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REC 0545

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Drug Profile

REC 0545

Alternative Names: Maapliv; REC-0545

Latest Information Update: 19 May 2026

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At a glance

  • Originator Assistance Publique Hopitaux de Paris; Recordati
  • Class Amino acids
  • Mechanism of Action Amino acid replacements
  • Orphan Drug Status

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

    Yes - Maple syrup urine disease
  • New Molecular Entity Yes

Highest Development Phases

  • Registered Maple syrup urine disease
  • Discontinued Genitourinary disorders; Overactive bladder

Most Recent Events

  • 28 Jul 2025 Registered for Maple syrup urine disease in European Union, Norway, Iceland, Liechtenstein (IV)
  • 31 Dec 2023 Clinical trials in Maple syrup urine disease (unspecified route) before December 2023 (Recordati pipeline, February 2024)
  • 31 Dec 2023 Recordati announces intention to file regulatory application for Maple syrup urine disease in 2023 (Recordati pipeline, February 2024)

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