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Avasopasem manganese FDA Approval Status

Last updated by Judith Stewart, BPharm on Dec 20, 2022.

FDA Approved: No
Generic name: avasopasem manganese
Company: Galera Therapeutics, Inc.
Treatment for: Mucositis

Avasopasem manganese is a selective small molecule dismutase mimetic in development for radiotherapy-induced severe oral mucositis (SOM) in patients with head and neck cancer (HNC) undergoing standard-of-care treatment.

Development timeline for avasopasem manganese

Aug  9, 2023Galera Receives Complete Response Letter from U.S. FDA for Avasopasem Manganese
Dec 12, 2022Galera Submits New Drug Application for Avasopasem for Severe Oral Mucositis
May 16, 2022Galera Announces Plan to Submit Avasopasem NDA by Year End
Oct 15, 2018Galera Therapeutics Announces Dosing of First Patient in Pivotal Phase 3 ‘ROMAN’ Clinical Trial of Avasopasem Manganese (GC4419)

Further information

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