Methionine

Generic Name: Methionine

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, Nephramine, Olimel, Periolimel, Plenamine, Premasol, Primene, Procalamine 3, Prosol, Travasol 10, Trophamine 10 %

Drug Type: Small Molecule

Chemical Formula: C_₅H_₁₁NO_₂S

CAS Number: 63-68-3

Unique Ingredient Identifier: AE28F7PNPL

Overview

A sulfur containing essential amino acid that is important in many body functions. It is a chelating agent for heavy metals.

Indication

Used for protein synthesis including the formation of SAMe, L-homocysteine, L-cysteine, taurine, and sulfate.

Associated Conditions

Hepatic Encephalopathy (HE)

Clinical Trials

Title	Posted	Study ID	Phase	Status	Sponsor
A Study of GH21 Combined With Previous Target Therapy or Immunotherapy in Patients With Advanced Solid Tumors	2024/03/20	NCT06322095	Phase 2	Recruiting	Suzhou Genhouse Bio Co., Ltd.
Expanded Access [11C] Methionine PET Imaging	2022/08/23	NCT05511714	N/A	AVAILABLE	St. Jude Children's Research Hospital
GnRHa + Letrozole in Non-obese Progestin-insensitive Endometrial Cancer and Atypical Hyperplasia Patients	2022/04/07	NCT05316935	Phase 2	Recruiting	Xiaojun Chen
Compare the Efficacy and the Safety of Taxotere and Nanoxel M as Neoadjuvant Chemotherapy in Breast Cancer	2022/01/26	NCT05207514	Phase 3	Terminated	Samyang Biopharmaceuticals Corporation
M-Tapa Block for Laparoscopic Inguinal Hernia Repair Surgery	2022/01/20	NCT05199922	Not Applicable	Completed	Medipol University
M-Tapa Block for Laparoscopic Cholesistectomy	2022/01/05	NCT05179629	Not Applicable	Completed	Medipol University
Effect of Sweetness Intensity of a Sucrose Solution on Blood Glucose Regulation and Energy Intake	2021/08/05	NCT04991714	Early Phase 1	Completed	University of Vienna
Impact of Dexamethasone Added to Intra-articular Morphine and Bupivacaine for Post-operative Analgesia After Knee Arthroscopy	2021/03/10	NCT04790292	Phase 4	Completed	Ain Shams University
Administration of Methionine in Patients With Pulmonary Alveolar Proteinosis by Mutation of the MARS Gene.	2019/03/22	NCT03887169	Phase 1	Completed	Assistance Publique - Hôpitaux de Paris
Remaxol® in Mechanical Jaundice of Non-malignant Origin	2018/02/01	NCT03418935	Phase 3	Completed	POLYSAN Scientific & Technological Pharmaceutical Company

FDA Drug Approvals

Approved Product	Manufacturer	NDC Code	Route	Strength	Effective Date
CLINIMIX	Baxter Healthcare Corporation	0338-0184	INTRAVENOUS	320 mg in 100 mL	4/13/2021
CLINIMIX E	Baxter Healthcare Company	0338-0210	INTRAVENOUS	320 mg in 100 mL	9/21/2020
CLINIMIX E	Baxter Healthcare Corporation	0338-0210	INTRAVENOUS	320 mg in 100 mL	9/21/2020
CLINIMIX	Baxter Healthcare Corporation	0338-1089	INTRAVENOUS	170 mg in 100 mL	4/13/2021
CLINIMIX	Baxter Healthcare Corporation	0338-1099	INTRAVENOUS	200 mg in 100 mL	4/13/2021
Aminosyn II	ICU Medical Inc.	0990-7171	INTRAVENOUS	258 mg in 100 mL	5/4/2022
CLINIMIX	Baxter Healthcare Corporation	0338-0194	INTRAVENOUS	320 mg in 100 mL	4/13/2021
CLINIMIX E	Baxter Healthcare Company	0338-1147	INTRAVENOUS	200 mg in 100 mL	9/21/2020
CLINIMIX E	Baxter Healthcare Corporation	0338-1147	INTRAVENOUS	200 mg in 100 mL	9/21/2020
CLINIMIX E	Baxter Healthcare Company	0338-1142	INTRAVENOUS	110 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
AMINOPLASMAL B.BRAUN 10% E SOLUTION FOR INFUSION	B. Braun Melsungen AG	SIN15411P	INFUSION, SOLUTION	4.40g/1000ml	1/23/2018
SMOFKABIVEN EXTRA NITROGEN EMULSION FOR INFUSION	Fresenius Kabi AB, Site Uppsala	SIN16135P	INJECTION, EMULSION	2.8g/1000ml	3/24/2021
NUTRIFLEX® OMEGA SPECIAL EMULSION FOR INFUSION	B. Braun Melsungen AG	SIN15469P	INJECTION, EMULSION	2.736g/1000ml	4/23/2018
SmofKabiven Emulsion for Infusion	Fresenius Kabi AB, Fresenius Kabi Austria GmbH	SIN14286P	INJECTION, EMULSION	4.3g /1000ml	1/8/2013
OLICLINOMEL N7-1000 E EMULSION FOR INFUSION	BAXTER SA, Ajinomoto North America Incorporated (Intermediate)	SIN12539P	EMULSION	1.60 g/l	5/6/2004
NUTRIFLEX® OMEGA PLUS EMULSION FOR INFUSION	B. Braun Melsungen AG	SIN15468P	INJECTION, EMULSION	1.880g/1000ml	4/23/2018
PERIOLIMEL N4E Emulsion for Infusion	Ajinomoto Health & Nutrition North America Inc. (Intermediate), Baxter S.A	SIN16888P	EMULSION	1.26g/L	10/20/2023
TROPHAMINE INJECTION 10%	B BRAUN MEDICAL INC	SIN07846P	INJECTION	0.34 g/100 ml	9/12/1994
SMOFKABIVEN EXTRA NITROGEN ELECTROLYTE-FREE EMULSION FOR INFUSION	Fresenius Kabi AB, Site Uppsala	SIN16136P	INJECTION, EMULSION	2.8g/1000ml	3/24/2021
NUTRIFLEX® OMEGA SPECIAL B. BRAUN EMULSION FOR INFUSION	B. Braun Melsungen AG	SIN16734P	INJECTION, EMULSION	2.736g/1000ml	3/7/2023

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
LA-FLAMING INJ.	N/A	FALKAN MEDICAL LIMITED	N/A	N/A	1/28/2010
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
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
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
PAN-VASOL SOLUTION FOR INJECTION	N/A	FALKAN MEDICAL LIMITED	N/A	N/A	4/23/2011
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
Mediherb P2-Detox	218993	Integria Healthcare Australia Pty Ltd	Medicine	A	1/8/2014
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
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 WITHOUT ELECTRLYTES IN 10% DEXTROSE	baxter corporation clintec nutrition division	N/A	Solution - Intravenous	170 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	170 MG / 100 ML	12/31/1996
2.75%TRAVASOL AMINO ACID INJ.W.ELEC.W.5%DEX.	clintec nutrition company	02143240	Liquid - Intravenous	110 MG / 100 ML	12/31/1996
4.25%TRAVASOL AMINO ACID INJ.W.ELECW.5%DEX.	clintec nutrition company	02143224	Liquid - Intravenous	170 MG / 100 ML	12/31/1996
5% TRAVASOL AMINO ACID INJECTION WITHOUT ELECTROLYTES IN 25% DEXTROSE	baxter corporation clintec nutrition division	02142244	Solution - Intravenous	200 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	145 MG / 100 ML	12/31/1993
FORMULA CW-CAPLET	body wise international llc	02138549	Tablet - Oral	25 MG	12/31/1995
CLINIMIX E	baxter corporation	02013967	Solution - Intravenous	290 MG / 100 ML	12/31/1993
5% TRAVASOL AMINO ACID INJECTION WITHOUT ELECTROLYTES IN 20% DEXTROSE	baxter corporation clintec nutrition division	02142252	Solution - Intravenous	200 MG / 100 ML	12/31/1996
5% TRAVASOL AMINO ACID INJECTION WITH ELECTROLYTES IN 20% DEXTROSE	baxter corporation clintec nutrition division	02142368	Solution - Intravenous	200 MG / 100 ML	12/31/1996

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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