Drugs / Glutamine
last change Aug 2026 re-read 9 days ago

Glutamine

Other / unclassified

Developed for
mucositis · Duchenne muscular dystrophy · enteritis · peripheral neuropathy · breast cancer · coronary artery disorder · COVID-19 · diabetes mellitus
+30 more · diarrheal disease · Hashimoto thyroiditis · hepatic veno-occlusive disease · herpes labialis · high grade malignant neoplasm · infectious disease · infectious disease with sepsis · lichen planus · muscular atrophy · necrotizing enterocolitis · neonatal sepsis · periodontitis · pneumonia · propionic acidemia · psoriasis · pulmonary venoocclusive disease · rheumatic heart disease · short bowel syndrome · sickle cell disease · toxic polyneuropathy · type 1 diabetes mellitus · type 2 diabetes mellitus · ulcerative colitis · critical illness polyneuropathy · dyspepsia · gastric cancer · irritable bowel syndrome · polyp of large intestine · respiratory failure · traumatic brain injury
Investigated by
National Center for Research Resources (NCRR) · National Cancer Institute (NCI) · National Institute of Allergy and Infectious Diseases (NIAID) · National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) · National Institutes of Health (NIH) · Ain Shams University
+51 more · Air Force Military Medical University, China · Assiut University · Baylor College of Medicine · Beth Faiman · Biruni University · Boston Medical Center · Children's Hospital Medical Center, Cincinnati · Children's National Research Institute · Children's Oncology Group · Columbia University · Cooperative International Neuromuscular Research Group · Emmaus Medical, Inc. · Emory University · Fresienius Kabi HK Ltd · Halic University · Hams Hamed Abdelrahman · Healios Oncology Nutrition · Hospital Authority, Hong Kong · Hospital General de Mexico · M.D. Anderson Cancer Center · Medical College of Wisconsin · NICHD Neonatal Research Network · Nanjing University School of Medicine · National Cancer Institute of Mexico · National Center for Complementary and Integrative Health (NCCIH) · Nemours Children's Clinic · Nestlé · Nicola Longo · Sanofi · Scandinavian Critical Care Trials Group · Scarborough General Hospital · Shahid Beheshti University · St. Jude Children's Research Hospital · The LAM Foundation · The Second Hospital of Nanjing Medical University · The University of Hong Kong · The University of Texas Health Science Center, Houston · Thrasher Research Fund · United States Department of Defense · University Hospital, Rouen · University of Colorado, Denver · University of Crete · University of Michigan · University of Missouri, Kansas City · University of Virginia · University of Wisconsin, Madison · Vanderbilt University Medical Center · Weill Medical College of Cornell University · Yanzhao · Yongquan Shi · Yuejiang Liu

Regulatory milestones approvals, filings & regulatory actions · 3 recorded

MilestoneJurisdictionBrandIndicationDateSentence it was read from
Filed Other Endari sickle cell S-Lepore disease 2021-06-15

“We are looking forward to Swissmedic’s review of our MA application for Endari®” emmausmedical.com ↗

Withdrawn EU (EMA) Xyndari sickle cell S-Lepore disease 2019-09-19

“today announced the withdrawal of its marketing authorization application (MAA) to the European Medicines Agency (EMA) for Xyndari™ (glutamine) for the treatment of sickle cell disease.” emmausmedical.com ↗

Refused (EMA) EU (EMA) Xyndari sickle cell S-Lepore disease 2019-05-30

“the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) adopted a negative opinion in relation to use of Xyndari™ (glutamine) in the...” emmausmedical.com ↗

Trials 42

PhaseRegistry idDatesIndicationSponsorStatusOutcome
Phase 15 trials
Phase 1 NCT04388371 Oct 2019 → Jun 2021 lymphangioleiomyomatosis Vanderbilt University Medical Center Completed No outcome recorded
Phase 1 NCT02351323 May 2010 → Aug 2014 type 2 diabetes mellitus Boston Medical Center Completed No outcome recorded
Phase 1 NCT00645879 Jul 2008 → Aug 2009 propionic acidemia Nicola Longo Completed No outcome recorded
Phase 1 NCT00178581 Jun 2005 → Sep 2006 — The University of Texas Health Science Center, Houston Terminated No outcome recorded
Phase 1 NCT00213551 Apr 2004 → Jun 2008 — University Hospital, Rouen Completed No outcome recorded
Phase 29 trials · 2 missed
Phase 2 NCT07466758 Oct 2024 → Mar 2026 muscular atrophy Biruni University Completed No outcome recorded
Phase 2 NCT06617182 Sep 2024 → Oct 2028 expected enteritis Yongquan Shi Recruiting No outcome recorded
Phase 2 NCT01607879 Mar 2014 → Jul 2018 prostate cancer Medical College of Wisconsin Completed Missed primary
Phase 2 NCT01783522 Feb → Nov 2013 chemotherapy-induced toxicity, peripheral neuropathy, plasma cell myeloma Beth Faiman Terminated No outcome recorded
Phase 2 NCT01794884 Jan 2013 → Mar 2014 coronary artery disorder, rheumatic heart disease Yuejiang Liu Completed No outcome recorded
Phase 2 NCT00913692 Jun 2009 → Dec 2011 herpes labialis National Institute of Allergy and Infectious Diseases (NIAID) Terminated No outcome recorded Stop: Enrollment
Phase 2 NCT00365768 Oct 2004 → Jun 2012 kidney cancer, leukemia, lymphoma, sarcoma +1 Columbia University Completed No outcome recorded
Phase 2 NCT00131508 May 2004 → Apr 2009 sickle cell disease St. Jude Children's Research Hospital Terminated Missed primary Stop: Enrollment
Phase 2 NCT00010634 Sep 1999 → Jul 2004 periodontitis National Center for Complementary and Integrative Health (NCCIH) Completed No outcome recorded
Phase 2/32 trials · 1 missed
Phase 2/3 NCT01263041 May 2011 → Feb 2014 infectious disease with sepsis, necrotizing enterocolitis Ain Shams University Completed No outcome recorded
Phase 2/3 NCT00016653 Jun 2000 → Dec 2006 Duchenne muscular dystrophy Cooperative International Neuromuscular Research Group Completed Missed primary
Phase 311 trials · 2 missed
Phase 3 NCT06031012 Sep 2023 → Oct 2025 mucositis Air Force Military Medical University, China Completed No outcome recorded
Phase 3 NCT05852990 Mar 2022 → Dec 2026 expected non-small cell lung carcinoma National Cancer Institute of Mexico Recruiting No outcome recorded
Phase 3 NCT04909905 May → Oct 2021 COVID-19 Assiut University Completed No outcome recorded
Phase 3 NCT03113240 Apr → Oct 2017 — Shahid Beheshti University Completed No outcome recorded
Phase 3 NCT01952847 Jul 2014 → Mar 2021 high grade malignant neoplasm M.D. Anderson Cancer Center Terminated Missed primary
Phase 3 NCT01087658 Feb 2010 → Mar 2013 colorectal neoplasm Sanofi Completed No outcome recorded
Phase 3 NCT00455247 Oct 2007 → Jan 2012 digestive system cancer Nestlé Completed No outcome recorded
Phase 3 NCT00133406 Jun 2006 → Dec 2011 diarrheal disease University of Virginia Unknown No outcome recorded
Phase 3 NCT00195013 Dec 2003 → May 2014 breast cancer, peripheral neuropathy Weill Medical College of Cornell University Completed No outcome recorded
Phase 3 NCT00005775 Jul 1999 → Dec 2000 fetal growth restriction, neonatal sepsis NICHD Neonatal Research Network Completed Missed primary
Phase 44 trials
Phase 4 NCT03782155 Jun → Aug 2021 diabetes mellitus Hospital General de Mexico Unknown No outcome recorded
Phase 4 NCT03867214 Jan 2019 → Mar 2021 mucositis, pneumonia Yanzhao Unknown No outcome recorded
Phase 4 NCT00204958 Feb 2004 → May 2007 bone marrow disorder, disease related to hematopoietic stem cell transplant University of Wisconsin, Madison Completed No outcome recorded
Phase 4 NCT00922714 Oct 2003 → May 2007 — Scandinavian Critical Care Trials Group Terminated No outcome recorded Stop: Enrollment
Phase not applicable11 trials
— NCT04693936 Feb 2021 → Sep 2024 Hashimoto thyroiditis, psoriasis University of Crete Unknown No outcome recorded
— NCT03917095 May → Jun 2019 ulcerative colitis The Second Hospital of Nanjing Medical University Unknown No outcome recorded
— NCT04442633 Apr → Aug 2019 lichen planus Hams Hamed Abdelrahman Completed No outcome recorded
— NCT03199638 Apr 2016 → Jun 2017 type 1 diabetes mellitus Nemours Children's Clinic Completed No outcome recorded
— NCT01758783 Jun 2012 → Jun 2013 enteritis Nanjing University School of Medicine Unknown No outcome recorded
— NCT01576003 Apr 2012 → Jun 2015 infectious disease, short bowel syndrome Children's Hospital Medical Center, Cincinnati Completed No outcome recorded
— NCT01750138 Jun 2011 → Jun 2014 — Scarborough General Hospital Unknown No outcome recorded
— NCT01239680 Jan 2011 → Nov 2013 — University of Missouri, Kansas City Completed No outcome recorded
— NCT00334984 Jan 2007 → ? undifferentiated high grade pleomorphic sarcoma of bone Children's Oncology Group Withdrawn No outcome recorded
— NCT00563498 Jul 2004 → Jun 2006 hepatic veno-occlusive disease, mucositis, pulmonary venoocclusive disease Hospital Authority, Hong Kong Unknown No outcome recorded
Comparator or background therapy16 trials
Phase 0 NCT05569993 Comparator Oct 2022 → Oct 2023 traumatic brain injury Assiut University Unknown No outcome recorded
Phase 1/2 NCT05655819 Comparator Feb 2023 → Dec 2025 dyspepsia David J. Cangemi Completed No outcome recorded
Phase 1/2 NCT04507945 Background Oct 2020 → Sep 2021 bowel dysfunction Nanjing University School of Medicine Unknown No outcome recorded
Phase 1/2 NCT02589145 Background Jun 2016 → Apr 2019 lymphoma M.D. Anderson Cancer Center Terminated No outcome recorded Stop: Enrollment
Phase 1/2 NCT02701673 Background Jun 2016 → Jun 2019 lymphoma M.D. Anderson Cancer Center Withdrawn No outcome recorded

News releases announcing trial results or a regulatory action · 38

DateIssuerRelease
2025-06-26 Emmaus Medical, Inc. Regulatory Emmaus Life Sciences Receives FDA Approval for Endari® Label Enhancements emmausmedical.com ↗
The additional information provides a more comprehensive characterization of Endari, including confirmation of dosing by body weight, no unwanted accumulation through twice daily dosing, and the ability to administer Endari with or without food.
2024-02-02 Emmaus Medical, Inc. Regulatory Emmaus Life Sciences Receives Marketing Authorization for Puerto Rico emmausmedical.com ↗
2023-07-13 Emmaus Medical, Inc. Regulatory Emmaus Life Sciences Receives Marketing Authorization for Endari® in Oman emmausmedical.com ↗
today announced that it has received marketing authorization from the Oman Ministry of Health for the commercial distribution and sale of Endari® (L-glutamine oral powder) in the country to treat sickle cell disease in patients five years of age and older.
2022-04-07 Emmaus Medical, Inc. Results Emmaus Life Sciences Presented Positive Real-World Data on the Efficacy of Endari® in Preventing Acute Complications from Sickle Cell Disease at the 62nd Annual Scientific Meeting of the British Society for Haematology emmausmedical.com ↗
Furthermore, as compared to baseline, the number of blood transfusions at 24, 48 and 72 weeks was considerably lower (median, from 3.0 to 0.0;p<0.00001).
2021-12-14 Emmaus Medical, Inc. Results Emmaus Life Sciences Presents Positive Transfusion Data from a Post-Hoc Analysis of its Phase 3 Clinical Study of Endari® in Patients With Sickle Cell Disease at the 63rd American Society of Hematology (ASH) Annual Meeting emmausmedical.com ↗
2021-10-26 Emmaus Medical, Inc. Regulatory Emmaus Life Sciences Submits Application for U.A.E. Marketing Authorization for Endari emmausmedical.com ↗
Emmaus Life Sciences, Inc. (OTC: EMMA) a commercial-stage biopharmaceutical company and leader in the treatment of sickle cell disease, today announced the submission of its application for marketing authorization of Endari® to the United Arab Emirates (U.A.E.) Ministry of Health.
2021-08-17 Emmaus Medical, Inc. Regulatory Emmaus Life Sciences Announces Bahrain Temporary License of Endari emmausmedical.com ↗
2021-07-15 Emmaus Medical, Inc. Regulatory Emmaus Life Sciences Announces Submission of Endari Marketing Authorization Application in Kuwait emmausmedical.com ↗
We are pleased to announce the submission of our marketing authorization application to the Kuwaiti authorities.
2021-06-15 Emmaus Medical, Inc. Regulatory Emmaus Life Sciences Announces Submission of Marketing Authorization Application to Swissmedic emmausmedical.com ↗
2021-05-26 Emmaus Medical, Inc. Regulatory Emmaus Life Sciences Announces Submission of Marketing Authorization Application for Endari to the Saudi Food and Drug Authority emmausmedical.com ↗
2020-12-03 Emmaus Medical, Inc. Regulatory Endari® Granted Orphan Drug Status in Switzerland emmausmedical.com ↗
Torrance CA, December 3, 2020 - Emmaus Life Sciences, Inc. (OTC: EMMA) , a leader in the treatment of sickle cell disease, announced today that the Swiss Agency for Therapeutic Products (Swissmedic) has granted orphan drug status to Endari®.
2020-11-10 Emmaus Medical, Inc. Regulatory Emmaus Life Sciences Submits Temporary License Application in Bahrain for Endari® emmausmedical.com ↗
announced today that it has submitted a temporary license application for Endari® to the National Health Regulatory Authority in the Kingdom of Bahrain.

All press releases naming this drug 49 releases

DateIssuerRelease

Evidence & citations 7 cited values

Every value below carries the sentence it was read from. 58 sources stand behind the page.

FieldValueCited text
Known as Glutamine “The intervention includes a personalised pharmaconutrition formula containing arginine, glutamine, and beta-hydroxy-beta-methylbutyrate (HMB).” NCT07466758 ↗
57

“the use of growth hormone, glutamine, modified diet and other measures proposed intestinal rehabilitation treatment.” NCT04507945 ↗

“Enteral Glutamine 0.3g/kg/day powdered glutamine to be mixed in with water and given via nasogastric tube q4 hrs.” NCT03113240 ↗

“Glutamine (L-Glutamin \&Chios Mastiha) 1 tablet per day” NCT04693936 ↗

“Drug: Glutamine” NCT01263041 ↗

NCT00255229 ↗

NCT05852990 ↗

NCT02701673 ↗

NCT01414244 ↗

NCT03199638 ↗

NCT02351323 ↗

Show 47 more sources

Known as AES-14 “Compare the efficacy of a new preparation of glutamine (AES-14) vs placebo in reducing the incidence of grade 3 or 4 chemotherapy-induced oral mucositis during the first course...” NCT00334984 ↗
Known as Dipeptiven “Additionally, glutamine (100 ml of Dipeptiven) will be added to the two-chamber bag.” NCT01704664 ↗
Known as L-Glutamin \&Chios Mastiha “Glutamine (L-Glutamin \&Chios Mastiha) 1 tablet per day” NCT04693936 ↗
Known as L-Glutamine “The aim of this study is to investigate the effect of parenteral L-Glutamine supplementation added to enteral nutrition on short-term ICU mortality (7 days) in Covid-19...” NCT04909905 ↗
Modality Other / unclassified “Glutamine is considered a conditionally essential amino acid during critical illness.” NCT00178581 ↗
Route Intravenous “glutamine or alanine IV over the last 5 hours” NCT00005889 ↗