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Home » Pipeline

Pipeline

January 18, 2021
Company Drug/Device Medical Condition Status
COVID-19 Trials and Actions
Codagenix

Serum Institute of India
COVI-VAC single-dose, intranasal, live attenuated vaccine against SARS-CoV-2 first patient dosed in phase 1 trial
DalCor Pharmaceuticals dalcetrapib oral anti-viral treatment for COVID-19 initiation of phase 2 trial
Innovation Pharmaceuticals Brilacidin hospitalized COVID-19 patients Fast-Track designation granted by the FDA for phase 2 trial
PerkinElmer PerkinElmer New Coronavirus Nucleic Acid Detection Kit testing of individuals without COVID-19 symptoms Emergency Use Authorization (EUA) granted by the FDA
Quanterix Simoa SARS-CoV-2 N Protein Antigen Test detection of SARS-CoV-2 virus nucleocapsid protein EUA granted by the FDA
Other Trials and Actions
Editas Medicine EDIT-301 sickle cell disease IND approved by the FDA
Vor Biopharma VOR33 acute myeloid leukemia IND approved by the FDA
Chipscreen Biosciences chiauranib second-line treatment of small-cell lung cancer IND approved by China’s National Medical Products Administration (NMPA)
Gracell Biotechnologies GC007g, allogeneic donor-derived anti-CD19 chimeric antigen receptor (CAR)-T cell therapy B-cell acute lymphoblastic leukemia IND approved by China’s NMPA
aTyr Pharma

Kyorin Pharma
ATYR1923 (KRP-R120) interstitial lung disease completed last subject visit in phase 1 trial
Jounce Therapeutics JTX-8064 as a monotherapy and in combination with either JTX-4014 or Keytruda advanced solid tumors initiation of phase 1 trial
Jupiter Orphan Therapeutics JOTROL rare diseases, including ataxias, lysosomal storage disorders and mitochondrial diseases first patient dosed in phase 1 trial
OX2 Therapeutics immunotherapy recurrent glioblastoma first patient dosed in phase 1 trial
Rezolute RZ402 diabetic macular edema initiation of phase 1 trial
Clearside Biomedical CLS-AX (axitinib injectable suspension) neovascular age-related macular degeneration (wet AMD) first patients enrolled in phase 1/2a trial
Felix Biotechnology YPT-01 chronic P. aeruginosa infections in cystic fibrosis initiation of phase 1/2 trial
Terns Pharmaceuticals TERN-101 nonalcoholic steatohepatitis patient enrollment complete in phase 2a trial
Adverum Biotechnologies ADVM-022 diabetic macular edema patient enrollment complete in phase 2 trial
Cytokinetics CK-274 hypertrophic cardiomyopathy first patient dosed in cohort 2 of phase 2 trial
Immutep eftilagimod alpha head and neck cancer patient enrollment complete in phase 2 trial
Cara Therapeutics oral Korsuva (difelikefalin) moderate-to-severe pruritus in patients suffering from notalgia paresthetica initiation of phase 2 trial
OncoSec Medical TAVO (tavokinogene telseplasmid) plus Opdivo (nivolumab) neoadjuvant therapy prior to surgery in patients with operable, locally or regionally advanced melanoma first patient dosed in phase 2 trial
Redhill Biopharma

Cosmo Pharmaceuticals
Rifamycin SV-MMX 600mg diarrhea-predominant irritable bowel syndrome completion of phase 2 trial
REMD Biotherapeutics volagidemab (REMD-477) type 1 diabetes patient enrollment complete in phase 2 trial
Mirum Pharmaceuticals volixibat primary sclerosing cholangitis first patient enrolled in phase 2b trial
RhoVac RV001 advanced prostate cancer first patient enrolled in phase 2b trial
Kintara Therapeutics VAL-083 newly diagnosed and recurrent glioblastoma initiation of patient recruitment in phase 2/3 trial
Prilenia Therapeutics pridopidine amyotrophic lateral sclerosis first patient enrolled in phase 2/3 trial
Arcutis Biotherapeutics topical roflumilast cream (ARQ-151) atopic dermatitis initiation of two phase 3 trials
Blue Earth Diagnostics 18F-fluciclovine, a positron emission tomography imaging radiopharmaceutical detecting recurrent brain metastases first patient dosed in phase 3 trial
Denovo Biopharma DB102 (enzastaurin) patients with newly diagnosed glioblastoma multiforme first patient dosed in phase 3 trial
Organogenesis ReNu, cryopreserved amniotic suspension allograft management of symptoms associated with knee osteoarthritis first patient enrolled in phase 3 trial
Pfizer PF-06939926 ambulatory male patients, ages 4 through 7, with Duchenne muscular dystrophy first patient dosed in phase 3 trial
Rockwell Medical

Wanbang Biopharmaceuticals
Triferic Dialysate patients with chronic kidney disease requiring hemodialysis first patient dosed in phase 3 trial
TauRx Pharmaceuticals hydromethylthionine mild cognitive impairment and mild-to-moderate Alzheimer’s disease patient enrollment complete in phase 3 trial
Orchard Therapeutics OTL-200, ex vivo autologous hematopoietic stem cell gene therapy early-onset metachromatic leukodystrophy Regenerative Medicine Advanced Therapy designation granted by the FDA
Gemini Therapeutics GEM103 age-related macular degeneration Fast-Track designation granted by the FDA
Leading Biosciences LB1148 postoperative gastrointestinal dysfunction associated with pediatric heart surgery Fast-Track designation granted by the FDA
Merus Zenocutuzumab patients with metastatic solid tumors harboring NRG1 gene fusions (NRG1+ cancers) that have progressed on standard-of-care therapy Fast-Track designation granted by the FDA
Abbott i-STAT Alinity TBI plasma test rapid handheld traumatic brain injury blood test approved by the FDA
ClearMind Biomedical Axonpen System illumination and visualization of intracranial tissue and fluids and the controlled aspiration of tissue and/or fluid during surgery approved by the FDA

 

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