[{"orgOrder":0,"company":"Alpha Cognition","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Alpha Cognition, Inc. Receives FDA\/PMDA Regulatory Guidance for Alpha-1062 Alzheimer's Therapy\n","therapeuticArea":"Neurology","highestDevelopmentStatus":"Phase I\/ Phase II","country":"CANADA","productType":"Undisclosed","productStatus":"New Molecular Entity","date":"April 2020","url1":"","url2":"","graph1":"Undisclosed","graph2":"Alpha Cognition"},{"orgOrder":0,"company":"Acasti Pharma","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Acasti Pharma to Present at the Oppenheimer Fall Healthcare Summit on September 21\u02e2\u1d57","therapeuticArea":"Neurology","highestDevelopmentStatus":"Phase I\/ Phase II","country":"CANADA","productType":"Small molecule","productStatus":"Approved","date":"September 2021","url1":"","url2":"","graph1":"Small molecule","graph2":"Acasti Pharma"},{"orgOrder":0,"company":"Alpha Cognition","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Alpha Cognition Announces the Acceptance of its US FDA Investigational New Drug Application (IND) for Lead Candidate, ALPHA-1062 for Mild to Moderate Alzheimer\u2019s Disease","therapeuticArea":"Neurology","highestDevelopmentStatus":"Phase I\/ Phase II","country":"CANADA","productType":"Small molecule","productStatus":"New Molecular Entity","date":"September 2021","url1":"","url2":"","graph1":"Small molecule","graph2":"Alpha Cognition"},{"orgOrder":0,"company":"PharmaTher","sponsor":"Alcami","pharmaFlowCategory":"D","amount":"Undisclosed","upfrontCash":"Undisclosed","newsHeadline":"PharmaTher Engages Alcami for Clinical and Commercial Manufacturing of Novel Ketamine Products","therapeuticArea":"Neurology","highestDevelopmentStatus":"Phase I\/ Phase II","country":"CANADA","productType":"Small molecule","productStatus":"Approved","date":"October 2021","url1":"","url2":"","graph1":"Small molecule","graph2":"PharmaTher"},{"orgOrder":0,"company":"PharmaTher","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"PharmaTher Announces Poster Presentation of Positive Efficacy and Safety Data from Phase 1\/2 Clinical Study of Ketamine in the Treatment of Levodopa-Induced Dyskinesia in Parkinson\u2019s Disease at Neuroscience 2022 by the Society for Neuroscience","therapeuticArea":"Neurology","highestDevelopmentStatus":"Phase I\/ Phase II","country":"CANADA","productType":"Small molecule","productStatus":"Approved","date":"November 2022","url1":"","url2":"","graph1":"Small molecule","graph2":"PharmaTher"},{"orgOrder":0,"company":"PharmaTher","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"PharmaTher Holdings Submits Fast Track Application to FDA for KETARX\u2122 (ketamine) for the Treatment of Parkinson\u2019s Disease","therapeuticArea":"Neurology","highestDevelopmentStatus":"Phase I\/ Phase II","country":"CANADA","productType":"Small molecule","productStatus":"Approved","date":"May 2023","url1":"","url2":"","graph1":"Small molecule","graph2":"PharmaTher"}]
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Ketarx™ (ketamine hydrochloride), is a non-barbiturate, rapid-acting general anesthetic and NMDA receptor antagonist used for induction of anesthesia diagnostic and surgical procedures typically in combination with a muscle relaxant in patients with parkinson’s Disease.
The data highlight that ketamine was safe, well-tolerated, and demonstrated that 100% of subjects treated with ketamine had reduction in dyskinesias indicating possible efficacy with a large effect size that warrants further investigation in a pivotal Phase 3 clinical study.
PharmaTher is evolving to become a leader in ketamine-based solutions for mental health, neurological and pain disorders, and partnering with Alcami as our exclusive manufacturer for the clinical and commercial supply of ketamine.
GTX-104 is an intravenous infusion targeting Subarachnoid Hemorrhage (SAH), a rare and life-threatening medical emergency in which bleeding occurs over the surface of the brain in the subarachnoid space between the brain.
ALPHA-1062 is proprietary, delayed release tablet formulation designed to treat Alzheimer’s disease is being developed as a new generation of AChEI designed to improve existing therapy by overcoming gastrointestinal side effects and tolerability limitations.
U.S. FDA agreed upon a clinical and regulatory pathway for the approval of Alpha-1062 and has suggested that a single pivotal trial, scheduled for mid-2021.