Betaine anhydrous

Drug Profile

Betaine anhydrous

Alternative Names: Cystadan; Cystadane; RM-003

Latest Information Update: 04 Jun 2016

Price : $50

At a glance

  • Originator Orphan Medical
  • Developer Recordati; ReqMed
  • Class Quaternary ammonium compounds; Small molecules; Trimethyl ammonium compounds
  • Mechanism of Action Methyltransferase stimulants
  • Orphan Drug Status

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

    Yes - Homocystinuria
  • 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.

  • New Molecular Entity Yes

Highest Development Phases

  • Marketed Homocystinuria
  • No development reported Infantile Refsum disease; Peroxisomal disorders; Zellweger syndrome

Most Recent Events

  • 03 Jun 2016 No development reported - Phase-III for Zellweger syndrome, Peroxisomal disorders and Infantile Refsum disease in Canada (PO)
  • 31 Dec 2007 Launched for Homocystinuria in European Union (PO)
  • 27 Jun 2005 Orphan Medical has been acquired by Jazz Pharmaceuticals
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