Leucovorin - PharmaKB

Leucovorin

Leucovorin (leucovorin) is a small molecule pharmaceutical. Leucovorin was first approved as Leucovorin calcium on 1982-01-01. It is used to treat folic acid deficiency and megaloblastic anemia in the USA.

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Events

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Commercial

Therapeutic Areas

Therapeutic Area	MeSH
hemic and lymphatic diseases	D006425
nutritional and metabolic diseases	D009750

Trade Name

FDA

EMA

Leucovorin (discontinued: Leucovorin, Wellcovorin)

Drug Products

FDA

EMA

New Drug Application (NDA)

Abbreviated New Drug Application (ANDA)

Leucovorin calcium

Tradename	Company	Number	Date	Products
WELLCOVORIN	GSK	N-018342 DISCN	1983-07-08	2 products, RLD
LEUCOVORIN CALCIUM	Hospira	N-008107 DISCN	1982-01-01	5 products, RLD
LEUCOVORIN CALCIUM	Xanodyne Pharmaceuticals	N-018459 DISCN	1986-01-30	1 products

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FDA

EMA

Brand Name	Status	Last Update
enbrace hr	unapproved drug other	2023-12-15
enlyte	unapproved drug other	2022-07-01
leucovorin	ANDA	2014-09-26
leucovorin calcium	ANDA	2024-10-14
paxlyte	unapproved drug other	2024-08-01
pyrimethamine leucovorin	unapproved drug other	2015-11-30

Indications

FDA

EMA

Indication	Ontology	MeSH	ICD-10
folic acid deficiency	EFO_0001070	D005494	E53.8
megaloblastic anemia	HP_0001889	D000749	D53.1

Agency Specific

FDA

EMA

No data

Patent Expiration

No data

ATC Codes

V: Various drug classes in atc

— V03: All other therapeutic products

— V03A: All other therapeutic products

— V03AF: Detoxifying agents for antineoplastic treatment

— V03AF03: Calcium folinate

HCPCS

Code	Description
J0640	Injection, leucovorin calcium, per 50 mg
J0641	Injection, levoleucovorin, not otherwise specified, 0.5 mg
J0642	Injection, levoleucovorin (khapzory), 0.5 mg

Clinical

Clinical Trials

2038 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	—	—	128	404	196	14	31	702
Adenocarcinoma	D000230	—	—	69	177	50	1	13	275
Pancreatic neoplasms	D010190	EFO_0003860	C25	86	177	37	1	16	272
Neoplasms	D009369	—	C80	109	102	38	1	4	224
Stomach neoplasms	D013274	EFO_0003897	C16	32	128	39	2	16	196
Liver neoplasms	D008113	EFO_1001513	C22.0	12	68	36	3	20	128
Neoplasm metastasis	D009362	EFO_0009708	—	22	71	33	4	7	122
Esophageal neoplasms	D004938	—	C15	19	66	16	1	4	94
Cholangiocarcinoma	D018281	—	C22.1	8	24	4	1	1	35
Non-small-cell lung carcinoma	D002289	—	—	16	7	—	1	—	18

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Indications Phases 3

Indication	MeSH	Ontology	ICD-10	Ph 1	Ph 2	Ph 3	Ph 4	Other	Total
Carcinoma	D002277	—	C80.0	35	101	47	—	20	185
Rectal neoplasms	D012004	—	—	28	109	41	—	8	174
Colonic neoplasms	D003110	—	C18	27	56	51	—	10	124
Hepatocellular carcinoma	D006528	—	C22.0	6	57	29	—	17	103
Leukemia	D007938	—	C95	20	51	33	—	4	99
Lymphoma	D008223	—	C85.9	25	57	20	—	7	97
Precursor cell lymphoblastic leukemia-lymphoma	D054198	—	—	13	41	30	—	3	79
Lymphoid leukemia	D007945	—	C91	13	37	27	—	3	72
Recurrence	D012008	—	—	17	25	10	—	3	52
Pancreatic ductal carcinoma	D021441	—	—	19	29	5	—	2	49

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Indications Phases 2

Indication	MeSH	Ontology	ICD-10	Ph 1	Ph 2	Ph 3	Ph 4	Other	Total
Ovarian neoplasms	D010051	EFO_0003893	C56	10	9	—	—	—	17
Renal cell carcinoma	D002292	EFO_0000376	—	12	7	—	—	1	17
Squamous cell neoplasms	D018307	—	—	4	10	—	—	—	10
Arthritis	D001168	HP_0001369	M05-M14	4	6	—	—	1	10
Appendiceal neoplasms	D001063	EFO_0003880	C18.1	5	4	—	—	1	10
Myeloid leukemia acute	D015470	—	C92.0	9	1	—	—	—	9
Squamous cell carcinoma of head and neck	D000077195	—	—	6	7	—	—	—	9
Rheumatoid arthritis	D001172	EFO_0000685	M06.9	4	6	—	—	—	9
Triple negative breast neoplasms	D064726	—	—	6	5	—	—	—	8
Multiple myeloma	D009101	—	C90.0	4	4	—	—	—	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
Prostatic neoplasms	D011471	—	C61	2	—	—	—	—	2
Infections	D007239	EFO_0000544	—	2	—	—	—	—	2
Primary myelofibrosis	D055728	—	D47.4	1	—	—	—	—	1
Anemia	D000740	HP_0001903	D64.9	1	—	—	—	—	1
Leukemia myeloid chronic atypical bcr-abl negative	D054438	—	C92.2	1	—	—	—	—	1
Myeloid leukemia accelerated phase	D015465	—	—	1	—	—	—	—	1
Thrombocytosis	D013922	HP_0001894	D75.83	1	—	—	—	—	1
Chondrosarcoma	D002813	—	—	1	—	—	—	—	1
Skin neoplasms	D012878	EFO_0004198	C44	1	—	—	—	—	1

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Indications Without Phase

Indication	MeSH	Ontology	ICD-10	Ph 1	Ph 2	Ph 3	Ph 4	Other	Total
Acquired immunodeficiency syndrome	D000163	EFO_0000765	B20	—	—	—	—	2	2
Stents	D015607	—	—	—	—	—	—	1	1
Adjuvant chemoradiotherapy	D059186	—	—	—	—	—	—	1	1
Aggression	D000374	EFO_0003015	—	—	—	—	—	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
Pancreatectomy	D010180	EFO_0002581	—	—	—	—	—	1	1
Vascular system injuries	D057772	—	T14.8	—	—	—	—	1	1
Microbiota	D064307	—	—	—	—	—	—	1	1

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Epidemiology

Epidemiological information for investigational and approved indications

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Drug

General

Drug common name	Leucovorin
INN	calcium folinate
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)NCC(CNc1ccc(C(=O)N[C@@H](CCC(=O)O)C(=O)O)cc1)N2C=O