Psychiatry/Psychology | Phase I Developments

Orexo

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SWEDEN Sweden

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Positive Results from Human PK Study Assessing Orexo's Intranasal Nalmefene Formulations for Opioid Overdose Reversal

Lead Product(s): Nalmefene

Therapeutic Area: Psychiatry/Psychology Product Name: OX125

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 June 30, 2020

Details:

The study was a cross-over, comparative bioavailability study in healthy volunteers to assess nalmefene absorption from three development formulations of OX125, Orexo's wholly-owned nasal nalmefene product, compared to a nalmefene intramuscular injection.

Impel NeuroPharma

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United States

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Impel NeuroPharma Announces Publication of Positive Results of SNAP 101 Study for INP105

Lead Product(s): Olanzapine

Therapeutic Area: Psychiatry/Psychology Product Name: INP105

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 June 30, 2020

Details:

Study shows INP105 achieves rapid absorption which may provide an effective, convenient, & noninvasive future alternative for treating acute agitation in the home, community, or hospital setting.

Seelos Therapeutics

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United States

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Seelos Therapeutics Announces Final Data from Phase I PK/PD Study of Intranasal Racemic Ketamine (SLS-002) and Clinical Development Plans

Lead Product(s): Ketamine Hydrochloride

Therapeutic Area: Psychiatry/Psychology Product Name: SLS-002

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 June 23, 2020

Details:

SLS-002 Was Safe and Well Tolerated Across All Doses with Resolution of Expected Group Mean Dissociative Side-Effects That Occurred in the Higher Dose Groups Within One Hour.

Lyndra Therapeutics

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United States

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Lyndra Therapeutics Achieves Critical Milestones Despite COVID-19 Headwinds

Lead Product(s): Risperidone

Therapeutic Area: Psychiatry/Psychology Product Name: Undisclosed

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 June 10, 2020

Details:

Lyndra Therapeutics completed enrollment and dosing of its Phase I clinical trial for an ultra-long-acting oral risperidone therapy to treat schizophrenia, ramping up manufacturing capabilities and growing its employee base by 28%.

Neurana Pharmaceuticals

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United States

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Neurana Pharmaceuticals Announces Publication of a Driving Study Demonstrating the Effects of Tolperisone

Lead Product(s): Tolperisone

Therapeutic Area: Psychiatry/Psychology Product Name: Undisclosed

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 May 12, 2020

Details:

The publication reports results from the Phase 1, threeway, randomized, blinded, three-period crossover study that evaluated cyclobenzaprine in neuromuscular conditions.

Cadent Therapeutics

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United States

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Cadent Therapeutics Closes $15 Million Final Equity Tranche of Series B Financing

Lead Product(s): CAD-9303

Therapeutic Area: Psychiatry/Psychology Product Name: Undisclosed

Highest Development Status: Phase I Product Type: Undisclosed

Partner/Sponsor/Collaborator: Cowen Healthcare Investments

Deal Size: $15.0 million Upfront Cash: Undisclosed

Deal Type: Series B Financing April 29, 2020

Details:

The Company plans to allocate all proceeds to continue development for its lead cognitive disorder asset, CAD-9303 for the treatment of the cognitive deficits and negative symptoms of schizophrenia.

Navitor Pharmaceuticals

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United States

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Supernus and Navitor Announce Development and Option Agreement for Orally Active mTORC1 Activator NV-5138

Lead Product(s): NV-5138

Therapeutic Area: Psychiatry/Psychology Product Name: Undisclosed

Highest Development Status: Phase I Product Type: Small molecule

Partner/Sponsor/Collaborator: Supernus Pharmaceuticals

Deal Size: $525.0 million? Upfront Cash: $25.0 million

Deal Type: Licensing Agreement April 21, 2020

Details:

Under the terms of the agreement, Supernus and Navitor will jointly conduct a Phase II clinical program for NV-5138 in treatment-resistant depression (TRD).

Mind Medicine

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CANADA Canada

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MindMed Initiates Dosing in Human Safety Study of Novel Treatment for Opioid Addiction, 18-MC

Lead Product(s): 18-Methoxycoronaridine

Therapeutic Area: Psychiatry/Psychology Product Name: Undisclosed

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 April 16, 2020

Details:

Data from the current human study is expected to help advance the planning and design of MindMed's future trials of 18-MC in opioid use disorder patients.

Seelos Therapeutics

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United States

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Seelos Therapeutics Announces Additional Interim Data from Phase I Studies of Intranasal Racemic Ketamine (SLS-002)

Lead Product(s): Ketamine Hydrochloride

Therapeutic Area: Psychiatry/Psychology Product Name: Undisclosed

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 March 24, 2020

Details:

Interim data disclosed includes the hemodynamic (vital signs) side effect profile to address the known and expected side effects of ketamine, which are increases in blood pressure and heart rate.

Seelos Therapeutics

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United States

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Seelos Therapeutics Announces Additional Interim Data from Phase I Studies of Intranasal Racemic Ketamine (SLS-002)

Lead Product(s): Ketamine Hydrochloride

Therapeutic Area: Psychiatry/Psychology Product Name: Undisclosed

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 February 26, 2020

Details:

Interim data from both studies has demonstrated that doses of 30mg, 60mg, 75mg and 90mg of SLS-002 have been generally safe and well-tolerated.

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Find Psychiatry/Psychology Drugs in Phase I Clinical Development

Phase I

Product Type

Companies

Orexo

Positive Results from Human PK Study Assessing Orexo's Intranasal Nalmefene Formulations for Opioid Overdose Reversal

Impel NeuroPharma

Impel NeuroPharma Announces Publication of Positive Results of SNAP 101 Study for INP105

Seelos Therapeutics

Seelos Therapeutics Announces Final Data from Phase I PK/PD Study of Intranasal Racemic Ketamine (SLS-002) and Clinical Development Plans

Lyndra Therapeutics

Lyndra Therapeutics Achieves Critical Milestones Despite COVID-19 Headwinds

Neurana Pharmaceuticals

Neurana Pharmaceuticals Announces Publication of a Driving Study Demonstrating the Effects of Tolperisone

Cadent Therapeutics

Cadent Therapeutics Closes $15 Million Final Equity Tranche of Series B Financing

Navitor Pharmaceuticals

Supernus and Navitor Announce Development and Option Agreement for Orally Active mTORC1 Activator NV-5138

Mind Medicine

MindMed Initiates Dosing in Human Safety Study of Novel Treatment for Opioid Addiction, 18-MC

Seelos Therapeutics

Seelos Therapeutics Announces Additional Interim Data from Phase I Studies of Intranasal Racemic Ketamine (SLS-002)

Seelos Therapeutics

Seelos Therapeutics Announces Additional Interim Data from Phase I Studies of Intranasal Racemic Ketamine (SLS-002)