# Avasopasem manganese

Source: https://onco.cc/drugs/avasopasem-manganese/  
OnCo record `avasopasem-manganese` (Treatment). Data CC BY-NC 4.0, attribute "Data from OnCo (onco.cc)"; commercial use needs a licence.

## TL;DR

Avasopasem is Galera Therapeutics' radioprotector for the severe mouth ulcers of head and neck chemoradiation; its phase 3 trial met its main goal but the FDA asked for another study in 2023.

## Summary

Avasopasem manganese is given by infusion before each radiotherapy fraction. The ROMAN phase 3 trial in head and neck cancer patients receiving cisplatin chemoradiation reduced the incidence of severe oral mucositis compared with placebo. The FDA issued a complete response letter in August 2023 asking for an additional trial before approval. A related compound, rucosopasem, is being tested to increase the effect of stereotactic radiotherapy on tumours rather than protect normal tissue.

## Fields

- Kind: Treatment
- Status: phase-3
- Last checked: 2026-09-24
- Tags: radiation-wave3
- Code: GC4419
- Modality: Superoxide dismutase mimetic small molecule
- Mechanism: A manganese complex that mimics the enzyme superoxide dismutase, converting the superoxide radicals that radiation creates in normal tissue into hydrogen peroxide, which healthy cells clear more easily than tumour cells.

## Sources

- ROMAN (eClinicalMedicine 2025): https://doi.org/10.1016/j.eclinm.2025.103539
- ClinicalTrials.gov NCT03689712: https://clinicaltrials.gov/study/NCT03689712
- ClinicalTrials.gov: trials of avasopasem: https://clinicaltrials.gov/search?intr=avasopasem

## Connected records

- cancers: [Head and neck squamous cell carcinoma](https://onco.cc/cancers/head-and-neck/)
- technologies: [Radioprotectors and normal-tissue sparing drugs](https://onco.cc/technologies/radioprotectors/)
- companies: [Galera Therapeutics](https://onco.cc/companies/galera-therapeutics/)
- trials: [ROMAN](https://onco.cc/trials/roman/)
- key papers: [Avasopasem manganese treatment for severe oral mucositis from chemoradiotherapy for locally advanced head and neck cancer: phase 3 randomized controlled trial (ROMAN)](https://onco.cc/key-papers/paper-roman-anderson-eclinicalmedicine-2025/)

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