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Enabling","graph3":"Mydecine","amount2":0,"highestDevelopmentShortName":"IND","therapeuticAreaShortName":"Psychiatry","amount2New":0,"dosageForm":"Oral","sponsorNew":"Mydecine \/ Inapplicable","highestDevelopmentStatusID":"5","companyTruncated":"Mydecine \/ Inapplicable"},{"orgOrder":0,"company":"KemPharm","sponsor":"Inapplicable","pharmaFlowCategory":"DU","therapeuticArea":"Psychiatry\/Psychology","country":"U.S.A","productType":"Controlled Substance","year":"2020","type":"Inapplicable","leadProduct":"Dexmethylphenidate","moa":"||Dopamine reuptake","graph1":"Psychiatry\/Psychology","graph2":"IND Enabling","graph3":"KemPharm","amount2":0,"highestDevelopmentShortName":"IND","therapeuticAreaShortName":"Psychiatry","amount2New":0,"dosageForm":"Undisclosed","sponsorNew":"KemPharm \/ Inapplicable","highestDevelopmentStatusID":"5","companyTruncated":"KemPharm \/ Inapplicable"},{"orgOrder":0,"company":"KemPharm","sponsor":"Inapplicable","pharmaFlowCategory":"DU","therapeuticArea":"Psychiatry\/Psychology","country":"U.S.A","productType":"Controlled Substance","year":"2021","type":"Inapplicable","leadProduct":"Dexmethylphenidate","moa":"||Dopamine reuptake","graph1":"Psychiatry\/Psychology","graph2":"IND Enabling","graph3":"KemPharm","amount2":0,"highestDevelopmentShortName":"IND","therapeuticAreaShortName":"Psychiatry","amount2New":0,"dosageForm":"Undisclosed","sponsorNew":"KemPharm \/ Inapplicable","highestDevelopmentStatusID":"5","companyTruncated":"KemPharm \/ Inapplicable"},{"orgOrder":0,"company":"Sparian Biosciences","sponsor":"National Institutes of Health","pharmaFlowCategory":"D","therapeuticArea":"Psychiatry\/Psychology","country":"U.S.A","productType":"Other Small Molecule","year":"2023","type":"Funding","leadProduct":"SBS-518","moa":"Undisclosed","graph1":"Psychiatry\/Psychology","graph2":"IND Enabling","graph3":"Sparian Biosciences","amount2":0,"highestDevelopmentShortName":"IND","therapeuticAreaShortName":"Psychiatry","amount2New":0,"dosageForm":"Undisclosed","sponsorNew":"Sparian Biosciences \/ National Institutes of Health","highestDevelopmentStatusID":"5","companyTruncated":"Sparian Biosciences \/ National Institutes of Health"},{"orgOrder":0,"company":"University of North Carolina","sponsor":"Department of Defense","pharmaFlowCategory":"D","therapeuticArea":"Psychiatry\/Psychology","country":"U.S.A","productType":"Other Small Molecule","year":"2022","type":"Funding","leadProduct":"Osanetant","moa":"NK-3 receptor","graph1":"Psychiatry\/Psychology","graph2":"IND Enabling","graph3":"University of North Carolina","amount2":0,"highestDevelopmentShortName":"IND","therapeuticAreaShortName":"Psychiatry","amount2New":0,"dosageForm":"Oral","sponsorNew":"University of North Carolina \/ Department of Defense","highestDevelopmentStatusID":"5","companyTruncated":"University of North Carolina \/ Department of Defense"},{"orgOrder":0,"company":"Psycheceutical","sponsor":"Inapplicable","pharmaFlowCategory":"DU","therapeuticArea":"Psychiatry\/Psychology","country":"U.S.A","productType":"Controlled Substance","year":"2023","type":"Inapplicable","leadProduct":"Ketamine Hydrochloride","moa":"NMDA receptor","graph1":"Psychiatry\/Psychology","graph2":"IND Enabling","graph3":"Psycheceutical","amount2":0,"highestDevelopmentShortName":"IND","therapeuticAreaShortName":"Psychiatry","amount2New":0,"dosageForm":"Topical Cream","sponsorNew":"Psycheceutical \/ Inapplicable","highestDevelopmentStatusID":"5","companyTruncated":"Psycheceutical \/ Inapplicable"},{"orgOrder":0,"company":"Psycheceutical","sponsor":"Ingenu CRO","pharmaFlowCategory":"D","therapeuticArea":"Psychiatry\/Psychology","country":"U.S.A","productType":"Controlled Substance","year":"2023","type":"Agreement","leadProduct":"Ketamine Hydrochloride","moa":"NMDA receptor","graph1":"Psychiatry\/Psychology","graph2":"IND Enabling","graph3":"Psycheceutical","amount2":0,"highestDevelopmentShortName":"IND","therapeuticAreaShortName":"Psychiatry","amount2New":0,"dosageForm":"Topical Cream","sponsorNew":"Psycheceutical \/ Ingenu CRO","highestDevelopmentStatusID":"5","companyTruncated":"Psycheceutical \/ Ingenu CRO"},{"orgOrder":0,"company":"Psycheceutical","sponsor":"Inapplicable","pharmaFlowCategory":"DU","therapeuticArea":"Psychiatry\/Psychology","country":"U.S.A","productType":"Controlled Substance","year":"2023","type":"Inapplicable","leadProduct":"Ketamine Hydrochloride","moa":"NMDA receptor","graph1":"Psychiatry\/Psychology","graph2":"IND Enabling","graph3":"Psycheceutical","amount2":0,"highestDevelopmentShortName":"IND","therapeuticAreaShortName":"Psychiatry","amount2New":0,"dosageForm":"Topical Cream","sponsorNew":"Psycheceutical \/ Inapplicable","highestDevelopmentStatusID":"5","companyTruncated":"Psycheceutical \/ Inapplicable"},{"orgOrder":0,"company":"Mydecine","sponsor":"Combat Stress","pharmaFlowCategory":"D","therapeuticArea":"Psychiatry\/Psychology","country":"CANADA","productType":"Controlled Substance","year":"2022","type":"Partnership","leadProduct":"Psilocybine","moa":"5-HT2A receptor","graph1":"Psychiatry\/Psychology","graph2":"IND Enabling","graph3":"Mydecine","amount2":0,"highestDevelopmentShortName":"IND","therapeuticAreaShortName":"Psychiatry","amount2New":0,"dosageForm":"Undisclosed","sponsorNew":"Mydecine \/ Combat Stress","highestDevelopmentStatusID":"5","companyTruncated":"Mydecine \/ Combat Stress"},{"orgOrder":0,"company":"Mydecine","sponsor":"Inapplicable","pharmaFlowCategory":"DU","therapeuticArea":"Psychiatry\/Psychology","country":"CANADA","productType":"Controlled Substance","year":"2021","type":"Inapplicable","leadProduct":"Psilocybine","moa":"5-HT2A receptor","graph1":"Psychiatry\/Psychology","graph2":"IND Enabling","graph3":"Mydecine","amount2":0,"highestDevelopmentShortName":"IND","therapeuticAreaShortName":"Psychiatry","amount2New":0,"dosageForm":"Undisclosed","sponsorNew":"Mydecine \/ Inapplicable","highestDevelopmentStatusID":"5","companyTruncated":"Mydecine \/ Inapplicable"},{"orgOrder":0,"company":"Protagenic Therapeutics","sponsor":"Undisclosed","pharmaFlowCategory":"D","therapeuticArea":"Psychiatry\/Psychology","country":"U.S.A","productType":"Peptide","year":"2020","type":"Financing","leadProduct":"PT00114","moa":"Undisclosed","graph1":"Psychiatry\/Psychology","graph2":"IND Enabling","graph3":"Protagenic Therapeutics","amount2":0,"highestDevelopmentShortName":"IND","therapeuticAreaShortName":"Psychiatry","amount2New":0,"dosageForm":"Undisclosed","sponsorNew":"Protagenic Therapeutics \/ Undisclosed","highestDevelopmentStatusID":"5","companyTruncated":"Protagenic Therapeutics \/ Undisclosed"},{"orgOrder":0,"company":"Delix Therapeutics","sponsor":"National Institutes of Health","pharmaFlowCategory":"D","therapeuticArea":"Psychiatry\/Psychology","country":"U.S.A","productType":"Other Small Molecule","year":"2023","type":"Funding","leadProduct":"DLX-007","moa":"Undisclosed","graph1":"Psychiatry\/Psychology","graph2":"IND Enabling","graph3":"Delix Therapeutics","amount2":0,"highestDevelopmentShortName":"IND","therapeuticAreaShortName":"Psychiatry","amount2New":0,"dosageForm":"Intramuscular","sponsorNew":"Delix Therapeutics \/ National Institutes of Health","highestDevelopmentStatusID":"5","companyTruncated":"Delix Therapeutics \/ National Institutes of Health"},{"orgOrder":0,"company":"Optimi Health","sponsor":"M\u0101tai Medical Research Institute","pharmaFlowCategory":"D","therapeuticArea":"Psychiatry\/Psychology","country":"CANADA","productType":"Controlled Substance","year":"2024","type":"Agreement","leadProduct":"Psilocybine","moa":"5-HT2A receptor","graph1":"Psychiatry\/Psychology","graph2":"IND Enabling","graph3":"Optimi Health","amount2":0,"highestDevelopmentShortName":"IND","therapeuticAreaShortName":"Psychiatry","amount2New":0,"dosageForm":"Oral","sponsorNew":"Optimi Health \/ M\u0101tai Medical Research Institute","highestDevelopmentStatusID":"5","companyTruncated":"Optimi Health \/ M\u0101tai Medical Research Institute"},{"orgOrder":0,"company":"Filament Health","sponsor":"Inapplicable","pharmaFlowCategory":"DU","therapeuticArea":"Psychiatry\/Psychology","country":"CANADA","productType":"Controlled Substance","year":"2023","type":"Inapplicable","leadProduct":"Psilocybine","moa":"5-HT2A receptor","graph1":"Psychiatry\/Psychology","graph2":"IND Enabling","graph3":"Filament Health","amount2":0,"highestDevelopmentShortName":"IND","therapeuticAreaShortName":"Psychiatry","amount2New":0,"dosageForm":"Undisclosed","sponsorNew":"Filament Health \/ Inapplicable","highestDevelopmentStatusID":"5","companyTruncated":"Filament Health \/ Inapplicable"},{"orgOrder":0,"company":"Cingulate Therapeutics, LLC","sponsor":"Undisclosed","pharmaFlowCategory":"D","therapeuticArea":"Psychiatry\/Psychology","country":"U.S.A","productType":"Other Small Molecule","year":"2025","type":"Funding","leadProduct":"Buspirone Hydrochloride","moa":"5-HT1A receptor","graph1":"Psychiatry\/Psychology","graph2":"IND Enabling","graph3":"Cingulate Therapeutics, LLC","amount2":0,"highestDevelopmentShortName":"IND","therapeuticAreaShortName":"Psychiatry","amount2New":0,"dosageForm":"Oral Tablet","sponsorNew":"Cingulate Therapeutics, LLC \/ Undisclosed","highestDevelopmentStatusID":"5","companyTruncated":"Cingulate Therapeutics, LLC \/ Undisclosed"}]

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

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                          Top Deals by Deal Size (USD bn)

                          01

                          German Wound Congress
                          Not Confirmed
                          German Wound Congress
                          Not Confirmed

                          Details : The funding will be used to accelerate the development of CTx-2103, a novel, multi-release tablet of buspirone, for the treatment of anxiety.

                          Product Name : CTx-2103

                          Product Type : Other Small Molecule

                          Upfront Cash : Undisclosed

                          April 09, 2025

                          Lead Product(s) : Buspirone Hydrochloride

                          Therapeutic Area : Psychiatry/Psychology

                          Highest Development Status : IND Enabling

                          Sponsor : Undisclosed

                          Deal Size : $3.0 million

                          Deal Type : Funding

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                          02

                          German Wound Congress
                          Not Confirmed
                          German Wound Congress
                          Not Confirmed

                          Details : BETR-001, a non-hallucinogenic derivative of LSD in development for major depressive disorder, anxiety disorder and neuropathic pain and other neuro-psychiatric and neurological disorders.

                          Product Name : BETR-001

                          Product Type : Other Small Molecule

                          Upfront Cash : Inapplicable

                          November 25, 2024

                          Lead Product(s) : 2-Bromo-Lysergic Acid Diethylamide

                          Therapeutic Area : Psychiatry/Psychology

                          Highest Development Status : IND Enabling

                          Sponsor : Inapplicable

                          Deal Size : Inapplicable

                          Deal Type : Inapplicable

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                          03

                          German Wound Congress
                          Not Confirmed
                          German Wound Congress
                          Not Confirmed

                          Details : The funding will support the first clinical trial to evaluate psilocybin's efficacy as a treatment for Opioid Use Disorder (OUD).

                          Product Name : Undisclosed

                          Product Type : Controlled Substance

                          Upfront Cash : Undisclosed

                          October 31, 2024

                          Lead Product(s) : Psilocybine

                          Therapeutic Area : Psychiatry/Psychology

                          Highest Development Status : IND Enabling

                          Sponsor : National Institute on Drug Abuse

                          Deal Size : $15.0 million

                          Deal Type : Funding

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                          04

                          German Wound Congress
                          Not Confirmed
                          German Wound Congress
                          Not Confirmed

                          Details : Under the terms of the agreement, Optimi will provide Mātai with a quantity of its validated GMP Full Spectrum Natural Psilocybin extract for the treatment of methamphetamine use disorder.

                          Product Name : Undisclosed

                          Product Type : Controlled Substance

                          Upfront Cash : Undisclosed

                          September 04, 2024

                          Lead Product(s) : Psilocybine

                          Therapeutic Area : Psychiatry/Psychology

                          Highest Development Status : IND Enabling

                          Sponsor : Mātai Medical Research Institute

                          Deal Size : Undisclosed

                          Deal Type : Agreement

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                          05

                          German Wound Congress
                          Not Confirmed
                          German Wound Congress
                          Not Confirmed

                          Details : TRP-8803 (Psilocin) provides a proprietary formulation of psilocin administered by IV infusion. It is being evaluated for the treatment of binge eating disorder, fibromyalgia.

                          Product Name : TRP-8802

                          Product Type : Controlled Substance

                          Upfront Cash : Inapplicable

                          August 01, 2024

                          Lead Product(s) : Psilocybine

                          Therapeutic Area : Psychiatry/Psychology

                          Highest Development Status : IND Enabling

                          Sponsor : Inapplicable

                          Deal Size : Inapplicable

                          Deal Type : Inapplicable

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                          06

                          German Wound Congress
                          Not Confirmed
                          German Wound Congress
                          Not Confirmed

                          Details : IMB-115 (sunobinop) is designed to bind to and activate the nociceptin/orphanin-FQ peptide receptor (NOP), being investigated for treatment of moderate to severe alcohol use disorder.

                          Product Name : IMB-115

                          Product Type : Other Small Molecule

                          Upfront Cash : Inapplicable

                          May 08, 2024

                          Lead Product(s) : Sunobinop

                          Therapeutic Area : Psychiatry/Psychology

                          Highest Development Status : IND Enabling

                          Sponsor : Inapplicable

                          Deal Size : Inapplicable

                          Deal Type : Inapplicable

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                          07

                          German Wound Congress
                          Not Confirmed
                          German Wound Congress
                          Not Confirmed

                          Details : Under the agreement, Healis intends to develop CKDB-501, a neuromodulator Serotype A botulinum toxin (BoNT/A) protein, for Major Depressive Disorder (MDD) and Post-Traumatic Stress Disorder (PTSD).

                          Product Name : CKDB-501

                          Product Type : Other Large Molecule

                          Upfront Cash : Undisclosed

                          February 01, 2024

                          Lead Product(s) : CKDB-501

                          Therapeutic Area : Psychiatry/Psychology

                          Highest Development Status : IND Enabling

                          Sponsor : Healis Therapeutics

                          Deal Size : Undisclosed

                          Deal Type : Agreement

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                          08

                          German Wound Congress
                          Not Confirmed
                          German Wound Congress
                          Not Confirmed

                          Details : SYT-510, a first-in-class inhibitor, targets the Endocannabinoid System to restore healthy brain function. It is being studied in preclinical trials for anxiety, PTSD, and mood-related disorders.

                          Product Name : SYT-510

                          Product Type : Other Small Molecule

                          Upfront Cash : Inapplicable

                          January 18, 2024

                          Lead Product(s) : SYT-510

                          Therapeutic Area : Psychiatry/Psychology

                          Highest Development Status : IND Enabling

                          Sponsor : Inapplicable

                          Deal Size : Inapplicable

                          Deal Type : Inapplicable

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                          09

                          German Wound Congress
                          Not Confirmed
                          German Wound Congress
                          Not Confirmed

                          Details : RespiRx is a drug device combination product that is the first truly inhalable nicotine replacement therapy (NRT) to assist smokers attempting to quit smoking.

                          Product Name : RespiRx

                          Product Type : Controlled Substance

                          Upfront Cash : Inapplicable

                          January 10, 2024

                          Lead Product(s) : Nicotine

                          Therapeutic Area : Psychiatry/Psychology

                          Highest Development Status : IND Enabling

                          Sponsor : Inapplicable

                          Deal Size : Inapplicable

                          Deal Type : Inapplicable

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                          10

                          German Wound Congress
                          Not Confirmed
                          German Wound Congress
                          Not Confirmed

                          Details : The grant will support further development of novel neuroplastogen and ibogaine analog, DLX-007, a novel, first-in-class, neuroplastogen being evaluated in a range of substance use disorders (SUDs), including opioid and stimulant use.

                          Product Name : DLX-007

                          Product Type : Other Small Molecule

                          Upfront Cash : Undisclosed

                          December 13, 2023

                          Lead Product(s) : DLX-007

                          Therapeutic Area : Psychiatry/Psychology

                          Highest Development Status : IND Enabling

                          Sponsor : National Institutes of Health

                          Deal Size : $0.3 million

                          Deal Type : Funding

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