Year
DEALS // DEV.
Country
Therapeutic Area
Study Phase
Deal Type
Product Type
Dosage Form
Lead Product
Target
Lead Product(s) : L-Glutamine
Therapeutic Area : Genetic Disease
Study Phase : Approved
Sponsor : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
ANI Pharmaceuticals Announces the FDA Approval and Launch of L-Glutamine Oral Powder
Details : ANI’s L-Glutamine Oral Powder is the the first AA-rated generic version of the reference listed drug (RLD) Endari indicated to reduce the acute complications of sickle cell disease.
Brand Name : Endari-Generic
Molecule Type : Small molecule
Upfront Cash : Not Applicable
July 15, 2024
Lead Product(s) : L-Glutamine
Therapeutic Area : Genetic Disease
Highest Development Status : Approved
Sponsor : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
Lead Product(s) : L-Glutamine
Therapeutic Area : Hematology
Study Phase : Approved
Sponsor : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
Emmaus Life Sciences Receives Marketing Authorization for Endari in Oman
Details : Endari (L-glutamine), an amino acid, is indicated to reduce the acute complications of sickle cell disease in adult and pediatric patients five years of age and older.
Brand Name : Endari
Molecule Type : Small molecule
Upfront Cash : Not Applicable
July 13, 2023
Lead Product(s) : L-Glutamine
Therapeutic Area : Hematology
Highest Development Status : Approved
Sponsor : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
Lead Product(s) : L-Glutamine
Therapeutic Area : Genetic Disease
Study Phase : Approved
Sponsor : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
Dr. Niihara Feted by Indian Government in Recognition of the Development of Endari®
Details : Endari (L-glutamine), is approved in the U.S. and several Gulf Cooperation Council countries to reduce the acute complications of sickle cell disease in adult and pediatric patients five years of age and older.
Brand Name : Endari
Molecule Type : Small molecule
Upfront Cash : Not Applicable
December 19, 2022
Lead Product(s) : L-Glutamine
Therapeutic Area : Genetic Disease
Highest Development Status : Approved
Sponsor : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
Lead Product(s) : L-Glutamine
Therapeutic Area : Genetic Disease
Study Phase : Approved
Sponsor : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
Endari® Receives Kuwaiti Marketing Authorization
Details : Endari is a prescription grade L-glutamine oral powder which is indicated to reduce the acute complications of sickle cell disease in adult and pediatric patients five years of age and older.
Brand Name : Endari
Molecule Type : Small molecule
Upfront Cash : Not Applicable
December 07, 2022
Lead Product(s) : L-Glutamine
Therapeutic Area : Genetic Disease
Highest Development Status : Approved
Sponsor : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
Lead Product(s) : L-Glutamine
Therapeutic Area : Genetic Disease
Study Phase : Approved
Sponsor : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
Details : Endari® (L-glutamine), an amino acid, is indicated to reduce the acute complications of sickle cell disease in adult and pediatric patients five years of age and older.
Brand Name : Endari
Molecule Type : Small molecule
Upfront Cash : Not Applicable
November 17, 2022
Lead Product(s) : L-Glutamine
Therapeutic Area : Genetic Disease
Highest Development Status : Approved
Sponsor : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
Lead Product(s) : L-Glutamine
Therapeutic Area : Genetic Disease
Study Phase : Approved
Sponsor : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
Details : Compared to baseline, patients had significantly fewer vaso-occlusive crises at 24, 48 and 72 weeks on Endari therapy, as well as fewer hospitalizations (median change from 3.0 to 0; p<0.00001) and fewer days in hospital (median change from 15.0 to 0; p<...
Brand Name : Endari
Molecule Type : Small molecule
Upfront Cash : Not Applicable
April 07, 2022
Lead Product(s) : L-Glutamine
Therapeutic Area : Genetic Disease
Highest Development Status : Approved
Sponsor : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
Lead Product(s) : L-Glutamine
Therapeutic Area : Genetic Disease
Study Phase : Approved
Sponsor : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
Emmaus Life Sciences Announces Endari® To Be Added to the Florida Medicaid Preferred Drug List
Details : Endari is a brand-name prescription medication. It’s FDA-approved to reduce the number of sudden complications of sickle cell disease (SCD) and how severe they are. One of the main complications is pain crisis, which is severe pain across the body.
Brand Name : Endari
Molecule Type : Small molecule
Upfront Cash : Not Applicable
March 29, 2022
Lead Product(s) : L-Glutamine
Therapeutic Area : Genetic Disease
Highest Development Status : Approved
Sponsor : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
Lead Product(s) : L-Glutamine
Therapeutic Area : Genetic Disease
Study Phase : Approved
Sponsor : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
Details : Endari®, Emmaus' prescription grade L-glutamine oral powder, was approved by the FDA in July 2017 for treating sickle cell disease in adult and pediatric patients five years of age and older.
Brand Name : Endari
Molecule Type : Small molecule
Upfront Cash : Not Applicable
March 04, 2022
Lead Product(s) : L-Glutamine
Therapeutic Area : Genetic Disease
Highest Development Status : Approved
Sponsor : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
Lead Product(s) : L-Glutamine
Therapeutic Area : Genetic Disease
Study Phase : Approved
Sponsor : Emmaus Life Sciences
Deal Size : Undisclosed
Deal Type : Agreement
Emmaus Life Sciences Enters into Agreement with Asembia to Provide Expanded Patient Support Services
Details : The agreement with Asembia is an important step for Emmaus, as their team will assist in streamlining the insurance authorization process for Endari as well as deployment of various patient assistance programs.
Brand Name : Endari
Molecule Type : Small molecule
Upfront Cash : Undisclosed
November 04, 2021
Lead Product(s) : L-Glutamine
Therapeutic Area : Genetic Disease
Highest Development Status : Approved
Sponsor : Emmaus Life Sciences
Deal Size : Undisclosed
Deal Type : Agreement
Lead Product(s) : L-Glutamine
Therapeutic Area : Genetic Disease
Study Phase : Approved
Sponsor : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
Emmaus Life Sciences Submits Application for U.A.E. Marketing Authorization for Endari®
Details : Endari®, Emmaus’ prescription grade L-glutamine oral powder, was approved by the FDA in July 2017 for treating sickle cell disease in adult and pediatric patients five years of age and older.
Brand Name : Endari
Molecule Type : Small molecule
Upfront Cash : Not Applicable
October 26, 2021
Lead Product(s) : L-Glutamine
Therapeutic Area : Genetic Disease
Highest Development Status : Approved
Sponsor : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
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