Pipeline

September 7, 2020
Company Drug/Device Medical Condition Status
COVID-19 Trials and Actions
Cartesian Therapeutics Descartes-30, RNA-engineered mesenchymal stem cell therapy patients with moderate-to-severe ARDS, including that caused by COVID-19 initiation of phase 1/2 trial
Aerpio Pharmaceuticals

Quantum Leap Healthcare Collaborative		 razuprotafib acute respiratory distress syndrome (ARDS) in severely ill COVID-19 patients dosing of first patient in phase 2 trial
Orpheris OP-101 hospitalized adults with severe COVID-19 enrollment of the first patients in phase 2 trial
Sound Pharmaceuticals ebselen (SPI-1005) adults with moderate or severe COVID-19 approval to begin two phase 2 trials granted by the FDA
Vir Biotechnology GlaxoSmithKline VIR-7831/ GSK4182136 treatment of COVID-19 in patients who are at high risk of hospitalization dosing of first patients in phase 2/3 trial
AstraZeneca AZD1222 COVID-19 vaccine phase 3 trial expanded to the U.S.
Can-Fite Biopharma piclidenoson COVID-19 IND approved by the FDA for phase 2 trial
INmune Bio Quellor immune mediated complications in COVID-19 patients IND approved by the FDA for phase 2 trial
Gilead Veklury (remdesivir) all hospitalized patients with COVID-19 Emergency Use Authorization (EUA) expanded by the FDA
Other Trials and Actions
Innovent IBI112 autoimmune disease dosing of first patient in phase 1 trial
Shattuck Labs SL-172154 ovarian cancer dosing of first patient in phase 1 trial
Transcenta Holding TST001 unresectable or metastatic solid tumors dosing of first patient in phase 1 trial
Bicycle Therapeutics BT1718 patients with MT1-MMP-positive squamous non-small-cell lung cancer and a basket of other MT1-MMP-positive solid tumors first patient dosed in phase 2a expansion portion of phase 1/2a trial
Treadwell Therapeutics CFI-402411 solid tumors first patients dosed in phase 1/2 trial
Annovis Bio ANVS401 patients with early Alzheimer’s disease and Parkinson’s disease initiation of patient dosing in phase 2a trial
Arena Pharmaceuticals etrasimod moderate-to-severe alopecia areata dosing of first patient in phase 2 trial
Bicycle Therapeutics

Oxurion		 THR-149 diabetic macular edema dosing of first patients in phase 2 trial
Embera NeuroTherapeutics EMB-001 cocaine use disorder dosing of first patients in phase 2 trial
Chi-Med HMPL-453 advanced intrahepatic cholangiocarcinoma initiation of phase 2 trial
POXEL R-pioglitazone (PXL065) patients with noncirrhotic biopsy-proven non-alcoholic steatohepatitis (NASH) initiation of phase 2 trial
NGM Pharmaceuticals aldafermin biopsy-confirmed NASH with stage 2 (F2) and F3 liver fibrosis patient enrollment complete in phase 2b trial
Provention Bio PRV-015 adult celiac patients not responding to a gluten-free diet initiation of phase 2b trial
Madrigal Pharmaceuticals resmetirom patients with NASH and fibrosis that is diagnosed using noninvasive assessments enrollment complete in phase 3 trial
Novan SB206 molluscum contagiosum initiation of phase 3 trial
AEON Biopharma ABP-450 cervical dystonia IND approved by the FDA
CStone Pharmaceuticals sugemalimab (CS1001) relapsed or refractory extranodal natural killer (NK)/T-cell lymphoma IND approved by the FDA
BioCryst Pharmaceuticals BCX9930 paroxysmal nocturnal hemoglobinuria Orphan Drug designation granted by the FDA
Plus Therapeutics Rhenium NanoLiposomes recurrent glioblastoma Orphan Drug designation granted by the FDA
Baxter Theranova kidney failure dialyzer enabling hemodialysis (HDx) therapy de novo approval granted by the FDA
Innocoll Holdings XARACOLL (bupivacaine HCl) Implant acute postsurgical pain relief for up to 24 hours in adults following open inguinal hernia repair approved by the FDA
Medtronic MiniMed 770G hybrid closed loop system insulin pump system for patients with type 1 diabetes approved by the FDA
Roche HIV-1/HIV-2 qualitative test ability to differentiate between HIV-1 and HIV-2 approved by the FDA

 

Upcoming Events

Featured Products

Featured Stories

Standard Operating Procedures for Risk-Based Monitoring of Clinical Trials

The information you need to adapt your monitoring plan to changing times.

Learn More Here