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Find FDA Investigational New Drug (IND) Submissions for Psychiatry/Psychology in UNITED STATES

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            Lead Product(s): Serdexmethylphenidate

            Therapeutic Area: Psychiatry/Psychology Product Name: KP879

            Highest Development Status: IND Enabling Product Type: Small molecule

            Partner/Sponsor/Collaborator: Not Applicable

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable January 27, 2021

            Details:

            KP879 is being developed as an extended-duration, agonist replacement therapy for the treatment of Stimulant Use Disorder (SUD), a condition for which there are no FDA-approved medications.

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            Lead Product(s): Cannabinoids

            Therapeutic Area: Psychiatry/Psychology Product Name: RLS 103

            Highest Development Status: IND Enabling Product Type: Small molecule

            Partner/Sponsor/Collaborator: Not Applicable

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable January 17, 2021

            Details:

            Receptor Life Sciences has completed a pre-investigational new drug meeting with the U.S. FDA. The meeting resulted in clear guidance on the regulatory requirements for the development and approval of RLS103 under section 505(b)(2).

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            Lead Product(s): Drinabant

            Therapeutic Area: Psychiatry/Psychology Product Name: OPNT004

            Highest Development Status: IND Enabling Product Type: Small molecule

            Partner/Sponsor/Collaborator: National Institutes of Health

            Deal Size: $0.8 million Upfront Cash: Undisclosed

            Deal Type: Funding January 08, 2021

            Details:

            IRISYS, has been awarded by the National Center for Advancing Translational Sciences (NCATS), one of 27 institutes of the NIH, to develop a new injectable formulation of Drinabant, a selective, high affinity cannabinoid receptor (CB-1) antagonist.

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            Lead Product(s): Sildenafil Citrate

            Therapeutic Area: Psychiatry/Psychology Product Name: CUREfilm Blue

            Highest Development Status: IND Enabling Product Type: Small molecule

            Partner/Sponsor/Collaborator: Not Applicable

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable January 05, 2021

            Details:

            CUREfilm Blue™ utilizes the Company’s patented and proprietary fast-dissolving drug delivery platform, known as CUREfilm™, to deliver the active pharmaceutical ingredient (API) sildenafil citrate.

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            Lead Product(s): Serdexmethylphenidate

            Therapeutic Area: Psychiatry/Psychology Product Name: KP879

            Highest Development Status: IND Enabling Product Type: Small molecule

            Partner/Sponsor/Collaborator: Not Applicable

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable December 22, 2020

            Details:

            KemPharm is developing KP879 as an extended-duration, agonist replacement therapy for the treatment of Stimulant Use Disorder (SUD). If the KP879 IND filing is accepted by the FDA, KemPharm intends to initiate efficacy studies of KP879 in 2021.

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            Lead Product(s): MEB-1170

            Therapeutic Area: Psychiatry/Psychology Product Name: MEB-1170

            Highest Development Status: IND Enabling Product Type: Small molecule

            Partner/Sponsor/Collaborator: National Institute on Drug Abuse

            Deal Size: $7.1 million Upfront Cash: Undisclosed

            Deal Type: Funding October 29, 2020

            Details:

            The funds will be used to progress the company's lead candidate MEB–1170, an analgesic drug candidate for the prevention and treatment of Opioid Use Disorder, through IND filing and Phase 1 clinical trials.

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            Lead Product(s): Dexmedetomidine Hydrochloride

            Therapeutic Area: Psychiatry/Psychology Product Name: BXCL501

            Highest Development Status: IND Enabling Product Type: Small molecule

            Partner/Sponsor/Collaborator: Not Applicable

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable October 26, 2020

            Details:

            BXCL501 is an investigational, proprietary, orally dissolving, sublingual thin film formulation of dexmedetomidine, for the treatment of acute agitation. The Company plans to initiate a Phase 2 trial within the next several months.

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            Lead Product(s): Quetiapine Fumarate

            Therapeutic Area: Psychiatry/Psychology Product Name: Undisclosed

            Highest Development Status: IND Enabling Product Type: Small molecule

            Partner/Sponsor/Collaborator: Not Applicable

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable October 07, 2020

            Details:

            The potential advantage of this alternative dosage form of Quetiapine Fumarate is that it may be preferred for adult patients who experience swallowing difficulties or for adults and adolescents who have trouble swallowing tablets.

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            Lead Product(s): PT00114

            Therapeutic Area: Psychiatry/Psychology Product Name: PT00114

            Highest Development Status: IND Enabling Product Type: Peptide

            Partner/Sponsor/Collaborator: Undisclosed

            Deal Size: $2.0 million Upfront Cash: Undisclosed

            Deal Type: Financing September 08, 2020