Drugs / L-glutamine

Regulatory milestones approvals, filings & regulatory actions · 1 recorded

MilestoneJurisdictionBrandIndicationDateSentence it was read from
Approved US (FDA) NUTRESTORE — 2004-06-10 fda.gov ↗

Trials 16

PhaseRegistry idDatesIndicationSponsorStatusOutcome
Phase 01 trial
Phase 0 NCT04019769 Mar 2020 → Jan 2021 atopic eczema National Institute of Allergy and Infectious Diseases (NIAID) Withdrawn No outcome recorded Stop: Enrollment
Phase 13 trials
Phase 1 NCT04634539 May 2021 → Jul 2023 pancreatic ductal adenocarcinoma Jun Gong, MD Completed No outcome recorded
Phase 1 NCT05106101 Jul 2019 → Dec 2022 large intestine disorder Emmaus Medical, Inc. Completed No outcome recorded
Phase 1 NCT03947879 May 2019 → May 2021 type 2 diabetes mellitus Hawaii Pacific Health Unknown No outcome recorded
Phase 26 trials · 2 missed
Phase 2 NCT06967428 Sep 2025 → Jan 2026 overdue — Independent Medical Alliance Not yet recruiting No outcome recorded
Phase 2 NCT04274114 Jan 2019 → May 2020 generalized anxiety disorder Hospital Universitario Dr. Jose E. Gonzalez Terminated No outcome recorded Stop: Enrollment
Phase 2 NCT01048905 Mar 2009 → Mar 2014 pulmonary hypertension, sickle cell disease, thalassemia UCSF Benioff Children's Hospital Oakland Completed No outcome recorded
Phase 2 NCT00296621 Feb 2006 → Feb 2008 Duchenne muscular dystrophy Assistance Publique - Hôpitaux de Paris Completed Missed primary
Phase 2 NCT00125788 Mar 2004 → Jul 2008 sickle cell disease, thalassemia Emmaus Medical, Inc. Completed Missed primary
Phase 2 NCT00586209 Feb 2004 → Aug 2008 sickle cell disease, thalassemia Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center Terminated No outcome recorded Stop: Business
Phase 2/31 trial
Phase 2/3 NCT07210450 Aug 2023 → May 2025 thalassemia Mazandaran University of Medical Sciences Completed No outcome recorded
Phase 31 trial · 1 met primary
Phase 3 NCT01179217 May 2010 → Mar 2014 sickle cell disease, sickle cell-beta zero-thalassemia Emmaus Medical, Inc. Completed Met primary
Phase 42 trials
Phase 4 NCT05371184 Jan 2022 → Jan 2023 sickle cell disease Ain Shams University Completed No outcome recorded
Phase 4 NCT04684381 Jan → Jun 2021 sickle cell disease Emmaus Medical, Inc. Completed No outcome recorded
Phase not applicable2 trials
— NCT05808010 Jun 2023 → Apr 2025 chronic atrophic gastritis Shandong Provincial Hospital Unknown No outcome recorded
— NCT04701463 Jan → Nov 2020 obesity disorder, skin disorder Azienda di Servizi alla Persona di Pavia Completed No outcome recorded

Press releases naming this drug 17 releases

DateIssuerRelease
2026-08-31 Emmaus Medical, Inc. Emmaus Life Sciencs Announces Agreement for Evaluation of L-glutamine for Pancreatic Cancer emmausmedical.com ↗
2019-10-09 Emmaus Medical, Inc. Emmaus Life Sciences Granted Patent in India for use of Pharmaceutical-grade L-glutamine in Treating Diverticulosis emmausmedical.com ↗
2019-09-03 Emmaus Medical, Inc. Emmaus Life Sciences Granted European Patent for use of Pharmaceutical-grade L-glutamine in Treating Diverticulosis emmausmedical.com ↗
2019-06-24 Emmaus Medical, Inc. Emmaus Life Sciences Announces Protocol for Study of Pharmaceutical-grade L-glutamine for the Treatment of Diabetes emmausmedical.com ↗
2018-09-19 Emmaus Medical, Inc. Emmaus, a Leader in Sickle Cell Disease Treatment, Signs Agreement with Cardinal Health to Solidify Distribution Network for Endari™ (L-glutamine oral powder) emmausmedical.com ↗
2018-08-27 Emmaus Medical, Inc. Emmaus, a Leader in Sickle Cell Disease Treatment, Signs Agreement with McKesson to Expand Distribution Network for Endari™ (L-glutamine oral powder) emmausmedical.com ↗
2018-07-30 Emmaus Medical, Inc. Emmaus Life Sciences Partners with DMS Pharmaceutical Group to Provide Endari™ (L-glutamine oral powder) to Military Personnel and Beneficiaries for Treatment of Sickle Cell Disease emmausmedical.com ↗
2018-07-18 Emmaus Medical, Inc. Emmaus Life Sciences Announces the New England Journal of Medicine has Published the Phase 3 Trial Results of Endari™ (L-Glutamine Oral Powder) in Sickle Cell Disease emmausmedical.com ↗
2018-07-11 Emmaus Medical, Inc. Emmaus Life Sciences Announces FDA Acceptance of IND Application for Clinical Study of L-glutamine for Treatment of Diverticulosis emmausmedical.com ↗
2018-03-12 Emmaus Medical, Inc. Emmaus Life Sciences Receives Validation From European Medicines Agency on Marketing Authorization Application for Sickle Cell Disease Treatment Xyndari (oral glutamine) emmausmedical.com ↗
2018-01-29 Emmaus Medical, Inc. Emmaus Life Sciences Announces Medicaid Coverage of Endari™ (L-glutamine oral powder) for Sickle Cell Disease in the United States emmausmedical.com ↗
2018-01-18 Emmaus Medical, Inc. Emmaus Life Sciences Announces Availability of Endari™ (L-glutamine oral powder) for Sickle Cell Disease in the United States emmausmedical.com ↗

Evidence & citations 5 cited values

Every value below carries the sentence it was read from. 18 sources stand behind the page.

FieldValueCited text
Known as L-Glutamine “This daily intervention over 3 months combines 4 g L-serine, 14 g L-glutamine, 3 g L-arginine, 2.5 g N-acetylcysteine, 5.75 g L-citrulline, 1 g vitamin C, and 5 g creatine to...” NCT06967428 ↗
15

“L-glutamine, L-arginine and calcium beta-hydroxy-beta-methylbutyrate” NCT04701463 ↗

NCT05808010 ↗

NCT01179217 ↗

NCT04634539 ↗

NCT07210450 ↗

NCT00125788 ↗

NCT04684381 ↗

NCT04019769 ↗

NCT00296621 ↗

NCT05106101 ↗

Show 5 more sources

Known as glutamine “Oral therapy with pharmaceutical-grade l-glutamine (USAN, glutamine) has been shown to increase the proportion of the reduced form of nicotinamide adenine dinucleotides in...” PMID 30021096 ↗ Jul 2018
1

“2 intervention periods: glutamine (0.5 g/kg/d) and placebo, 4 months each” PMID 19421321 ↗ May 2009

Action Restore “Glutamine supplementation can normalize this defect in mTORC1.” NCT04019769 ↗
Modality Other / unclassified “Glutamine is an amino acid.” NCT04019769 ↗
Route Oral “Approximately 0.3 g/kg total daily dose of L-glutamine will be orally administered” NCT00125788 ↗