Danegaptide

Gap Junction Modulator (dipeptide Antiarrhythmic)Rx: InvestigationalCompound: Investigational

Also known as: Danegaptide hydrochloride, Gap junction antiarrhythmic peptide analog, ZP1609

Educational Only — Not medical advice. Consult a qualified clinician before using any peptide.

Summary

Danegaptide (formerly ZP1609) is a synthetic dipeptide analog of rotigaptide developed by Zealand Pharma. It acts as a gap junction enhancer targeting connexin 43, investigated for cardioprotection in the context of acute myocardial infarction and ischemia-reperfusion injury. It has been evaluated in Phase II clinical trials for reducing infarct size in ST-elevation myocardial infarction (STEMI) patients undergoing primary percutaneous coronary intervention (PCI), but has not achieved regulatory approval.

Mechanism of Action

Selectively enhances gap junction intercellular communication by stabilizing connexin 43 (Cx43) in its phosphorylated, open-channel state, thereby improving electrical coupling between cardiomyocytes and reducing arrhythmogenesis during ischemia-reperfusion injury.

Routes of Administration

Intravenous

Goals & Uses

  • Prevention of ischemia-reperfusion injuryCardioprotection / CytoprotectionModerate
  • Antiarrhythmic effect during reperfusionArrhythmia PreventionLow
  • Reduction of myocardial infarct sizeCardioprotectionModerate
  • Improvement of cardiac conductionElectrophysiologyLow

Contraindications

  • Severe pre-existing arrhythmia not related to ischemiaCardiacModerate
  • Known hypersensitivity to danegaptide or excipientsAllergyHigh

Adverse Effects

  • Injection site reactionsLocalUncommon
  • HypotensionCardiovascularUncommonLow blood pressure
  • NauseaGastrointestinalUncommonFeeling of sickness or urge to vomit
  • BradycardiaCardiovascularRare

Drug Interactions

  • Antiarrhythmic agents (Class I/III)Moderate
  • Thrombolytics / antiplatelet agentsLow

Population Constraints

  • Severe renal impairmentOrgan ImpairmentRelative
  • Pediatric patientsAgeRelative
  • Pregnant or lactating womenReproductiveRelative
  • Severe hepatic impairmentOrgan ImpairmentRelative

Regulatory Status

  • European UnionInvestigationalPhase II trial conducted in Europe; no marketing authorization application filed with EMA.
  • United StatesInvestigationalInvestigated under IND; Phase II completed but no NDA filed. Development appears inactive.
  • United KingdomInvestigationalNo approval or active development status in the UK.

Has not received approval from FDA, EMA, or other major regulatory agencies. Development was halted after Phase II results did not demonstrate significant reduction in infarct size versus placebo in STEMI patients. No current active development programs publicly known.

Evidence & Sources

No sources recorded yet.

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