Levocarnitine

Overview

Constituent of striated muscle and liver. It is used therapeutically to stimulate gastric and pancreatic secretions and in the treatment of hyperlipoproteinemias.

Indication

⑴用于继发性肉碱缺乏症。主要用于慢性肾衰长期血透患者因肉碱缺乏产生的一系列并发症状，临床表现如心肌病、骨骼肌病、心律失常、高脂血症，以及低血压和透析中肌痉挛等。 ⑵用于罕见病β-酮硫解酶缺乏症（BKD）和原发性肉碱缺乏症（PCD）。 ⑶用于罕见病戊二酸Ⅰ型。 ⑷用于维持罕见病同型半胱氨酸血症引起的血液游离肉碱的正常水平。

Associated Conditions

Carnitine Deficiency
Congenital carnitine deficiency
Secondary Carnitine deficiency

Clinical Trials

Title	Posted	Study ID	Phase	Status	Sponsor
Medical Treatment Alone Versus Varicocelectomy Versus Varicocelectomy and Medical Treatment	2025/06/12	NCT07016867	Not Applicable	Recruiting	South Valley University
Effect of L-carnitine on Disease Activity in Patients With Mild to Moderate Knee Osteoarthritis	2025/05/07	NCT06960694	Phase 2	Not yet recruiting	Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh
Effect of L-carnitine Supplementation on Phenylalanine and Brain-derived Neurotrophic Factor Levels in Infants and Children With Phenylketonuria	2025/03/28	NCT06901323	Phase 4	Active, not recruiting	Mansoura University
L-carnitine Supplementation in Rheumatoid Arthritis Patients	2024/12/31	NCT06753565	Phase 2	Recruiting	German University in Cairo
Effect of L-Carnitine on Biomarkers of Myocardial Reperfusion Injury in Patients With STEMI	2024/08/21	NCT06564909	Phase 2	Recruiting	Ain Shams University
Carnitine Supplementation in Pediatric Hemodialysis Patients	2023/07/17	NCT05948124	Early Phase 1	Recruiting	Ain Shams University
Impact of Hemodialysis on Plasma Carnitine Levels in Patients With End Stage Renal Disease	2023/04/18	NCT05817799	Phase 2	Completed	Bahria University
L-carnitine in Modulating Pain and Inflammation in Rheumatoid Arthritis	2023/03/31	NCT05792527	Phase 3	Recruiting	Tanta University
Effects of L-carnitine Therapy on the Heart of Maintenance Hemodialysis Patients	2023/01/06	NCT05673239	Phase 4	Completed	The First Affiliated Hospital of Zhejiang Chinese Medical University
The Possible Efficacy and Safety of L-carnitine and Biotin as Adjunctive Therapies in Children With Moderate Persistent Asthma	2022/11/30	NCT05632549	Phase 3	Active, not recruiting	Tanta University

FDA Drug Approvals

Approved Product	Manufacturer	NDC Code	Route	Strength	Effective Date
Levocarnitine	Hikma Pharmaceuticals USA Inc.	0143-9852	INTRAVENOUS	1 g in 5 mL	5/8/2023
Levocarnitine	Rising Pharma Holdings, Inc.	16571-762	ORAL	330 mg in 1 1	2/14/2023
Levocarnitine	Rising Pharmaceuticals, Inc.	64980-503	ORAL	1 g in 10 mL	12/21/2021
Levocarnitine	Akorn	50383-172	ORAL	330 mg in 1 1	11/10/2022
Carnitor	Leadiant Biosciences, Inc.	54482-147	INTRAVENOUS	1 g in 5 mL	11/20/2023
Levocarnitine	Akorn	50383-171	ORAL	1 g in 10 mL	3/14/2022
Levocarnitine	ANI Pharmaceuticals, Inc.	70954-139	ORAL	1 g in 10 mL	11/12/2022
Levocarnitine	Novitium Pharma LLC	70954-139	ORAL	1 g in 10 mL	11/12/2022
Carnitor SF	Leadiant Biosciences, Inc.	54482-148	ORAL	1 g in 10 mL	11/21/2023
Lipovite	Perdido Key Health and Wellness Inc	70104-128	INTRAMUSCULAR	1 mg in 1 mL	11/23/2015

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
No HSA approvals found for this drug.

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
CARNITENE SOLUTION 30%	N/A	SINO-ASIA PHARMACEUTICAL SUPPLIES LIMITED	N/A	N/A	7/23/1992

TGA Drug Approvals

Approved Product	ARTG ID	Sponsor	Registration Type	Status	Registration Date
Ultra Muscleze Forest Berries	305454	FIT-BioCeuticals Pty Ltd	Medicine	A	6/27/2018
SUPER 23	405350	Genius Industries Pty Ltd	Medicine	A	2/24/2023
Wealthy Health R.J. Plus	125152	Universal Pharmaceuticals Pty Ltd	Medicine	A	1/18/2006
Ultra Nature Selancy Men	407238	Selima Pharmaceuticals	Medicine	A	4/3/2023
Healthy Haniel Sugar Balance and Weight Loss Support	452611	Hannah Haniel Pty Ltd	Medicine	A	6/18/2024
SLIMist	123288	Slimist Wholesale Pty Ltd	Medicine	A	11/2/2005
INC. CARNITINE	227739	RF Six Pty Ltd	Medicine	A	9/9/2014
Pregnancy Multivitamin & Minerals 1	322113	Health Spring Australia	Medicine	A	8/21/2019
Para Tone	406083	Interclinical Laboratories Pty Ltd	Medicine	A	3/10/2023
Hepatothin	408405	Ferngrove Pharmaceuticals Australia Pty Ltd	Medicine	A	5/3/2023

Health Canada Drug Approvals

Approved Product	Company	DIN	Dosage Form	Strength	Market Date
CARNITOR	leadiant biosciences, inc	02144336	Solution - Oral	100 MG / ML	12/31/1995
CARNITOR	leadiant biosciences, inc	02144328	Tablet - Oral	330 MG	12/31/1995
ODAN LEVOCARNITINE	odan laboratories ltd	02492105	Solution - Oral	100 MG / ML	11/18/2019
CARNITOR	leadiant biosciences, inc	02144344	Solution - Intravenous	200 MG / ML	12/31/1995

CIMA AEMPS Drug Approvals

Approved Product	Company	Registration Number	Pharmaceutical Form	Prescription Type	Status
SECABIOL 300 mg/ml SOLUCION ORAL	Laboratorios Normon S.A.	56242	SOLUCIÓN ORAL	Medicamento Sujeto A Prescripción Médica	Not 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.

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