Phenylalanine

Overview

Phenylalanine is an essential aromatic amino acid that is a precursor of melanin, dopamine, noradrenalin (norepinephrine), and thyroxine.

Indication

L-phenylalanine may be helpful in some with depression. It may also be useful in the treatment of vitiligo. There is some evidence that L-phenylalanine may exacerbate tardive dyskinesia in some schizophrenic patients and in some who have used neuroleptic drugs.

Associated Conditions

No associated conditions information available.

Clinical Trials

Title	Posted	Study ID	Phase	Status	Sponsor
Sequential Treatments or Combinations Including Dasatinib, Quercetin, Fisetin and/or Temozolomide for the Treatment of Previously Treated Glioma With Residual Disease	2025/06/17	NCT07025226	Early Phase 1	Not yet recruiting	Mayo Clinic
Salivary Fluoride Clearance	2024/12/16	NCT06735235	Phase 1	Completed	Procter and Gamble
An Investigational Scan (18F-DOPA PET/CT) for Improving the Clinical Management of Brain Tumors	2024/10/31	NCT06667726	Phase 2	Not yet recruiting	Mayo Clinic
Functional Imaging in Prediction of Response to Abemaciclib for Advanced Hormone Receptor-Positive, HER2-Negative Breast Cancer	2023/12/21	NCT06179303	Phase 2	Recruiting	University of Washington
Short Course Radiotherapy for the Treatment of Patients with Glioblastoma, SAGA Study	2023/03/23	NCT05781321	Phase 2	Recruiting	Mayo Clinic
IBI334 in Subjects With Unresectable, Locally Advanced or Metastatic Solid Tumors	2023/03/20	NCT05774873	Phase 1	Recruiting	Innovent Biologics (Suzhou) Co. Ltd.
A HR20031 BE Study on Healthy Subjects	2023/01/12	NCT05682495	Phase 1	Completed	Shandong Suncadia Medicine Co., Ltd.
An Imaging Agent (Fluorodopa F 18) With Positron Emission Tomography/Magnetic Resonance Imaging for Assessing Treatment Response in Patients With High-Grade Soft Tissue Sarcomas	2022/09/29	NCT05560009	N/A	Completed	Mayo Clinic
Depression and Driving	2022/07/07	NCT05446805	N/A	Recruiting	Ganesh Babulal
A Research Study Looking at New Protein-based Tablets in Healthy Men - Oral Formulation II	2022/04/18	NCT05333107	Phase 1	Completed	Novo Nordisk A/S

FDA Drug Approvals

Approved Product	Manufacturer	NDC Code	Route	Strength	Effective Date
CLINIMIX	Baxter Healthcare Corporation	0338-0184	INTRAVENOUS	448 mg in 100 mL	4/13/2021
CLINIMIX E	Baxter Healthcare Company	0338-0210	INTRAVENOUS	448 mg in 100 mL	9/21/2020
CLINIMIX E	Baxter Healthcare Corporation	0338-0210	INTRAVENOUS	448 mg in 100 mL	9/21/2020
CLINIMIX	Baxter Healthcare Corporation	0338-1089	INTRAVENOUS	238 mg in 100 mL	4/13/2021
CLINIMIX	Baxter Healthcare Corporation	0338-1099	INTRAVENOUS	280 mg in 100 mL	4/13/2021
Aminosyn II	ICU Medical Inc.	0990-7171	INTRAVENOUS	447 mg in 100 mL	5/4/2022
CLINIMIX	Baxter Healthcare Corporation	0338-0194	INTRAVENOUS	448 mg in 100 mL	4/13/2021
CLINIMIX E	Baxter Healthcare Company	0338-1147	INTRAVENOUS	280 mg in 100 mL	9/21/2020
CLINIMIX E	Baxter Healthcare Corporation	0338-1147	INTRAVENOUS	280 mg in 100 mL	9/21/2020
CLINIMIX E	Baxter Healthcare Company	0338-1142	INTRAVENOUS	154 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
SMOFKABIVEN EXTRA NITROGEN EMULSION FOR INFUSION	Fresenius Kabi AB, Site Uppsala	SIN16135P	INJECTION, EMULSION	3.3g/1000ml	3/24/2021
AMINOSTERIL N-HEPA FOR INTRAVENOUS INFUSION 8%	FRESENIUS KABI AUSTRIA GMBH	SIN10000P	INJECTION	0.88 g/l	9/15/1998
SmofKabiven Electrolyte Free Emulsion for Infusion	Fresenius Kabi AB, Fresenius Kabi Austria GmbH	SIN14292P	INJECTION, EMULSION	5.1g /1000ml	1/16/2013
KABIVEN PERIPHERAL EMULSION FOR INFUSION	FRESENIUS KABI AB, FRESENIUS KABI AUSTRIA GMBH	SIN11718P	INJECTION	1.6 g/l	11/16/2001
OLICLINOMEL N7-1000 E EMULSION FOR INFUSION	BAXTER SA, Ajinomoto North America Incorporated (Intermediate)	SIN12539P	EMULSION	2.24 g/l	5/6/2004
NUTRIFLEX® OMEGA PLUS EMULSION FOR INFUSION	B. Braun Melsungen AG	SIN15468P	INJECTION, EMULSION	3.368g/1000ml	4/23/2018
PERIOLIMEL N4E Emulsion for Infusion	Ajinomoto Health & Nutrition North America Inc. (Intermediate), Baxter S.A	SIN16888P	EMULSION	1.76g/L	10/20/2023
TROPHAMINE INJECTION 10%	B BRAUN MEDICAL INC	SIN07846P	INJECTION	0.48 g/100 ml	9/12/1994
AMINOPLASMAL B.BRAUN 10% E SOLUTION FOR INFUSION	B. Braun Melsungen AG	SIN15411P	INFUSION, SOLUTION	4.70g/1000ml	1/23/2018
NUTRIFLEX® OMEGA SPECIAL B. BRAUN EMULSION FOR INFUSION	B. Braun Melsungen AG	SIN16734P	INJECTION, EMULSION	4.916g/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
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
NUTRIFLEX OMEGA SPECIAL EMULSION FOR INFUSION	N/A	B BRAUN MEDICAL SA	N/A	N/A	1/11/2012
PAN-AMIN G INJ	N/A	LUEN CHEONG HONG	N/A	N/A	5/17/1979
PAN-AMIN G SOLUTION FOR INFUSION 500ML	N/A	otsuka pharmaceutical (h.k.) limited	N/A	N/A	4/5/2012
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
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
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 WITH ELECTROLYTES IN 10% DEXTROSE	baxter corporation clintec nutrition division	N/A	Solution - Intravenous	238 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	238 MG / 100 ML	12/31/1996
2.75%TRAVASOL AMINO ACID INJ.W.ELEC.W.5%DEX.	clintec nutrition company	02143240	Liquid - Intravenous	154 MG / 100 ML	12/31/1996
4.25%TRAVASOL AMINO ACID INJ.W.ELECW.5%DEX.	clintec nutrition company	02143224	Liquid - Intravenous	238 MG / 100 ML	12/31/1996
5% TRAVASOL AMINO ACID INJECTION WITHOUT ELECTROLYTES IN 25% DEXTROSE	baxter corporation clintec nutrition division	02142244	Solution - Intravenous	280 MG / 100 ML	12/31/1996
5% TRAVASOL AMINO ACID INJECTION WITHOUT ELECTROLYTES IN 20% DEXTROSE	baxter corporation clintec nutrition division	02142252	Solution - Intravenous	280 MG / 100 ML	12/31/1996
5% TRAVASOL AMINO ACID INJECTION WITH ELECTROLYTES IN 20% DEXTROSE	baxter corporation clintec nutrition division	02142368	Solution - Intravenous	280 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	238 MG / 100 ML	12/31/1996
OLIMEL 5.7% E	baxter corporation	02352532	Emulsion - Intravenous	3.95 G / L	1/19/2011
AMINOSYN-PF 10%	hospira healthcare ulc	00731366	Solution - Intravenous	427 MG / 100 ML	12/31/1990

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.

Related News

PTC Therapeutics' Sephience Receives Positive CHMP Opinion for Phenylketonuria Treatment Across All Age Groups

4 months ago

The European Medicines Agency's CHMP has issued a positive opinion for Sephience (sepiapterin) to treat phenylketonuria in patients of all ages and disease severities, addressing a significant unmet medical need.

PKU GOLIKE Demonstrates Superior Metabolic Control in Phenylketonuria Patients

8 months ago

Relief Therapeutics' PKU GOLIKE showed improved metabolic control in pediatric PKU patients during prolonged fasting, compared to standard amino acid substitutes.

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