MedPath

Leucine

Generic Name
Leucine
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
C6H13NO2
CAS Number
61-90-5
Unique Ingredient Identifier
GMW67QNF9C

Overview

An essential branched-chain amino acid important for hemoglobin formation.

Indication

Indicated to assist in the prevention of the breakdown of muscle proteins that sometimes occur after trauma or severe stress.

Associated Conditions

  • Hypoalbuminemia

Clinical Trials

Title
Posted
Study ID
Phase
Status
Sponsor
2024/08/30
Phase 2
Recruiting
2024/01/10
Early Phase 1
Active, not recruiting
2023/12/26
Phase 1
Completed
2023/06/15
Phase 3
Active, not recruiting
2022/04/11
Phase 4
Completed
2021/02/15
Phase 4
Completed
BON WOOK KOO
2020/05/21
Phase 2
Completed
Universidade de Passo Fundo
2020/02/18
Phase 2
Terminated
Hospital Universitario Dr. Jose E. Gonzalez
2019/03/04
Phase 2
Terminated
2017/12/06
Phase 2
Completed

FDA Drug Approvals

Approved Product
Manufacturer
NDC Code
Route
Strength
Effective Date
Baxter Healthcare Corporation
0338-0184
INTRAVENOUS
584 mg in 100 mL
4/13/2021
Baxter Healthcare Company
0338-0210
INTRAVENOUS
584 mg in 100 mL
9/21/2020
Baxter Healthcare Corporation
0338-0210
INTRAVENOUS
584 mg in 100 mL
9/21/2020
Baxter Healthcare Corporation
0338-1089
INTRAVENOUS
311 mg in 100 mL
4/13/2021
Baxter Healthcare Corporation
0338-1099
INTRAVENOUS
365 mg in 100 mL
4/13/2021
ICU Medical Inc.
0990-7171
INTRAVENOUS
1500 mg in 100 mL
5/4/2022
Baxter Healthcare Corporation
0338-0194
INTRAVENOUS
584 mg in 100 mL
4/13/2021
Baxter Healthcare Company
0338-1147
INTRAVENOUS
365 mg in 100 mL
9/21/2020
Baxter Healthcare Corporation
0338-1147
INTRAVENOUS
365 mg in 100 mL
9/21/2020
Baxter Healthcare Company
0338-1142
INTRAVENOUS
201 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
GLAMIN SOLUTION FOR INFUSION
SIN09906P
INJECTION
7.9 g/1000 ml
7/27/1998
AMINOPLASMAL-15% INFUSION
SIN08352P
INJECTION
11.4 g/l
9/14/1995
TROPHAMINE INJECTION 10%
SIN07846P
INJECTION
1.4 g/100 ml
9/12/1994
SYNTHAMIN 17 WITHOUT ELECTROLYTES 10% AMINO ACID INTRAVENOUS INFUSION
SIN09992P
INJECTION
7.30 g/l
9/15/1998
OLIMEL N7E Emulsion for Infusion
SIN16889P
EMULSION
3.07g/L
10/20/2023
AMINOPLASMAL B.BRAUN 10% E SOLUTION FOR INFUSION
SIN15411P
INFUSION, SOLUTION
8.90g/1000ml
1/23/2018
OLIMEL N9E Emulsion for Infusion
SIN16890P
EMULSION
3.95g/L
10/20/2023
SmofKabiven Peripheral Emulsion for Infusion
SIN14287P
INJECTION, EMULSION
7.4g /1000ml
1/8/2013
AMINOVEN SOLUTION FOR INFUSION 5%
SIN11682P
INJECTION
3.7 g/1000 ml
9/25/2001
NUTRIFLEX® OMEGA SPECIAL EMULSION FOR INFUSION
SIN15469P
INJECTION, EMULSION
4.384g/1000ml
4/23/2018

NMPA Drug Approvals

Approved Product
Company
Approval Number
Drug Type
Dosage Form
Approval Date
No NMPA approvals found for this drug.

PPB Drug Approvals

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
310 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
310 MG / 100 ML
12/31/1996
2.75%TRAVASOL AMINO ACID INJ.W.ELEC.W.5%DEX.
clintec nutrition company
02143240
Liquid - Intravenous
201 MG / 100 ML
12/31/1996
4.25%TRAVASOL AMINO ACID INJ.W.ELECW.5%DEX.
clintec nutrition company
02143224
Liquid - Intravenous
310 MG / 100 ML
12/31/1996
5% TRAVASOL AMINO ACID INJECTION WITHOUT ELECTROLYTES IN 25% DEXTROSE
baxter corporation clintec nutrition division
02142244
Solution - Intravenous
365 MG / 100 ML
12/31/1996
5% TRAVASOL AMINO ACID INJECTION WITHOUT ELECTROLYTES IN 20% DEXTROSE
baxter corporation clintec nutrition division
02142252
Solution - Intravenous
365 MG / 100 ML
12/31/1996
5% TRAVASOL AMINO ACID INJECTION WITH ELECTROLYTES IN 20% DEXTROSE
baxter corporation clintec nutrition division
02142368
Solution - Intravenous
365 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
310 MG / 100 ML
12/31/1996
OLIMEL 5.7% E
baxter corporation
02352532
Emulsion - Intravenous
3.95 G / L
1/19/2011
AMINOSYN 8.5%
hospira healthcare ulc
00613320
Solution - Intravenous
810 MG / 100 ML
12/31/1984

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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