[{"company":"Neuraptive Therapeutics","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Neuraptive Therapeutics Announces FDA has Granted Fast Track Designation to NTX-001 Clinical Development Program","therapeuticArea":"Trauma (Emergency, Injury, Surgery)","highestDevelopmentStatus":"IND Enabling","country":"U.S.A","productType":"Small molecule","productStatus":"New Molecular Entity","date":"May 2020","url1":"","url2":"","graph1":"Small molecule","graph2":"Neuraptive Therapeutics"},{"company":"ReAlta Life Sciences","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"ReAlta Life Sciences Announces U.S. FDA Clearance of First Investigational New Drug Application for RLS-0071","therapeuticArea":"Trauma (Emergency, Injury, Surgery)","highestDevelopmentStatus":"IND Enabling","country":"UNITED KINGDOM","productType":"Peptide","productStatus":"New Molecular Entity","date":"July 2020","url1":"","url2":"","graph1":"Peptide","graph2":"ReAlta Life Sciences"},{"company":"American CryoStem Corporation","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"American Cryo Stem Announces: FDA Has Cleared Its Investigational New Drug (IND) for Post-Concussion Syndrome for PhaseII Clinical Trial","therapeuticArea":"Trauma (Emergency, Injury, Surgery)","highestDevelopmentStatus":"IND Enabling","country":"U.S.A","productType":"Cell and Gene therapy","productStatus":"New Molecular Entity","date":"September 2020","url1":"","url2":"","graph1":"Cell and Gene therapy","graph2":"American CryoStem Corporation"},{"company":"Recce Pharmaceuticals","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Recce Pharmaceuticals Receives Ethics Approval to Start Phase I\/II Study Evaluating Topical Spray-On Synthetic Antibiotic RECCE\u00ae 327 on Chronic Burn Wounds","therapeuticArea":"Trauma (Emergency, Injury, Surgery)","highestDevelopmentStatus":"IND Enabling","country":"AUSTRALIA","productType":"Small molecule","productStatus":"New Molecular Entity","date":"October 2020","url1":"","url2":"","graph1":"Small molecule","graph2":"Recce Pharmaceuticals"},{"company":"Neuronasal","sponsor":"ATAI Life Sciences","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"ATAI Life Sciences Announces Neuronasal Completes Pilot Study, Receives IND Clearance to Continue into Phase I Trials of mTBI Therapeutic","therapeuticArea":"Trauma (Emergency, Injury, Surgery)","highestDevelopmentStatus":"IND Enabling","country":"U.S.A","productType":"Small molecule","productStatus":"Approved","date":"September 2020","url1":"","url2":"","graph1":"Small molecule","graph2":"Neuronasal"},{"company":"Neuronasal","sponsor":"ATAI Life Sciences","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Neuronasal, Inc. Announces Completion of Pilot Study, Receives IND Clearance to Continue into Phase I Trials of mTBI Therapeutic","therapeuticArea":"Trauma (Emergency, Injury, Surgery)","highestDevelopmentStatus":"IND Enabling","country":"U.S.A","productType":"Small molecule","productStatus":"Approved","date":"November 2020","url1":"","url2":"","graph1":"Small molecule","graph2":"Neuronasal"},{"company":"Ortho Regenerative Technologies","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Ortho Regenerative Technologies Receives Clinical Hold Letter from The U.S. FDA","therapeuticArea":"Trauma (Emergency, Injury, Surgery)","highestDevelopmentStatus":"IND Enabling","country":"CANADA","productType":"Undisclosed","productStatus":"New Molecular Entity","date":"June 2021","url1":"","url2":"","graph1":"Undisclosed","graph2":"Ortho Regenerative Technologies"},{"company":"Odyssey Health","sponsor":"Not 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2021","url1":"","url2":"","graph1":"Small molecule","graph2":"Odyssey Health"},{"company":"Odyssey Health","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Odyssey Group International Approved to Start Human Trial to Treat Concussion","therapeuticArea":"Trauma (Emergency, Injury, Surgery)","highestDevelopmentStatus":"IND Enabling","country":"U.S.A","productType":"Small molecule","productStatus":"New Molecular Entity","date":"September 2021","url1":"","url2":"","graph1":"Small molecule","graph2":"Odyssey Health"},{"company":"Revive Therapeutics","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Revive Therapeutics Files for FDA Orphan Drug Designation for Bucillamine in the Prevention of Ischemia-Reperfusion Injury During Liver Transplantation","therapeuticArea":"Trauma (Emergency, Injury, Surgery)","highestDevelopmentStatus":"IND Enabling","country":"CANADA","productType":"Small molecule","productStatus":"Approved","date":"November 2021","url1":"","url2":"","graph1":"Small molecule","graph2":"Revive Therapeutics"},{"company":"Revive Therapeutics","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Revive Therapeutics Receives FDA Orphan Drug Designation for Bucillamine in the Prevention of Ischemia-Reperfusion Injury During Liver Transplantation","therapeuticArea":"Trauma (Emergency, Injury, Surgery)","highestDevelopmentStatus":"IND Enabling","country":"CANADA","productType":"Small molecule","productStatus":"Approved","date":"February 2022","url1":"","url2":"","graph1":"Small molecule","graph2":"Revive Therapeutics"},{"company":"Wesana Health","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Wesana Health Announces Positive Feedback From Pre-IND Meeting With FDA on SANA-013","therapeuticArea":"Trauma (Emergency, Injury, Surgery)","highestDevelopmentStatus":"IND Enabling","country":"U.S.A","productType":"Small molecule","productStatus":"New Molecular Entity","date":"March 2022","url1":"","url2":"","graph1":"Small molecule","graph2":"Wesana Health"},{"company":"ECP Pharma","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"ECP Pharma Developing Innovative Drug Products For Neurological and Central Nervous System Diseases","therapeuticArea":"Trauma (Emergency, Injury, Surgery)","highestDevelopmentStatus":"IND Enabling","country":"U.S.A","productType":"Small molecule","productStatus":"New Molecular Entity","date":"March 2022","url1":"","url2":"","graph1":"Small molecule","graph2":"ECP Pharma"},{"company":"ECP Pharma","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"ECP Pharma\u2019s Path Forward Clearer After FDA\u2019s Response To Pre-IND Submission On Its Neurological, CNS Diseases Drug Products","therapeuticArea":"Trauma (Emergency, Injury, Surgery)","highestDevelopmentStatus":"IND Enabling","country":"U.S.A","productType":"Small molecule","productStatus":"New Molecular Entity","date":"June 2022","url1":"","url2":"","graph1":"Small molecule","graph2":"ECP Pharma"}]
Details:
ECP-101, unique drug therapy involving cannabinoids and psychedelics will be used to promote a quick recovery and overcome the long term consequences often seen with mTBI.
Lead Product(s):
ECP-101
Therapeutic Area: Trauma (Emergency, Injury, Surgery)
Product Name: ECP-101
Highest Development Status: IND Enabling
Product Type: Small molecule
Partner/Sponsor/Collaborator:
Not Applicable
Deal Size: Not Applicable
Upfront Cash: Not Applicable
Deal Type: Not Applicable
June 07, 2022
Details:
ECP-101, unique drug therapy involving cannabinoids and psychedelics will be used to promote a quick recovery and overcome the long term consequences often seen with mTBI.
Lead Product(s):
ECP-101
Therapeutic Area: Trauma (Emergency, Injury, Surgery)
Product Name: ECP-101
Highest Development Status: IND Enabling
Product Type: Small molecule
Partner/Sponsor/Collaborator:
Not Applicable
Deal Size: Not Applicable
Upfront Cash: Not Applicable
Deal Type: Not Applicable
March 22, 2022
Details:
The Company received positive written responses from the FDA, outlining the requirements to open the IND and commence with clinical studies for SANA-013,for the treatment of Traumatic Brain Injury (TBI) related major depressive disorder.
Lead Product(s):
Psilocybine,Cannabidiol
Therapeutic Area: Trauma (Emergency, Injury, Surgery)
Product Name: SANA-013
Highest Development Status: IND Enabling
Product Type: Small molecule
Partner/Sponsor/Collaborator:
Not Applicable
Deal Size: Not Applicable
Upfront Cash: Not Applicable
Deal Type: Not Applicable
March 14, 2022
Details:
The ODD validates strategy in pursuing novel uses of Bucillamine, a cysteine derivative reactivating this endogenous defense against oxidant injury for rare disorders and life-threatening conditions, including infectious diseases and preventing IRI.
Lead Product(s):
Bucillamine
Therapeutic Area: Trauma (Emergency, Injury, Surgery)
Product Name: Undisclosed
Highest Development Status: IND Enabling
Product Type: Small molecule
Partner/Sponsor/Collaborator:
Not Applicable
Deal Size: Not Applicable
Upfront Cash: Not Applicable
Deal Type: Not Applicable
February 15, 2022
Details:
Revive believes the use of Bucillamine during liver transplantation has the potential to be a safe and effective approach to address the unmet medical need for a novel strategy to limit or prevent ischemia–reperfusion injury (IRI) during liver transplantation.
Lead Product(s):
Bucillamine
Therapeutic Area: Trauma (Emergency, Injury, Surgery)
Product Name: Undisclosed
Highest Development Status: IND Enabling
Product Type: Small molecule
Partner/Sponsor/Collaborator:
Not Applicable
Deal Size: Not Applicable
Upfront Cash: Not Applicable
Deal Type: Not Applicable
November 23, 2021
Details:
The initial approved study will be a single 1-day dose for each subject but will graduate to single doses for 5-days upon secondary approval. PRV-002 toxicology studies have shown it to be tolerated three times a day for 14-days.
Lead Product(s):
PRV-002
Therapeutic Area: Trauma (Emergency, Injury, Surgery)
Product Name: PRV-002
Highest Development Status: IND Enabling
Product Type: Small molecule
Partner/Sponsor/Collaborator:
Not Applicable
Deal Size: Not Applicable
Upfront Cash: Not Applicable
Deal Type: Not Applicable
September 01, 2021
Details:
PRV-002 continues to pass all the required steps to enter human trials. Successful completion of these IND-enabling studies provides confidence that our drug is safe, active and stable.
Lead Product(s):
PRV-002
Therapeutic Area: Trauma (Emergency, Injury, Surgery)
Product Name: PRV-002
Highest Development Status: IND Enabling
Product Type: Small molecule
Partner/Sponsor/Collaborator:
Not Applicable
Deal Size: Not Applicable
Upfront Cash: Not Applicable
Deal Type: Not Applicable
August 04, 2021
Details:
The cardiac receptor, hERG, which maintains electrical homeostasis was assayed with PRV-002. Findings showed no significant cardiac liability at proposed concussion treatment concentrations.
Lead Product(s):
PRV-002
Therapeutic Area: Trauma (Emergency, Injury, Surgery)
Product Name: PRV-002
Highest Development Status: IND Enabling
Product Type: Small molecule
Partner/Sponsor/Collaborator:
Not Applicable
Deal Size: Not Applicable
Upfront Cash: Not Applicable
Deal Type: Not Applicable
June 29, 2021
Details:
FDA has requested additional CMC
related information on Ortho Regenerative's Investigational New Drug application to begin a phase I/II clinical trial for ORTHO-R, its drug/biologic combination product candidate used as an adjunct to SOC surgery in rotator cuff tear repair.
Lead Product(s):
ORTHO-R
Therapeutic Area: Trauma (Emergency, Injury, Surgery)
Product Name: ORTHO-R
Highest Development Status: IND Enabling
Product Type: Undisclosed
Partner/Sponsor/Collaborator:
Not Applicable
Deal Size: Not Applicable
Upfront Cash: Not Applicable
Deal Type: Not Applicable
June 04, 2021
Details:
Neuronasal has been granted Investigational New Drug (IND) clearance by the U.S. Food and Drug Administration (FDA) to continue its plans for a Phase I clinical trial, and is doing so in partnership with ATAI Life Sciences.
Lead Product(s):
N-Acetylcysteine
Therapeutic Area: Trauma (Emergency, Injury, Surgery)
Product Name: Undisclosed
Highest Development Status: IND Enabling
Product Type: Small molecule
Partner/Sponsor/Collaborator:
ATAI Life Sciences
Deal Size: Not Applicable
Upfront Cash: Not Applicable
Deal Type: Not Applicable
November 12, 2020
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