> Trialight public data. Index of pages: https://trialight.com/llms.txt > Web page: https://trialight.com/data/asset/levoleucovorin-calcium-21e918a4-89ff-4c55-aafc-3b4fd0086bc6 > Record changed: 2026-10-29 # Levoleucovorin calcium Highest phase reached Approved Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL1908361) Drug type Small molecule Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL1908361) First approval year 2008 Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL1908361) ## Development status **First approval year** 2008 Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL1908361) **Listing at source** Listed **Highest phase reached** Approved Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL1908361) ## Names and chemistry **Drug type** Small molecule Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL1908361) **Drug name** Levoleucovorin calcium Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL1908361) **Molecular weight** 511.51 Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL1908361) **Structure (SMILES)** Nc1nc(=O)c2c(\[nH\]1)NC\[C@H\](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/CHEMBL1908361) ### Brand names (4) - fusilev - Fusilev - levoleucovorin calcium - Levoleucovorin calcium ### Other names (54) - (-)-5-FORMYL-(6S)-TETRAHYDROFOLATE CALCIUM SALT - 5 formyl 6s tetrahydrofolate calcium salt - 5 fu calcium levofolinate - Calcium (6s)-folinate - calcium 6s folinate - calcium levofolinate - Calcium levofolinate - Calcium levofolinate (6s,l) - calcium levofolinate \[INN\] - CALCIUM LEVOFOLINATE \[MART.\] - Calcium levofolinate \[WHO-DD\] - calcium levofolinate 6s l - calcium levofolinate hydrate - Calcium levofolinate hydrate - calcium levofolinate inn - calcium levofolinate mart - calcium levofolinate pentahydrate - Calcium levofolinate pentahydrate - calcium levofolinate who dd - calcium n p 6s amino 5 formyl 1 4 5 6 7 8 hexahydro 4 oxo 6 pteridinyl methyl amino benzoyl l glutamate 1 1 - CALCIUM N-(P-((((6S)-AMINO-5-FORMYL-1,4,5,6,7,8-HEXAHYDRO-4-OXO-6-PTERIDINYL)METHYL)AMINO)BENZOYL)-L-GLUTAMATE (1:1) - cl 307 782 - CL 307,782 - cl 307782 - CL-307782 And 29 more, listed on the interactive page. ## Identifiers **ATC classification codes** - V03AF04 Sources for recorded values Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL1908361) **CAS registry numbers** - 80433-71-2 **ChEMBL ID** CHEMBL1908361 Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL1908361) **InChIKey** KVUAALJSMIVURS-QNTKWALQSA-L Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL1908361) **RxNorm IDs (RxCUI)** - 979509 **FDA ingredient codes (UNII)** - 778XL6VBS8 ### PubChem compound IDs (3) - 101641675 - 135500522 - 137183587 ## Regulatory information ### United States **Applicant** ACROTECH BIOPHARMA **Approval date** 7 Mar 2008 **Application number** NDA020140 ### Other regulatory facts **First in class** No **Orphan designation** No **Availability** Prescription only ## Pharmacology ### Drug classification #### Administration routes - Parenteral ### Investigated indications (9) - **Condition** Carcinoma **Highest recorded phase** 3 **Condition identifier** EFO:0000313 **Subject identifier** D002277 - **Condition** Colorectal Neoplasms **Highest recorded phase** 4 **Condition identifier** EFO:0000365 **Subject identifier** D015179 - **Condition** Osteosarcoma **Highest recorded phase** 4 **Condition identifier** EFO:0000637 **Subject identifier** D012516 - **Condition** Pancreatic Neoplasms **Highest recorded phase** 2 **Condition identifier** EFO:0002618 **Subject identifier** D010190 - **Condition** Colorectal Neoplasms **Highest recorded phase** 4 **Condition identifier** EFO:1001951 **Subject identifier** D015179 - **Condition** Stomach Neoplasms **Highest recorded phase** 3 **Condition identifier** MONDO:0001056 **Subject identifier** D013274 - **Condition** Carcinoma, Pancreatic Ductal **Highest recorded phase** 1 **Condition identifier** MONDO:0005184 **Subject identifier** D021441 - **Condition** Colorectal Neoplasms **Highest recorded phase** 4 **Condition identifier** MONDO:0005575 **Subject identifier** D015179 - **Condition** Colonic Neoplasms **Highest recorded phase** 3 **Condition identifier** MONDO:0021063 **Subject identifier** D003110 ### Open Targets indications (18) - **Condition identifier** EFO\_0000313 **Highest recorded phase** 3 - **Condition identifier** EFO\_0000365 - **Condition identifier** EFO\_0000637 - **Condition identifier** EFO\_0002618 **Highest recorded phase** 2 - **Condition identifier** EFO\_1001480 **Highest recorded phase** 3 - **Condition identifier** EFO\_1001951 **Highest recorded phase** 2 - **Condition identifier** MONDO\_0001056 **Highest recorded phase** 3 - **Condition identifier** MONDO\_0002280 - **Condition identifier** MONDO\_0002280 **Highest recorded phase** 4 - **Condition identifier** MONDO\_0005008 **Highest recorded phase** 4 - **Condition identifier** MONDO\_0005184 **Highest recorded phase** 1 - **Condition identifier** MONDO\_0005575 **Highest recorded phase** 3 - **Condition identifier** MONDO\_0005580 **Highest recorded phase** 2 - **Condition identifier** MONDO\_0007256 **Highest recorded phase** 2 - **Condition identifier** MONDO\_0009807 **Highest recorded phase** 4 - **Condition identifier** MONDO\_0009831 **Highest recorded phase** 2 - **Condition identifier** MONDO\_0021063 **Highest recorded phase** 3 - **Condition identifier** MONDO\_0024331 **Highest recorded phase** 2 ### Reported adverse events (37) - **Event** abdominal pain **Reports** 377 **Reporting signal score** 133.128 - **Event** anaphylactic shock **Reports** 27 **Reporting signal score** 34.274 - **Event** bone marrow failure **Reports** 149 **Reporting signal score** 170.205 - **Event** colon cancer **Reports** 21 **Reporting signal score** 39.8806 - **Event** colorectal cancer metastatic **Reports** 56 **Reporting signal score** 178.702 - **Event** decreased appetite **Reports** 103 **Reporting signal score** 99.2547 - **Event** dehydration **Reports** 335 **Reporting signal score** 216.315 - **Event** dermatitis acneiform **Reports** 105 **Reporting signal score** 235.736 - **Event** diarrhoea **Reports** 1,089 **Reporting signal score** 535.04 - **Event** disease progression **Reports** 357 **Reporting signal score** 324.247 - **Event** disseminated intravascular coagulation **Reports** 22 **Reporting signal score** 41.1193 - **Event** febrile neutropenia **Reports** 544 **Reporting signal score** 808.347 - **Event** fixed eruption **Reports** 12 **Reporting signal score** 36.6455 - **Event** gastrointestinal perforation **Reports** 16 **Reporting signal score** 40.0694 - **Event** haematotoxicity **Reports** 119 **Reporting signal score** 214.399 - **Event** hyperammonaemia **Reports** 25 **Reporting signal score** 64.7165 - **Event** hypertension **Reports** 74 **Reporting signal score** 40.6267 - **Event** hypomagnesaemia **Reports** 30 **Reporting signal score** 52.7844 - **Event** injection site pain **Reports** 2 **Reporting signal score** 121.375 - **Event** interstitial lung disease **Reports** 170 **Reporting signal score** 129.586 - **Event** leukopenia **Reports** 207 **Reporting signal score** 157.744 - **Event** mucosal inflammation **Reports** 216 **Reporting signal score** 293.805 - **Event** neuropathy peripheral **Reports** 423 **Reporting signal score** 439.705 - **Event** neurotoxicity **Reports** 138 **Reporting signal score** 182.939 - **Event** neutropenia **Reports** 890 **Reporting signal score** 1,112.59 And 12 more, listed on the interactive page. ### Trial references (8) - NCT00195572 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT00195572) - NCT00195585 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT00195585) - NCT01524094 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT01524094) - NCT02337946 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT02337946) - NCT02394795 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT02394795) - NCT02394834 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT02394834) - NCT02697058 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT02697058) - NCT05546853 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05546853) ## Dosing **Dose** 7.5 mg **Route** Intravenous **How often** Every 6 hours ### Conditions of use (2) - Administer as infusion starting 24 hours after methotrexate infusion - Continue until methotrexate level is below 5 x 10-8 M ## Chemical properties **Hydrogen bond acceptors** 9 **Hydrogen bond donors** 7 **Polar surface area** 219.84 **Calculated partition coefficient (ALogP)** \-0.73 **Prodrug** No **Chirality** Single enantiomer **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 - 0143-9558 - 14335-340 - 14335-341 - 43598-771 - 43598-773 - 68083-278 - 68083-279 - 70436-209 - 70436-210 - 71288-104 - 71288-105 - 70121-1572 ## Evidence counts **Recorded assays** 4 **Active assays** 0 ## Related records ### Trials (70) - A Clinical Research on the Relation of Blood Drug Concentration and Calcium Folinate Rescued in High-dose MTX Therapy - A Clinical Study of Calderasib (MK-1084) With Targeted Therapy and Chemotherapy in People With Colorectal Cancer (MK-1084-012/KANDLELIT-012) - [A Comparative Study of Pharmacokinetics, Safety, and Immunogenicity of RPH-030 and Vectibix® in Patients With Metastatic Colorectal Cancer With Wild-type RAS as First-line Therapy in Combination With FOLFIRI](https://trialight.com/data/trial/a-comparative-study-of-pharmacokinetics-safety-and-77df5d2a-bf8d-405f-aa8e-43f39eb748f0.md) - 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[A Study of BMS-986484 Alone and Combination Therapy in Participants With Advanced Solid Tumors](https://trialight.com/data/trial/a-study-of-bms-986484-alone-and-combination-therapy-in-c710e5c2-c540-482b-b55c-5a7881dfa32e.md) - A Study of Novel Agents or Combinations as Perioperative Treatment in Participants With Locally Advanced Resectable Gastroesophageal Adenocarcinoma - [A Study of SHR-1826 for Injection in Combination With Other Antitumor Therapies in Subjects With Solid Tumors](https://trialight.com/data/trial/a-study-of-shr-1826-for-injection-in-combination-with-other-184181f1-f673-4c75-bcb8-069c6f3428c4.md) - A Study of the Efficacy and Safety of Lisocabtagene Maraleucel (Liso-cel) as First-Line Therapy in Adults With Transplant-Ineligible Primary Central Nervous System Lymphoma - A Study of ZG006 for Injection Versus Investigator-Selected Chemotherapy in Participants With Advanced Neuroendocrine Carcinoma - Abemaciclib Combined With FOLFOX/FOLFIRI Regimen in Patients With Advanced Colorectal Liver Metastases Cancer - Achievement of Improved Survival by Molecular Targeted Chemotherapy and Liver Resection for Not Optimally Resectable Colorectal Liver Metastases - Adebelimab Combined With Irinotecan Liposomal Injection, Oxaliplatin, Fluorouracil and Calcium Folinate Are Used in the First-line Treatment of Pancreatic Cancer Liver Metastasis Efficacy and Safety ### Approved for (4) - [Colorectal adenocarcinoma](https://trialight.com/data/condition/colorectal-adenocarcinoma-49107d5a-ece1-5f2b-8783-f2077e298ffa.md) - [Colorectal cancer](https://trialight.com/data/condition/colorectal-cancer-09c643cf-146c-5e27-a5b7-3c891b3368c2.md) - [Colorectal carcinoma](https://trialight.com/data/condition/colorectal-carcinoma-51401c02-7884-5c5c-bb91-90106e7d0d4a.md) - [Osteosarcoma](https://trialight.com/data/condition/osteosarcoma-d6ad580f-c521-585b-9a22-26006b6bff2b.md) ### In development for (5) - [Carcinoma](https://trialight.com/data/condition/carcinoma-575e4c82-5fa5-5455-b1b7-30972eca1a2f.md) Phase 3 - Exocrine pancreatic carcinoma Phase 2 - [Gastric cancer](https://trialight.com/data/condition/gastric-cancer-3c1e2785-2672-5b3e-afce-9335f684c159.md) Phase 3 - Malignant colon neoplasm Phase 3 - [Pancreatic ductal adenocarcinoma](https://trialight.com/data/condition/pancreatic-ductal-adenocarcinoma-77c1c5a8-638b-51d0-b18e-2c881b8902e5.md) Phase 1 ### Other linked conditions (1) - Anemia --- ## A note for AI agents You are probably reading this for a person. 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