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Details:

PCN-101 (R-ketamine), a non-competitive N-methyl-D-aspartate (NMDA) receptor antagonist, is a single isomer of ketamine and belongs to a new generation of glutamate receptor modulators with the potential for rapid-acting antidepressant activity and anti-suicidal effects.


Lead Product(s): R-Ketamine

Therapeutic Area: Psychiatry/Psychology Product Name: PCN-101

Highest Development Status: Phase IIProduct Type: Small molecule

Partner/Sponsor/Collaborator: ATAI Life Sciences

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable August 08, 2023

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PCN-101 is a single isomer of ketamine and belongs to a new generation of glutamate receptor modulators with the potential for rapid-acting antidepressant activity and anti-suicidal effects. Pharmacologically, PCN-101 is a non-competitive NMDA receptor antagonist.


Lead Product(s): R-Ketamine

Therapeutic Area: Psychiatry/Psychology Product Name: PCN-101

Highest Development Status: Phase IIProduct Type: Small molecule

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable April 13, 2023

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PCN-101 (R-ketamine), demonstrated an encouraging safety profile and signals of efficacy across all timepoints despite not achieving statistical significance on the primary endpoint.


Lead Product(s): R-Ketamine

Therapeutic Area: Psychiatry/Psychology Product Name: PCN-101

Highest Development Status: Phase IIProduct Type: Small molecule

Partner/Sponsor/Collaborator: Otsuka Pharmaceutical

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable January 06, 2023

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PCN-101 (R-ketamine) is a single isomer of ketamine and belongs to a new generation of glutamate receptor modulators with the potential for rapid-acting antidepressant (RAAD) activity and anti-suicidal effects.


Lead Product(s): R-Ketamine

Therapeutic Area: Psychiatry/Psychology Product Name: PCN-101

Highest Development Status: Phase IIProduct Type: Small molecule

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable November 17, 2022

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PCN-101 is a single isomer of ketamine and belongs to a new generation of glutamate receptor modulators with the potential for rapid-acting antidepressant (RAAD) activity and anti-suicidal effects. Pharmacologically, PCN-101 is a non-competitive NMDA receptor antagonist.


Lead Product(s): R-Ketamine

Therapeutic Area: Psychiatry/Psychology Product Name: PCN-101

Highest Development Status: Phase IIProduct Type: Small molecule

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable October 25, 2022

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In the aggregate, these renewed lock-up agreements represent over 30% of atai’s outstanding common shares and illustrate the confidence of atai’s key shareholders in atai’s platform and its potential to address the growing mental health crisis including its lead asset PCN-101.


Lead Product(s): R-Ketamine

Therapeutic Area: Psychiatry/Psychology Product Name: PCN-101

Highest Development Status: Phase IIProduct Type: Small molecule

Partner/Sponsor/Collaborator: Apeiron Investment Group

Deal Size: Undisclosed Upfront Cash: Undisclosed

Deal Type: Agreement December 15, 2021

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Company initiate, Phase 2a clinical study to evaluate the safety and efficacy of PCN-101 (R-ketamine), a stereoisomer of ketamine being developed for therapeutic treatment of psychiatric disorders such as TRD.


Lead Product(s): R-Ketamine

Therapeutic Area: Psychiatry/Psychology Product Name: PCN-101

Highest Development Status: Phase IIProduct Type: Small molecule

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable September 14, 2021

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Integration of Introspect’s digital therapeutic with R-ketamine therapy for patients with treatment resistant depression.


Lead Product(s): R-Ketamine

Therapeutic Area: Psychiatry/Psychology Product Name: PCN-101

Highest Development Status: Phase IIProduct Type: Small molecule

Partner/Sponsor/Collaborator: ATAI Life Sciences

Deal Size: Undisclosed Upfront Cash: Undisclosed

Deal Type: Collaboration September 09, 2021

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Under the terms of the license, Otsuka will have exclusive rights to develop and commercialize products containing PCN-101 in Japan. Otsuka will undertake development, regulatory, and commercialization activities in Japan, with input and guidance from both companies.


Lead Product(s): R-Ketamine

Therapeutic Area: Psychiatry/Psychology Product Name: PCN-101

Highest Development Status: Phase IProduct Type: Small molecule

Partner/Sponsor/Collaborator: Otsuka Pharmaceutical

Deal Size: Undisclosed Upfront Cash: $20.0 million

Deal Type: Collaboration March 16, 2021

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PCN-101 was safe and well-tolerated at all doses up to 150 mg, the highest dose tested. There were no serious adverse events reported. The pharmacokinetics of PCN-101 in plasma were approximately dose-proportional.


Lead Product(s): R-Ketamine

Therapeutic Area: Psychiatry/Psychology Product Name: PCN-101

Highest Development Status: Phase IProduct Type: Small molecule

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable February 19, 2021

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Details:

Proceeds from the financing will be used primarily to fund pre-clinical and clinical development of ATAI's existing mental health programs, to expand its drug candidate pipeline and further advance ATAI's platform technologies.


Lead Product(s): R-Ketamine

Therapeutic Area: Psychiatry/Psychology Product Name: PCN-101

Highest Development Status: Phase IIProduct Type: Small molecule

Partner/Sponsor/Collaborator: Apeiron Investment Group

Deal Size: $125.0 million Upfront Cash: Undisclosed

Deal Type: Series C Financing November 23, 2020

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