Pipeline

January 11, 2021
Company Drug/Device Medical Condition Status
COVID-19 Trials and Actions
Arcturus Therapeutics ARCT-021, COVID-19 vaccine COVID-19 IND approved by the FDA for a phase 2 trial
Windtree Therapeutics lucinactant acute lung injury in adults with COVID-19-associated lung injury and acute respiratory distress syndrome first patient dosed in phase 2 trial
Nirmidas Biotech MidaSpot COVID-19 Antibody Combo Detection Kit COVID-19 rapid antibody IgG/IgM test Emergency Use Authorization granted by the FDA
Moderna COVID-19 Vaccine COVID-19 approved by the European Commission
Other Trials and Actions
BlueRock Therapeutics pluripotent stem cell-derived dopaminergic neurons Parkinson's disease IND approved by the FDA
CURE Pharma CUREfilm Blue, an oral soluble film of sildenafil citrate erectile dysfunction IND approved by the FDA
Forge Biologics FBX-101 Krabbe disease IND approved by the FDA
Inozyme INZ-701 adults with ENPP1 deficiency IND approved by the FDA
Precigen PRGN-2012 recurrent respiratory papillomatosis IND approved by the FDA
Union Therapeutics oral orismilast plaque psoriasis in adults IND approved by the FDA
VISEN Pharmaceuticals TransCon C-Type Natriuretic Peptide achondroplasia IND approved by the National Medical Products Administration (NMPA) of the People's Republic of China for a phase 2 trial
Everest Medicines sacituzumab govitecan-hziy metastatic urothelial cancer Phase 3 trial authorized by the NMPA of the People's Republic of China
F-star Therapeutics FS222 advanced malignancies first patient dosed in phase 1 trial
IDEAYA Biosciences IDE196 and crizotinib metastatic uveal melanoma first patient dosed in phase 1 trial
Replimune Group RP3 alone and in combination with anti-PD-1 therapy advanced solid tumors first patient dosed in phase 1 trial
Vir Biotechnology VIR-1111; HIV T-cell vaccine HIV initiation of phase 1 trial
AsclepiX Therapeutics AXT107 diabetic macular edema first patient dosed in phase 1/2a trial
Harpoon Therapeutics HPN328 Small-cell lung cancer and other tumors associated with DLL3 expression first patient dosed in phase 1/2 trial
Metacrine MET409 (50 mg) in combination with empagliflozin (Jardiance) patients with both type 2 diabetes mellitus and nonalcoholic steatohepatitis first patient dosed in phase 2a trial
Aptinyx NYX-2925 painful diabetic peripheral neuropathy patient enrollment recommenced in phase 2 trial
Immutep eftilagimod alpha in combination with Keytruda (pembrolizumab) head and neck cancer patient enrollment complete in phase 2 trial
Lexicon Pharma LX9211 post-herpetic neuralgia first patients dosed in phase 2 trial
Graybug Vision GB-102 wet age-related macular degeneration completion of patient dosing in phase 2b trial
Axsome Therapeutics AXS-05 Alzheimer’s disease agitation initiation of phase 3 trial
Biohaven Pharma troriluzole obsessive-compulsive disorder initiation of phase 3 trial
InflaRx vilobelimab (IFX-1) antineutrophil cytoplasmic antibody-associated vasculitis patient enrollment complete in phase 3 trial
Kedrion Pharma 10% intravenous immunoglobulin primary immunodeficiency disease patient enrollment complete in phase 3 trial
Ocuphire Pharma Nyxol night-vision disturbances initiation of phase 3 trial
Ocuphire Pharma Nyxol reversal of pharmacologically induced mydriasis patient enrollment complete in phase 3 trial
PharmaEssentia ropeginterferon alfa-2b (P1101) essential thrombocythemia initiation of phase 3 trial
TLC TLC599 osteoarthritis knee pain patient enrollment complete in phase 3 trial
Inversago Pharma INV-101 Prader-Willi syndrome Rare Pediatric Disease designation granted by the FDA
Genentech tiragolumab in combination with Tecentriq (atezolizumab) first-line treatment of patients with metastatic nonsmall-cell lung cancer with high PD-L1 expression with no EGFR or ALK genomic tumor aberrations Breakthrough Therapy designation granted by the FDA
Ascentage Pharma APG-2575 acute myeloid leukemia Orphan Drug designation granted by the FDA
Bioserenity Neuronaute EEG System and IceCap EEG wearable device remote monitoring of electrical brain activity in patients with epilepsy approved by the FDA

 

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