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Home » Pipeline

Pipeline

November 2, 2020
Company Drug/Device Medical Condition Status
COVID-19 Trials and Actions
Nektar Therapeutics bempegaldesleukin (NKTR-214) adults diagnosed with mild COVID-19 infection IND approved by the FDA for phase 1b trial
Nitric Oxide Innovations NOviricid, 30 mg sodium nitrite oral lozenge African Americans diagnosed with COVID-19 IND approved by the FDA for phase 2b/3 trial
Ampio Pharmaceuticals inhaled Ampion added to the standard of care COVID-19 infected patients hospitalized for respiratory distress initiation of phase 1 trial
HiFiBiO Therapeutics HFB30132A treatment and prevention of COVID-19 dosing complete in first cohort of phase 1 trial
aTyr Pharma ATYR1923 COVID-19 patients with severe respiratory complications patient enrollment complete in phase 2 trial
Boehringer Ingelheim BI 764198 patients hospitalized with SARS-CoV-2 with severe respiratory complications initiation of phase 2 trial
Immutep eftilagimod alpha (IMP321) hospitalized patients with COVID-19 initiation of phase 2 trial
Olatec Therapeutics dapansutrile capsules patients with moderate COVID-19 symptoms and evidence of early Cytokine Release Syndrome initiation of phase 2 trial
ANA Therapeutics oral niclosamide (ANA001) patients with moderate COVID-19 initiation of phase 2/3 trial
Biophytis SA Sarconeos (BIO101) patients with COVID-19-related respiratory failure first patient enrolled in Brazil in phase 2/3 trial
AstraZeneca AZD1222 COVID-19 vaccine U.S portion of phase 3 trial resumed
Moderna mRNA-1273 COVID-19 vaccine patient enrollment complete in phase 3 trial
Agena Bioscience assARRAY SARS-CoV-2 Panel qualitative detection of the SARS-CoV-2 coronavirus Emergency Use Authorization (EUA) granted by the FDA
Gilead Sciences Veklury (remdesivir) patients with COVID-19 requiring hospitalization approved by the FDA
Other Trials and Actions
ATAI Life Sciences Neuronasal (intranasal delivery of low doses of N-acetylcysteine) acute mild traumatic brain injury IND approved by FDA
BioXcel Therapeutics BXCL501 agitation associated with delirium IND approved by the FDA
Insignis Therapeutics

HLK Pharmacin
N-001(oral epinephrine prodrug) allergic reactions, including anaphylaxis IND approved by the FDA
Vanda Pharmaceuticals VSJ-110 allergic conjunctivitis IND approved by the FDA
Y-mAbs Therapeutics 177Lu-omburtamab-DTPA B7-H3 positive central nervous system and leptomeningeal metastasis tumors IND approved by the FDA
Asieris Pharmaceuticals APL-1501 bladder cancer, urinary tract infection clinical trial approved in Australia
BioInvent International BI-1808 ovarian cancer, nonsmall-cell lung cancer and cutaneous T-cell lymphoma clinical trial approved in Europe
Exelixis XL092 alone and in combination with atezolizumab (Tecentriq) advanced solid tumors first patient enrolled in phase 1 trial
Plus Therapeutics Rhenium NanoLiposomes recurrent glioblastoma first patient treated in final cohort of phase 1 trial
Genome & Company GEN-001 solid tumors first patient dosed in phase 1/1b trial
Gmax Biopharm GMA301 pulmonary arterial hypertension first patient dosed in phase 1b trial
ImmunoMolecular Therapeutics IMT-002 patients with HLA-DQ8 positive type 1 diabetes initiation of phase 1b trial
ALX Oncology ALX148 higher-risk myelodysplastic syndrome first patient dosed in the phase 1/2 trial
HOOKIPA Pharma HB-202/HB-201 alternating vector therapy human papillomavirus 16-positive (HPV16+) cancers first patient dosed in phase 1/2 trial
Oncolytis Biotech

Roche
pelareorep plus atezolizumab (Tecentriq) metastatic pancreatic and colorectal and advanced anal cancers initiation of phase 1/2 trial
Syntrix Pharmaceuticals SX-682 myelodysplastic syndromes and metastatic melanoma patient dosing complete in phase 1/2 trial
Arcutis Biotherapeutics ARQ-252 adults with chronic hand eczema patient enrollment complete in phase 1b/2 trial
Sumitomo Dainippon Pharma Oncology dubermatinib (TP-0903) plus decitabine patients 60 years or older with newly diagnosed acute myeloid leukemia with TP53 mutations and/or complex karyotype first patient dosed in phase 1b/2 trial
Annovis Bio ANVS401 early Alzheimer’s disease patient enrollment resumed following suspension of phase 2 trial due to COVID-19
BioLineRx motixafortide first-line metastatic pancreatic ductal adenocarcinoma initiation of phase 2 trial
Novartis NIS793 first-line metastatic pancreatic ductal adenocarcinoma initiation of phase 2 trial
PDS Biotech PDS0101 locally advanced cervical cancer initiation of phase 2 trial
Phosplatin Therapeutics PT-112 metastatic castration-resistant prostate cancer first patient dosed in phase 2 trial
Aerie Pharmaceuticals AR-15512 dry eye disease initiation of phase 2b trial
PTC Therapeutics vatiquinone (PTC743) mitochondrial epilepsy initiation of phase 2/3 trial
Castle Creek Biosciences debcoemagene autofice (FCX-007) recessive dystrophic epidermolysis bullosa first patient dosed in phase 3 trial
Innate Pharma

AstraZeneca
monalizumab plus cetuximab recurrent or metastatic squamous cell carcinoma of the head and neck in patients previously treated with platinum-based chemotherapy and PD-(L)1 inhibitors first patient dosed in phase 3 trial
MediWound NexoBrid hospitalized children with severe thermal burns patient enrollment complete in phase 3 trial
Polyphor balixafortide metastatic breast cancer patient enrollment complete in phase 3 trial
Prilenia Therapeutics pridopidine patients with early stage Huntington’s disease first patients enrolled in phase 3 trial
RegeneRx

ReGenTree
0.1% RGN-259 eye drops dry eye syndrome last patient enrolled in phase 3 trial
Prevail Therapeutics PR001 neuronopathic Gaucher disease Fast-Track designation granted by the FDA
Passage Bio PBKR03 Krabbe disease (Globoid Cell Leukodystrophy) Rare Pediatric Disease designation and Orphan Drug designation granted by the FDA
reVision Therapeutics REV-0100 Stargardt disease Rare Pediatric Disease designation and Orphan Drug designation granted by the FDA
Taysha Gene Therapies TSHA-104 SURF1-associated Leigh syndrome Rare Pediatric Disease designation and Orphan Drug designation granted by the FDA
Adaptive Phage Therapeutics PhageBank prosthetic joint infections Orphan Drug designation granted by the FDA
Kezar Life Sciences KZR-616 polymyositis and dermatomyositis Orphan Drug designation granted by the FDA
Cala Health Cala Trio action tremors in the hands of adults with Parkinson’s disease Breakthrough Device designation granted by the FDA
Abiomed Abiomed Breethe OXY-1 System cardiopulmonary bypass support for patients whose lungs can no longer provide sufficient end organ oxygenation approved by the FDA
Bayer FoundationOneCDx companion diagnostic for Vitrakvi (larotrectinib) to help identify NTRK gene fusion-positive patients approved by the FDA
Kala Pharmaceuticals Eysuvis (loteprednol etabonate ophthalmic suspension) 0.25% short-term (up to two weeks) treatment for dry eye disease approved by the FDA
Medtronic Abre venous self-expanding stent system use in the iliofemoral veins in patients with symptomatic deep venous obstruction approved by the FDA

 

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