CMX-2043

Summary

CMX-2043 is an investigational cyclic disulfide peptide derived from alpha-lipoic acid, developed primarily for cardioprotection during percutaneous coronary intervention (PCI) and for renal protection during cardiac surgery. It has demonstrated reduction of myocardial and renal ischemia-reperfusion injury in preclinical and early clinical studies. It was evaluated in Phase 2 clinical trials (CENTAURI and ARBITER trials) with mixed results on primary endpoints.

Mechanism of Action

CMX-2043 is a lipoic acid derivative cyclic disulfide peptide that acts as a mitochondria-targeted antioxidant and cytoprotective agent. It reduces reactive oxygen species (ROS), stabilizes mitochondrial membrane potential, inhibits the mitochondrial permeability transition pore (mPTP), and modulates cell survival signaling pathways including PI3K/Akt, thereby protecting cardiomyocytes and renal cells from ischemia-reperfusion injury.

Routes of Administration

Goals & Uses

• Cardioprotection during PCICardiovascularModerate
• Mitochondrial ROS reductionAntioxidant/CytoprotectionModerate
• Renal protection during cardiac surgeryNephrologyModerate
• Reduction of ischemia-reperfusion injuryCardiovascular/SurgicalModerate

Contraindications

• Severe hepatic impairmentOrganModerateLiver function concerns
• Hypersensitivity to CMX-2043 or lipoic acid derivativesAllergyHigh

Adverse Effects

• Elevated liver enzymes (transient)HepaticRare
• Injection site reactionsLocalUncommon
• HeadacheNeurologicUncommonPain in the head or upper neck
• HypotensionCardiovascularUncommonLow blood pressure
• NauseaGastrointestinalUncommonFeeling of sickness or urge to vomit

Drug Interactions

• Anticoagulants (e.g., heparin)Low
• Antioxidant supplements (e.g., alpha-lipoic acid, vitamin E)Low

Population Constraints

• PregnancyReproductive SafetyRelative
• Severe renal impairmentOrgan ImpairmentRelative
• Pediatric patientsAgeRelative

Regulatory Status

• European UnionUnknownNo EMA approval or IMPD publicly reported as of knowledge cutoff.
• United StatesInvestigationalStudied under IND; no FDA approval granted. Phase 2 trials completed without subsequent approval filing reported.
• United KingdomUnknownNo MHRA approval reported.

CMX-2043 has received no regulatory approval from FDA, EMA, or other major agencies. It has been studied under IND regulations in Phase 1 and Phase 2 trials. Development has been led by Ischemix Inc. No current approvals for any indication as of the knowledge cutoff.

Evidence & Sources

No sources recorded yet.