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

FDA approval date

EMA approval date

Patent expiration date

Study first post date

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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	2025-01-02
enlyte	unapproved drug other	2022-07-01
leucovorin	ANDA	2014-09-26
leucovorin calcium	ANDA	2025-09-29
paxlyte	unapproved drug other	2024-12-19
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	—	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

3182 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	—	—	144	423	207	12	35	745
Pancreatic neoplasms	D010190	EFO_0003860	C25	95	190	43	1	19	300
Neoplasms	D009369	—	C80	135	112	48	2	9	276
Rectal neoplasms	D012004	—	—	50	156	66	1	14	267
Colonic neoplasms	D003110	—	C18	53	104	72	1	15	217
Stomach neoplasms	D013274	EFO_0003897	C16	33	137	41	2	15	208
Adenocarcinoma	D000230	—	—	46	142	32	1	10	205
Neoplasm metastasis	D009362	EFO_0009708	—	38	84	31	1	6	149
Liver neoplasms	D008113	EFO_1001513	C22.0	12	59	31	1	19	115
Lymphoma	D008223	—	C85.9	18	49	18	1	7	83

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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	19	70	33	—	11	122
Hepatocellular carcinoma	D006528	—	C22.0	10	63	29	—	18	114
Precursor cell lymphoblastic leukemia-lymphoma	D054198	—	C91.0	19	44	27	—	5	85
Leukemia	D007938	—	C95	11	40	24	—	4	72
Ovarian neoplasms	D010051	EFO_0003893	C56	38	30	6	—	4	67
Pancreatic ductal carcinoma	D021441	—	—	24	33	6	—	2	59
Gastrointestinal neoplasms	D005770	—	C26.9	20	23	8	—	3	43
Recurrence	D012008	—	—	18	18	6	—	4	40
Biliary tract neoplasms	D001661	—	C24.9	8	34	4	—	3	40
Breast neoplasms	D001943	EFO_0003869	C50	17	20	3	—	3	39

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Indications Phases 2

Indication	MeSH	Ontology	ICD-10	Ph 1	Ph 2	Ph 3	Ph 4	Other	Total
Healthy volunteers/patients	—	—	—	9	2	—	—	15	26
Endometrial neoplasms	D016889	EFO_0004230	—	12	11	—	—	—	16
Myeloid leukemia acute	D015470	—	C92.0	13	4	—	—	—	15
Triple negative breast neoplasms	D064726	—	—	11	8	—	—	—	15
Cognitive dysfunction	D060825	—	G31.84	1	3	—	—	10	14
Squamous cell carcinoma of head and neck	D000077195	—	—	6	9	—	—	—	12
Mantle-cell lymphoma	D020522	—	C83.1	4	7	—	—	—	11
Appendiceal neoplasms	D001063	EFO_0003880	C18.1	6	4	—	—	1	11
Aging	D000375	GO_0007568	R41.81	—	2	—	—	9	11
Hodgkin disease	D006689	—	C81	7	5	—	—	—	10

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Indications Phases 1

Indication	MeSH	Ontology	ICD-10	Ph 1	Ph 2	Ph 3	Ph 4	Other	Total
Pharmacokinetics	D010599	—	—	5	—	—	—	1	6
Gastrointestinal stromal tumors	D046152	EFO_0000505	C49.A	5	—	—	—	—	5
T-cell lymphoma cutaneous	D016410	—	C84.A	3	—	—	—	2	5
Sezary syndrome	D012751	—	C84.1	3	—	—	—	1	4
Chronic obstructive pulmonary disease	D029424	EFO_0000341	J44.9	2	—	—	—	1	3
Skin neoplasms	D012878	EFO_0004198	C44	1	—	—	—	1	2
Necrosis	D009336	—	—	1	—	—	—	1	2
Pseudomyxoma peritonei	D011553	EFO_0007456	—	1	—	—	—	1	2
Drug interactions	D004347	—	—	2	—	—	—	—	2
Therapeutic equivalency	D013810	—	—	2	—	—	—	—	2

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Indications Without Phase

Indication	MeSH	Ontology	ICD-10	Ph 1	Ph 2	Ph 3	Ph 4	Other	Total
Gyrate atrophy	D015799	—	—	—	—	—	—	12	12
Breast feeding	D001942	—	—	—	—	—	—	8	8
Avitaminosis	D001361	EFO_0005878	E56.9	—	—	—	—	7	7
Alopecia	D000505	—	L64	—	—	—	—	5	5
Healthy diet	D000072001	—	—	—	—	—	—	5	5
Feeding behavior	D005247	—	—	—	—	—	—	5	5
Diet therapy	D004035	—	—	—	—	—	—	4	4
Child development	D002657	—	—	—	—	—	—	4	4
Nutritional status	D009752	—	—	—	—	—	—	4	4
Postoperative cognitive complications	D000079690	—	—	—	—	—	—	4	4

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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