Nepadutant

Summary

Nepadutant (MEN 11420) is a selective, potent NK2 receptor antagonist developed primarily for gastrointestinal and respiratory indications. It has been investigated for irritable bowel syndrome (IBS) and infantile colic, with exploratory studies in asthma. It remains in research/investigational status and has not received regulatory approval.

Mechanism of Action

Selective antagonist of the neurokinin 2 (NK2) receptor, blocking the actions of tachykinins such as neurokinin A, thereby reducing smooth muscle contraction and neurogenic inflammation in the gut and airways

Routes of Administration

Goals & Uses

• Visceral PainPain / GastroenterologyModerate
• Asthma / BronchoconstrictionRespiratoryLow
• Irritable Bowel Syndrome (IBS)GastrointestinalModerate
• Infantile ColicGastrointestinal / PediatricLow

Contraindications

• Hypersensitivity to nepadutant or excipientsAllergyHigh

Adverse Effects

• Injection site reactionsLocalUncommon
• HeadacheNeurologicUncommonPain in the head or upper neck
• Gastrointestinal discomfortGastrointestinalUncommon

Drug Interactions

• CYP3A4 substrates / inhibitorsLow

Population Constraints

• PregnancyReproductive SafetyRelative
• Pediatric populations (neonates/infants)AgeRelative
• Severe hepatic impairmentOrgan ImpairmentRelative

Regulatory Status

• European UnionInvestigationalDeveloped by Menarini in Italy; Phase II trials conducted in Europe; no marketing authorization granted
• United StatesInvestigationalNot approved by FDA; investigated under research protocols
• United KingdomInvestigationalNo MHRA approval; remains investigational

Nepadutant has not been approved by any major regulatory authority. Clinical development was primarily conducted by Menarini Research. Investigated in Phase II trials for irritable bowel syndrome and infantile colic.

Evidence & Sources

No sources recorded yet.