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

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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	2026-02-10
enlyte	unapproved drug other	2022-07-01
lederle leucovorin	unapproved drug for use in drug shortage	2025-12-18
leucovorin	ANDA	2014-09-26
leucovorin calcium	ANDA	2025-12-09
paxlyte	unapproved drug other	2025-12-08
pyrimethamine leucovorin	unapproved drug other	2015-11-30
vykoura	New Drug Application	2026-02-05

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

3257 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	—	—	152	428	210	13	39	762
Pancreatic neoplasms	D010190	EFO_0003860	C25	103	197	45	1	21	312
Neoplasms	D009369	—	C80	140	118	48	2	10	283
Rectal neoplasms	D012004	—	—	50	156	66	1	14	267
Colonic neoplasms	D003110	—	C18	55	104	72	2	16	221
Stomach neoplasms	D013274	EFO_0003897	C16	36	139	41	2	16	213
Adenocarcinoma	D000230	—	—	39	139	32	1	10	199
Neoplasm metastasis	D009362	EFO_0009708	—	37	85	31	1	6	149
Liver neoplasms	D008113	EFO_1001513	C22.0	12	60	30	1	20	116
Lymphoma	D008223	—	C85.9	18	49	16	1	7	81

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Indications Phases 3

Indication	MeSH	Ontology	ICD-10	Ph 1	Ph 2	Ph 3	Ph 4	Other	Total
Hepatocellular carcinoma	D006528	—	C22.0	11	66	29	—	19	118
Carcinoma	D002277	—	C80.0	18	66	30	—	11	116
Precursor cell lymphoblastic leukemia-lymphoma	D054198	—	C91.0	19	45	27	—	5	86
Leukemia	D007938	—	C95	11	39	22	—	4	69
Pancreatic ductal carcinoma	D021441	—	—	27	35	6	—	2	62
Gastrointestinal neoplasms	D005770	—	C26.9	20	23	8	—	4	44
Recurrence	D012008	—	—	18	20	6	—	4	42
Biliary tract neoplasms	D001661	—	C24.9	8	34	5	—	3	41
Peritoneal neoplasms	D010534	—	—	13	18	11	—	2	38
Fallopian tube neoplasms	D005185	—	—	16	16	8	—	—	33

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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	—	—	16	27
Triple negative breast neoplasms	D064726	—	—	12	9	—	—	—	16
Endometrial neoplasms	D016889	EFO_0004230	—	12	11	—	—	—	16
Myeloid leukemia acute	D015470	—	C92.0	13	4	—	—	—	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
Aging	D000375	GO_0007568	R41.81	—	2	—	—	9	11
Hodgkin disease	D006689	—	C81	7	5	—	—	—	10
Acinar cell carcinoma	D018267	—	—	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
Acute kidney injury	D058186	—	N17	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

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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
Nutritional status	D009752	—	—	—	—	—	—	5	5
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
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