Alanine

Overview

Alanine is a non-essential amino acid that occurs in high levels in its free state in plasma. It is produced from pyruvate by transamination. It is involved in sugar and acid metabolism, increases immunity, and provides energy for muscle tissue, brain, and the central nervous system.

Indication

Used for protein synthesis.

Associated Conditions

No associated conditions information available.

Clinical Trials

Title	Posted	Study ID	Phase	Status	Sponsor
The Separate and Combined Glucagonotropic Effects of Glucose-dependent Insulinotropic Polypeptide and Alanine in Subjects With and Without Type 1 Diabetes	2025/03/18	NCT06881472	Not Applicable	ENROLLING_BY_INVITATION	Asger Lund, MD
The Glucagonotropic Effects of Glucose-dependent Insulinotropic Polypeptide and Alanine in Healthy Individuals	2024/05/17	NCT06419686	Phase 1	Recruiting	University Hospital, Gentofte, Copenhagen
Effects of Alanine in Patients With Nonalcoholic Steatohepatitis	2008/01/07	NCT00586885	Not Applicable	Completed	Keith D Lindor, M.D.
Gluconeogenesis in Very Low Birth Weight Infants Who Are Receiving Nutrition By Intravenous Infusion	2000/06/05	NCT00005889	Not Applicable	UNKNOWN	National Center for Research Resources (NCRR)

FDA Drug Approvals

Approved Product	Manufacturer	NDC Code	Route	Strength	Effective Date
CLINIMIX	Baxter Healthcare Corporation	0338-0184	INTRAVENOUS	1656 mg in 100 mL	4/13/2021
CLINIMIX E	Baxter Healthcare Company	0338-0210	INTRAVENOUS	1656 mg in 100 mL	9/21/2020
CLINIMIX E	Baxter Healthcare Corporation	0338-0210	INTRAVENOUS	1656 mg in 100 mL	9/21/2020
CLINIMIX	Baxter Healthcare Corporation	0338-1089	INTRAVENOUS	880 mg in 100 mL	4/13/2021
CLINIMIX	Baxter Healthcare Corporation	0338-1099	INTRAVENOUS	1035 mg in 100 mL	4/13/2021
Aminosyn II	ICU Medical Inc.	0990-7171	INTRAVENOUS	1490 mg in 100 mL	5/4/2022
CLINIMIX	Baxter Healthcare Corporation	0338-0194	INTRAVENOUS	1656 mg in 100 mL	4/13/2021
CLINIMIX E	Baxter Healthcare Company	0338-1147	INTRAVENOUS	1035 mg in 100 mL	9/21/2020
CLINIMIX E	Baxter Healthcare Corporation	0338-1147	INTRAVENOUS	1035 mg in 100 mL	9/21/2020
CLINIMIX E	Baxter Healthcare Company	0338-1142	INTRAVENOUS	570 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	0.54 g/100 ml	9/12/1994
AMINOPLASMAL-15% INFUSION	B BRAUN MELSUNGEN AG	SIN08352P	INJECTION	22.35 g/l	9/14/1995
AMINOPLASMAL B.BRAUN 10% E SOLUTION FOR INFUSION	B. Braun Melsungen AG	SIN15411P	INFUSION, SOLUTION	10.50g/1000ml	1/23/2018
KABIVEN EMULSION FOR INFUSION	FRESENIUS KABI AB, FRESENIUS KABI AUSTRIA GMBH	SIN11657P	INJECTION	4.7 g/1000 ml	9/4/2001
SmofKabiven Peripheral Emulsion for Infusion	Fresenius Kabi AB	SIN14287P	INJECTION, EMULSION	14.0g/1000ml	1/8/2013
PRIMENE 10% AMINO ACID INTRAVENOUS INFUSION	BIEFFE MEDITAL S.P.A.	SIN10252P	INJECTION	8 g/l	9/23/1998
AMINOVEN SOLUTION FOR INFUSION 15%	Fresenius Kabi Austria GmbH (Graz)	SIN16337P	INFUSION, SOLUTION	25g/L	9/30/2021
AMINOVEN SOLUTION FOR INFUSION 5%	FRESENIUS KABI AUSTRIA GMBH	SIN11682P	INJECTION	7.000 g/1000 ml	9/25/2001
NUTRIFLEX® OMEGA SPECIAL EMULSION FOR INFUSION	B. Braun Melsungen AG	SIN15469P	INJECTION, EMULSION	6.792g/1000ml	4/23/2018
SMOFKABIVEN EXTRA NITROGEN ELECTROLYTE-FREE EMULSION FOR INFUSION	Fresenius Kabi AB, Site Uppsala	SIN16136P	INJECTION, EMULSION	9.2g/1000ml	3/24/2021

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
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
NUTRIFLEX OMEGA PLUS EMULSION FOR INFUSION	N/A	B BRAUN MEDICAL SA	N/A	N/A	1/11/2012
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

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
Dr. Nature Hangover Relief Before Meal	418109	Health Sharing Group Pty Ltd	Medicine	A	8/14/2023
ElementAll Diet	447331	Factors Group Australia Pty Ltd	Medicine	A	5/1/2024

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	880 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	880 MG / 100 ML	12/31/1996
2.75%TRAVASOL AMINO ACID INJ.W.ELEC.W.5%DEX.	clintec nutrition company	02143240	Liquid - Intravenous	570 MG / 100 ML	12/31/1996
4.25%TRAVASOL AMINO ACID INJ.W.ELECW.5%DEX.	clintec nutrition company	02143224	Liquid - Intravenous	880 MG / 100 ML	12/31/1996
5% TRAVASOL AMINO ACID INJECTION WITHOUT ELECTROLYTES IN 25% DEXTROSE	baxter corporation clintec nutrition division	02142244	Solution - Intravenous	1.04 G / 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	520 MG / 100 ML	12/31/1993
CLINIMIX E	baxter corporation	02013967	Solution - Intravenous	1.04 G / 100 ML	12/31/1993
5% TRAVASOL AMINO ACID INJECTION WITHOUT ELECTROLYTES IN 20% DEXTROSE	baxter corporation clintec nutrition division	02142252	Solution - Intravenous	1.04 G / 100 ML	12/31/1996
5% TRAVASOL AMINO ACID INJECTION WITH ELECTROLYTES IN 20% DEXTROSE	baxter corporation clintec nutrition division	02142368	Solution - Intravenous	1.04 G / 100 ML	12/31/1996
4.25% TRAVASOL AMINO ACID INJECTION WITHOUT ELECTROLYTES IN 25% DEXTROSE	baxter corporation clintec nutrition division	02142295	Solution - Intravenous	880 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
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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