Ibodutant

Tachykinin NK2 Receptor Antagonist (peptide Derived Small Molecule)Rx: InvestigationalCompound: Investigational

Also known as: ibodutant, MEN15596

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

Summary

Ibodutant (MEN15596) is a selective NK2 receptor antagonist developed primarily for the treatment of irritable bowel syndrome with diarrhea (IBS-D) in women. It demonstrated efficacy in reducing abdominal pain and improving stool consistency in Phase III clinical trials, though it has not received regulatory approval.

Mechanism of Action

Selective antagonist of the neurokinin 2 (NK2) receptor, blocking the action of tachykinins such as neurokinin A, thereby reducing visceral hypersensitivity, colonic motility, and pain signaling in the gut.

Routes of Administration

Oral

Goals & Uses

  • Improvement of stool consistency in IBS-DGastrointestinal Symptom ManagementModerate
  • Relief of abdominal pain in IBS-DGastrointestinal Symptom ManagementModerate
  • Overall IBS-D symptom responseQuality Of LifeModerate
  • Reduction of visceral hypersensitivityNociception / Pain ModulationLow

Contraindications

  • Severe hepatic impairmentOrganModerateLiver function concerns
  • Known hypersensitivity to ibodutantAllergy/ImmunologyHigh

Adverse Effects

  • NasopharyngitisInfectiousUncommon
  • HeadacheNeurologicCommonPain in the head or upper neck
  • NauseaGastrointestinalUncommonFeeling of sickness or urge to vomit
  • Upper respiratory tract infectionInfectiousUncommon

Drug Interactions

  • Strong CYP3A4 inducers (e.g., rifampicin, carbamazepine)Moderate
  • Strong CYP3A4 inhibitors (e.g., ketoconazole, clarithromycin)Moderate

Population Constraints

  • Male patientsSex BasedRelative
  • Pediatric patientsAgeRelative
  • Pregnant womenReproductiveRelative

Regulatory Status

  • European UnionInvestigationalNot approved by EMA. Phase III IRIS program conducted in Europe; no marketing authorization granted.
  • United StatesInvestigationalNot approved by the FDA. Phase III data generated but no NDA filing publicly confirmed.
  • United KingdomUnknownNo MHRA approval known; status follows EU pre-Brexit investigational classification.

Ibodutant was investigated in Phase III trials (IRIS program) for IBS-D. Despite showing statistically significant efficacy in women, it has not been approved by the FDA or EMA as of the latest available data. Development status beyond Phase III is uncertain.

Evidence & Sources

No sources recorded yet.

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