Avasopasem Manganese

Summary

Avasopasem Manganese (CHEMBL4297957) is a phase-3 clinical-stage small molecule; indicated across 7 conditions including stomatitis and esophagitis.

At a glance

• Status: Max clinical phase 3 (not approved)
• Modality: Small molecule
• Indications: 7 conditions
• Clinical trials: 8

Identifiers

Drug identity and classification

Field	Value
ChEMBL ID	CHEMBL4297957
Name	Avasopasem Manganese
Type	Small molecule
Max phase	3

Also known as: Avasopasem manganese, Avasopasem manganese dichloride, Avasopasem manganeso, GC-4419, Gc4419, GC4419, M-40419, SC-72325A, AVASOPASEM MANGANESE

Targets

Targets

No target linkage available.

Bioactivity

No ChEMBL bioactivity rows at pChembl ≥ 5 (expected for biologics / antibodies).

Target pathways

No target-pathway data for this drug (no mapped target genes).

Indications & clinical

Indications

7 indications (0 at ChEMBL trial phase 4). Phase below is the highest clinical-trial phase recorded for this drug against each disease — not the molecule’s overall approval status (that is in the Summary).

Indication	Trial phase	MONDO	EFO
stomatitis	3	MONDO:0004842	EFO:1001904
esophagitis	2	MONDO:0001409	HP:0100633
severe acute respiratory syndrome	2	MONDO:0005091	MONDO:0100096
oropharynx cancer	1	MONDO:0004608	MONDO:0044926
oral cavity squamous cell carcinoma	1	MONDO:0004958	EFO:0000199
kidney disorder	1	MONDO:0005240	EFO:0003086

1 further indication record had no mapped disease name (EFO/MeSH-only) or were duplicates, and are omitted.

Clinical trials

Total trials: 8.

Phase distribution

Phase	Trials
PHASE1	4
PHASE2	2
PHASE3	1
PHASE1/PHASE2	1

Top trials by phase / activity

NCT	Phase	Status	Title
NCT03689712	PHASE3	COMPLETED	ROMAN: Phase 3 Trial Investigating the Effects of GC4419 on Radiation Induced Oral Mucositis in Head/Neck Cancer Patients
NCT03340974	PHASE1/PHASE2	COMPLETED	Pilot Dose Escalation Trial of Stereotactic Body Radiation Therapy (SBRT) in Combination With GC4419 in Pancreatic Cancer
NCT04529850	PHASE2	COMPLETED	Ph 2 Open Label Study of GC4419 to Reduce SOM Associated With Chemoradiotherapy for Head and Neck Cancer
NCT04555096	PHASE2	TERMINATED	A Trial of GC4419 in Patients With Critical Illness Due to COVID-19
NCT01921426	PHASE1	COMPLETED	A Phase 1 Dose Escalation Study of GC4419 in Combination With Chemoradiation for Squamous Cell Cancer of the Head & Neck
NCT03163173	PHASE1	COMPLETED	A Study to Investigate the Absorption, Metabolism, Excretion, and Mass Balance of GC4419 in Healthy Adult Subjects
NCT03792971	PHASE1	COMPLETED	Study to Evaluate the Effects of 90 mg Intravenous Infusions of GC4419 on the Single Dose Pharmacokinetics of Dextromethorphan in Healthy Adult Subjects
NCT05412472	PHASE1	COMPLETED	Study to Evaluate the Effects of Renal Impairment on the Pharmacokinetics, Safety and Tolerability of GC4419

Clinical evidence (CIViC)

No CIViC predictive evidence (expected for non-precision-medicine drugs).

Pharmacology

Pharmacogenomics

No PharmGKB pharmacogenomic data curated for this drug.

Related molecules

Related molecules

No competitor molecules sharing a primary target (ChEMBL phase ≥2 or PubChem drug-class).