Drugs in Dev. Infections and Infectious Diseases
IND Enabling
Canada 
Lead Product(s) : Apabetalone
Therapeutic Area : Infections and Infectious Diseases
Study Phase : IND Enabling
Sponsor : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Details : The planned Phase 2 trial will be an open-label study evaluating the safety and efficacy of oral apabetalone, in combination with standard of care for patients hospitalized with COVID-19.
Product Name : RVX-208
Product Type : Other Small Molecule
Upfront Cash : Inapplicable
December 04, 2021
Lead Product(s) : Apabetalone
Therapeutic Area : Infections and Infectious Diseases
Highest Development Status : IND Enabling
Sponsor : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Lead Product(s) : Onternabez,Dexamethasone
Therapeutic Area : Infections and Infectious Diseases
Study Phase : IND Enabling
Sponsor : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Details : The proposed patient study will evaluate the safety, tolerability, pharmacokinetics, and preliminary efficacy of ascending doses of ARDS-003 in hospitalized COVID-19 patients with pneumonia and at risk of developing acute respiratory distress syndrome.
Product Name : ARDS-003
Product Type : Other Small Molecule
Upfront Cash : Inapplicable
May 04, 2021
Lead Product(s) : Onternabez,Dexamethasone
Therapeutic Area : Infections and Infectious Diseases
Highest Development Status : IND Enabling
Sponsor : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Lead Product(s) : Vasculotide
Therapeutic Area : Infections and Infectious Diseases
Study Phase : IND Enabling
Sponsor : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Details : U.S. Food and Drug Administration (FDA) has allowed its Investigational New Drug (IND) application for AV-001, a Tie2 tyrosine kinase receptor agonist, as a potential treatment for hospitalized patients diagnosed with moderate-to-severe COVID-19 disease.
Product Name : AV-001
Product Type : Peptide
Upfront Cash : Inapplicable
December 11, 2020
Lead Product(s) : Vasculotide
Therapeutic Area : Infections and Infectious Diseases
Highest Development Status : IND Enabling
Sponsor : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Lead Product(s) : Palmitoylethanolamide
Therapeutic Area : Infections and Infectious Diseases
Study Phase : IND Enabling
Sponsor : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
FSD Pharma Announces Phase 2 Clinical Trial IND Filing With The FDA to Treat Patients With COVID-19
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.
Product Name : FSD201
Product Type : Other Small Molecule
Upfront Cash : Inapplicable
August 31, 2020
Lead Product(s) : Palmitoylethanolamide
Therapeutic Area : Infections and Infectious Diseases
Highest Development Status : IND Enabling
Sponsor : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Lead Product(s) : Bucillamine
Therapeutic Area : Infections and Infectious Diseases
Study Phase : IND Enabling
Sponsor : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
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.
Product Name : Undisclosed
Product Type : Other Small Molecule
Upfront Cash : Inapplicable
June 30, 2020
Lead Product(s) : Bucillamine
Therapeutic Area : Infections and Infectious Diseases
Highest Development Status : IND Enabling
Sponsor : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Lead Product(s) : Ifenprodil Tartrate
Therapeutic Area : Infections and Infectious Diseases
Study Phase : IND Enabling
Sponsor : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Details : The 40-patient, 4-week trial, is designed to test the effect of Ifenprodil in COVID-19 infected patients with severe pneumonia.
Product Name : NP-120
Product Type : Other Small Molecule
Upfront Cash : Inapplicable
April 23, 2020
Lead Product(s) : Ifenprodil Tartrate
Therapeutic Area : Infections and Infectious Diseases
Highest Development Status : IND Enabling
Sponsor : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Lead Product(s) : Palmitoylethanolamide
Therapeutic Area : Infections and Infectious Diseases
Study Phase : IND Enabling
Sponsor : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
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 compati...
Product Name : FSD201
Product Type : Other Small Molecule
Upfront Cash : Inapplicable
March 06, 2020
Lead Product(s) : Palmitoylethanolamide
Therapeutic Area : Infections and Infectious Diseases
Highest Development Status : IND Enabling
Sponsor : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Lead Product(s) : Bucillamine
Therapeutic Area : Infections and Infectious Diseases
Study Phase : IND Enabling
Sponsor : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
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 CO...
Product Name : Undisclosed
Product Type : Other Small Molecule
Upfront Cash : Inapplicable
March 06, 2020
Lead Product(s) : Bucillamine
Therapeutic Area : Infections and Infectious Diseases
Highest Development Status : IND Enabling
Sponsor : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
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