Endari

(L-glutamine)

Phase 3Small molecule

EEmmaus Medical, Inc.

Endari is one of 269 small molecule programs targeting Pulmonary Hypertension. It is currently in Phase 3.

Indications

Total Trials

Active Trials

268

Competitors

FDA Applications

NDA/BLA/ANDA regulatory filings

Pipeline

Status by Indication[3][1]

Indication

Pulmonary HypertensionActive, not recruiting

AnemiaActive, not recruiting

Diabetes MellitusActive, not recruiting

Pancreatic CancerActive, not recruiting

Duchenne Muscular DystrophyActive, not recruiting

Sickle Cell DiseaseActive, not recruiting

Generalized Anxiety DisorderActive, not recruiting

ThalassemiaActive, not recruiting

Pulmonary HypertensionPhase 2

Active, not recruiting

AnemiaPhase 2

Active, not recruiting

Diabetes MellitusPhase 1

Active, not recruiting

Pancreatic CancerPhase 1

Active, not recruiting

Duchenne Muscular DystrophyPhase 2

Active, not recruiting

Sickle Cell DiseasePhase 3

Active, not recruiting

Generalized Anxiety DisorderPhase 2

Active, not recruiting

ThalassemiaPhase 2

Active, not recruiting

Competition

Competitive Landscape

1063 competitors in Pancreatic Cancer

#DrugCompanyPhaseTrials

Endari

EEmmaus Medical, Inc.

Phase 3

1 2

Gemzar

GGynecologic Oncology Group

Byetta

1 4

MS Contin

Merck & Co.

Preclinical

1 5

Medrol

Pfizer

Preclinical

1 6

Feraheme

AAzurity Pharmaceuticals

Preclinical

1 7

ABI-007

Bristol-Myers Squibb

Preclinical

2 8

Active Comparator

Moderna

Preclinical

1 9

LDE225

Novartis

Preclinical

1 10

Sulfonylureas

Eli Lilly

Preclinical

Ranked by pipeline maturity and clinical activity. Current drug highlighted in teal.

Clinical

Trials by Indication[1]

Thalassemia2 trials

L-Glutamine Therapy for Sickle Cell Anemia and Sickle ß0 Thalassemia

Completed·EEmmaus Medical, Inc.·Phase 2·NCT00125788·70 enrolled

Effect of L-Glutamine on Pulmonary Artery Pressure in Patients With Non-Transfusion-Dependent Thalassemia

Completed·MMazandaran University of Medical Sciences·Phase 2/3·NCT07210450·8 enrolled

Sickle Cell Disease2 trials

A Phase III Safety and Efficacy Study of L-Glutamine to Treat Sickle Cell Disease or Sickle βo-thalassemia

Completed·EEmmaus Medical, Inc.·Phase 3·NCT01179217·230 enrolled

Pharmacokinetics and Safety of Endari (L-glutamine) in Sickle Cell Disease Patients

Completed·EEmmaus Medical, Inc.·Phase 4·NCT04684381·13 enrolled

Generalized Anxiety Disorder1 trial

Treatment of Adults With Generalized Anxiety Disorder Using Glutamine

Terminated·HHospital Universitario Dr. Jose E. Gonzalez·Phase 2·NCT04274114·38 enrolled

Treatment1 trial

L-glutamine Treatment in Patients With Diverticulosis

Completed·EEmmaus Medical, Inc.·Phase 1·NCT05106101·9 enrolled

Duchenne Muscular Dystrophy1 trial

Effect of Oral Glutamine on Muscle Mass and Function in Duchenne Muscular Dystrophy

Completed·AAssistance Publique - Hôpitaux de Paris·Phase 2·NCT00296621·30 enrolled

5 more indications

Pancreatic Cancer1 trial

Trial of First-line L-glutamine With Gemcitabine and Nab-paclitaxel in Advanced Pancreatic Cancer

Completed·—·Phase 1·NCT04634539·18 enrolled

Immune Dysregulation1 trial

Glutamine Supplementation in People With Immune Dysregulation

Withdrawn·NNational Institute of Allergy and Infectious Diseases (NIAID)·Phase 1·NCT04019769

Diabetes Mellitus1 trial

The Effect of Pharmaceutical Grade L-glutamine (Endari) on Glycemic Control in Patients With Diabetes Mellitus Type II

Unknown status·HHawaii Pacific Health·Phase 1·NCT03947879·25 enrolled

Pulmonary Hypertension1 trial

Glutamine Therapy for Hemolysis-Associated Pulmonary Hypertension

Completed·UUCSF Benioff Children's Hospital Oakland·Phase 2·NCT01048905·13 enrolled

Anemia1 trial

L-Glutamine Therapy for Sickle Cell Anemia

Terminated·LLundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center·Phase 2·NCT00586209·15 enrolled

Regulatory

FDA Approval Timeline[4]

Jun 10, 2004

NUTRESTORE

NDA NDA021667

Jul 7, 2017

ENDARI

NDA NDA208587

Sources

References

[1]
ClinicalTrials.gov — 12 trial records for L-glutamine. U.S. National Library of Medicine, National Institutes of Health.
[2]
ChEMBL — L-glutamine compound record. European Bioinformatics Institute (EMBL-EBI).
[3]
Open Targets Platform — Drug–disease associations for L-glutamine. EMBL-EBI & Wellcome Sanger Institute.
[4]
OpenFDA — FDA approval records (NDA NDA208587). U.S. Food & Drug Administration.
[5]
SEC EDGAR — Emmaus Medical, Inc. company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Modality: Small molecule[2]
Highest Phase: Phase 3[1]
Company: EEmmaus Medical, Inc.

Endari

Status by Indication[3][1]

Competitive Landscape

Trials by Indication[1]

Thalassemia2 trials

Sickle Cell Disease2 trials

Generalized Anxiety Disorder1 trial

Treatment1 trial

Duchenne Muscular Dystrophy1 trial

Pancreatic Cancer1 trial

Immune Dysregulation1 trial

Diabetes Mellitus1 trial

Pulmonary Hypertension1 trial

Anemia1 trial

FDA Approval Timeline[4]

References

Drug Info

Quick Facts

Related News