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Lead Product(s): Palmitoylethanolamide
Therapeutic Area: Infections and Infectious Diseases Product Name: FSD201
Highest Development Status: Phase II Product Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable December 15, 2020
Details:
FDA has authorized randomized, controlled, double-blind study on 352 patients. The Company is expected to conduct this trial in 25-30 Medical Centers and Hospitals in North America.
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Lead Product(s): Palmitoylethanolamide
Therapeutic Area: Infections and Infectious Diseases Product Name: FSD201
Highest Development Status: Phase II Product Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable September 28, 2020
Details:
The U.S FDA has authorized the initiation of a Phase 2 study for the use of FSD201 (ultramicronized palmitoylethanolamide, or ultramicronized PEA) to treat COVID-19, the disease caused by the SARS-CoV-2 virus.
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Lead Product(s): Palmitoylethanolamide
Therapeutic Area: Infections and Infectious Diseases Product Name: FSD201
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 31, 2020
Details:
The FSD201 COVID-19 Trial will be a multicenter study that assesses the efficacy and safety of FSD201 dosed at 600mg or 1200mg twice-daily, together with standard of care compared to SOC alone in hospitalized patients with COVID-19 disease.
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Lead Product(s): Palmitoylethanolamide
Therapeutic Area: Infections and Infectious Diseases Product Name: FSD201
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 22, 2020
Details:
FSD Pharma announced favorable topline results from its Phase 1 randomized, double-blind, placebo-controlled study of ultramicronized palmitoylethanolamide (PEA), or FSD201.
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Lead Product(s): Palmitoylethanolamide
Therapeutic Area: Infections and Infectious Diseases 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 June 03, 2020
Details:
The trial will be a randomized, controlled, double-blind, U.S. multicenter study to assess the efficacy and safety of FSD-201 dosed 600mg/1200mg twice-daily plus standard of care versus SOC alone in symptomatic patients with clinical presentation compatible with COVID-19.
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Lead Product(s): Palmitoylethanolamide
Therapeutic Area: Immunology 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 09, 2020
Details:
Approval to initiate a Phase 1, randomized, double-blind, placebo-controlled study to evaluate the safety, tolerability and pharmacokinetics of ultra-micronized-PEA in normal healthy volunteers.
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Lead Product(s): Cannabinoids
Therapeutic Area: Neurology Product Name: Undisclosed
Highest Development Status: Undisclosed Product Type: Small molecule
Partner/Sponsor/Collaborator: Solarvest BioEnergy
Deal Size: Undisclosed Upfront Cash: Undisclosed
Deal Type: Agreement February 04, 2020
Details:
Under the amended Research Agreement, FSD Pharma has agreed to issue additional class B subordinate voting shares to Solarvest, which will enable Solarvest to fund the CBD Research Project.
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