L-Glutamine

Sold as Nutrestore, Endari. Every FDA application for this active ingredient: 2 branded and 3 generic.

As of Nov 14, 2026, FDA lists 5 applications for L-Glutamine (sold as Nutrestore, Endari), first approved Jun 10, 2004, with 0 new uses approved and 0 published complete response letters.

First approved: Jun 10, 2004
Applications: 5
New uses approved: 0
Complete response letters: 0

Orphan Designations (FDA)

One designation, 1 approved for the designated use; see all orphan designations

Treatment of sickle cell diseaseEmmaus Medical, Inc. · designated Aug 1, 2001 · approved Jul 7, 2017

Clinical Trials

41 open or ongoing studies name this ingredient as an intervention, including as a comparator; newest first. See all


Effectiveness and Safety of Cellbooster Hair in Healthy SubjectsHair and Scalp Health · Suisselle	Not applicable	Not yet recruiting	Nov 10, 2026
Targeted Nutritional Intervention (HMB, Arginine, Glutamine) in Patients With Pancreatic CancerPDAC, Pancreas Adenocarcinoma (MSI-H) · Fondazione Policlinico Universitario Agostino Gemelli IRCCS	Not applicable	Not yet recruiting	Oct 20, 2026
Trial of First-line Gemcitabine and Nab-paclitaxel With or Without L-glutamine in Advanced Pancreatic CancerPancreatic Cancer · Jun Gong, MD	Phase 2	Not yet recruiting	Oct 8, 2026
Investigating Near-Threshold Perception During Ultrasonic Deep Brain StimulationConsciousness, Level Altered · University of Michigan	Not applicable	Not yet recruiting	Sep 25, 2026
Phase 1/2 Study of KRRO-121 in Healthy Volunteers and Patients With UCDUrea Cycle Disorders, Inborn, Urea Cycle Disorders · Korro Bio, Inc.	Phase 1 / Phase 2	Recruiting	Aug 19, 2026
EAT-ING: Enhancing Anticancer Treatment Safety Via Immunomodulatory Nutritional Support in Advanced Gastrointestinal CancersGastrointestinal Cancer · IRCCS San Raffaele	Not applicable	Not yet recruiting	May 15, 2026
A DNAJB1-PRKACA Fusion Kinase Peptide Vaccine Combined With Glutamine Antagonist DRP-104, Nivolumab, and Ipilimumab in Patients With Advanced Stage Fibrolamellar Carcinoma (FLC)Liver Cancer (Fibrolamellar Hepatocellular Cancer (FLC)) · Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins	Phase 1	Recruiting	Feb 24, 2026
GynMDD Add-On to Supportive Psychotherapy in Mild to Moderate DepressionDepression, Depression Disorder · Fondation FondaMental	Not applicable	Recruiting	Feb 18, 2026

Applications

NDAs, BLAs and generic ANDAs for this ingredient, oldest first; each opens its full history


Jun 10, 2004	NutrestoreNDA 21667 · New molecular entity	Emmaus Medcl	3	Discontinued
Jul 7, 2017	EndariNDA 208587 · New formulation or manufacturer	Emmaus Medcl	4	Marketed
Jul 8, 2024	L-GlutamineANDA 215647	Novitium Pharma	1	Marketed
May 14, 2026	L-GlutamineANDA 219750	Pharmobedient	0	Marketed
May 26, 2026	L-GlutamineANDA 219722	Annora Pharma	0	Marketed

Applications, approvals and products come from FDA's Drugs@FDA data files, refreshed weekly, grouped by active ingredient as FDA spells it. Complete response letters are FDA's published letters. Medicare spending is CMS's Part D and Part B dashboard, matched to this ingredient by generic name; shortages are FDA's shortage list, matched by application number; clinical trials are ClinicalTrials.gov studies naming the ingredient as an intervention, refreshed daily; safety programs are FDA's REMS list, matched by application number or, for shared programs, by ingredient. Drugs@FDA