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.

Download report

Favorite

Events Timeline

Commercial

Clinical

Drug

Target

Variants

Financial

Trends

Safety

Events Timeline

YTD

Max

Events

FDA approval date

EMA approval date

Patent expiration date

Study first post date

Last update post date

Start date

Primary completion date

Completion date

Results first post date

Mock data
Subscribe for the real data

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

Hide discontinued

Labels

FDA

EMA

Brand Name	Status	Last Update
enbrace hr	unapproved drug other	2025-12-17
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

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

2221 clinical trials

View more details

Mock data
Subscribe for the real data

Indications Phases 4

Indication	MeSH	Ontology	ICD-10	Ph 1	Ph 2	Ph 3	Ph 4	Other	Total
Colorectal neoplasms	D015179	—	—	142	415	205	12	32	733
Pancreatic neoplasms	D010190	EFO_0003860	C25	98	191	43	1	19	300
Rectal neoplasms	D012004	—	—	47	152	66	1	10	257
Colonic neoplasms	D003110	—	C18	52	102	72	2	12	212
Stomach neoplasms	D013274	EFO_0003897	C16	35	137	41	2	16	211
Adenocarcinoma	D000230	—	—	36	134	30	1	10	191
Neoplasm metastasis	D009362	EFO_0009708	—	34	81	30	1	6	141
Liver neoplasms	D008113	EFO_1001513	C22.0	12	58	31	1	19	114
Esophageal neoplasms	D004938	—	C15	16	53	8	1	5	73
Cholangiocarcinoma	D018281	—	C22.1	7	31	6	1	1	44

Show 22 more

Indications Phases 3

Indication	MeSH	Ontology	ICD-10	Ph 1	Ph 2	Ph 3	Ph 4	Other	Total
Neoplasms	D009369	—	C80	118	109	46	—	5	247
Hepatocellular carcinoma	D006528	—	C22.0	11	64	29	—	19	116
Carcinoma	D002277	—	C80.0	16	65	31	—	11	115
Precursor cell lymphoblastic leukemia-lymphoma	D054198	—	C91.0	18	43	27	—	3	81
Lymphoma	D008223	—	C85.9	18	48	16	—	7	79
Leukemia	D007938	—	C95	11	38	22	—	2	66
Pancreatic ductal carcinoma	D021441	—	—	26	35	6	—	2	61
Gastrointestinal neoplasms	D005770	—	C26.9	19	21	8	—	4	42
Biliary tract neoplasms	D001661	—	C24.9	8	34	5	—	3	41
Non-hodgkin lymphoma	D008228	—	C85.9	11	15	7	—	3	32

Show 131 more

Indications Phases 2

Indication	MeSH	Ontology	ICD-10	Ph 1	Ph 2	Ph 3	Ph 4	Other	Total
Ovarian neoplasms	D010051	EFO_0003893	C56	13	8	—	—	—	19
Myeloid leukemia acute	D015470	—	C92.0	11	3	—	—	—	13
Rheumatoid arthritis	D001172	EFO_0000685	M06.9	5	8	—	—	—	11
Mantle-cell lymphoma	D020522	—	C83.1	4	7	—	—	—	11
Hodgkin disease	D006689	—	C81	7	5	—	—	—	10
Squamous cell carcinoma of head and neck	D000077195	—	—	6	7	—	—	—	10
Arthritis	D001168	EFO_0005856	M05-M14	4	6	—	—	1	10
Triple negative breast neoplasms	D064726	—	—	7	5	—	—	—	9
Squamous cell neoplasms	D018307	—	—	4	9	—	—	—	9
B-cell chronic lymphocytic leukemia	D015451	—	C91.1	5	3	—	—	—	8

Show 130 more

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	5	—	—	—	—	5
Sezary syndrome	D012751	—	C84.1	3	—	—	—	1	4
T-cell lymphoma cutaneous	D016410	—	C84.A	3	—	—	—	1	4
Chondrosarcoma	D002813	—	—	2	—	—	—	—	2
Pseudomyxoma peritonei	D011553	EFO_0007456	—	1	—	—	—	1	2
Thrombocytosis	D013922	—	D75.83	1	—	—	—	—	1
Skin neoplasms	D012878	EFO_0004198	C44	1	—	—	—	—	1
Pharyngeal neoplasms	D010610	—	C14.0	1	—	—	—	—	1
Adult t-cell leukemia-lymphoma	D015459	—	C91.5	1	—	—	—	—	1
T-cell leukemia	D015458	—	—	1	—	—	—	—	1

Show 30 more

Indications Without Phase

Indication	MeSH	Ontology	ICD-10	Ph 1	Ph 2	Ph 3	Ph 4	Other	Total
Folic acid deficiency	D005494	EFO_0001070	E53.8	—	—	—	—	7	7
Gyrate atrophy	D015799	—	—	—	—	—	—	4	4
Spinal dysraphism	D016135	EFO_1001210	Q05	—	—	—	—	4	4
Vitamin b 12 deficiency	D014806	EFO_0000734	E53.8	—	—	—	—	3	3
Malnutrition	D044342	EFO_0008572	E40-E46	—	—	—	—	3	3
Anencephaly	D000757	—	Q00.0	—	—	—	—	2	2
Stents	D015607	—	—	—	—	—	—	1	1
Adjuvant chemoradiotherapy	D059186	—	—	—	—	—	—	1	1
Aggression	D000374	EFO_0003015	—	—	—	—	—	1	1
Brain death	D001926	—	G93.82	—	—	—	—	1	1

Show 29 more

Epidemiology

Epidemiological information for investigational and approved indications

View more details

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