Serine

Overview

A non-essential amino acid occurring in natural form as the L-isomer. It is synthesized from glycine or threonine. It is involved in the biosynthesis of purines; pyrimidines; and other amino acids.

Background

A non-essential amino acid occurring in natural form as the L-isomer. It is synthesized from glycine or threonine. It is involved in the biosynthesis of purines; pyrimidines; and other amino acids.

Indication

Used as a natural moisturizing agent in some cosmetics and skin care products.

Associated Conditions

Iron Deficiency Anemia (IDA)
Iron Deficiency (ID)

Clinical Trials

Title	Posted	Study ID	Phase	Status	Sponsor
Hereditary Sensory Neuropathy Serine Trial	2023/11/02	NCT06113055	Phase 2	Recruiting	University College, London
The Effect of Intradialytic Parenteral Nutrition on Nutritional Status and Quality of Life in Hemodialysis Patients	2019/09/18	NCT04094038	Phase 4	Active, not recruiting	Erasmus Medical Center
The Effect of Higher Protein Dosing in Critically Ill Patients: A Multicenter Randomized Trial	2019/07/09	NCT04012333	Phase 3	Withdrawn	RWTH Aachen University
Reaching Protein Target With SmofKabiven® Extra Nitrogen vs Olimel N9E During the Early Phase of Acute Critical Illness	2019/06/20	NCT03992716	Phase 4	Terminated	Fresenius Kabi
Tolerability and Efficacy of L-Serine in Patients With Amyotrophic Lateral Sclerosis (ALS)	2018/07/09	NCT03580616	Phase 2	Terminated	Elijah W. Stommel
Phase IIa L-serine Trial for eAD	2017/02/23	NCT03062449	Phase 2	Terminated	Aleksandra Stark
Determining the Safety of L-serine in ALS	2013/04/19	NCT01835782	Phase 1	UNKNOWN	Phoenix Neurological Associates, LTD
L-Serine Supplementation in Hereditary Sensory Neuropathy Type 1	2012/11/27	NCT01733407	Phase 1	Completed	Massachusetts General Hospital
Trial of Supplemental Parenteral Nutrition in Under and Over Weight Critically Ill Patients (TOP-UP)	2010/09/21	NCT01206166	Phase 3	Terminated	Clinical Evaluation Research Unit at Kingston General Hospital
Gemcitabine With or Without WX-671 in Treating Patients With Locally Advanced Pancreatic Cancer That Cannot Be Removed By Surgery	2007/07/11	NCT00499265	Phase 2	Completed	Heidelberg Pharma AG

FDA Drug Approvals

Approved Product	Manufacturer	NDC Code	Route	Strength	Effective Date
CLINIMIX	Baxter Healthcare Corporation	0338-0184	INTRAVENOUS	400 mg in 100 mL	4/13/2021
CLINIMIX E	Baxter Healthcare Company	0338-0210	INTRAVENOUS	400 mg in 100 mL	9/21/2020
CLINIMIX E	Baxter Healthcare Corporation	0338-0210	INTRAVENOUS	400 mg in 100 mL	9/21/2020
CLINIMIX	Baxter Healthcare Corporation	0338-1089	INTRAVENOUS	213 mg in 100 mL	4/13/2021
CLINIMIX	Baxter Healthcare Corporation	0338-1099	INTRAVENOUS	250 mg in 100 mL	4/13/2021
Aminosyn II	ICU Medical Inc.	0990-7171	INTRAVENOUS	795 mg in 100 mL	5/4/2022
CLINIMIX	Baxter Healthcare Corporation	0338-0194	INTRAVENOUS	400 mg in 100 mL	4/13/2021
CLINIMIX E	Baxter Healthcare Company	0338-1147	INTRAVENOUS	250 mg in 100 mL	9/21/2020
CLINIMIX E	Baxter Healthcare Corporation	0338-1147	INTRAVENOUS	250 mg in 100 mL	9/21/2020
CLINIMIX E	Baxter Healthcare Company	0338-1142	INTRAVENOUS	138 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
VAMINOLACT INTRAVENOUS SOLUTION	FRESENIUS KABI AUSTRIA GMBH	SIN07428P	INJECTION	3.8 g/1000 ml	5/12/1993
AMINOVEN SOLUTION FOR INFUSION 10%	FRESENIUS KABI AUSTRIA GMBH	SIN11829P	INJECTION	6.500 g/1000 ml	2/28/2002
PRIMENE 10% AMINO ACID INTRAVENOUS INFUSION	BIEFFE MEDITAL S.P.A.	SIN10252P	INJECTION	4 g/l	9/23/1998
AMINOSTERIL N-HEPA FOR INTRAVENOUS INFUSION 8%	FRESENIUS KABI AUSTRIA GMBH	SIN10000P	INJECTION	2.24 g/l	9/15/1998
SmofKabiven Emulsion for Infusion	Fresenius Kabi AB, Fresenius Kabi Austria GmbH	SIN14286P	INJECTION, EMULSION	6.5g /1000ml	1/8/2013
KABIVEN PERIPHERAL EMULSION FOR INFUSION	FRESENIUS KABI AB, FRESENIUS KABI AUSTRIA GMBH	SIN11718P	INJECTION	0.94 g/l	11/16/2001
NUTRIFLEX® OMEGA PLUS EMULSION FOR INFUSION	B. Braun Melsungen AG	SIN15468P	INJECTION, EMULSION	2.880g/1000ml	4/23/2018
PERIOLIMEL N4E Emulsion for Infusion	Ajinomoto Health & Nutrition North America Inc. (Intermediate), Baxter S.A	SIN16888P	EMULSION	1.00g/L	10/20/2023
TROPHAMINE INJECTION 10%	B BRAUN MEDICAL INC	SIN07846P	INJECTION	0.38 g/100 ml	9/12/1994
AMINOPLASMAL B.BRAUN 10% E SOLUTION FOR INFUSION	B. Braun Melsungen AG	SIN15411P	INFUSION, SOLUTION	2.30g/1000ml	1/23/2018

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
NUTRIFLEX OMEGA SPECIAL EMULSION FOR INFUSION	N/A	B BRAUN MEDICAL SA	N/A	N/A	1/11/2012
NUTRIFLEX OMEGA PLUS EMULSION FOR INFUSION	N/A	B BRAUN MEDICAL SA	N/A	N/A	1/11/2012
NUTRINEAL PD-4 W/1.1% AA PERITONEAL DIAL SOLN	N/A	Vantive Healthcare Limited	N/A	N/A	12/31/2003
NUTRINEAL PD4 SOLUTION	N/A	Vantive Healthcare Limited	N/A	N/A	9/9/1999

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
ElementAll Diet	447331	Factors Group Australia Pty Ltd	Medicine	A	5/1/2024
Para Tone	406083	Interclinical Laboratories Pty Ltd	Medicine	A	3/10/2023

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