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Home » Pipeline

Pipeline

October 5, 2020
Company Drug/Device Medical Condition Status
COVID-19 Trials and Actions
Covistat/Ensysce Biosciences oral nafamostat acute respiratory failure due to COVID-19 initiation of phase 1 trial
Covaxx UB-612 COVID-19 vaccine first patient dosed in phase 1 trial
Stemedica Cell Technologies intravenous allogeneic mesenchymal stem cells patients with moderate to severe lung injury due to COVID-19 IND approved by the FDA for phase 2 trial
Windtree Therapeutics lyo lucinactant COVID-19 associated lung injury and acute respiratory distress syndrome IND approved by the FDA for phase 2 trial
FSD Pharma FSD201 (ultramicronized palmitoylethanolamide) hospitalized patients with COVID-19 initiation of phase 2 trial
Novavax NVX-CoV2373 (COVID-19 vaccine) COVID-19 initiation of phase 3 trial
Organicell Regenerative Medicine Zofin acellular therapy patients with SARS-CoV-2 who have mild to moderate COVID-19, or who are judged by a healthcare provider to be at high risk of progression to moderate disease expanded access protocol granted by the FDA
ADial Pharmaceuticals Assure/FaStep COVID-19 IgG/IgM Rapid Test Device antibody point-of-care test for COVID-19 Emergency Use Authorization (EUA) granted by the FDA
Cepheid Xpert Xpress SARS-CoV-2/Flu/RSV molecular diagnostic test qualitative detection of the viruses causing COVID-19, Flu A, Flu B, and RSV infections from a single patient sample EUA granted by the FDA
Hologic Panther Fusion SARS-CoV-2 assay testing of individuals without symptoms or other reasons to suspect COVID-19 infection EUA granted by the FDA
Quotient MosaiQ COVID-19 antibody test detection of COVID-19 antibodies EUA granted by the FDA
Other Trials and Actions
Aerie Pharmaceuticals AR-15512 (TRPM8 agonist) eye drop dry eye disease IND approved by the FDA
IRLAB mesdopetam (IRL790) levodopa-induced dyskinesias in Parkinson's disease IND approved by the FDA
Inversago Pharma INV-101 Prader-Willi syndrome and non-alcoholic steatohepatitis initiation of phase 1 trial
Kuur Therapeutics KUR-502 relapsed/refractory CD19-positive malignancies first patients dosed in phase 1 trial
Prelude Therapeutics PRT1419 relapsed/refractory hematologic malignancies first patients dosed in phase 1 trial
Zucara Therapeutics ZT-01 type 1 diabetes first patient dosed in phase 1 trial
BioMarin BMN 307 phenylketonuria first patient dosed in phase 1/2 trial
Codiak Biosciences exoSTING advanced metastatic or recurrent, injectable solid tumors first patients dosed in phase 1/2 trial
Aptinyx NYX-2925 fibromyalgia patient recruitment recommenced in phase 2 trial
Calithera Biosciences telaglenastat (CB-839) nonsmall-cell lung cancer first patient dosed in phase 2 trial
Concert Pharmaceuticals CTP-692 schizophrenia patient enrollment complete in phase 2 trial
Ocular Therapeutics OTX-CSI (cyclosporine intracanalicular insert) dry eye disease first patients dosed in phase 2 trial
Aurinia voclosporin ophthalmic solution dry eye syndrome last patient study visit in phase 2/3 trial
CiVi Biopharma/Eicos Sciences CIVI030 (intravenous iloprost) systemic sclerosis patient recruitment resumed in phase 3 trial
Eisai lorcaserin Dravet syndrome initiation of phase 3 trial
Harbour BioMed batoclimab (HBM 9161) myasthenia gravis (MG) and adult immune thrombocytopenia first patient dosed in phase 3 trials
Infinity eganelisib (IPI-549) in combination with a checkpoint inhibitor and chemotherapy patients with inoperable locally advanced or metastatic triple-negative breast cancer, in the first-line setting Fast-Track designation granted by the FDA
AbbVie elezanumab (ABT-555) spinal cord injury Orphan Drug and Fast-Track designations granted by the FDA
Neurophth Therapeutics NR082 (rAAV2-ND4, NFS-0) Leber's Hereditary Optic Neuropathy associated with ND4 mutation Orphan Drug designation granted by the FDA
CSL Behring Haegarda (C1 Esterase Inhibitor Subcutaneous [human] routine prophylaxis to prevent hereditary angioedema attacks in patients 6 years of age and older approved by the FDA for expanded indication
Eton Pharmaceuticals Alkindi Sprinkle (hydrocortisone) oral granules replacement therapy for adrenocortical insufficiency in children under 17 years of age approved by the FDA
GlaxoSmithKline Nucala (mepolizumab) hypereosinophilic syndrome (HES) without an identifiable non-blood-related cause of the disease in adults and children 12 years of age and older approved by the FDA for expanded indication
Janssen Simponi Aria (golimumab) active polyarticular juvenile idiopathic arthritis and active psoriatic arthritis in patients 2 years of age and older approved by the FDA
Masimo Rad-G Pulse Oximeter pulse oximetry and respiration rate monitoring approved by the FDA
Pfizer Xeljanz (tofacitinib) children and adolescents 2 years and older with active polyarticular-course juvenile idiopathic arthritis approved by the FDA for expanded indication
Shionogi Fetroja (cefiderocol) hospital-acquired bacterial pneumonia and ventilator-associated bacterial pneumonia approved by the FDA for expanded indication
Vertex Pharmaceuticals Kalydeco (ivacaftor) children with cystic fibrosis ages four months to less than six months old who have at least one mutation in their CFTR gene approved by the FDA for expanded indication

 

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