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Ezetimibe/obicetrapib - NewAmsterdam Pharma

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Drug Profile

Ezetimibe/obicetrapib - NewAmsterdam Pharma

Alternative Names: obicetrapib/ezetimibe - NewAmsterdam Pharma

Latest Information Update: 27 Aug 2025

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At a glance

  • Originator NewAmsterdam Pharma
  • Developer Menarini; NewAmsterdam Pharma
  • Class Amines; Antidementias; Antihyperlipidaemics; Azetidines; Fluorobenzenes; Phenols; Propanols; Pyrimidines; Quinolines; Small molecules; Trihalomethanes
  • Mechanism of Action Cholesterol absorption inhibitors; Cholesterol ester transfer protein inhibitors; NPC1L1 protein inhibitors
  • Orphan Drug Status

    Orphan designation is assigned by a regulatory body to encourage companies to develop drugs for rare diseases.

    No
  • New Molecular Entity Yes

Highest Development Phases

  • Preregistration Dyslipidaemias; Hypercholesterolaemia
  • Phase III Cardiovascular disorders; Hyperlipoproteinaemia type II

Most Recent Events

  • 18 Aug 2025 Preregistration for Dyslipidaemias (Adjunctive treatment) in European Union (PO)
  • 18 Aug 2025 Preregistration for Hypercholesterolaemia (Adjunctive treatment) in European Union (PO)
  • 18 Aug 2025 EMA accepts NDA for Ezetimibe/obicetrapib for Hypercholesterolaemia and Dyslipidaemias for review

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