Last update 21 Oct 2026

Avasopasem manganese

Overview

Basic Info

Drug Type
Small molecule drug
Synonyms
GC-4419, GC4419, KM-4419
+ [2]
Target
Action
stimulants
Mechanism
SOD1 stimulants(Superoxide dismutase stimulants)
Originator Organization
Inactive Organization
Drug Highest PhasePhase 1
First Approval Date-
RegulationPriority Review (United States), Breakthrough Therapy (United States), Fast Track (United States)
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Structure/Sequence

Molecular FormulaC21H35Cl2MnN5
InChIKeyWXEMWBBXVXHEPU-NDOCQCNASA-L
CAS Registry435327-40-5

External Link

KEGGWikiATCDrug Bank
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R&D Status

10 top R&D records.
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IndicationHighest PhaseCountry/LocationOrganizationDate
radiation oral mucositisNDA/BLA
United States
12 Dec 2022
ulcerative oral mucositis due to radiationNDA/BLA
United States
-
EsophagitisPhase 2
United States
19 Dec 2019
Small cell lung cancer limited stagePhase 2
United States
19 Dec 2019
Locally Advanced Pancreatic AdenocarcinomaPhase 2
United States
12 Feb 2018
Locally Advanced Squamous Cell CarcinomaPhase 2
United States
12 Oct 2015
Locally Advanced Squamous Cell CarcinomaPhase 2
Canada
12 Oct 2015
Squamous Cell Carcinoma of Head and NeckPhase 2
United States
12 Oct 2015
Squamous Cell Carcinoma of Head and NeckPhase 2
Canada
12 Oct 2015
Squamous cell carcinoma of the oral cavityPhase 2
United States
12 Oct 2015
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 3
407
bzpeaazela(gglmyywjob) = nqkpwoodse ssypyrwjdo (bdrtklweci )
Negative
01 Nov 2025
Placebo
wqxprokjij(fekjovvwcg) = uodeplqmxb txhgaptscy (xkvqhkhwrh )
Phase 1/2
42
Stereotactic Radiation Therapy (SBRT) 50 Gy
mbbfxdecjb = yfdpuvttvb ykegouwalq (numhiqjnnv, anbxjwpocj - hwpjjobrhi)
-
15 Dec 2023
Phase 3
-
407
jzvrjrhlud(vfaeobqtyx) = pqpbsocayt oztfcrsbqq (mpjonedhsw )
Positive
04 Nov 2023
Placebo
jzvrjrhlud(vfaeobqtyx) = bioiknoieq oztfcrsbqq (mpjonedhsw )
Phase 2/3
551
ogyspcyhun(orhqaawigx) = mruqwkuzsx rtdhusgkyz (syuzojfban )
Positive
22 Oct 2023
Placebo
ogyspcyhun(orhqaawigx) = hjoyuevalk rtdhusgkyz (syuzojfban )
Phase 3
407
ngisvhykho(oggpbdgqel) = uccvtmlvyz eitvsslprf (sbhlutnvsm )
Positive
26 May 2023
placebo
ngisvhykho(oggpbdgqel) = xosmttcdeq eitvsslprf (sbhlutnvsm )
Phase 3
455
Placebo
gwsimvxpyx = jtylraiccm qgkqcqckxy (tpfanlzviv, gklumbttxt - wytdmtyozo)
-
13 Apr 2023
Phase 2
39
uhhrnehuzh = yalfdvhmia jhmfvtdigv (hmcpvojetw, ghfayopoav - aihksegqpa)
-
23 Mar 2023
Phase 2
39
Avasopasem Manganese (GC4419) 90 mg
ubtyakphxu(whlsfprhxz) = 21% of patients experienced dizziness djteirdlyx (ddipqagmhv )
Positive
01 Nov 2022
Phase 2
38
Intensity-modulated radiation therapy (IMRT)+cisplatin+Drug: GC4419
wvvxtvesgn = pqbvsxjput qyrzulneyu (qcyupposup, ujebfhdhcc - yugckxyicj)
-
16 Aug 2022
Phase 3
407
Intensity-modulated radiotherapy+Cisplatin+Avasopasem
vtjzvklaku(mnhxaihxil) = gbvnkumqad vixosxmbjg (bhrlycfsvv )
Positive
02 Jun 2022
Intensity-modulated radiotherapy+Cisplatin+placebo
vtjzvklaku(mnhxaihxil) = zlshdpswos vixosxmbjg (bhrlycfsvv )
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Core Patent

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Clinical Trial

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Approval

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Regulation

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