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Aminolevulinic acid - Biofrontera

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Drug Profile

Aminolevulinic acid - Biofrontera

Alternative Names: 5-Aminolevulinic acid - Biofrontera; Ameluz; Aminolevulinic acid hydrochloride - Biofrontera; BF-200 ALA

Latest Information Update: 13 Jun 2025

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At a glance

  • Originator ASAT AG
  • Developer Biofrontera AG; Louis Widmer
  • Class Amino acids; Antianaemics; Antineoplastics; Diagnostic agents; Imaging agents; Keto acids; Levulinic acids; Nootropics; Skin disorder therapies; Small molecules; Vascular disorder therapies
  • Mechanism of Action Photosensitisers
  • Orphan Drug Status

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

    No
  • New Molecular Entity No

Highest Development Phases

  • Marketed Actinic keratosis; Basal cell cancer
  • Phase II Acne vulgaris
  • No development reported Condylomata acuminata

Most Recent Events

  • 03 Jun 2025 Biofrontera announces the inclusion of the patent for propylene glycol-free formulation of Ameluz® nanoemulsion gel in the US FDA’s Orange Book
  • 15 May 2025 Biofrontera has patent protection for aminolevulinic acid nanoemulsion gel until 2043
  • 15 May 2025 Biofrontera completes enrolment in its phase-IIb trial for Acne vulgaris in USA

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