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Endari (L-glutamine oral powder)

The following drug information is obtained from various newswires, published medical journal articles, and medical conference presentations.

Approval Status:

Approved July 2017

Specific Treatments:

sickle cell disease

Therapeutic Areas

General Information

Endari (L-glutamine oral powder) reduces oxidant damage to red blood cells by improving the redox potential of nicotinamide adenine dinucleotide (NAD), a coenzyme that has been identified as the primary regulator of oxidation. 

Endari is specifically indicated to reduce the severe complications of sickle cell disease (SCD) in adult and pediatric patients age 5 and older.

Endari is supplied as a powder for oral administration.

 

 

Clinical Results

FDA Approval

The FDA approval of Endari was supported by efficacy data from a 48-week randomized, double-blind, placebo-controlled, multicenter Phase IIIclinical trial evaluating the effects of Endari, prescription grade L-glutamine, as compared to placebo on 230 adults and children with SCD. The results demonstrated that Endari reduced the frequency of sickle cell crises by 25% and hospitalizations by 33%. Additional findings showed a decrease in cumulative hospital days by 41% and lower incidence of ACS by more than 60%. 

Side Effects

Adverse effects associated with the use of Endari may include, but are not limited to, the following:

  • constipation
  • nausea
  • headache
  • abdominal pain
  • cough
  • pain in extremity
  • back pain
  • chest pain (non-cardiac)

Mechanism of Action

Endari (L-glutamine oral powder) reduces oxidant damage to red blood cells by improving the redox potential of nicotinamide adenine dinucleotide (NAD), a coenzyme that has been identified as the primary regulator of oxidation. 

Additional Information

For additional information regarding Endari or sickle cell disease, please visit http://www.emmausmedical.com

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