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Drug & Device Pipeline News
Company | Drug/Device | Medical Condition | Status |
---|---|---|---|
Trials Authorized | |||
HuidaGene Therapeutics | HG004 | RPE65 mutation-associated inherited retinal dystrophies | IND for a phase 1 trial approved by the FDA |
Arugula Sciences | SIG002 | Symptomatic osteoarthritis of the joint in the big toe | IND for a phase 1 trial approved by the FDA |
Deka Biosciences | DK210 | EGFR+ advanced solid tumors | IND for a phase 1 trial approved by the FDA |
Ellipses Pharma | EP0042 | Acute myeloid leukemia | IND for a phase 1 trial approved by the FDA |
Escient Pharmaceuticals | EP262 | Mast cell-mediated disorders | IND for a phase 1 trial approved by the FDA |
Rise Therapeutics | R-3750 | Ulcerative colitis | IND for a phase 1 trial approved by the FDA |
Arcturus Therapeutics | ARCT-032 | Cystic fibrosis | Phase 1 trial authorized by New Zealand’s regulatory authority |
Centessa Pharmaceuticals | LB101 | Solid tumors | IND for a phase 1/2 trial approved by the FDA |
GreenLight Biosciences | COVID-19 booster vaccine | COVID-19 | Phase 1/2 trial authorized by Rwanda’s regulatory authority |
Ascletis Pharma | ASC10 | Respiratory syncytial virus | IND for a phase 2a trial approved by the FDA |
BioAegis Therapeutics | Recombinant plasma gelsolin | Acute respiratory distress syndrome | IND for a phase 2 trial approved by the FDA |
Edesa Biotech | EB06 | Vitiligo | Phase 2 trial authorized by Canada’s regulatory authority |
Trials Initiated | |||
Oligomerix | OLX-07010 | Alzheimer’s disease and other neurodegenerative disorders | Initiation of a phase 1a trial |
Bristol Myers Squibb | EXS4318 | Immunology and inflammation indications | Initiation of a phase 1 trial |
Anaveon | ANV419 | Advanced melanoma | Initiation of a phase 1/2 trial |
Aptose Biosciences | Tuspetinib | Relapsed/ refractory acute myeloid leukemia | Initiation of a phase 1/2 trial |
C4 Therapeutics | CFT1946 | BRAF V600 mutant solid tumors | Initiation of a phase 1/2 trial |
Marengo Therapeutics | STAR0602 | PD-1 refractory advanced solid tumors | Initiation of a phase 1/2 trial |
Arrowhead Pharmaceuticals | ARO-MMP7 | Idiopathic pulmonary fibrosis | Initiation of a phase 1/2a trial |
Qurient | Q702 plus Keytruda (pembrolizumab) | Advanced solid cancers | Initiation of a phase 1b/2 trial |
AmMax Bio | AMB-05X | Tenosynovial giant cell tumor | Initiation of a phase 2b trial |
FSD Pharma | FSD201 | Chronic pain associated with idiopathic mast cell activation syndrome | Initiation of a phase 2 trial |
First Wave BioPharma | Enhanced adrulipase formulation | Exocrine pancreatic insufficiency in patients with cystic fibrosis | Initiation of a phase 2 trial |
SONIRE Therapeutics | High-intensity focused ultrasound therapy system | Unresectable pancreatic cancer | Initiation of a phase 2 trial in Japan |
Daiichi Sankyo | Datopotamab deruxtecan plus pembrolizumab with or without platinum chemotherapy | Previously untreated advanced or metastatic non-squamous non-small cell lung cancer | Initiation of a phase 3 trial |
GSK | Bepirovirsen | Chronic hepatitis B infection | Initiation of two phase 3 trials |
Sciwind Biosciences | Ecnoglutide | Type 2 diabetes | Initiation of a phase 3 trial in China |
Approvals | |||
GSK | Jesduvroq (daprodustat) | Anemia of chronic kidney disease in adults on dialysis | Approved by the FDA |
Eli Lilly | Jaypirca (pirtobrutinib) | Adults with relapsed/ refractory mantle cell lymphoma following at least two lines of systemic therapy, including a BTK inhibitor | Approved by the FDA |
Stemline Therapeutics | Orserdu (elacestrant) | ESR1 mutated, ER+, HER2- advanced or metastatic breast cancer | Approved by the FDA |
Merck | Keytruda (pembrolizumab) | Adjuvant treatment of stage IB, II or IIIA non-small cell lung cancer | Approved by the FDA for expanded indication |
Abbott | Proclaim XR spinal cord stimulation system | Painful diabetic peripheral neuropathy | Approved by the FDA |
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