[{"orgOrder":0,"company":"CervoMed","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Diffusion Pharmaceuticals Evaluating TSC Against Acute Respiratory Distress Syndrome (ARDS) in COVID-19 Patients","therapeuticArea":"Infections and Infectious Diseases","highestDevelopmentStatus":"Undisclosed","country":"U.S.A","productType":"Small molecule","productStatus":"New Molecular Entity","date":"April 2020","url1":"","url2":"","graph1":"Infections and Infectious Diseases","graph2":"Undisclosed"},{"orgOrder":0,"company":"CervoMed","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Diffusion Pharmaceuticals Announces Pre-IND Submission to the FDA of Design for TSC Trials to Treat ARDS in COVID-19","therapeuticArea":"Infections and Infectious Diseases","highestDevelopmentStatus":"Preclinical","country":"U.S.A","productType":"Small molecule","productStatus":"New Molecular Entity","date":"April 2020","url1":"","url2":"","graph1":"Infections and Infectious Diseases","graph2":"Preclinical"},{"orgOrder":0,"company":"CervoMed","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Diffusion Pharmaceuticals Announces FDA Accelerated Review of TSC Clinical Development Plan to Treat COVID-19 Patients with ARDS","therapeuticArea":"Infections and Infectious Diseases","highestDevelopmentStatus":"Preclinical","country":"U.S.A","productType":"Small molecule","productStatus":"New Molecular Entity","date":"May 2020","url1":"","url2":"","graph1":"Infections and Infectious Diseases","graph2":"Preclinical"},{"orgOrder":0,"company":"CervoMed","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Diffusion Pharmaceuticals Receives Accelerated FDA Response to Proposed TSC COVID-19 Clinical Trial Program","therapeuticArea":"Infections and Infectious Diseases","highestDevelopmentStatus":"Undisclosed","country":"U.S.A","productType":"Small molecule","productStatus":"New Molecular Entity","date":"May 2020","url1":"","url2":"","graph1":"Infections and Infectious Diseases","graph2":"Undisclosed"},{"orgOrder":0,"company":"Romanian National Institute of Infectious Diseases","sponsor":"CervoMed","pharmaFlowCategory":"D","amount":"Undisclosed","upfrontCash":"Undisclosed","newsHeadline":"Diffusion Pharma and Romanian National Institute of Infectious Diseases Join Hands to Expand Clinical Trial Program of TSC for COVID-19","therapeuticArea":"Pulmonary\/Respiratory Diseases","highestDevelopmentStatus":"Preclinical","country":"","productType":"Small molecule","productStatus":"New Molecular Entity","date":"May 2020","url1":"","url2":"","graph1":"Pulmonary\/Respiratory Diseases","graph2":"Preclinical"},{"orgOrder":0,"company":"CervoMed","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Diffusion Pharmaceuticals Files Clinical Trial Application for European Phase 1a\/1b Study of TSC in COVID-19 Patients","therapeuticArea":"Infections and Infectious Diseases","highestDevelopmentStatus":"Preclinical","country":"U.S.A","productType":"Small molecule","productStatus":"New Molecular Entity","date":"June 2020","url1":"","url2":"","graph1":"Infections and Infectious Diseases","graph2":"Preclinical"},{"orgOrder":0,"company":"CervoMed","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Diffusion Pharmaceuticals Files IND for International Phase 1b\/2b COVID-19 Clinical Program With TSC","therapeuticArea":"Infections and Infectious Diseases","highestDevelopmentStatus":"IND Enabling","country":"U.S.A","productType":"Small molecule","productStatus":"New Molecular Entity","date":"July 2020","url1":"","url2":"","graph1":"Infections and Infectious Diseases","graph2":"IND Enabling"},{"orgOrder":0,"company":"CervoMed","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Diffusion Pharmaceuticals Receives FDA Guidance for International Phase 1b\/2b COVID-19 Clinical Program with TSC","therapeuticArea":"Infections and Infectious Diseases","highestDevelopmentStatus":"IND Enabling","country":"U.S.A","productType":"Small molecule","productStatus":"New Molecular Entity","date":"July 2020","url1":"","url2":"","graph1":"Infections and Infectious Diseases","graph2":"IND Enabling"},{"orgOrder":0,"company":"CervoMed","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Dosing Underway for Diffusion Pharma's Lead Asset in Early-Stage COVID-19 Study","therapeuticArea":"Infections and Infectious Diseases","highestDevelopmentStatus":"Phase I","country":"U.S.A","productType":"Small molecule","productStatus":"New Molecular Entity","date":"September 2020","url1":"","url2":"","graph1":"Infections and Infectious Diseases","graph2":"Phase I"},{"orgOrder":0,"company":"CervoMed","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Diffusion Pharmaceuticals Completes Phase 1b Study of TSC in Hospitalized COVID-19 Patients","therapeuticArea":"Infections and Infectious Diseases","highestDevelopmentStatus":"Phase I","country":"U.S.A","productType":"Small molecule","productStatus":"New Molecular Entity","date":"February 2021","url1":"","url2":"","graph1":"Infections and Infectious Diseases","graph2":"Phase I"},{"orgOrder":0,"company":"CervoMed","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Diffusion Pharmaceuticals Doses First Participants in TCOM Study","therapeuticArea":"Pulmonary\/Respiratory Diseases","highestDevelopmentStatus":"Phase I\/ Phase II","country":"U.S.A","productType":"Small molecule","productStatus":"New Molecular Entity","date":"March 2021","url1":"","url2":"","graph1":"Pulmonary\/Respiratory Diseases","graph2":"Phase I\/ Phase II"},{"orgOrder":0,"company":"CervoMed","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Diffusion Pharmaceuticals Reports Final Results from Its Phase 1b Study of Trans Sodium Crocetinate in Hospitalized COVID-19 Patients","therapeuticArea":"Infections and Infectious Diseases","highestDevelopmentStatus":"Phase I","country":"U.S.A","productType":"Small molecule","productStatus":"New Molecular Entity","date":"May 2021","url1":"","url2":"","graph1":"Infections and Infectious Diseases","graph2":"Phase I"},{"orgOrder":0,"company":"CervoMed","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Diffusion Pharmaceuticals Reports Positive Trend in Oxygenation from TCOM Trial","therapeuticArea":"Pulmonary\/Respiratory Diseases","highestDevelopmentStatus":"Phase I","country":"U.S.A","productType":"Small molecule","productStatus":"New Molecular Entity","date":"June 2021","url1":"","url2":"","graph1":"Pulmonary\/Respiratory Diseases","graph2":"Phase I"},{"orgOrder":0,"company":"CervoMed","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Diffusion Pharmaceuticals Doses First Participants in Altitude Trial","therapeuticArea":"Pulmonary\/Respiratory Diseases","highestDevelopmentStatus":"Phase I\/ Phase II","country":"U.S.A","productType":"Small molecule","productStatus":"New Molecular Entity","date":"November 2021","url1":"","url2":"","graph1":"Pulmonary\/Respiratory Diseases","graph2":"Phase I\/ Phase II"},{"orgOrder":0,"company":"CervoMed","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Diffusion Pharmaceuticals Completes Dosing in Altitude Trial","therapeuticArea":"Pulmonary\/Respiratory Diseases","highestDevelopmentStatus":"Phase I","country":"U.S.A","productType":"Small molecule","productStatus":"New Molecular Entity","date":"April 2022","url1":"","url2":"","graph1":"Pulmonary\/Respiratory Diseases","graph2":"Phase I"},{"orgOrder":0,"company":"CervoMed","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Diffusion Pharmaceuticals Announces Positive Effects in Altitude Trial","therapeuticArea":"Pulmonary\/Respiratory Diseases","highestDevelopmentStatus":"Phase I","country":"U.S.A","productType":"Small molecule","productStatus":"New Molecular Entity","date":"June 2022","url1":"","url2":"","graph1":"Pulmonary\/Respiratory Diseases","graph2":"Phase I"},{"orgOrder":0,"company":"CervoMed","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Diffusion Pharmaceuticals to Initiate Phase 2 Trial in Patients with Glioblastoma Multiforme Incorporating Innovative Imaging Methodology to Evaluate Tumor Oxygenation","therapeuticArea":"Oncology","highestDevelopmentStatus":"Phase III","country":"U.S.A","productType":"Small molecule","productStatus":"New Molecular Entity","date":"July 2022","url1":"","url2":"","graph1":"Oncology","graph2":"Phase III"},{"orgOrder":0,"company":"CervoMed","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Diffusion Pharmaceuticals Announces Strategic Review Process to Evaluate Value-Enhancing Alternatives Including Opportunities to Better Leverage TSC","therapeuticArea":"Oncology","highestDevelopmentStatus":"Phase III","country":"U.S.A","productType":"Small molecule","productStatus":"New Molecular Entity","date":"October 2022","url1":"","url2":"","graph1":"Oncology","graph2":"Phase III"}]
Find Clinical Drug Pipeline Developments & Deals for Trans Sodium Crocetinate
Trans sodium crocetinate (TSC), is being developed to enhance the diffusion of oxygen to tissues with low oxygen levels, also known as hypoxia, a serious complication of many of medicine’s most intractable and difficult-to-treat conditions.
Diffusion aligns with FDA on design of an open-label, dose-escalation, Phase 2 safety and efficacy study of trans sodium crocetinate (“TSC”) in newly diagnosed glioblastoma multiforme (“GBM”) patients.
Positive effects for Trans Sodium Crocetinate on post-exercise recovery based when comparing measurements 10 min post-exercise to measurements at the end of the exercise interval.
Trans sodium crocetinate (TSC), is being developed to enhance the diffusion of oxygen to tissues with low oxygen levels, also known as hypoxia, a serious complication of many of medicine’s most intractable and difficult-to-treat conditions.
Company’s lead product candidate, trans sodium crocetinate (“TSC”), in normal healthy volunteers subjected to incremental levels of physical exertion while exposed to hypoxic and hypobaric conditions, or simulated altitude.
In this trial, transcutaneous oxygen monitoring (“TCOM”) was used to measure the direct pharmacodynamic effects of TSC on peripheral tissue oxygenation in healthy normal volunteers.
Topline results based upon analyses of primary endpoint data from trial announced in February 2021, indicating that trans sodium crocetinate in hospitalized COVID-19 patients was safe and well-tolerated when administered on more frequent dosing regimen
The TCOM trial is a randomized, double blind, placebo controlled, pharmacokinetic, pharmacodynamic study of TSC that will enroll up to 30 healthy volunteers.
The external safety monitoring committee, established as part of the trial protocol, met to review safety data from the final, 1.5 mg/kg dose of TSC, cohort and determined that no dose-limiting toxicities or serious adverse events were observed.
The Phase 1b study trial will be a randomized, placebo-controlled safety and efficacy study of TSC in hospitalized COVID-19 patients that will be conducted in the United States and Europe after consultation with, and approval from, local regulatory authorities.