# Galera Therapeutics

Source: https://onco.cc/companies/galera-therapeutics/  
OnCo record `galera-therapeutics` (Company). Data CC BY-NC 4.0, attribute "Data from OnCo (onco.cc)"; commercial use needs a licence.

## TL;DR

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.

## Fields

- Kind: Company
- Last checked: 2026-09-11
- Also known as: Galera Therapeutics, Inc.; Galera
- Tags: ctgov-sponsor
- HQ: Malvern, PA
- Type: biotech
- Website: https://www.galeratx.com

## Sources

- Official website: https://www.galeratx.com
- ClinicalTrials.gov: trials led by Galera Therapeutics, Inc.: https://clinicaltrials.gov/search?lead=Galera%20Therapeutics%2C%20Inc.
- Wikidata: https://www.wikidata.org/wiki/Q140046053

## Connected records

- cancers: [Head and neck squamous cell carcinoma](https://onco.cc/cancers/head-and-neck/)
- fronts: [Radiation Therapy](https://onco.cc/fronts/radiation/), [Supportive Care & Survivorship](https://onco.cc/fronts/supportive-care/)
- terms: [Clinical trial](https://onco.cc/terms/clinical-trial/), [Pivotal (registrational) trial](https://onco.cc/terms/pivotal-trial/)

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