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

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            Lead Product(s): Levomethadone Hydrochloride

            Therapeutic Area: Psychiatry/Psychology Product Name: LYN-014

            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 May 06, 2021

            Details:

            LYN-014 is designed to address a critical unmet need for people with opioid use disorder and provide consistent target therapeutic levels of levomethadone over the course of an entire week from a single, once-weekly oral capsule.

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            Lead Product(s): Deuterated tryptamine

            Therapeutic Area: Psychiatry/Psychology Product Name: CYB003

            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 April 13, 2021

            Details:

            Cybin plans to advance the pre-clinical work for its orally dissolving tablet (“ODT”) formulation of CYB003 and its inhaled formulation of CYB004, two of the Company’s deuterated tryptamine development candidates.

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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).