Aminolevulinic acid - Biofrontera

Drug Profile

Aminolevulinic acid - Biofrontera

Alternative Names: 5-Aminolevulinic acid - Biofrontera; Ameluz; Aminolevulinic acid hydrochloride - Biofrontera; BF-200 ALA; L01XD04

Latest Information Update: 24 Aug 2016

Price : $50

At a glance

  • Originator ASAT AG
  • Developer Biofrontera AG; Louis Widmer
  • Class Amino acids; Antineoplastics; Keto acids; Levulinic acids; Oxidants; Skin disorder therapies; Small molecules
  • 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
  • On Fast track

    Fast track status is assigned by the US FDA so therapies with the potential to address unmet needs can move faster through development.

    No
  • New Molecular Entity No
  • Available For Licensing Yes

Highest Development Phases

  • Marketed Actinic keratosis
  • Phase III Basal cell cancer
  • No development reported Condylomata acuminata

Most Recent Events

  • 21 Jul 2016 The Committee for Medicinal Products for Human Use adopts a positive opinion recommending an extension to the existing indication of Actinic keratosis for aminolevulinic acid
  • 11 May 2016 Registered for Actinic keratosis in USA (Topical)
  • 15 Apr 2016 Biofrontera completes a phase III trial in Basal cell carcinoma in Germany and United Kingdom (NCT02144077)
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