Leucine

Overview

An essential branched-chain amino acid important for hemoglobin formation.

Indication

Indicated to assist in the prevention of the breakdown of muscle proteins that sometimes occur after trauma or severe stress.

Associated Conditions

Hypoalbuminemia

Clinical Trials

Title	Posted	Study ID	Phase	Status	Sponsor
Leucine in Midlife Depression	2024/08/30	NCT06580145	Phase 2	Recruiting	Emory University
The Effect of Carnitine Supplementation on Cardiac Function and Lipid Profile in Patients With Drug Resistant Epilepsy on Ketogenic Diet	2024/01/10	NCT06198803	Early Phase 1	Active, not recruiting	Ain Shams University
Maximal Use Study to Determine the Pharmacokinetics of L-arginine After Exaggerated Oral Use of COL101	2023/12/26	NCT06182267	Phase 1	Completed	Colgate Palmolive
Evaluation of the Impact of L- Carnitine in Intradialytic Hypotension in Pediatric Patients on Regular Hemodialysis	2023/06/15	NCT05905692	Phase 3	Active, not recruiting	Ain Shams University
High-dose L-Carnitine and Diaphragmatic Function Assessed by Ultrasonography in Patients With Respiratory Failure.	2022/04/11	NCT05322447	Phase 4	Completed	Ain Shams University
The Effect of Lidocaine Patch for Postoperative Pain	2021/02/15	NCT04754451	Phase 4	Completed	BON WOOK KOO
L Brevis for Traumatic Oral Lesions in Orthodontic Patients	2020/05/21	NCT04398511	Phase 2	Completed	Universidade de Passo Fundo
Treatment of Adults With Generalized Anxiety Disorder Using Glutamine	2020/02/18	NCT04274114	Phase 2	Terminated	Hospital Universitario Dr. Jose E. Gonzalez
Isatuximab in Combination With Chemotherapy in Pediatric Patients With Relapsed/Refractory Acute Lymphoblastic Leukemia or Acute Myeloid Leukemia	2019/03/04	NCT03860844	Phase 2	Terminated	Sanofi
The Effect Of NS-0200 and NS-0300 Versus Placebo on Weight In Obesity	2017/12/06	NCT03364335	Phase 2	Completed	NuSirt Biopharma

FDA Drug Approvals

Approved Product	Manufacturer	NDC Code	Route	Strength	Effective Date
CLINIMIX	Baxter Healthcare Corporation	0338-0184	INTRAVENOUS	584 mg in 100 mL	4/13/2021
CLINIMIX E	Baxter Healthcare Company	0338-0210	INTRAVENOUS	584 mg in 100 mL	9/21/2020
CLINIMIX E	Baxter Healthcare Corporation	0338-0210	INTRAVENOUS	584 mg in 100 mL	9/21/2020
CLINIMIX	Baxter Healthcare Corporation	0338-1089	INTRAVENOUS	311 mg in 100 mL	4/13/2021
CLINIMIX	Baxter Healthcare Corporation	0338-1099	INTRAVENOUS	365 mg in 100 mL	4/13/2021
Aminosyn II	ICU Medical Inc.	0990-7171	INTRAVENOUS	1500 mg in 100 mL	5/4/2022
CLINIMIX	Baxter Healthcare Corporation	0338-0194	INTRAVENOUS	584 mg in 100 mL	4/13/2021
CLINIMIX E	Baxter Healthcare Company	0338-1147	INTRAVENOUS	365 mg in 100 mL	9/21/2020
CLINIMIX E	Baxter Healthcare Corporation	0338-1147	INTRAVENOUS	365 mg in 100 mL	9/21/2020
CLINIMIX E	Baxter Healthcare Company	0338-1142	INTRAVENOUS	201 mg in 100 mL	9/21/2020

EMA Drug Approvals

Approved Product	Authorization Holder	Status	Issued Date
No EMA approvals found for this drug.

HSA Drug Approvals

Approved Product	Manufacturer	Approval Number	Dosage Form	Strength	Approval Date
GLAMIN SOLUTION FOR INFUSION	FRESENIUS KABI AUSTRIA GMBH	SIN09906P	INJECTION	7.9 g/1000 ml	7/27/1998
AMINOPLASMAL-15% INFUSION	B BRAUN MELSUNGEN AG	SIN08352P	INJECTION	11.4 g/l	9/14/1995
TROPHAMINE INJECTION 10%	B BRAUN MEDICAL INC	SIN07846P	INJECTION	1.4 g/100 ml	9/12/1994
SYNTHAMIN 17 WITHOUT ELECTROLYTES 10% AMINO ACID INTRAVENOUS INFUSION	BAXTER HEALTHCARE LTD	SIN09992P	INJECTION	7.30 g/l	9/15/1998
OLIMEL N7E Emulsion for Infusion	Ajinomoto Health & Nutrition North America Inc. (Intermediate), Baxter S.A	SIN16889P	EMULSION	3.07g/L	10/20/2023
AMINOPLASMAL B.BRAUN 10% E SOLUTION FOR INFUSION	B. Braun Melsungen AG	SIN15411P	INFUSION, SOLUTION	8.90g/1000ml	1/23/2018
OLIMEL N9E Emulsion for Infusion	Ajinomoto Health & Nutrition North America Inc. (Intermediate), Baxter S.A	SIN16890P	EMULSION	3.95g/L	10/20/2023
SmofKabiven Peripheral Emulsion for Infusion	Fresenius Kabi AB	SIN14287P	INJECTION, EMULSION	7.4g /1000ml	1/8/2013
AMINOVEN SOLUTION FOR INFUSION 5%	FRESENIUS KABI AUSTRIA GMBH	SIN11682P	INJECTION	3.7 g/1000 ml	9/25/2001
NUTRIFLEX® OMEGA SPECIAL EMULSION FOR INFUSION	B. Braun Melsungen AG	SIN15469P	INJECTION, EMULSION	4.384g/1000ml	4/23/2018

NMPA Drug Approvals

Approved Product	Company	Approval Number	Drug Type	Dosage Form	Approval Date
No NMPA approvals found for this drug.

PPB Drug Approvals

Approved Product	Registration No.	Company	Licence No.	Strength	Registration Date
LA-FLAMING INJ.	N/A	FALKAN MEDICAL LIMITED	N/A	N/A	1/28/2010
VAMINOLACT I.V. SOLUTION	N/A	FRESENIUS KABI HONG KONG LIMITED	N/A	N/A	10/14/1992
OLIMEL N9E EMULSION FOR INFUSION	N/A	Baxter Healthcare Ltd	N/A	N/A	10/24/2013
NUTRIFLEX OMEGA SPECIAL EMULSION FOR INFUSION	N/A	B BRAUN MEDICAL SA	N/A	N/A	1/11/2012
SMOFKABIVEN EMULSION FOR INFUSION	N/A	FRESENIUS KABI HONG KONG LIMITED	N/A	N/A	5/26/2011
PAN-AMIN G INJ	N/A	LUEN CHEONG HONG	N/A	N/A	5/17/1979
NUTRIFLEX OMEGA PLUS EMULSION FOR INFUSION	N/A	B BRAUN MEDICAL SA	N/A	N/A	1/11/2012
PAN-AMIN G SOLUTION FOR INFUSION 500ML	N/A	otsuka pharmaceutical (h.k.) limited	N/A	N/A	4/5/2012
AMINOGEN-S SOLUTION FOR INFUSION	N/A	wings pharmaceutical ltd	N/A	N/A	8/15/2013
LIVACT GRANULES	N/A	EISAI (HONG KONG) COMPANY LIMITED	N/A	N/A	6/6/2014

TGA Drug Approvals

Approved Product	ARTG ID	Sponsor	Registration Type	Status	Registration Date
SYNTHAMIN 17 Amino acid 10% with Electrolytes and Glucose 25% 1000mL injection AHB6350	19609	Baxter Healthcare Pty Ltd	Medicine	A	9/30/1991
AMINOVEN amino acid 10% solution for infusion 500 mL bottle	117659	Fresenius Kabi Australia Pty Ltd	Medicine	A	10/22/2007
SMOFKABIVEN amino acids 5.1% / lipids 3.8% / glucose 12.7% / electrolytes 0.7% emulsion for intravenous infusion bag 1970 mL	180546	Fresenius Kabi Australia Pty Ltd	Medicine	A	1/9/2012
OLICLINOMEL N4-550 E 1000 mL IV emulsion for infusion with electrolytes bag	136599	Baxter Healthcare Pty Ltd	Medicine	A	9/4/2007
OLICLINOMEL N4-550 E 2500 mL IV emulsion for infusion with electrolytes bag	141396	Baxter Healthcare Pty Ltd	Medicine	A	9/4/2007
OLIMEL N5-860E Emulsion for intravenous infusion	197417	Baxter Healthcare Pty Ltd	Medicine	A	8/9/2013
Top Life Cellenova	330661	Homart Pharmaceuticals Pty Ltd	Medicine	A	3/3/2020
Olimel N12-640 emulsion for intravenous infusion bag.	303755	Baxter Healthcare Pty Ltd	Medicine	A	7/1/2019
ABC Boost NMN III	371487	Australia Biotechnology Group Pty Ltd	Medicine	A	7/22/2021
MUSASHI SLEEP RECOVERY	308710	Vitaco Health Australia Pty Ltd	Medicine	A	8/28/2018

Health Canada Drug Approvals

Approved Product	Company	DIN	Dosage Form	Strength	Market Date
4.25% TRAVASOL AMINO ACID INJECTION WITH ELECTROLYTES IN 10% DEXTROSE	baxter corporation clintec nutrition division	N/A	Solution - Intravenous	310 MG / 100 ML	12/31/1996
4.25% TRAVASOL AMINO ACID INJECTION WITHOUT ELECTRLYTES IN 10% DEXTROSE	baxter corporation clintec nutrition division	N/A	Solution - Intravenous	310 MG / 100 ML	12/31/1996
2.75%TRAVASOL AMINO ACID INJ.W.ELEC.W.5%DEX.	clintec nutrition company	02143240	Liquid - Intravenous	201 MG / 100 ML	12/31/1996
4.25%TRAVASOL AMINO ACID INJ.W.ELECW.5%DEX.	clintec nutrition company	02143224	Liquid - Intravenous	310 MG / 100 ML	12/31/1996
5% TRAVASOL AMINO ACID INJECTION WITHOUT ELECTROLYTES IN 25% DEXTROSE	baxter corporation clintec nutrition division	02142244	Solution - Intravenous	365 MG / 100 ML	12/31/1996
5% TRAVASOL AMINO ACID INJECTION WITHOUT ELECTROLYTES IN 20% DEXTROSE	baxter corporation clintec nutrition division	02142252	Solution - Intravenous	365 MG / 100 ML	12/31/1996
5% TRAVASOL AMINO ACID INJECTION WITH ELECTROLYTES IN 20% DEXTROSE	baxter corporation clintec nutrition division	02142368	Solution - Intravenous	365 MG / 100 ML	12/31/1996
4.25% TRAVASOL AMINO ACID INJECTION WITHOUT ELECTROLYTES IN 25% DEXTROSE	baxter corporation clintec nutrition division	02142295	Solution - Intravenous	310 MG / 100 ML	12/31/1996
OLIMEL 5.7% E	baxter corporation	02352532	Emulsion - Intravenous	3.95 G / L	1/19/2011
AMINOSYN 8.5%	hospira healthcare ulc	00613320	Solution - Intravenous	810 MG / 100 ML	12/31/1984

CIMA AEMPS Drug Approvals

Approved Product	Company	Registration Number	Pharmaceutical Form	Prescription Type	Status
No CIMA AEMPS (Spain) approvals found for this drug.

Philippines FDA Drug Approvals

Approved Product	Company	License Number	Dosage Form	Strength	Approval Date
No Philippines FDA approvals found for this drug.

Saudi SFDA Drug Approvals

Approved Product	Company	License Number	Dosage Form	Strength	Approval Date
No Saudi SFDA approvals found for this drug.

Malaysia NPRA Drug Approvals

Approved Product	Company	Registration Number	Dosage Form	Strength	Approval Date
No Malaysia NPRA approvals found for this drug.

UK EMC Drug Information

Medicine Name	MA Holder	MA Number	Pharmaceutical Form	Active Ingredient	Authorization Date
No UK EMC drug information found for this drug.

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