Levoleucovorin - PharmaKB

Levoleucovorin

Khapzory, Levoleucovorin (levoleucovorin) is a small molecule pharmaceutical. Levoleucovorin was first approved as Fusilev on 2008-03-07.

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Commercial

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Trade Name

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EMA

Khapzory, Levoleucovorin (discontinued: Fusilev, Khapzory, Levoleucovorin)

Drug Products

FDA

EMA

New Drug Application (NDA)

Abbreviated New Drug Application (ANDA)

Levoleucovorin

Tradename	Company	Number	Date	Products
KHAPZORY	Acrotech Biopharma	N-211226 RX	2018-10-19	1 products, RLD, RS

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Levoleucovorin calcium

Tradename	Company	Number	Date	Products
FUSILEV	Acrotech Biopharma	N-020140 DISCN	2008-03-07	3 products, RLD
LEVOLEUCOVORIN CALCIUM	Allergan	N-208723 DISCN	2016-09-29	1 products, RLD

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FDA

EMA

Brand Name	Status	Last Update
khapzory	New Drug Application	2026-03-17
levoleucovorin	ANDA	2023-08-01
levoleucovorin calcium	ANDA	2023-08-29

Indications

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EMA

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Agency Specific

FDA

EMA

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Patent Expiration

Patent	Expires	Flag	FDA Information
Levoleucovorin, Khapzory, Acrotech Biopharma
11541012	2039-03-25	DP

ATC Codes

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HCPCS

Code	Description
J0641	Injection, levoleucovorin, not otherwise specified, 0.5 mg
J0642	Injection, levoleucovorin (khapzory), 0.5 mg

Clinical

Clinical Trials

1268 clinical trials

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Indications Phases 4

Indication	MeSH	Ontology	ICD-10	Ph 1	Ph 2	Ph 3	Ph 4	Other	Total
Colorectal neoplasms	D015179	—	—	86	255	141	4	21	465
Rectal neoplasms	D012004	—	—	39	93	47	1	6	174
Pancreatic neoplasms	D010190	EFO_0003860	C25	54	92	34	1	8	164
Colonic neoplasms	D003110	—	C18	40	76	57	1	8	164
Adenocarcinoma	D000230	—	—	18	71	20	1	6	107
Stomach neoplasms	D013274	EFO_0003897	C16	25	63	18	1	6	101
Neoplasm metastasis	D009362	EFO_0009708	—	18	40	15	1	4	73
Liver neoplasms	D008113	EFO_1001513	C22.0	8	19	9	1	4	37
Cholangiocarcinoma	D018281	—	C22.1	6	17	3	1	—	25
Non-small-cell lung carcinoma	D002289	—	—	13	4	—	2	—	16

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Indications Phases 3

Indication	MeSH	Ontology	ICD-10	Ph 1	Ph 2	Ph 3	Ph 4	Other	Total
Neoplasms	D009369	—	C80	64	66	24	—	4	143
Precursor cell lymphoblastic leukemia-lymphoma	D054198	—	C91.0	14	34	23	—	3	67
Lymphoma	D008223	—	C85.9	8	37	13	—	6	58
Esophageal neoplasms	D004938	—	C15	15	34	4	—	3	47
Leukemia	D007938	—	C95	4	28	15	—	2	46
Carcinoma	D002277	—	C80.0	8	24	13	—	4	45
Pancreatic ductal carcinoma	D021441	—	—	15	20	6	—	1	36
Hepatocellular carcinoma	D006528	—	C22.0	8	21	8	—	2	35
Burkitt lymphoma	D002051	—	C83.7	5	16	7	—	—	27
Gastrointestinal neoplasms	D005770	—	C26.9	15	12	2	—	3	25

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Indications Phases 2

Indication	MeSH	Ontology	ICD-10	Ph 1	Ph 2	Ph 3	Ph 4	Other	Total
Myeloid leukemia acute	D015470	—	C92.0	9	3	—	—	—	11
Ovarian neoplasms	D010051	EFO_0003893	C56	6	5	—	—	—	11
Myelodysplastic syndromes	D009190	—	D46	8	3	—	—	—	10
Mantle-cell lymphoma	D020522	—	C83.1	3	7	—	—	—	10
Hodgkin disease	D006689	—	C81	6	4	—	—	—	9
Sarcoma	D012509	—	—	3	6	—	—	—	9
Osteosarcoma	D012516	—	—	3	5	—	—	1	8
Breast neoplasms	D001943	EFO_0003869	C50	3	4	—	—	—	7
B-cell chronic lymphocytic leukemia	D015451	—	C91.1	4	3	—	—	—	7
Rheumatoid arthritis	D001172	EFO_0000685	M06.9	2	6	—	—	—	7

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Indications Phases 1

Indication	MeSH	Ontology	ICD-10	Ph 1	Ph 2	Ph 3	Ph 4	Other	Total
Gastrointestinal stromal tumors	D046152	EFO_0000505	C49.A	4	—	—	—	—	4
Immunoblastic lymphadenopathy	D007119	EFO_1001350	C86.5	2	—	—	—	1	3
Diarrhea	D003967	—	R19.7	1	—	—	—	1	2
Sezary syndrome	D012751	—	C84.1	1	—	—	—	1	2
T-cell lymphoma cutaneous	D016410	—	C84.A	1	—	—	—	1	2
Pseudomyxoma peritonei	D011553	EFO_0007456	—	1	—	—	—	1	2
Prostatic neoplasms	D011471	—	C61	1	—	—	—	—	1
Castration-resistant prostatic neoplasms	D064129	—	—	1	—	—	—	—	1
Anemia	D000740	EFO_0004272	D64.9	1	—	—	—	—	1
Thrombocytosis	D013922	—	D75.83	1	—	—	—	—	1

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Indications Without Phase

Indication	MeSH	Ontology	ICD-10	Ph 1	Ph 2	Ph 3	Ph 4	Other	Total
Aggression	D000374	EFO_0003015	—	—	—	—	—	1	1
Invasive hydatidiform mole	D002820	—	D39.2	—	—	—	—	1	1
Juvenile arthritis	D001171	EFO_1002007	M08	—	—	—	—	1	1
Behavior	D001519	GO_0007610	STY/T053	—	—	—	—	1	1
Microbiota	D064307	—	—	—	—	—	—	1	1
Healthy diet	D000072001	—	—	—	—	—	—	1	1
Ultrasonic therapy	D014464	—	—	—	—	—	—	1	1
Multiple primary neoplasms	D009378	—	—	—	—	—	—	1	1
Overweight	D050177	—	E66.3	—	—	—	—	1	1
Liver cirrhosis	D008103	EFO_0001422	K74.0	—	—	—	—	1	1

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Epidemiology

Epidemiological information for investigational and approved indications

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Drug

General

Drug common name	Levoleucovorin
INN	calcium levofolinate
Description	Folinic acid, also known as leucovorin, is a medication used to decrease the toxic effects of methotrexate and pyrimethamine. It is also used in combination with 5-fluorouracil to treat colorectal cancer and pancreatic cancer, may be used to treat folate deficiency that results in anemia, and methanol poisoning. It is taken by mouth, injection into a muscle, or injection into a vein.
Classification	Small molecule
Drug class	—
Image (chem structure or protein)
Structure (InChI/SMILES or Protein Sequence)	Nc1nc(=O)c2c([nH]1)NC[C@H](CNc1ccc(C(=O)N[C@@H](CCC(=O)O)C(=O)O)cc1)N2C=O