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Data updated: May 26, 2026

LEUCOVORIN CALCIUM PRESERVATIVE FREE (leucovorin calcium)

Oncology Approved 1995-05-23

Leucovorin calcium rescue is indicated after high dose methotrexate therapy in osteosarcoma. Leucovorin calcium is also indicated to diminish the toxicity and counteract the effects of impaired methotrexate elimination and of inadvertent over dosages of folic acid antagonists. Leucovorin calcium is indicated in the treatment of megaloblastic anemias due to folic acid deficiency when oral therapy is not feasible.

Source: FDA Label • SAGENT PHARMS
Jump to: Indications Approvals Trials Competitors Safety Patents
10
Indications
--
Phase 3 Trials
31
Years on Market

Details

Status
Prescription
First Approved
1995-05-23
Routes
INJECTION, INTRAMUSCULAR, INTRAVENOUS
Dosage Forms
INJECTABLE, SOLUTION

Companies

SAGENT PHARMS SAGENT PHARMS INC Fresenius Kabi Hikma Pfizer AM REGENT Viatris Teva
Active Ingredient: LEUCOVORIN CALCIUM

LEUCOVORIN CALCIUM PRESERVATIVE FREE Approval History

1996
1997
1998
1999
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2001
2002
2003
2004
2005
2006
2007
2008
2009
2010
2011
2012
2013
2014
2015
2016
2017
2018
2019
2020
2021
2022
2023
2024
2025
2026
Original
New Indication
New Form
Label Update
34 FDA actions from 1995 to 2017
Oct 2017 ORIGINAL
Update
May 2017 ORIGINAL
Update
Sep 2012 ORIGINAL
Update · Not Applicable

What LEUCOVORIN CALCIUM PRESERVATIVE FREE Treats

10 FDA approvals

Originally approved for its first indication in 1995 . Covers 10 distinct patient populations.

  • Other (10)
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Clinical Trial Registry

122 trials
Trial Sponsor ID Phase Status Title
NCT06696768 NCI-2024-09416 NCI-2024-09416, 10655 Ph 1 recruiting Clinical Trial of an Anti-cancer Drug, CA-4948 (Emavusertib), in Combination With Chemotherapy Treatment (FOLFOX Plus Bevacizumab) in Metastatic Colorectal Cancer
NCT05564403 NCI-2022-07833 NCI-2022-07833, EAY191-A6 Ph 2 active not recruiting Study of Chemotherapy, With or Without Binimetinib in Advanced Biliary Tract Cancers in 2nd Line Setting (A ComboMATCH Treatment Trial)
NCT05836584 NCI-2023-03192 NCI-2023-03192, EA2212 Ph 2 active not recruiting Testing Immunotherapy (Atezolizumab) With or Without Chemotherapy in Locoregional MSI-H/dMMR Gastric and Gastroesophageal Junction (GEJ) Cancer
NCT05677490 A022102 NCI-2022-08569 Ph 3 recruiting mFOLFIRINOX Versus mFOLFOX With or Without Nivolumab for the Treatment of Advanced, Unresectable, or Metastatic HER2 Negative Esophageal, Gastroesophageal Junction, and Gastric Adenocarcinoma
NCT03801876 NRG-GI006 NCI-2018-03378, NRG-GI006 Ph 3 recruiting Comparing Proton Therapy to Photon Radiation Therapy for Esophageal Cancer
NCT04248452 EA2183 NCI-2019-06460, EA2183 Ph 3 active not recruiting Testing the Addition of Radiotherapy to the Usual Treatment (Chemotherapy) for Patients With Esophageal and Gastric Cancer That Has Spread to a Limited Number of Other Places in the Body
NCT04233866 EA2186 NCI-2019-08286, EA2186 Ph 2 active not recruiting Comparing Two Treatment Combinations, Gemcitabine and Nab-Paclitaxel With 5-Fluorouracil, Leucovorin, and Liposomal Irinotecan for Older Patients With Pancreatic Cancer That Has Spread
NCT03959085 AALL1732 NCI-2019-02845, AALL1732 Ph 3 recruiting Inotuzumab Ozogamicin and Post-Induction Chemotherapy in Treating Patients With High-Risk B-ALL, Mixed Phenotype Acute Leukemia, and B-LLy
NCT02912559 results posted NCI-2016-01417 NCI-2016-01417, A021502 Ph 3 active not recruiting Combination Chemotherapy With or Without Atezolizumab in Treating Patients With Stage III Colon Cancer and Deficient DNA Mismatch Repair
NCT06958328 LAP100 NRG-GI011 NCI-2025-01624, NRG-GI011 Ph 3 recruiting Testing Higher Dose Radiation Therapy for Locally Advanced Pancreatic Cancer
NCT02112916 results posted NCI-2014-00712 NCI-2014-00712, s14-01925 Ph 3 active not recruiting Combination Chemotherapy With or Without Bortezomib in Treating Younger Patients With Newly Diagnosed T-Cell Acute Lymphoblastic Leukemia or Stage II-IV T-Cell Lymphoblastic Lymphoma
NCT02101853 results posted NCI-2014-00631 NCI-2014-00631, s15-00970 Ph 3 active not recruiting Blinatumomab in Treating Younger Patients With Relapsed B-cell Acute Lymphoblastic Leukemia
NCT03914625 NCI-2019-02187 NCI-2019-02187, AALL1731 Ph 3 active not recruiting A Study to Investigate Blinatumomab in Combination With Chemotherapy in Patients With Newly Diagnosed B-Lymphoblastic Leukemia
NCT02883049 results posted NCI-2011-03797 NCI-2011-03797, S12-01254 Ph 3 active not recruiting Combination Chemotherapy in Treating Young Patients With Newly Diagnosed High-Risk B Acute Lymphoblastic Leukemia and Ph-Like TKI Sensitive Mutations
NCT02981628 AALL1621 NCI-2016-01494, AALL1621 Ph 2 recruiting Inotuzumab Ozogamicin in Treating Younger Patients With B-Lymphoblastic Lymphoma or Relapsed or Refractory CD22 Positive B Acute Lymphoblastic Leukemia
NCT03007147 AALL1631 NCI-2016-01588, AALL1631 Ph 3 active not recruiting Imatinib Mesylate and Combination Chemotherapy in Treating Patients With Newly Diagnosed Philadelphia Chromosome Positive Acute Lymphoblastic Leukemia
NCT02003222 results posted NCI-2013-02229 NCI-2013-02229, ECOG-E1910 Ph 3 active not recruiting Combination Chemotherapy With or Without Blinatumomab in Treating Patients With Newly Diagnosed BCR-ABL-Negative B Lineage Acute Lymphoblastic Leukemia
NCT07214298 I-4316824 NCI-2025-06680, I-4316824 Ph 1, Ph 2 recruiting Pegcetacoplan in Combination With Modified FOLFIRINOX for the Treatment of Metastatic Pancreatic Ductal Adenocarcinoma
NCT06078709 PHOX GMROR2241 NCI-2023-07432, GMROR2241 Ph 2 recruiting Preoperative Hypofractionated Radiotherapy With FOLFOX for Esophageal or Gastroesophageal Junction Adenocarcinoma
NCT06247787 PEPN2312 NCI-2023-11026, PEPN2312 Ph 1 recruiting A Study to Find the Highest Dose of Imetelstat in Combination With Fludarabine and Cytarabine for Patients With AML, MDS or JMML That Has Come Back or Does Not Respond to Therapy
NCT00792948 results posted NCI-2009-00800 NCI-2009-00800, S0805 Ph 2 active not recruiting Combination Chemotherapy With or Without Donor Stem Cell Transplant in Treating Patients With Acute Lymphoblastic Leukemia
NCT06821997 I-4064824 NCI-2025-00732, I-4064824 Ph 2 recruiting NALIRIFOX Before Surgery for the Treatment of Borderline Resectable Pancreatic Ductal Adenocarcinoma, Nectar Trial
NCT01190930 results posted AALL0932 NCI-2011-02599, CDR0000683227 Ph 3 active not recruiting Risk-Adapted Chemotherapy in Treating Younger Patients With Newly Diagnosed Standard-Risk Acute Lymphoblastic Leukemia or Localized B-Lineage Lymphoblastic Lymphoma
NCT02366819 IRB14-0594 NCI-2014-02574, IRB14-0594 Ph 4 suspended Genetic Analysis-Guided Irinotecan Hydrochloride Dosing of mFOLFIRINOX in Treating Patients With Locally Advanced Gastroesophageal or Stomach Cancer
NCT02723994 INCB 18424-269 AALL1521 Ph 2 completed A Phase 2 Study of Ruxolitinib With Chemotherapy in Children With Acute Lymphoblastic Leukemia
NCT02047474 results posted 1306012255 NCI-2013-02349, 1306012255 Ph 2 completed Combination Chemotherapy Before and After Surgery in Treating Patients With Localized Pancreatic Cancer
NCT02890355 results posted NCI-2015-02248 NCI-2015-02248, S1513 Ph 2 completed FOLFIRI or Modified FOLFIRI and Veliparib as Second Line Therapy in Treating Patients With Metastatic Pancreatic Cancer
NCT04094688 SOLARIS results posted A021703 NCI-2019-01034, U10CA180821 Ph 3 active not recruiting Vitamin D3 With Chemotherapy and Bevacizumab in Treating Patients With Advanced or Metastatic Colorectal Cancer
NCT04340141 A021806 NCI-2020-01560, U10CA180821 Ph 3 active not recruiting Testing the Use of the Usual Chemotherapy Before and After Surgery for Removable Pancreatic Cancer
NCT07363408 25512 NCI-2025-09719, 25512 Ph 1 not yet recruiting Ivonescimab and ADG126, Alone, and in Combination With Leucovorin and Fluorouracil or FOLFIRI Regimen for the Treatment of Microsatellite Stable Advanced/Metastatic Colorectal Cancer
NCT03020030 16-001 Ph 3 active not recruiting Treatment of Newly Diagnosed Acute Lymphoblastic Leukemia in Children and Adolescents
NCT05688215 22-001565 NCI-2022-10208 Ph 1, Ph 2 recruiting Zimberelimab and Quemliclustat in Combination With Chemotherapy for the Treatment of Patients With Borderline Resectable and Locally Advanced Pancreatic Adenocarcinoma
NCT04539808 results posted STUDY00021614 NCI-2020-06277, STUDY00021614 Ph 2 active not recruiting NeoOPTIMIZE: Early Switching of mFOLFIRINOX or Gemcitabine/Nab-Paclitaxel Before Surgery for the Treatment of Resectable, Borderline Resectable, or Locally-Advanced Unresectable Pancreatic Cancer
NCT00335816 mskcc 12-201 P30CA033572, R01CA090559 Ph 2 active not recruiting Radiation Therapy and Fluorouracil With or Without Combination Chemotherapy Followed by Surgery in Treating Patients With Stage II or Stage III Rectal Cancer
NCT05802056 MC220404 NCI-2023-02250, MC220404 Ph 1 recruiting Aldesleukin With Nivolumab and Standard Chemotherapy for Treatment of Gastric Cancer With Peritoneal Metastasis
NCT02553460 results posted TINI NCI-2015-01493 Ph 1, Ph 2 active not recruiting Total Therapy for Infants With Acute Lymphoblastic Leukemia (ALL) I
NCT07271355 24756 NCI-2025-08527, 24756 Ph 3 not yet recruiting Pressurized Intraperitoneal Aerosolized Chemotherapy With Mitomycin for the Treatment of Unresectable Appendix or Colorectal Cancer With Peritoneal Metastases, The IMPACT Trial
NCT05627635 22251 NCI-2022-09458, 22251 Ph 1, Ph 2 active not recruiting FOLFOX and Bevacizumab in Combination With Botensilimab and Balstilimab (3B-FOLFOX) for the Treatment of Microsatellite Stable (MSS) Metastatic Colorectal Cancer
NCT04205968 S1922 NCI-2019-04213, S1922 Ph 2 recruiting Ramucirumab and Paclitaxel or FOLFIRI in Advanced Small Bowel Cancers
NCT04821284 20F.1207 R01CA199646, JT 15477 Ph 1, Ph 2 active not recruiting Sonoporation and Chemotherapy for the Treatment of Pancreatic Cancer
NCT04363801 DisTinGuish results posted DEK-DKK1-P205 Ph 2 terminated A Study of DKN-01 in Combination With Tislelizumab ± Chemotherapy in Patients With Gastric or Gastroesophageal Cancer
NCT05610163 JANUS A022104 NCI-2022-07800, U10CA180821 Ph 2 active not recruiting Testing the Addition of an Anti-Cancer Drug, Irinotecan, to the Standard Chemotherapy Treatment (FOLFOX) After Long-Course Radiation Therapy for Advanced-Stage Rectal Cancers to Improve the Rate of Complete Response and Long-Term Rates of Organ Preservation
NCT06780787 24589 NCI-2025-00072, 24589 Ph 2 recruiting FOLFOX, Botensilimab, and Balstilimab for the Treatment of Localized Rectal Cancer Before Surgery
NCT00873275 08005 P30CA033572, CHNMC-08005 Ph 1 completed Ursodiol, Combination Chemotherapy, and Bevacizumab in Treating Patients With Stage IV Colorectal Cancer
NCT02730546 results posted MC1541 NCI-2016-00508, 15-005311 Ph 1, Ph 2 completed Pembrolizumab, Combination Chemotherapy, and Radiation Therapy Before Surgery in Treating Adult Patients With Locally Advanced Gastroesophageal Junction or Gastric Cardia Cancer That Can Be Removed by Surgery
NCT02419495 2014-0640 NCI-2015-00693, 2014-0640 Ph 1 terminated Phase IB Study to Evaluate the Safety of Selinexor (KPT-330) in Combination With Multiple Standard Chemotherapy or Immunotherapy Agents in Patients With Advanced Malignancies
NCT04068103 results posted NRG-GI005 NCI-2019-01068, NRG-GI005 Ph 2, Ph 3 active not recruiting Circulating Tumor DNA Testing in Predicting Treatment for Patients With Stage IIA Colon Cancer After Surgery
NCT04761614 OSU-20096 NCI-2021-00018 Ph 1 completed Riluzole in Combination With mFOLFOX6 and Bevacizumab in Treating Patients With Metastatic Colorectal Cancer
NCT02828358 results posted NCI-2016-00973 NCI-2016-00973, s17-00488 Ph 2 completed Azacitidine and Combination Chemotherapy in Treating Infants With Acute Lymphoblastic Leukemia and KMT2A Gene Rearrangement
NCT01814501 results posted OSU-11131 NCI-2013-00432 Ph 2 completed Panitumumab and Chemotherapy in Patients With Advanced Colorectal Cancer After Prior Therapy With Bevacizumab

Showing 50 of 122 trials

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Key Completed Trials

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Completed studies with published results, ranked by significance

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Trial Timeline

ClinicalTrials.gov ↗ Pro

Full development history with FDA approval milestones

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Understanding FDA Approval Types
Count Type What it means
- ORIG Original approval - drug first enters market
- SUPPL - Efficacy New indication (new disease/condition approved)
- SUPPL - Labeling Label text changes (warnings, dosing updates)
- SUPPL - Manufacturing Production changes (new facility)
- SUPPL - Chemistry Formulation changes (new dosage strength)

Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.

LEUCOVORIN CALCIUM PRESERVATIVE FREE FDA Label Details

Indications & Usage

FDA Label (PDF)

Leucovorin calcium rescue is indicated after high dose methotrexate therapy in osteosarcoma. Leucovorin calcium is also indicated to diminish the toxicity and counteract the effects of impaired methotrexate elimination and of inadvertent over dosages of folic acid antagonists. Leucovorin calcium is indicated in the treatment of megaloblastic anemias due to folic acid deficiency when oral therapy is not feasible. Leucovorin is also indicated for use in combination with 5-fluorouracil to prolong survival in the palliative treatment of patients with advanced colorectal cancer. Leucovorin should n...

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Data Sources

FDA Approval: ANDA200855 → Label: DailyMed → Trials: ClinicalTrials.gov →

Data sourced from official FDA and NIH databases. Click links to verify on original sources.