Levoleucovorin - PharmaKB

Levoleucovorin

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

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Commercial

Therapeutic Areas

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Trade Name

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EMA

Fusilev, Khapzory (generic drugs available since 2015-03-09)

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

Show 1 discontinued

Levoleucovorin calcium

Tradename	Company	Number	Date	Products
FUSILEV	Acrotech Biopharma	N-020140 RX	2008-03-07	1 products, RLD, RS

Show 2 discontinued

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Indications

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Agency Specific

FDA

EMA

No data

Patent Expiration

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

ATC Codes

V: Various drug classes in atc

— V03: All other therapeutic products

— V03A: All other therapeutic products

— V03AF: Detoxifying agents for antineoplastic treatment

— V03AF04: Calcium levofolinate

HCPCS

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

Clinical

Clinical Trials

1375 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	—	—	64	223	130	4	15	401
Neoplasms	D009369	—	C80	52	39	12	1	—	95
Precursor cell lymphoblastic leukemia-lymphoma	D054198	—	C91.0	21	47	27	4	4	91
Stomach neoplasms	D013274	EFO_0003897	C16	22	52	15	1	5	85
Adenocarcinoma	D000230	—	—	11	37	13	1	4	60
Lymphoma	D008223	—	C85.9	7	29	10	1	4	49
Non-small-cell lung carcinoma	D002289	—	—	9	19	9	1	1	35
Liver neoplasms	D008113	EFO_1001513	C22.0	6	13	8	1	3	28
Neoplasm metastasis	D009362	EFO_0009708	—	2	7	4	1	—	13
Anemia	D000740	HP_0001903	D64.9	1	—	1	3	3	8

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Indications Phases 3

Indication	MeSH	Ontology	ICD-10	Ph 1	Ph 2	Ph 3	Ph 4	Other	Total
Pancreatic neoplasms	D010190	EFO_0003860	C25	43	70	25	—	3	123
Rectal neoplasms	D012004	—	—	20	38	17	—	3	73
Leukemia	D007938	—	C95	8	31	15	—	3	54
Colonic neoplasms	D003110	—	C18	15	24	17	—	4	53
Esophageal neoplasms	D004938	—	C15	10	29	2	—	1	37
Pancreatic ductal carcinoma	D021441	—	—	8	14	3	—	—	23
Hiv infections	D015658	EFO_0000764	B20	5	2	8	—	8	23
Hepatocellular carcinoma	D006528	—	C22.0	1	11	7	—	3	20
Myeloid leukemia acute	D015470	—	C92.0	6	6	5	—	—	15
Myelodysplastic syndromes	D009190	—	D46	8	5	2	—	—	14

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Indications Phases 2

Indication	MeSH	Ontology	ICD-10	Ph 1	Ph 2	Ph 3	Ph 4	Other	Total
Renal cell carcinoma	D002292	EFO_0000376	—	10	6	—	—	1	14
Ovarian neoplasms	D010051	EFO_0003893	C56	6	6	—	—	—	11
Gastrointestinal neoplasms	D005770	—	C26.9	7	4	—	—	1	9
Sarcoma	D012509	—	—	3	6	—	—	—	9
Melanoma	D008545	—	—	6	4	—	—	—	7
Breast neoplasms	D001943	EFO_0003869	C50	2	4	—	—	—	6
Hodgkin disease	D006689	—	C81	2	5	—	—	—	6
Male infertility	D007248	EFO_0004248	N46	—	1	—	—	5	6
Burkitt lymphoma	D002051	—	C83.7	1	6	—	—	—	6
Multiple myeloma	D009101	—	C90.0	3	3	—	—	—	5

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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	3	—	—	—	—	3
Diarrhea	D003967	HP_0002014	R19.7	1	—	—	—	2	3
Brain neoplasms	D001932	EFO_0003833	C71	2	—	—	—	—	2
Hyperhomocysteinemia	D020138	—	—	1	—	—	—	1	2
Healthy volunteers/patients	—	—	—	2	—	—	—	—	2
Leukemia myeloid chronic atypical bcr-abl negative	D054438	—	C92.2	1	—	—	—	—	1
Thrombocytosis	D013922	HP_0001894	D75.83	1	—	—	—	—	1
Osteomyelitis	D010019	EFO_0003102	M86	1	—	—	—	—	1
Ovarian epithelial carcinoma	D000077216	—	—	1	—	—	—	—	1
Malaria	D008288	EFO_0001068	B54	1	—	—	—	—	1

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Indications Without Phase

Indication	MeSH	Ontology	ICD-10	Ph 1	Ph 2	Ph 3	Ph 4	Other	Total
Pre-eclampsia	D011225	EFO_0000668	O14	—	—	—	—	3	3
Diet therapy	D004035	—	—	—	—	—	—	2	2
Hypercholesterolemia	D006937	HP_0003124	—	—	—	—	—	2	2
Ataxia telangiectasia	D001260	Orphanet_100	G11.3	—	—	—	—	1	1
Brain death	D001926	—	G93.82	—	—	—	—	1	1
Invasive hydatidiform mole	D002820	—	D39.2	—	—	—	—	1	1
Juvenile arthritis	D001171	EFO_1002007	M08	—	—	—	—	1	1
T-cell lymphoma	D016399	—	—	—	—	—	—	1	1
Impulsive behavior	D007175	—	—	—	—	—	—	1	1
Pseudomyxoma peritonei	D011553	EFO_0007456	—	—	—	—	—	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