Levocarnitine - PharmaKB

Levocarnitine

Carnitor, Levocarnitine (levocarnitine) is a small molecule pharmaceutical. Levocarnitine was first approved as Carnitor on 1985-12-27. It is used to treat deficiency diseases in the USA.

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Clinical

Drug

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Financial

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Events Timeline

YTD

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Events

FDA approval date

EMA approval date

Patent expiration date

Study first post date

Last update post date

Start date

Primary completion date

Completion date

Results first post date

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Commercial

Therapeutic Areas

Therapeutic Area	MeSH
nutritional and metabolic diseases	D009750

Trade Name

FDA

EMA

Carnitor, Carnitor sf, Levocarnitine, Levocarnitine sf (discontinued: Carnitor, Levocarnitine)

Drug Products

FDA

EMA

New Drug Application (NDA)

Abbreviated New Drug Application (ANDA)

Levocarnitine

Tradename	Company	Number	Date	Products
CARNITOR	Leadiant Biosciences	N-018948 RX	1985-12-27	1 products, RLD, RS
CARNITOR	Leadiant Biosciences	N-020182 RX	1992-12-16	1 products, RLD, RS
CARNITOR	Leadiant Biosciences	N-019257 RX	1986-04-10	1 products, RLD, RS
CARNITOR SF	Leadiant Biosciences	N-019257 RX	2007-03-28	1 products, RLD

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Labels

FDA

EMA

Brand Name	Status	Last Update
carnitor	New Drug Application	2024-10-30
carnitor sf	New Drug Application	2024-11-04
levocarnitine	ANDA	2025-05-28

Indications

FDA

EMA

Indication	Ontology	MeSH	ICD-10
deficiency diseases	EFO_1001067	D003677	E63

Agency Specific

FDA

EMA

No data

Patent Expiration

No data

ATC Codes

A: Alimentary tract and metabolism drugs

— A16: Other alimentary tract and metabolism products in atc

— A16A: Other alimentary tract and metabolism products in atc

— A16AA: Amino acids and derivatives

— A16AA01: Levocarnitine

HCPCS

Code	Description
J1955	Injection, levocarnitine, per 1 gm

Clinical

Clinical Trials

289 clinical trials

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Indications Phases 4

Indication	MeSH	Ontology	ICD-10	Ph 1	Ph 2	Ph 3	Ph 4	Other	Total
Hiv infections	D015658	EFO_0000764	B20	—	8	2	1	5	16
Fatigue	D005221	—	R53.83	—	4	6	1	6	16
Syndrome	D013577	—	—	—	6	3	1	7	15
Infertility	D007246	EFO_0000545	—	1	2	—	1	7	11
Male infertility	D007248	EFO_0004248	N46	1	2	—	1	6	9
Non-alcoholic fatty liver disease	D065626	EFO_0003095	K75.81	—	2	1	2	4	9
Fatty liver	D005234	EFO_0003934	—	—	2	1	2	4	9
Peripheral nervous system diseases	D010523	—	G64	—	3	3	1	1	8
Malnutrition	D044342	EFO_0008572	E40-E46	1	—	—	4	3	8
Peripheral arterial disease	D058729	EFO_0004265	—	2	—	2	2	—	6

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Indications Phases 3

Indication	MeSH	Ontology	ICD-10	Ph 1	Ph 2	Ph 3	Ph 4	Other	Total
Chronic kidney failure	D007676	EFO_0003884	N18.6	—	8	2	—	1	10
Heart failure	D006333	EFO_0003144	I50	1	5	2	—	1	6
Type 2 diabetes mellitus	D003924	EFO_0001360	E11	—	3	1	—	1	5
Muscular atrophy	D009133	—	—	1	3	1	—	1	5
Leukemia	D007938	—	C95	1	1	1	—	1	4
Kidney diseases	D007674	EFO_0003086	N08	—	1	1	—	2	4
Diabetes mellitus	D003920	EFO_0000400	E08-E13	—	2	1	—	1	4
Dyslipidemias	D050171	—	—	—	2	1	—	1	4
Septic shock	D012772	—	A48.3	2	2	1	—	—	4
Spinal muscular atrophy	D009134	EFO_0003823	G12.1	1	3	1	—	—	4

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Indications Phases 2

Indication	MeSH	Ontology	ICD-10	Ph 1	Ph 2	Ph 3	Ph 4	Other	Total
Insulin resistance	D007333	EFO_0002614	E88.819	—	3	—	—	5	8
Brain injuries	D001930	—	S06.9	1	1	—	—	2	3
Autistic disorder	D001321	EFO_0003758	F84.0	1	1	—	—	1	3
Metabolic syndrome	D024821	EFO_0000195	E88.810	—	2	—	—	1	3
Keratoconjunctivitis sicca	D007638	EFO_1000906	—	—	1	—	—	1	2
Dry eye syndromes	D015352	—	H04.12	—	1	—	—	1	2
Patient compliance	D010349	—	—	—	1	—	—	1	2
Chronic fatigue syndrome	D015673	EFO_0004540	G93.31	—	1	—	—	1	2
Body weight	D001835	EFO_0004338	—	—	1	—	—	1	2
Depression	D003863	—	F33.9	—	1	—	—	1	2

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Indications Phases 1

Indication	MeSH	Ontology	ICD-10	Ph 1	Ph 2	Ph 3	Ph 4	Other	Total
Healthy volunteers/patients	—	—	—	2	—	—	—	5	7
Diet therapy	D004035	—	—	1	—	—	—	3	4
Cardiovascular diseases	D002318	EFO_0000319	I98	1	—	—	—	2	3
Mitochondrial diseases	D028361	EFO_0000591	—	1	—	—	—	2	3
Oligospermia	D009845	—	N46.1	1	—	—	—	1	2
Epilepsy	D004827	EFO_0000474	G40.9	1	—	—	—	1	2
Drug resistant epilepsy	D000069279	—	—	1	—	—	—	1	2
Chronic progressive multiple sclerosis	D020528	EFO_0003840	—	1	—	—	—	—	1
Pancreatitis	D010195	EFO_0000278	K85	1	—	—	—	—	1
Chronic pancreatitis	D050500	EFO_0000342	K86.1	1	—	—	—	—	1

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Indications Without Phase

Indication	MeSH	Ontology	ICD-10	Ph 1	Ph 2	Ph 3	Ph 4	Other	Total
Brain diseases	D001927	—	G93.40	—	—	—	—	4	4
Glucose intolerance	D018149	HP_0000833	R73.03	—	—	—	—	3	3
Hyperlipidemias	D006949	EFO_0003774	E78.5	—	—	—	—	3	3
Weight loss	D015431	—	—	—	—	—	—	3	3
Hepatic encephalopathy	D006501	—	K72.91	—	—	—	—	3	3
Liver cirrhosis	D008103	EFO_0001422	K74.0	—	—	—	—	2	2
Fibrosis	D005355	—	—	—	—	—	—	2	2
Overweight	D050177	—	E66.3	—	—	—	—	2	2
Humans	D006801	—	STY/T016	—	—	—	—	2	2
Culture media	D003470	—	—	—	—	—	—	2	2

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Epidemiology

Epidemiological information for investigational and approved indications

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Drug

General

Drug common name	Levocarnitine
INN	levocarnitine
Description	Carnitine is an amino-acid betaine that is butanoate substituted with a hydroxy group at position C-3 and a trimethylammonium group at C-4. It has a role as a human metabolite and a mouse metabolite. It is functionally related to a butyrate. It is a conjugate base of a carnitinium.
Classification	Small molecule
Drug class	—
Image (chem structure or protein)
Structure (InChI/SMILES or Protein Sequence)	C[N+](C)(C)C[C@H](O)CC(=O)[O-]