Glutamine - Emmaus Medical

Drug Profile

Glutamine - Emmaus Medical

Alternative Names: L-glutamine - Emmaus Medical; Levoglutamide; NutreStore; PGLG - Emmaus Medical; SCD therapy

Latest Information Update: 03 Feb 2017

Price : $50

At a glance

  • Originator Nutritional Restart Pharmaceutical
  • Developer Emmaus Medical; Nutritional Restart Pharmaceutical
  • Class Basic amino acids; Diamino amino acids; Neutral amino acids; Small molecules
  • Mechanism of Action Antioxidants; Protein synthesis modulators
  • Orphan Drug Status

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

    Yes - Sickle cell anaemia; Short bowel syndrome
  • 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.

    Sickle cell anaemia
  • New Molecular Entity Yes

Highest Development Phases

  • Marketed Short bowel syndrome
  • Preregistration Sickle cell anaemia
  • Phase III Thalassaemia

Most Recent Events

  • 01 Feb 2017 Emmaus Life Sciences receives Notice of Allowance to its patent for glutamine in USA
  • 10 Jan 2017 The US FDA sets Prescription Drug User Fee Act (PDUFA) date of July 7, 2017 for NDA review for Sickle cell anaemia (In adolescents, In children, In adults)
  • 13 Dec 2016 Emmaus Life Sciences receives patent allowance for glutamine in Japan
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