{"entity":{"id":"galera-therapeutics","kind":"company","name":"Galera Therapeutics","aka":["Galera Therapeutics, Inc.","Galera"],"tldr":"Galera developed avasopasem, a synthetic enzyme mimic meant to prevent the severe mouth ulcers of head and neck radiotherapy; the FDA declined approval in 2023 despite a positive phase 3 trial.","summary":"Galera Therapeutics, based in Malvern, Pennsylvania, developed avasopasem manganese, a superoxide dismutase mimetic, to reduce severe oral mucositis in patients having chemoradiotherapy for head and neck cancer. The phase 3 ROMAN trial met its primary endpoint but the FDA issued a complete response letter in 2023 asking for a further trial. Its trials remain on ClinicalTrials.gov under Galera as lead sponsor.","asOf":"2026-09-11","links":[{"label":"Official website","url":"https://www.galeratx.com"},{"label":"ClinicalTrials.gov: trials led by Galera Therapeutics, Inc.","url":"https://clinicaltrials.gov/search?lead=Galera%20Therapeutics%2C%20Inc."},{"label":"Wikidata","url":"https://www.wikidata.org/wiki/Q140046053"}],"tags":["ctgov-sponsor"],"related":[],"cancers":["head-and-neck"],"sections":["supportive-care","radiation"],"technologies":[],"targets":[],"drugs":[],"companies":[],"institutions":[],"pathways":[],"terms":["pivotal-trial","clinical-trial"],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"notes":[],"provenance":{"editedBy":"OnCo ingestion (ClinicalTrials.gov v2 + sponsor websites)","editedOn":"2026-09-11"},"hq":"Malvern, PA","country":"US","companyType":"biotech","website":"https://www.galeratx.com","stage":"public","investors":[],"funding":[]},"route":"/companies/galera-therapeutics/","neighbours":{"cancer":[{"id":"head-and-neck","kind":"cancer","name":"Head and neck squamous cell carcinoma","route":"/cancers/head-and-neck/"}],"section":[{"id":"radiation","kind":"section","name":"Radiation Therapy","route":"/fronts/radiation/"},{"id":"supportive-care","kind":"section","name":"Supportive Care & Survivorship","route":"/fronts/supportive-care/"}],"term":[{"id":"clinical-trial","kind":"term","name":"Clinical trial","route":"/terms/clinical-trial/"},{"id":"pivotal-trial","kind":"term","name":"Pivotal (registrational) trial","route":"/terms/pivotal-trial/"}]}}