Tryptophan

Overview

An essential amino acid that is necessary for normal growth in infants and for nitrogen balance in adults. It is a precursor of indole alkaloids in plants. It is a precursor of serotonin (hence its use as an antidepressant and sleep aid). It can be a precursor to niacin, albeit inefficiently, in mammals.

Indication

Tryptophan may be useful in increasing serotonin production, promoting healthy sleep, managing depression by enhancing mental and emotional well-being, managing pain tolerance, and managing weight.

Associated Conditions

Renal Failure, Chronic Renal Failure
Depression
Acute Renal Failure (ARF)

Clinical Trials

Title	Posted	Study ID	Phase	Status	Sponsor
Tryptophan for Impaired AhR Signaling in Celiac Disease	2022/10/12	NCT05576038	Not Applicable	Recruiting	McMaster University
The Effects of Kynurenine Aminotransferase Inhibition in People With Schizophrenia	2019/07/09	NCT04013555	Phase 1	Completed	University of Maryland, Baltimore
Tryptophan MRI in People With Schizophrenia and Healthy Controls	2014/02/20	NCT02067975	Phase 2	Completed	University of Maryland, Baltimore
A Placebo Controlled Trial Of L-Tryptophan In Post-Operative Delirium	2009/03/19	NCT00865202	Phase 3	Completed	University of Colorado, Denver
Double Blind Study of Trp01 in Patients With Alzheimer's Disease	2005/09/20	NCT00202124	Phase 4	Completed	Queen's University
Tryptophan and Behavior Therapy for Cocaine Abuse - 1	1999/09/21	NCT00000324	Phase 2	Completed	National Institute on Drug Abuse (NIDA)

FDA Drug Approvals

Approved Product	Manufacturer	NDC Code	Route	Strength	Effective Date
CLINIMIX	Baxter Healthcare Corporation	0338-0184	INTRAVENOUS	144 mg in 100 mL	4/13/2021
CLINIMIX E	Baxter Healthcare Company	0338-0210	INTRAVENOUS	144 mg in 100 mL	9/21/2020
CLINIMIX E	Baxter Healthcare Corporation	0338-0210	INTRAVENOUS	144 mg in 100 mL	9/21/2020
CLINIMIX	Baxter Healthcare Corporation	0338-1089	INTRAVENOUS	77 mg in 100 mL	4/13/2021
CLINIMIX	Baxter Healthcare Corporation	0338-1099	INTRAVENOUS	90 mg in 100 mL	4/13/2021
Aminosyn II	ICU Medical Inc.	0990-7171	INTRAVENOUS	300 mg in 100 mL	5/4/2022
CLINIMIX	Baxter Healthcare Corporation	0338-0194	INTRAVENOUS	144 mg in 100 mL	4/13/2021
CLINIMIX E	Baxter Healthcare Company	0338-1147	INTRAVENOUS	90 mg in 100 mL	9/21/2020
CLINIMIX E	Baxter Healthcare Corporation	0338-1147	INTRAVENOUS	90 mg in 100 mL	9/21/2020
CLINIMIX E	Baxter Healthcare Company	0338-1142	INTRAVENOUS	50 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
AMINOSTERIL N-HEPA FOR INTRAVENOUS INFUSION 8%	FRESENIUS KABI AUSTRIA GMBH	SIN10000P	INJECTION	0.7 g/l	9/15/1998
OLIMEL N7E Emulsion for Infusion	Ajinomoto Health & Nutrition North America Inc. (Intermediate), Baxter S.A	SIN16889P	EMULSION	0.74g/L	10/20/2023
GLAMIN SOLUTION FOR INFUSION	FRESENIUS KABI AUSTRIA GMBH	SIN09906P	INJECTION	1.9 g/1000 ml	7/27/1998
SmofKabiven Peripheral Emulsion for Infusion	Fresenius Kabi AB	SIN14287P	INJECTION, EMULSION	2.0g/1000ml	1/8/2013
NUTRIFLEX® OMEGA SPECIAL EMULSION FOR INFUSION	B. Braun Melsungen AG	SIN15469P	INJECTION, EMULSION	0.800g/1000ml	4/23/2018
OLICLINOMEL N4-550 E EMULSION FOR INFUSION	BAXTER SA, Ajinomoto North America Incorporated (Intermediate)	SIN12542P	EMULSION	0.40 g/l	5/6/2004
SmofKabiven Emulsion for Infusion	Fresenius Kabi AB, Fresenius Kabi Austria GmbH	SIN14286P	INJECTION, EMULSION	2.0g/1000ml	1/8/2013
SmofKabiven Electrolyte Free Emulsion for Infusion	Fresenius Kabi AB, Fresenius Kabi Austria GmbH	SIN14292P	INJECTION, EMULSION	2.0g/1000ml	1/16/2013
KABIVEN PERIPHERAL EMULSION FOR INFUSION	FRESENIUS KABI AB, FRESENIUS KABI AUSTRIA GMBH	SIN11718P	INJECTION	0.4 g/l	11/16/2001
OLICLINOMEL N7-1000 E EMULSION FOR INFUSION	BAXTER SA, Ajinomoto North America Incorporated (Intermediate)	SIN12539P	EMULSION	0.72 g/l	5/6/2004

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
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
PAN-AMIN G SOLUTION FOR INFUSION 500ML	N/A	otsuka pharmaceutical (h.k.) limited	N/A	N/A	4/5/2012
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
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
NAD+NMN Plus	373212	Aus Nature Pharmaceuticals Pty Ltd	Medicine	A	8/20/2021
Ketuzz	380972	TTB International Pty Ltd	Medicine	A	12/16/2021

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