CNM-Au8

Phase 2Small molecule

CClene Nanomedicine

CNM-Au8 is one of 61 small molecule programs targeting Amyotrophic Lateral Sclerosis. It is currently in Phase 2.

Indications

Total Trials

Active Trials

Competitors

Pipeline

Status by Indication[3][1]

Indication

Amyotrophic Lateral SclerosisActive, not recruiting

Multiple SclerosisActive, not recruiting

Amyotrophic Lateral SclerosisPhase 2

Active, not recruiting

Multiple SclerosisPhase 2/Phase 3

Active, not recruiting

Competition

Competitive Landscape

560 competitors in Multiple Sclerosis

#DrugCompanyPhaseTrials

Betaseron

Bayer

Preclinical

16 2

Kesimpta

Novartis

Preclinical

15 3

Tysabri

Biogen

Preclinical

14 4

Avonex

EMD Serono

Preclinical

22 5

Campath

GGenzyme, a Sanofi Company

Preclinical

12 6

Zinbryta

Roche

Preclinical

2 7

Flomax

Sanofi

Preclinical

1 8

Pred Forte

Myfortic

Novantrone

Ranked by pipeline maturity and clinical activity. Current drug highlighted in teal.

Timeline

Expected Milestones

Q3 2028

Phase 2/3Recruiting

Trial

NCT04297683

Clinical

Trials by Indication[1]

Trial2 trials

HEALEY ALS Platform Trial - Regimen C CNM-Au8

Completed·MMerit E. Cudkowicz, MD·Phase 2/3·NCT04414345·161 enrolled

HEALEY ALS Platform Trial - Master Protocol

Recruiting·MMerit E. Cudkowicz, MD·Phase 2/3·NCT04297683·1,500 enrolled

Multiple Sclerosis2 trials

A Multi-Center, Open-Label Long-Term Extension Study of CNM-Au8 In Patients With Stable Relapsing Multiple Sclerosis

Completed·CClene Nanomedicine·Phase 2/3·NCT04626921·55 enrolled

Nanocrystalline Gold to Treat Remyelination Failure in Chronic Optic Neuropathy In Multiple Sclerosis

Terminated·CClene Nanomedicine·Phase 2·NCT03536559·73 enrolled

ESS2 trials

Intermediate Expanded Access Protocol CNMAu8.EAP04

Available·CClene Nanomedicine··NCT06408727

Intermediate Expanded Access Protocol CNMAu8.EAP03

Temporarily not available·CClene Nanomedicine··NCT04081714

ALS1 trial

Two Intermediate Expanded Access Protocols (EAP) CNMAu8.EAP01 and CNMAu8.EAP02 for ALS

Available·CClene Nanomedicine··NCT05281484

Amyotrophic Lateral Sclerosis1 trial

Therapeutic Nanocatalysis to Slow Disease Progression of Amyotrophic Lateral Sclerosis (ALS)

Completed·CClene Nanomedicine·Phase 2·NCT04098406·45 enrolled

Sources

References

[1]
ClinicalTrials.gov — 8 trial records for CNM-Au8. U.S. National Library of Medicine, National Institutes of Health.
[2]
ChEMBL — CNM-Au8 compound record. European Bioinformatics Institute (EMBL-EBI).
[3]
Open Targets Platform — Drug–disease associations for CNM-Au8. EMBL-EBI & Wellcome Sanger Institute.
[4]
SEC EDGAR — Clene Nanomedicine company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Modality: Small molecule[2]
Highest Phase: Phase 2[1]
Company: CClene Nanomedicine

CNM-Au8

Status by Indication[3][1]

Competitive Landscape

Expected Milestones

Q3 2028

Trials by Indication[1]

Trial2 trials

Multiple Sclerosis2 trials

ESS2 trials

ALS1 trial

Amyotrophic Lateral Sclerosis1 trial

References

Drug Info

Quick Facts

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