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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.
Lead Product(s): L-Glutamine
Therapeutic Area: Hematology Product Name: Endari
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable July 13, 2023
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.
Lead Product(s): L-Glutamine
Therapeutic Area: Genetic Disease Product Name: Endari
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable December 19, 2022
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.
Lead Product(s): L-Glutamine
Therapeutic Area: Genetic Disease Product Name: Endari
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable December 07, 2022
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.
Lead Product(s): L-Glutamine
Therapeutic Area: Genetic Disease Product Name: Endari
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable November 17, 2022
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<0.00001).
Lead Product(s): L-Glutamine
Therapeutic Area: Genetic Disease Product Name: Endari
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable April 07, 2022
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.
Lead Product(s): L-Glutamine
Therapeutic Area: Genetic Disease Product Name: Endari
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable March 29, 2022
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.
Lead Product(s): L-Glutamine
Therapeutic Area: Genetic Disease Product Name: Endari
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable March 04, 2022
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.
Lead Product(s): L-Glutamine
Therapeutic Area: Genetic Disease Product Name: Endari
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Emmaus Life Sciences
Deal Size: Undisclosed Upfront Cash: Undisclosed
Deal Type: Agreement November 04, 2021
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.
Lead Product(s): L-Glutamine
Therapeutic Area: Genetic Disease Product Name: Endari
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable October 26, 2021
Details:
The application follows Emmaus’ announcement that the SFDA had granted Endari® a priority review designation as part of its program to expedite the review of drugs that are expected to have a significant impact on the treatment of a disease with unmet medical need.
Lead Product(s): L-Glutamine
Therapeutic Area: Genetic Disease Product Name: Endari
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable August 18, 2020
Details:
The study is utilizing the same pharmaceutical-grade L-glutamine (PGLG) oral powder used in Endari® to evaluate the change in the number and size of colonic diverticula and assess safety.
Lead Product(s): L-Glutamine
Therapeutic Area: Gastroenterology Product Name: Undisclosed
Highest Development Status: Phase IProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable August 05, 2020
Details:
European Medicines Agency (EMA) issued scientific advice to Emmaus regarding the clinical development pathway for Xyndari™ for the treatment of sickle cell disease.
Lead Product(s): L-Glutamine
Therapeutic Area: Genetic Disease Product Name: Xyndari
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable July 29, 2020
Details:
Emmaus Life Sciences has engaged Partner International to lead the out-licensing activity for Emmaus’ prescription grade L-glutamine (PGLG) oral powder for use in the treatment of diverticulosis.
Lead Product(s): L-Glutamine
Therapeutic Area: Gastroenterology Product Name: Undisclosed
Highest Development Status: Phase IProduct Type: Small molecule
Partner/Sponsor/Collaborator: Emmaus Life Sciences
Deal Size: Undisclosed Upfront Cash: Undisclosed
Deal Type: Licensing Agreement July 16, 2020
Details:
Endari® is approved in Israel as in the U.S. as an amino acid indicated to reduce the acute complications of sickle cell disease in adult and pediatric patients five years of age and older.
Lead Product(s): L-Glutamine
Therapeutic Area: Genetic Disease Product Name: Endari
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable June 29, 2020
Details:
Acceptance by Saudi Food & Drug Authority will expedite the review process for Emmaus Life Sciences's lead candidate Endari® for treatment of sickle cell disease.
Lead Product(s): L-Glutamine
Therapeutic Area: Genetic Disease Product Name: Undisclosed
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable April 16, 2020
Details:
A marginal but decreased size in some of the diverticula compared to the baseline. Indications of Healing and Normalization of Bowel Movements Observed in the Initial Patient.
Lead Product(s): L-Glutamine
Therapeutic Area: Gastroenterology Product Name: Undisclosed
Highest Development Status: Phase IProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable January 29, 2020
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