal Type: Series C Financing September 17, 2020

            Details:

            XWPharma expects to use proceeds to advance clinical development of the company’s lead investigational programs: XW10172, a GABAB receptor agonist intended for the treatment of sleep disorders in narcolepsy, Parkinson’s disease and other neurodegenerative diseases.

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            Lead Product(s): Oxybutynin,Atomoxetine Hydrochloride

            Therapeutic Area: Sleep Product Name: AD109

            Highest Development Status: Phase II Product Type: Small molecule

            Partner/Sponsor/Collaborator: Not Applicable

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable September 17, 2020

            Details:

            In this healthy volunteer study, R-oxybutynin, a key component of AD109, demonstrated a favorable pharmacokinetic (PK) profile and was well tolerated with no adverse events related to the study drug.

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            Lead Product(s): Daridorexant

            Therapeutic Area: Sleep Product Name: Undisclosed

            Highest Development Status: Phase III Product Type: Small molecule

            Partner/Sponsor/Collaborator: Syneos Health

            Deal Size: Undisclosed Upfront Cash: Undisclosed

            Deal Type: Collaboration August 31, 2020

            Details:

            The strategic collaboration brings Idorsia’s lead investigational compound, daridorexant, and expertise in the science of the orexin system, together with Syneos Health’s robust customer-facing sales expertise and proven track record in launching new products in the US.

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            Lead Product(s): Reboxetine

            Therapeutic Area: Sleep Product Name: AXS-12

            Highest Development Status: Phase II Product Type: Small molecule

            Partner/Sponsor/Collaborator: Not Applicable

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable August 28, 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.

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            Lead Product(s): IMB-115

            Therapeutic Area: Sleep Product Name: IMB-115

            Highest Development Status: Phase I Product Type: Small molecule

            Partner/Sponsor/Collaborator: Not Applicable

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable August 28, 2020

            Details:

            IMB-115 is a novel, highly potent and selective partial agonist for nociceptin/orphanin-FQ peptide (NOP) receptors designed to promote sleep onset and maintenance at doses that show minimal or no residual next-day somnolence (drowsiness) or psychomotor impairment.

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