Histidine

Overview

An essential amino acid that is required for the production of histamine.

Indication

The actions of supplemental L-histidine are entirely unclear. It may have some immunomodulatory as well as antioxidant activity. L-histidine may be indicated for use in some with rheumatoid arthritis. It is not indicated for treatment of anemia or uremia or for lowering serum cholesterol.

Associated Conditions

No associated conditions information available.

Clinical Trials

Title	Posted	Study ID	Phase	Status	Sponsor
CAbotégravir LENacapavir DUal Long Acting	2024/10/26	NCT06657885	Phase 2	Not yet recruiting	Institut de Médecine et d'Epidémiologie Appliquée - Fondation Internationale Léon M'Ba
Histidine Oral Supplementation as a Therapeutic Modality for Alzheimer's Disease	2023/12/14	NCT06169826	Phase 4	Withdrawn	Wake Forest University Health Sciences
Histaminergic Basis of Fatigue in Multiple Sclerosis	2021/02/21	NCT04764383	Phase 2	Withdrawn	University of Miami
Role of Terminal Warm Blood Cardioplegia as Myocardial Protection in the Use of Histidine-Tryptophan-Ketoglutarate Cardioplegia in Complex Congenital Heart Surgery	2015/12/01	NCT02618824	Phase 2	UNKNOWN	National Cardiovascular Center Harapan Kita Hospital Indonesia

FDA Drug Approvals

Approved Product	Manufacturer	NDC Code	Route	Strength	Effective Date
CLINIMIX	Baxter Healthcare Corporation	0338-0184	INTRAVENOUS	384 mg in 100 mL	4/13/2021
CLINIMIX E	Baxter Healthcare Company	0338-0210	INTRAVENOUS	384 mg in 100 mL	9/21/2020
CLINIMIX E	Baxter Healthcare Corporation	0338-0210	INTRAVENOUS	384 mg in 100 mL	9/21/2020
CLINIMIX	Baxter Healthcare Corporation	0338-1089	INTRAVENOUS	204 mg in 100 mL	4/13/2021
CLINIMIX	Baxter Healthcare Corporation	0338-1099	INTRAVENOUS	240 mg in 100 mL	4/13/2021
Aminosyn II	ICU Medical Inc.	0990-7171	INTRAVENOUS	450 mg in 100 mL	5/4/2022
CLINIMIX	Baxter Healthcare Corporation	0338-0194	INTRAVENOUS	384 mg in 100 mL	4/13/2021
CLINIMIX E	Baxter Healthcare Company	0338-1147	INTRAVENOUS	240 mg in 100 mL	9/21/2020
CLINIMIX E	Baxter Healthcare Corporation	0338-1147	INTRAVENOUS	240 mg in 100 mL	9/21/2020
CLINIMIX E	Baxter Healthcare Company	0338-1142	INTRAVENOUS	132 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
TROPHAMINE INJECTION 10%	B BRAUN MEDICAL INC	SIN07846P	INJECTION	0.48 g/100 ml	9/12/1994
SYNTHAMIN 17 WITHOUT ELECTROLYTES 10% AMINO ACID INTRAVENOUS INFUSION	BAXTER HEALTHCARE LTD	SIN09992P	INJECTION	4.80 g/l	9/15/1998
AMINOPLASMAL-15% INFUSION	B BRAUN MELSUNGEN AG	SIN08352P	INJECTION	5.25 g/l	9/14/1995
AMINOPLASMAL B.BRAUN 10% E SOLUTION FOR INFUSION	B. Braun Melsungen AG	SIN15411P	INFUSION, SOLUTION	3.00g/1000ml	1/23/2018
AMINOVEN SOLUTION FOR INFUSION 15%	Fresenius Kabi Austria GmbH (Graz)	SIN16337P	INFUSION, SOLUTION	7.3g/L	9/30/2021
KABIVEN EMULSION FOR INFUSION	FRESENIUS KABI AB, FRESENIUS KABI AUSTRIA GMBH	SIN11657P	INJECTION	2 g/1000 ml	9/4/2001
SmofKabiven Peripheral Emulsion for Infusion	Fresenius Kabi AB	SIN14287P	INJECTION, EMULSION	3.0g /1000ml	1/8/2013
PRIMENE 10% AMINO ACID INTRAVENOUS INFUSION	BIEFFE MEDITAL S.P.A.	SIN10252P	INJECTION	3.8 g/l	9/23/1998
AMINOVEN SOLUTION FOR INFUSION 5%	FRESENIUS KABI AUSTRIA GMBH	SIN11682P	INJECTION	1.500g/1000 ml	9/25/2001
NUTRIFLEX® OMEGA SPECIAL EMULSION FOR INFUSION	B. Braun Melsungen AG	SIN15469P	INJECTION, EMULSION	2.368g/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
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
SMOFKABIVEN EMULSION FOR INFUSION	N/A	FRESENIUS KABI HONG KONG LIMITED	N/A	N/A	5/26/2011
PAN-AMIN G SOLUTION FOR INFUSION 500ML	N/A	otsuka pharmaceutical (h.k.) limited	N/A	N/A	4/5/2012
PAN-AMIN G INJ	N/A	LUEN CHEONG HONG	N/A	N/A	5/17/1979
NUTRINEAL PD4 SOLUTION	N/A	Vantive Healthcare Limited	N/A	N/A	9/9/1999
NUTRINEAL PD-4 W/1.1% AA PERITONEAL DIAL SOLN	N/A	Vantive Healthcare Limited	N/A	N/A	12/31/2003
LA-FLAMING INJ.	N/A	FALKAN MEDICAL LIMITED	N/A	N/A	1/28/2010
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
NOVOSEVEN RT eptacog alfa (activated) (bhk) 8mg powder for injection vial with pre-filled diluent syringe	206197	Novo Nordisk Pharmaceuticals Pty Ltd	Medicine	A	5/1/2013
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
Ketuzz	380972	TTB International Pty Ltd	Medicine	A	12/16/2021

Health Canada Drug Approvals

Approved Product	Company	DIN	Dosage Form	Strength	Market Date
4.25% TRAVASOL AMINO ACID INJECTION WITHOUT ELECTRLYTES IN 10% DEXTROSE	baxter corporation clintec nutrition division	N/A	Solution - Intravenous	204 MG / 100 ML	12/31/1996
4.25% TRAVASOL AMINO ACID INJECTION WITH ELECTROLYTES IN 10% DEXTROSE	baxter corporation clintec nutrition division	N/A	Solution - Intravenous	204 MG / 100 ML	12/31/1996
2.75%TRAVASOL AMINO ACID INJ.W.ELEC.W.5%DEX.	clintec nutrition company	02143240	Liquid - Intravenous	132 MG / 100 ML	12/31/1996
4.25%TRAVASOL AMINO ACID INJ.W.ELECW.5%DEX.	clintec nutrition company	02143224	Liquid - Intravenous	204 MG / 100 ML	12/31/1996
5% TRAVASOL AMINO ACID INJECTION WITHOUT ELECTROLYTES IN 25% DEXTROSE	baxter corporation clintec nutrition division	02142244	Solution - Intravenous	240 MG / 100 ML	12/31/1996
2.5% TRAVASOL AMINO ACID INJECTION WITH ELECTROLYTES IN 10% DEXTROSE CLINIMIX	baxter corporation clintec nutrition division	02013975	Solution - Intravenous	110 MG / 100 ML	12/31/1993
CLINIMIX E	baxter corporation	02013967	Solution - Intravenous	220 MG / 100 ML	12/31/1993
5% TRAVASOL AMINO ACID INJECTION WITHOUT ELECTROLYTES IN 20% DEXTROSE	baxter corporation clintec nutrition division	02142252	Solution - Intravenous	240 MG / 100 ML	12/31/1996
5% TRAVASOL AMINO ACID INJECTION WITH ELECTROLYTES IN 20% DEXTROSE	baxter corporation clintec nutrition division	02142368	Solution - Intravenous	240 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	204 MG / 100 ML	12/31/1996

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
CELSIOR SOLUCION PARA LA CONSERVACION DE ORGANOS	Institut Georges Lopez	73767	SOLUCIÓN PARA CONSERVACIÓN DE ÓRGANOS	Uso Hospitalario	Commercialized
CORHUM SOLUCIÓN PARA CARDIOPLEJIA	S.A.L.F. S.P.A. Laboratorio Farmacologico	89242	SOLUCION PARA CARDIOPLEJIA	Uso Hospitalario	Not Commercialized
AMINOVEN INFANT 10% SOLUCION PARA PERFUSION	Fresenius Kabi España, S.A.U.	59628	SOLUCIÓN PARA PERFUSIÓN	Uso Hospitalario	Commercialized
CUSTODIOL SOLUCION PARA CARDIOPLEJIA Y PARA CONSERVACION DE ORGANOS	Dr. Franz Koehler Chemie Gmbh	84838	SOLUCION PARA CARDIOPLEJIA/CONSERVACION DE ORGANOS	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
LIPOFLEX SPECIAL SIN ELECTROLITOS EMULSION PARA PERFUSION EFG	B. Braun Melsungen Ag	82266	EMULSIÓN 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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