> Trialight public data. Index of pages: https://trialight.com/llms.txt
> Web page: https://trialight.com/data/asset/leucovorin-calcium-8da292ca-1b92-4365-b525-77d897b1c096
> Record changed: 2026-10-13

# Leucovorin calcium

Highest phase reached

Approved

Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL1201138)

Drug type

Small molecule

Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL1201138)

First approval year

1952

Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL1201138)

## Development status

**First approval year**

1952

Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL1201138)

**Listing at source**

Listed

**Highest phase reached**

Approved

Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL1201138)

## Names and chemistry

**Drug type**

Small molecule

Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL1201138)

**Drug name**

Leucovorin calcium

Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL1201138)

**Molecular weight**

511.51

Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL1201138)

**Structure (SMILES)**

Nc1nc(=O)c2c(\[nH\]1)NCC(CNc1ccc(C(=O)N\[C@@H\](CCC(=O)\[O-\])C(=O)\[O-\])cc1)N2C=O.\[Ca+2\]

Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL1201138)

### Brand names (8)

- leucovorin calcium
- Leucovorin calcium
- leucovorin calcium component of folfox
- Leucovorin calcium component of folfox
- leucovorin calcium preservative free
- Leucovorin calcium preservative free
- wellcovorin
- Wellcovorin

### Other names (54)

- 5 fluorouracil leucovorin calcium
- anhydrous calcium folinate
- Anhydrous calcium folinate
- calcium folinate
- Calcium folinate
- CALCIUM FOLINATE \[EP MONOGRAPH\]
- calcium folinate \[INN\]
- CALCIUM FOLINATE \[JAN\]
- CALCIUM FOLINATE \[MART.\]
- CALCIUM FOLINATE \[VANDF\]
- Calcium folinate \[WHO-DD\]
- calcium folinate ep monograph
- calcium folinate inn
- calcium folinate jan
- calcium folinate mart
- calcium folinate pentahydrate
- Calcium folinate pentahydrate
- calcium folinate vandf
- calcium folinate who dd
- calcium n p 6rs 2 amino 5 formyl 5 6 7 8 tetrahydro 4 hydroxy 6 pteridinyl methyl amino benzoyl l glutamate 1 1
- CALCIUM N-(P-((((6RS)-2-AMINO-5-FORMYL-5,6,7,8-TETRAHYDRO-4-HYDROXY-6-PTERIDINYL)METHYL)AMINO)BENZOYL)-L-GLUTAMATE (1:1)
- folfox component leucovorin calcium
- Folfox component leucovorin calcium
- folic acid related compound a
- Folic acid related compound a

And 29 more, listed on the interactive page.

## Identifiers

**ATC classification codes**

- V03AF03

Sources for recorded values

Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL1201138)

**CAS registry numbers**

- 1492-18-8

**ChEMBL ID**

CHEMBL1201138

Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL1201138)

**InChIKey**

KVUAALJSMIVURS-ZEDZUCNESA-L

Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL1201138)

**RxNorm IDs (RxCUI)**

- 225852

**FDA ingredient codes (UNII)**

- RPR1R4C0P4

### PubChem compound IDs (3)

- 78759347
- 135403647
- 135883785

## Regulatory information

### United States

**Applicant**

AVYXA HOLDINGS

**Approval date**

3 Feb 2026

**Application number**

NDA220406

### Other regulatory facts

**Patents**

1

**Designations**

2

**Earliest recorded loss of exclusivity**

23 Dec 2044

**First in class**

No

**Fast track**

No

**Breakthrough designation**

No

**Orphan designation**

No

**Priority review**

No

**Orphan exclusivity**

No

**Accelerated approval**

No

**Availability**

Prescription only

## Pharmacology

### Drug classification

#### Administration routes

- Oral
- Parenteral

### Investigated indications (114)

- **Condition**  
Leukemia, Biphenotypic, Acute

**Highest recorded phase**  
3

**Condition identifier**  
EFO:0000094

**Subject identifier**  
D015456
- **Condition**  
Stomach Neoplasms

**Highest recorded phase**  
3

**Condition identifier**  
EFO:0000178

**Subject identifier**  
D013274
- **Condition**  
Carcinoma, Squamous Cell

**Highest recorded phase**  
1

**Condition identifier**  
EFO:0000181

**Subject identifier**  
D002294
- **Condition**  
Carcinoma, Hepatocellular

**Highest recorded phase**  
3

**Condition identifier**  
EFO:0000182

**Subject identifier**  
D006528
- **Condition**  
Hodgkin Disease

**Highest recorded phase**  
2

**Condition identifier**  
EFO:0000183

**Subject identifier**  
D006689
- **Condition**  
Myelodysplastic Syndromes

**Highest recorded phase**  
1

**Condition identifier**  
EFO:0000198

**Subject identifier**  
D009190
- **Condition**  
Neoplasms, Plasma Cell

**Highest recorded phase**  
2

**Condition identifier**  
EFO:0000200

**Subject identifier**  
D054219
- **Condition**  
Leukemia, Biphenotypic, Acute

**Highest recorded phase**  
3

**Condition identifier**  
EFO:0000209

**Subject identifier**  
D015456
- **Condition**  
Lymphoma, T-Cell, Peripheral

**Highest recorded phase**  
2

**Condition identifier**  
EFO:0000211

**Subject identifier**  
D016411
- **Condition**  
Precursor Cell Lymphoblastic Leukemia-Lymphoma

**Highest recorded phase**  
3

**Condition identifier**  
EFO:0000220

**Subject identifier**  
D054198
- **Condition**  
Leukemia, Myeloid, Acute

**Highest recorded phase**  
1

**Condition identifier**  
EFO:0000222

**Subject identifier**  
D015470
- **Condition**  
Adenocarcinoma

**Highest recorded phase**  
3

**Condition identifier**  
EFO:0000228

**Subject identifier**  
D000230
- **Condition**  
Burkitt Lymphoma

**Highest recorded phase**  
2

**Condition identifier**  
EFO:0000309

**Subject identifier**  
D002051
- **Condition**  
Carcinoma

**Highest recorded phase**  
3

**Condition identifier**  
EFO:0000313

**Subject identifier**  
D002277
- **Condition**  
Colorectal Neoplasms

**Highest recorded phase**  
3

**Condition identifier**  
EFO:0000365

**Subject identifier**  
D015179
- **Condition**  
Lymphoma, Large B-Cell, Diffuse

**Highest recorded phase**  
2

**Condition identifier**  
EFO:0000403

**Subject identifier**  
D016403
- **Condition**  
Stomach Neoplasms

**Highest recorded phase**  
3

**Condition identifier**  
EFO:0000503

**Subject identifier**  
D013274
- **Condition**  
Leukemia

**Highest recorded phase**  
3

**Condition identifier**  
EFO:0000565

**Subject identifier**  
D007938
- **Condition**  
Lymphoma

**Highest recorded phase**  
3

**Condition identifier**  
EFO:0000574

**Subject identifier**  
D008223
- **Condition**  
Neoplasms

**Highest recorded phase**  
3

**Condition identifier**  
EFO:0000616

**Subject identifier**  
D009369
- **Condition**  
Osteosarcoma

**Highest recorded phase**  
4

**Condition identifier**  
EFO:0000637

**Subject identifier**  
D012516
- **Condition**  
Arthritis, Rheumatoid

**Highest recorded phase**  
2

**Condition identifier**  
EFO:0000685

**Subject identifier**  
D001172
- **Condition**  
Sarcoma

**Highest recorded phase**  
2

**Condition identifier**  
EFO:0000691

**Subject identifier**  
D012509
- **Condition**  
Carcinoma, Squamous Cell

**Highest recorded phase**  
1

**Condition identifier**  
EFO:0000707

**Subject identifier**  
D002294
- **Condition**  
Melanoma

**Highest recorded phase**  
1

**Condition identifier**  
EFO:0000756

**Subject identifier**  
D008545

And 89 more, listed on the interactive page.

### Open Targets indications (148)

- **Condition identifier**  
EFO\_0000182

**Highest recorded phase**  
3
- **Condition identifier**  
EFO\_0000220

**Highest recorded phase**  
3
- **Condition identifier**  
EFO\_0000228

**Highest recorded phase**  
3
- **Condition identifier**  
EFO\_0000365

**Highest recorded phase**  
3
- **Condition identifier**  
EFO\_0000503

**Highest recorded phase**  
3
- **Condition identifier**  
EFO\_0000565

**Highest recorded phase**  
3
- **Condition identifier**  
EFO\_0000574

**Highest recorded phase**  
3
- **Condition identifier**  
EFO\_0000616

**Highest recorded phase**  
3
- **Condition identifier**  
EFO\_0000637
- **Condition identifier**  
EFO\_0001064

**Highest recorded phase**  
3
- **Condition identifier**  
EFO\_0002618

**Highest recorded phase**  
3
- **Condition identifier**  
EFO\_0002916

**Highest recorded phase**  
3
- **Condition identifier**  
EFO\_0003060

**Highest recorded phase**  
2
- **Condition identifier**  
EFO\_0003100
- **Condition identifier**  
EFO\_0003833
- **Condition identifier**  
EFO\_0003860

**Highest recorded phase**  
3
- **Condition identifier**  
EFO\_0003891

**Highest recorded phase**  
2
- **Condition identifier**  
EFO\_0003897

**Highest recorded phase**  
3
- **Condition identifier**  
EFO\_0004142

**Highest recorded phase**  
3
- **Condition identifier**  
EFO\_0004288
- **Condition identifier**  
EFO\_0005221

**Highest recorded phase**  
2
- **Condition identifier**  
EFO\_0006859

**Highest recorded phase**  
2
- **Condition identifier**  
EFO\_0007517

**Highest recorded phase**  
1
- **Condition identifier**  
EFO\_0009708

**Highest recorded phase**  
3
- **Condition identifier**  
EFO\_1000318

**Highest recorded phase**  
2

And 123 more, listed on the interactive page.

### Reported adverse events (22)

- **Event**  
abdominal pain

**Reports**  
270

**Reporting signal score**

99.8297
- **Event**  
bone marrow failure

**Reports**  
108

**Reporting signal score**

126.956
- **Event**  
dehydration

**Reports**  
252

**Reporting signal score**

177.397
- **Event**  
diarrhoea

**Reports**  
734

**Reporting signal score**

342.031
- **Event**  
drug toxicity

**Reports**  
67

**Reporting signal score**

100.173
- **Event**  
febrile neutropenia

**Reports**  
357

**Reporting signal score**

510.055
- **Event**  
haematotoxicity

**Reports**  
64

**Reporting signal score**

99.7886
- **Event**  
injection site pain

**Reports**  
2

**Reporting signal score**

82.2819
- **Event**  
leukopenia

**Reports**  
143

**Reporting signal score**

107.823
- **Event**  
mucosal inflammation

**Reports**  
143

**Reporting signal score**

187.716
- **Event**  
nausea

**Reports**  
510

**Reporting signal score**

82.1883
- **Event**  
neuropathy peripheral

**Reports**  
260

**Reporting signal score**

242.03
- **Event**  
neurotoxicity

**Reports**  
111

**Reporting signal score**

161.418
- **Event**  
neutropenia

**Reports**  
635

**Reporting signal score**

806.836
- **Event**  
palmar-plantar erythrodysaesthesia syndrome

**Reports**  
95

**Reporting signal score**

106.078
- **Event**  
pulmonary embolism

**Reports**  
146

**Reporting signal score**

80.2798
- **Event**  
pyrexia

**Reports**  
382

**Reporting signal score**

120.148
- **Event**  
skin toxicity

**Reports**  
52

**Reporting signal score**

94.825
- **Event**  
small intestinal obstruction

**Reports**  
60

**Reporting signal score**

85.0207
- **Event**  
stomatitis

**Reports**  
138

**Reporting signal score**

124.09
- **Event**  
thrombocytopenia

**Reports**  
295

**Reporting signal score**

207.248
- **Event**  
vomiting

**Reports**  
494

**Reporting signal score**

171.032

### Trial references (898)

- NCT00000658  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT00000658)
- NCT03169790  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT03169790)
- NCT00000714  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT00000714)
- NCT00000724  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT00000724)
- NCT00000730  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT00000730)
- NCT00001013  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT00001013)
- NCT00001014  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT00001014)
- NCT00001016  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT00001016)
- NCT00000794  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT00000794)
- NCT00000966  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT00000966)
- NCT00001449  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT00001449)
- NCT00003331  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT00003331)
- NCT00003925  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT00003925)
- NCT00004913  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT00004913)
- NCT00005068  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT00005068)
- NCT00007878  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT00007878)
- NCT00009815  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT00009815)
- NCT00009828  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT00009828)
- NCT00020488  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT00020488)
- NCT00021073  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT00021073)
- NCT00042861  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT00042861)
- NCT00042874  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT00042874)
- NCT00043121  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT00043121)
- NCT00044785  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT00044785)
- NCT00080990  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT00080990)

And 873 more, listed on the interactive page.

## Dosing

**Dose**

1-2 mg/kg/day (for patients less than 40kg) or 1-2 mg/kg/day (for patients 40kg or more)

**Route**

Oral

**How often**

Once daily or in divided doses up to 6 times per day

### Conditions of use (2)

- Administer with or without food
- Do not crush

## Chemical properties

**Hydrogen bond acceptors**

9

**Hydrogen bond donors**

7

**Polar surface area**

219.84

**Calculated partition coefficient (ALogP)**

\-0.73

**Prodrug**

No

**Chirality**

Racemic

**Inorganic**

No

**Rule-of-five violations**

1

**Rotatable bonds**

10

**Heavy atoms**

35

**Molecular formula**

C20H21CaN7O7

**Monoisotopic mass**

511.1128369

**Natural product**

Yes

## National Drug Codes

- 0054-4496
- 0054-4497
- 0054-4498
- 0054-4499
- 0054-8496
- 0069-5886
- 0143-9368
- 0143-9552
- 0143-9553
- 0143-9554
- 0143-9555
- 0555-0484
- 0555-0485
- 0904-7584
- 25021-813
- 25021-814
- 25021-815
- 25021-816
- 25021-828
- 42806-133
- 42806-134
- 42806-358
- 42806-359
- 50742-181
- 50742-182

And 36 more, listed on the interactive page.

## Evidence counts

**Recorded assays**

1

**Active assays**

0

## Related records

### Trials (423)

- 05-001: Treatment of Acute Lymphoblastic Leukemia in Children
- 5-FU Based Maintenance Therapy in RAS Wild Type Metastatic Colorectal Cancer After Induction With FOLFOX Plus Panitumumab
- A Compassionate Treatment Protocol for the Use of Trimetrexate Glucuronate (Neutrexin) With Leucovorin Protection for European Adult Patients (>= 13 Years Old) With Pneumocystis Carinii Pneumonia
- A Compassionate Treatment Protocol for the Use of Trimetrexate Glucuronate With Leucovorin Protection for Patients With Pneumocystis Carinii Pneumonia.
- A Multicenter, Clinical Study of FOLFOXIRI With Bevacizumab As First-line Therapy in Patients With mCRC
- A Phase 2 Study of Ruxolitinib With Chemotherapy in Children With Acute Lymphoblastic Leukemia
- A Phase I, Pharmacological, and Biological Study of OSI-774 in Combination With FOLFOX 4 (5-FU, Leucovorin, and Oxaliplatin) and Bevacizumab (Avastin) in Patients With Advanced Colorectal Cancer
- A Phase II Study of Envofolimab and BD0801 With/Without Chemotherapy in Patients With Advanced Solid Tumors
- A Phase III Randomized Trial of Low-Dose Versus Standard-Dose mBACOD Chemotherapy With rGM-CSF for Treatment of AIDS-Associated Non-Hodgkin's Lymphoma
- A Pilot Study of Oral Clindamycin and Pyrimethamine for the Treatment of Toxoplasmic Encephalitis in Patients With AIDS
- A Randomized, Double-Blind, Placebo Controlled Study of l-Leucovorin in Combination With Trimethoprim / Sulfamethoxazole in the Therapy of Pneumocystis Carinii Pneumonia in Patients With the Acquired Immunodeficiency Syndrome
- A Study of Amivantamab and FOLFIRI Versus Cetuximab/Bevacizumab and FOLFIRI in Participants With KRAS/NRAS and BRAF Wild-type Colorectal Cancer Who Have Previously Received Chemotherapy
- [A Study of Amivantamab and mFOLFOX6 or FOLFIRI Versus Cetuximab and mFOLFOX6 or FOLFIRI as First-line Treatment in Participants With KRAS/NRAS and BRAF Wild-type Unresectable or Metastatic Left-sided Colorectal Cancer](https://trialight.com/data/trial/a-study-of-amivantamab-and-mfolfox6-or-folfiri-versus-f08135dc-3ba8-4c39-aaab-784557b79343.md)
- A Study of Azithromycin Plus Pyrimethamine in the Treatment of a Brain Infection in Patients With AIDS
- A Study of DKN-01 in Combination With Tislelizumab ± Chemotherapy in Patients With Gastric or Gastroesophageal Cancer
- A Study of MRG007 Combination Therapy for Advanced Colorectal Cancer
- A Study of Neutrexin Plus Leucovorin in the Treatment of Pneumocystis Carinii Pneumonia (PCP)
- A Study of Pyrimethamine in the Treatment of Infection by a Certain Parasite in HIV-Positive Patients
- A Study of Trimetrexate in the Treatment of Pneumocystis Carinii Pneumonia (PCP) in Patients With AIDS Not Previously Treated for PCP
- A Study of Trimetrexate Plus Leucovorin in Children With Pneumocystis Carinii Pneumonia

### Approved for (1)

- [Osteosarcoma](https://trialight.com/data/condition/osteosarcoma-d6ad580f-c521-585b-9a22-26006b6bff2b.md)

### In development for (111)

- Acute lymphoblastic leukemia Phase 3
- [Acute myeloid leukemia](https://trialight.com/data/condition/acute-myeloid-leukemia-b0971a7a-c18d-544e-bd7f-b1a13b9caa30.md) Phase 1
- [Adenocarcinoma](https://trialight.com/data/condition/adenocarcinoma-b5c321d1-7c49-5bf9-abd0-dfa99dbd5f29.md) Phase 3
- Adult glioblastoma Phase 1
- Anaplastic astrocytoma Phase 1
- Anaplastic large cell lymphoma Phase 2
- Anaplastic oligodendroglioma Phase 1
- Appendix cancer Phase 2
- Autism Phase 2
- Autism spectrum disorder 1 Phase 2
- B-cell acute lymphoblastic leukemia Phase 3
- Bile duct cancer Phase 2
- Bile duct carcinoma Phase 2
- [Biliary tract cancer](https://trialight.com/data/condition/biliary-tract-cancer-6b9535c9-ccaa-5b47-8c46-0d05d39d7c62.md) Phase 3
- [Biliary tract neoplasm](https://trialight.com/data/condition/biliary-tract-neoplasm-5b757066-5940-52f7-aa7d-e5aafdc5b54e.md) Phase 3
- Brain cancer Phase 3
- [Brain neoplasm](https://trialight.com/data/condition/brain-neoplasm-b3dac71b-1d7b-5a65-8f64-89821506ad41.md) Phase 3
- [Breast cancer](https://trialight.com/data/condition/breast-cancer-8ac10da3-93bd-54c5-a93b-265bc6699689.md) Phase 2
- Burkitt lymphoma Phase 2
- [Cancer](https://trialight.com/data/condition/cancer-703b1dfc-4812-50eb-83f4-d7a205d16bdb.md) Phase 3

---

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