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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): Bucillamine
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 30, 2020
Details:
The Phase 3 confirmatory clinical will enroll up to 800 patients that will be randomized 1:1:1 to receive Bucillamine 100 mg three times a day, Bucillamine 200 mg TID or placebo TID for up to 14 days.
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Lead Product(s): Bucillamine
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:
Company has filed its Clinical Trial Application with Health Canada and provides an update on the filing of its IND package to the U.S. FDA for the proposed Phase 3 clinical trial to evaluate Bucillamine in the treatment of patients with mild-moderate COVID-19.
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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): Ifenprodil Tartrate
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 April 23, 2020
Details:
The 40-patient, 4-week trial, is designed to test the effect of Ifenprodil in COVID-19 infected patients with severe pneumonia.
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