Arginine

Generic Name: Arginine

Brand Names: Aminosyn II 7 %, Sulfite-free, Aminosyn-PF 7%, Clinimix 2.75/5, Clinimix E 2.75/5, Clinisol 15, Freamine 6.9, Freamine III 10, Hepatamine 8, Olimel, Periolimel, Plenamine, Premasol, Primene, Procalamine 3, Prosol, R-gene, Travasol 10, Trophamine 10 %

Drug Type: Small Molecule

Chemical Formula: C_₆H_₁₄N_₄O_₂

CAS Number: 74-79-3

Unique Ingredient Identifier: 94ZLA3W45F

Overview

An essential amino acid that is physiologically active in the L-form.

Indication

Used for nutritional supplementation, also for treating dietary shortage or imbalance.

Associated Conditions

Acromegaly
Craniopharyngioma
Disorders of urea cycle metabolism
Gigantism
Hyperammonaemia
Hypophysectomy
Kidney Damage
Panhypopituitarism
Pituitary Dwarfism
Pituitary Neoplasms
Pituitary trauma
Problems of growth and stature

Clinical Trials

Title	Posted	Study ID	Phase	Status	Sponsor
Human Albumin Infusion in Liver Cirrhosis and Overt Hepatic Encephalopathy (HACHE)	2024/07/03	NCT06483737	Not Applicable	Recruiting	General Hospital of Shenyang Military Region
Low-dose Arginine-vasopressin Supplementation on Post-transplant Acute Kidney Injury After Liver Transplantation (AVENIR Trial)	2024/04/03	NCT06344442	Phase 3	Not yet recruiting	Assistance Publique - Hôpitaux de Paris
Study of Felzartamab in Healthy Adult Subjects	2024/02/29	NCT06285201	Phase 1	Completed	TJ Biopharma Co., Ltd.
Reduction of Dentine Hypersensitivity After Use of Different Dentifrices	2024/02/23	NCT06273930	Phase 1	Recruiting	Armed Forces Institute of Dentistry, Pakistan
Triamcinolone Acetonide as an Adjuvant to Pre-emptive Scalp Infiltration for Relief of Post-craniotomy Pain in Adults	2023/10/06	NCT06069804	Phase 4	Completed	Beijing Tiantan Hospital
Comparative Study of Rinsulin R (GEROPHARM) and Humulin Regular (Eli Lilly) Euglycemic Hyperinsulinemic Clamp Method	2023/09/22	NCT06050343	Not Applicable	Completed	Geropharm
Common and Differentiated Representations Between Social Exclusion and Social Separation	2023/06/27	NCT05920707	Not Applicable	Recruiting	University of Electronic Science and Technology of China
Arginine Replacement Therapy in COVID-19	2023/05/11	NCT05855330	Phase 2	Recruiting	Emory University
2-year Caries Clinical Study: Arginine Fluoride-Free Toothpastes vs. NaF Toothpaste	2022/09/30	NCT05560945	Phase 3	Completed	Colgate Palmolive
Management of Acute Pulmonary Hypertensive Crisis in Children With Known Pulmonary Arterial Hypertension	2022/06/30	NCT05439460	Phase 4	Completed	Stanford University

FDA Drug Approvals

Approved Product	Manufacturer	NDC Code	Route	Strength	Effective Date
CLINIMIX	Baxter Healthcare Corporation	0338-0184	INTRAVENOUS	920 mg in 100 mL	4/13/2021
CLINIMIX E	Baxter Healthcare Company	0338-0210	INTRAVENOUS	920 mg in 100 mL	9/21/2020
CLINIMIX E	Baxter Healthcare Corporation	0338-0210	INTRAVENOUS	920 mg in 100 mL	9/21/2020
CLINIMIX	Baxter Healthcare Corporation	0338-1089	INTRAVENOUS	489 mg in 100 mL	4/13/2021
CLINIMIX	Baxter Healthcare Corporation	0338-1099	INTRAVENOUS	575 mg in 100 mL	4/13/2021
Aminosyn II	ICU Medical Inc.	0990-7171	INTRAVENOUS	1527 mg in 100 mL	5/4/2022
CLINIMIX	Baxter Healthcare Corporation	0338-0194	INTRAVENOUS	920 mg in 100 mL	4/13/2021
CLINIMIX E	Baxter Healthcare Company	0338-1147	INTRAVENOUS	575 mg in 100 mL	9/21/2020
CLINIMIX E	Baxter Healthcare Corporation	0338-1147	INTRAVENOUS	575 mg in 100 mL	9/21/2020
CLINIMIX E	Baxter Healthcare Company	0338-1142	INTRAVENOUS	316 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
SmofKabiven Emulsion for Infusion	Fresenius Kabi AB, Fresenius Kabi Austria GmbH	SIN14286P	INJECTION, EMULSION	12.0g /1000ml	1/8/2013
SmofKabiven Electrolyte Free Emulsion for Infusion	Fresenius Kabi AB, Fresenius Kabi Austria GmbH	SIN14292P	INJECTION, EMULSION	12.0g /1000ml	1/16/2013
NUTRIFLEX® OMEGA PLUS EMULSION FOR INFUSION	B. Braun Melsungen AG	SIN15468P	INJECTION, EMULSION	2.592g/1000ml	4/23/2018
PERIOLIMEL N4E Emulsion for Infusion	Ajinomoto Health & Nutrition North America Inc. (Intermediate), Baxter S.A	SIN16888P	EMULSION	2.48g/L	10/20/2023
TROPHAMINE INJECTION 10%	B BRAUN MEDICAL INC	SIN07846P	INJECTION	1.2 g/100 ml	9/12/1994
AMINOPLASMAL B.BRAUN 10% E SOLUTION FOR INFUSION	B. Braun Melsungen AG	SIN15411P	INFUSION, SOLUTION	11.50g/1000ml	1/23/2018
SmofKabiven Peripheral Emulsion for Infusion	Fresenius Kabi AB	SIN14287P	INJECTION, EMULSION	12.0g /1000ml	1/8/2013
NUTRIFLEX® OMEGA SPECIAL B. BRAUN EMULSION FOR INFUSION	B. Braun Melsungen AG	SIN16734P	INJECTION, EMULSION	3.780g/1000ml	3/7/2023
VAMINOLACT INTRAVENOUS SOLUTION	FRESENIUS KABI AUSTRIA GMBH	SIN07428P	INJECTION	4.1 g/1000 ml	5/12/1993
AMINOSTERIL N-HEPA FOR INTRAVENOUS INFUSION 8%	FRESENIUS KABI AUSTRIA GMBH	SIN10000P	INJECTION	10.72 g/l	9/15/1998

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
PERIOLIMEL N4E EMULSION FOR INFUSION	N/A	Baxter Healthcare Ltd	N/A	N/A	10/24/2013
PAN-AMIN G INJ	N/A	LUEN CHEONG HONG	N/A	N/A	5/17/1979
PAN-AMIN G SOLUTION FOR INFUSION 500ML	N/A	otsuka pharmaceutical (h.k.) limited	N/A	N/A	4/5/2012
NUTRIFLEX OMEGA PLUS EMULSION FOR INFUSION	N/A	B BRAUN MEDICAL SA	N/A	N/A	1/11/2012
AMINOGEN-S SOLUTION FOR INFUSION	N/A	wings pharmaceutical ltd	N/A	N/A	8/15/2013

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
Olimel N12-640 emulsion for intravenous infusion bag.	303755	Baxter Healthcare Pty Ltd	Medicine	A	7/1/2019
SMOFKABIVEN LOW OSMO amino acids 2.5%, electrolytes 0.4%, lipids 3.5% & glucose 6.8% emulsion for intravenous infusion 2500 mL biofine bag	329619	Fresenius Kabi Australia Pty Ltd	Medicine	A	8/27/2020
SMOFKABIVEN ELECTROLYTE FREE amino acids 5.1% / lipids 3.8% / glucose 12.7% emulsion for intravenous infusion bag 2463 mL	180550	Fresenius Kabi Australia Pty Ltd	Medicine	A	1/9/2012
GLAMIN amino acids/dipeptides 250mL intravenous infusion injection bottle	77749	Fresenius Kabi Australia Pty Ltd	Medicine	A	5/29/2002

Health Canada Drug Approvals

Approved Product	Company	DIN	Dosage Form	Strength	Market Date
TRAVASOL INJ WITHOUT ELECTROLYTES 5.5%	baxter corporation	00388742	Solution - Intravenous	570 MG / 100 ML	12/31/1978
ESSEPNA	fresenius kabi canada ltd	02510324	Solution - Intravenous	1.2 G / 100 ML	1/25/2023
AMINOSYN RF INJECTION	hospira healthcare ulc	00640131	Solution - Intravenous	600 MG / 100 ML	12/31/1986
20% PROSOL	baxter corporation	02141450	Liquid - Intravenous	1.96 G / 100 ML	10/9/1996
TRAVASOL	baxter corporation	00872296	Solution - Intravenous	1.15 G / 100 ML	12/31/1991
TRAVASOL	baxter corporation	00388769	Solution - Intravenous	1.04 G / 100 ML	12/31/1980
TRAVASOL E	baxter corporation	00285528	Solution - Intravenous	1.04 G / 100 ML	12/31/1974
TRAVASOL AMINO ACID INJ 5.5%	baxter corporation	00306444	Solution - Intravenous	570 MG / 100 ML	12/31/1981
AMINOSYN II 5% INJ	ABBOTT LABORATORIES, LIMITED	00742643	Liquid - Intravenous	509 MG / 100 ML	12/31/1988
AMINOSYN 10% W ELECTROLYTES	ABBOTT LABORATORIES, LIMITED	00558966	Liquid - Intravenous	980 MG / 100 ML	12/31/1984

CIMA AEMPS Drug Approvals

Approved Product	Company	Registration Number	Pharmaceutical Form	Prescription Type	Status
NEPHROTECT SOLUCION PARA PERFUSION	Fresenius Kabi Deutschland Gmbh	67038	SOLUCIÓN PARA PERFUSIÓN	Uso Hospitalario	Commercialized
SMOFKABIVEN PERIFERICO EMULSION PARA PERFUSION	Fresenius Kabi España, S.A.U.	70513	EMULSIÓN PARA PERFUSIÓN	Uso Hospitalario	Commercialized
PEDIAVEN G20 SOLUCION PARA PERFUSION	Fresenius Kabi España, S.A.U.	78951	SOLUCIÓN PARA PERFUSIÓN	Uso Hospitalario	Not Commercialized
AMINOVEN INFANT 10% SOLUCION PARA PERFUSION	Fresenius Kabi España, S.A.U.	59628	SOLUCIÓN PARA PERFUSIÓN	Uso Hospitalario	Commercialized
SMOFKABIVEN EXTRA NITROGEN EMULSION PARA PERFUSION	Fresenius Kabi España, S.A.U.	82509	EMULSIÓN PARA PERFUSIÓN	Uso Hospitalario	Commercialized
SMOFKABIVEN SIN ELECTROLITOS CENTRAL EMULSION PARA PERFUSION	Fresenius Kabi España, S.A.U.	70892	EMULSIÓN PARA PERFUSIÓN	Uso Hospitalario	Commercialized
OMEGAFLEX ESPECIAL EMULSION PARA PERFUSION	B. Braun Melsungen Ag	82104	EMULSIÓN PARA PERFUSIÓN	Uso Hospitalario	Commercialized
LIPOFLEX SPECIAL SIN ELECTROLITOS EMULSION PARA PERFUSION EFG	B. Braun Melsungen Ag	82266	EMULSIÓN PARA PERFUSIÓN	Uso Hospitalario	Commercialized
SYNTHAMIN 17 REFORMULADO SOLUCION PARA PERFUSION	Baxter S.L.	58196	SOLUCIÓN PARA PERFUSIÓN	Uso Hospitalario	Commercialized
AMINOPLASMAL PAED 10% SOLUCION PARA PERFUSION	B. Braun Melsungen Ag	78871	SOLUCIÓN PARA PERFUSIÓN	Uso Hospitalario	Commercialized

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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