Avasopasem manganese
- Generic Name
- Avasopasem manganese
- Drug Type
- Small Molecule
- Chemical Formula
- C21H35Cl3MnN5
- CAS Number
- 435327-40-5
- Unique Ingredient Identifier
- EY1WA413UL
- Background
Avasopasem manganese, also known as GC4419, is a highly-selective small molecule mimetic of superoxide dismutase (SOD) being investigated for the reduction of radiation-induced severe oral mucositis. This drug has potential application for radiation-induced esophagitis and oral mucositis, in addition to being currently tested against COVID-19.
Study to Evaluate the Effects of Renal Impairment on the Pharmacokinetics, Safety and Tolerability of GC4419
- First Posted Date
- 2022-06-09
- Last Posted Date
- 2022-06-09
- Lead Sponsor
- Galera Therapeutics, Inc.
- Target Recruit Count
- 26
- Registration Number
- NCT05412472
- Locations
- ๐บ๐ธ
Inventiv Health Clinical -Research Pharmacy Unit, Miami, Florida, United States
๐บ๐ธUniversity of Miami Division of Clinical Pharmacology, Miami, Florida, United States
A Trial of GC4419 in Patients With Critical Illness Due to COVID-19
- First Posted Date
- 2020-09-18
- Last Posted Date
- 2022-03-18
- Lead Sponsor
- Galera Therapeutics, Inc.
- Target Recruit Count
- 16
- Registration Number
- NCT04555096
- Locations
- ๐บ๐ธ
Saint Louis University, Saint Louis, Missouri, United States
๐บ๐ธUniversity of Iowa, Iowa City, Iowa, United States
๐บ๐ธMercy Research, Saint Louis, Missouri, United States
Study to Evaluate the Effects of 90 mg Intravenous Infusions of GC4419 on the Single Dose Pharmacokinetics of Dextromethorphan in Healthy Adult Subjects
- First Posted Date
- 2019-01-04
- Last Posted Date
- 2019-06-19
- Lead Sponsor
- Galera Therapeutics, Inc.
- Target Recruit Count
- 13
- Registration Number
- NCT03792971
- Locations
- ๐บ๐ธ
Inventiv Health Clinical - Research Pharmacy Unit, Miami, Florida, United States
Pilot Dose Escalation Trial of Stereotactic Body Radiation Therapy (SBRT) in Combination With GC4419 in Pancreatic Cancer
- Conditions
- Stereotactic Body Radiation TherapyPancreatic Cancer
- Interventions
- Drug: PlaceboRadiation: Stereotactic Radiation Therapy (SBRT) 50 GyRadiation: Stereotactic Radiation Therapy (SBRT) 55 Gy
- First Posted Date
- 2017-11-14
- Last Posted Date
- 2023-12-15
- Lead Sponsor
- Galera Therapeutics, Inc.
- Target Recruit Count
- 42
- Registration Number
- NCT03340974
- Locations
- ๐บ๐ธ
Dana Farber Cancer Institute, Boston, Massachusetts, United States
๐บ๐ธUT Southwestern Medical Center, Dallas, Texas, United States
๐บ๐ธDuke University Medical Center, Durham, North Carolina, United States
A Study to Investigate the Absorption, Metabolism, Excretion, and Mass Balance of GC4419 in Healthy Adult Subjects
- First Posted Date
- 2017-05-22
- Last Posted Date
- 2017-11-17
- Lead Sponsor
- Galera Therapeutics, Inc.
- Target Recruit Count
- 6
- Registration Number
- NCT03163173
- Locations
- ๐บ๐ธ
Celerion, Lincoln, Nebraska, United States
A Phase 1 Dose Escalation Study of GC4419 in Combination With Chemoradiation for Squamous Cell Cancer of the Head & Neck
- Conditions
- Squamous Cell Carcinoma of the Oral CavitySquamous Cell Carcinoma of the Oropharynx
- Interventions
- First Posted Date
- 2013-08-13
- Last Posted Date
- 2016-09-22
- Lead Sponsor
- Galera Therapeutics, Inc.
- Target Recruit Count
- 30
- Registration Number
- NCT01921426
- Locations
- ๐บ๐ธ
Summa Health System- Cooper Cancer Center, Akron, Ohio, United States
๐บ๐ธLakeland Regional Cancer Center, Lakeland, Florida, United States
๐บ๐ธWashington University School of Medicine, St. Louis, Missouri, United States
Drug Development Updates
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