TheraRadar
Data updated: May 26, 2026

LEUCOVORIN CALCIUM

Trial Activity: Stable 111 active trials
Oncology Approved 1952-06-20

Leucovorin calcium tablets are indicated to diminish the toxicity and counteract the effects of impaired methotrexate elimination and of inadvertent overdosages of folic acid antagonists.

Source: FDA Label • Hikma
Jump to: Indications Approvals Trials Competitors Safety Patents

Development Insights

ImmunityBio, Inc. conducting 20 trials (7%)
461 indications explored (Broad Platform)
→ colorectal cancer (34 trials)
→ gastric cancer (22 trials)
→ pancreatic cancer (18 trials)
28
Indications
--
Phase 3 Trials
1
Priority Reviews
73
Years on Market

Details

Status
Prescription
First Approved
1952-06-20
Routes
ORAL, Injection, INJECTION, INTRAMUSCULAR, INTRAVENOUS
Dosage Forms
TABLET, Injectable, INJECTABLE, FOR SOLUTION, SOLUTION

Companies

Hikma PHARMACHEMIE QUAD PHARMS ELKINS SINN Teva Pfizer XANODYNE PHARM ABIC PHARMACHEMIE USA INGENUS PHARMS LLC LEADING ANI PHARMS ABRAXIS PHARM Fresenius Kabi PAR PHARM GLAND MEITHEAL HAINAN POLY EPIC PHARMA LLC
Active Ingredient: LEUCOVORIN CALCIUM

LEUCOVORIN CALCIUM Approval History

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Original
New Indication
New Form
Label Update
433 FDA actions from 1952 to 2026 · 3 indication expansions
May 2026 SUPPL
Label · Labeling
Nov 2025 ORIGINAL
Update
Feb 2025 SUPPL
Label · Labeling

What LEUCOVORIN CALCIUM Treats

28 FDA approvals

Originally approved for its first indication in 1952 . Covers 28 distinct patient populations.

  • Other (28)
📋

Clinical Trial Registry

377 trials
Trial Sponsor ID Phase Status Title
NCT06124157 NCI-2023-09214 NCI-2023-09214, AALL2131 Ph 2 recruiting A Study Testing the Combination of Dasatinib or Imatinib to Chemotherapy Treatment With Blinatumomab for Children, Adolescents, and Young Adults With Philadelphia Chromosome Positive (Ph+) or ABL-Class Philadelphia Chromosome-Like (Ph-Like) B-cell Acute Lymphoblastic Leukemia (B-ALL)
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)
NCT04210115 3475-975 MK-3475-975, KEYNOTE-975 Ph 3 active not recruiting Study of Pembrolizumab (MK-3475) Versus Placebo in Participants With Esophageal Carcinoma Who Are Receiving Chemotherapy and Radiation Therapy (MK-3475-975/KEYNOTE-975)
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
NCT02997228 NCI-2016-01961 NCI-2016-01961, NRG-GI004/S1610 Ph 3 active not recruiting Testing the Addition of Atezolizumab to Combination Chemotherapy or Atezolizumab Alone for Metastatic Colon or Rectal Cancer, the COMMIT Study
NCT05564377 NCI-2022-06842 NCI-2022-06842, EAY191 Ph 2 recruiting Targeted Therapy Directed by Genetic Testing in Treating Patients With Locally Advanced or Advanced Solid Tumors, The ComboMATCH Screening Trial
NCT06317662 NCI-2024-01994 NCI-2024-01994, AALL2321 Ph 2 recruiting Testing the Addition of the Anti-cancer Drug Venetoclax and/or the Anti-cancer Immunotherapy Blinatumomab to the Usual Chemotherapy Treatment for Infants With Newly Diagnosed KMT2A-rearranged or KMT2A-non-rearranged Leukemia
NCT06205485 NEO-RT CCTG-CO32 CCTG-CO32, NCI-2023-10515 Ph 3 recruiting Neoadjuvant Chemotherapy, Excision And Observation vs Chemoradiotherapy For Rectal Cancer
NCT05647122 EGRET D9350C00001 2022-501570-18-00 Ph 1 recruiting First in Human Study of AZD9592 in Solid Tumors
NCT07043400 BGB-A317-316 2025-522862-58-00 Ph 3 recruiting A Study to Investigate Tislelizumab Administered as Subcutaneous Injection Versus Intravenous Infusion Plus Chemotherapy in Patients With Unresectable or Metastatic Gastric or Gastroesophageal Junction Adenocarcinoma
NCT07554521 BGB-A317-217 Ph 2 recruiting A Study to Evaluate Efficacy and Safety of Tislelizumab Plus Chemotherapy for Locally Advanced Unresectable or Metastatic Gastric or Gastroesophageal Adenocarcinoma and Esophageal Squamous Cell Carcinoma in Racial and Ethnic Minority Patients in the United States
NCT07318805 C6321001 2025-524387-38-00 Ph 1 recruiting A Study to Learn About the Study Medicine Called PF-08032562 in People With Advanced or Metastatic Solid Tumors
NCT05568095 STAR-221 STAR-221 jRCT2051220179, MOH_2023-04-30_012590 Ph 3 active not recruiting A Clinical Trial of a New Combination Treatment, Domvanalimab and Zimberelimab, Plus Chemotherapy, for People With an Upper Gastrointestinal Tract Cancer That Cannot be Removed With Surgery That Has Spread to Other Parts of the Body
NCT04864067 NOAHS-ARC FONDECYT 11201291 Ph 2 completed No Operation After Short Course Radiotherapy Followed By Consolidation Chemotherapy In Locally Advanced Rectal Cancer
NCT05379595 OrigAMI-1 CR109215 61186372GIC2002, 2021-006629-23 Ph 1, Ph 2 recruiting A Study of Amivantamab Monotherapy and in Addition to Standard-of-Care Chemotherapy in Participants With Advanced or Metastatic Colorectal 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
NCT03109288 170083 17-I-0083 Ph 1, Ph 2 recruiting Targeting Residual Activity By Precision, Biomarker-Guided Combination Therapies of Multiple Sclerosis (TRAP-MS)
NCT03801876 NRG-GI006 NCI-2018-03378, NRG-GI006 Ph 3 recruiting Comparing Proton Therapy to Photon Radiation Therapy for Esophageal Cancer
NCT07076212 103973 Ph 2 recruiting Evaluating NALIRIFOX vs Modified Gemcitabine, Nab-Paclitaxel and Cisplatin in Patients With Locally Advanced and Metastatic Pancreatic Adenocarcinoma
NCT05365581 2138-CL-0101 jRCT2031210644, CTR20241945 Ph 1 recruiting A Study of ASP2138 Given by Itself or Given With Other Cancer Treatments in Adults With Stomach Cancer, Gastroesophageal Junction Cancer, or Pancreatic Cancer
NCT05355701 C4761001 BRAF Class 2 Ph 1 recruiting A Study to Learn About the Study Medicine Called PF-07799933 in People With Advanced Solid Tumors With BRAF Alterations.
NCT05863195 EA2222 NCI-2023-02357, EA2222 Ph 3 recruiting Testing Pump Chemotherapy in Addition to Standard of Care Chemotherapy Versus Standard of Care Chemotherapy Alone for Patients With Unresectable Colorectal Liver Metastases: The PUMP Trial
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
NCT05146739 results posted NCI-2021-10020 NCI-2021-10020, PEPN2113-APAL2020C Ph 1 active not recruiting Highest Dose of Uproleselan in Combination With Fludarabine and Cytarabine for Patients With Acute Myeloid Leukemia, Myelodysplastic Syndrome, or Mixed Phenotype Acute Leukemia Relapsed or Refractory That Expresses E-selectin Ligand on the Cell Membrane
NCT05083481 1570-CL-0101 jRCT2031220527, KEYNOTE-E59 Ph 1, Ph 2 active not recruiting A Study of ASP1570 Taken by Itself, or ASP1570 Taken Together With Either Pembrolizumab, Standard Therapies, or Both, in Adults With Solid Tumors
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
NCT04481204 2020-0075 NCI-2020-04886, 2020-0075 Ph 2 withdrawn New and Emerging Therapies for the Treatment of Resectable, Borderline Resectable, or Locally Advanced Pancreatic Cancer, PIONEER-Panc Study
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
NCT05067283 KANDLELIT-001 1084-001 MK-1084-001, jRCT2041220034 Ph 1 recruiting A Study of Calderasib (MK-1084) in KRAS Mutant Advanced Solid Tumors (MK-1084-001)
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
NCT06469944 3475-06C MK-3475-06C, KEYMAKER-06C Ph 1, Ph 2 recruiting Substudy 06C: A Study of Investigational Agents With Pembrolizumab (MK-3475) and Chemotherapy in Participants With First-Line Locally Advanced Unresectable/Metastatic Gastroesophageal Adenocarcinoma (MK-3475-06C/KEYMAKER-U06)
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
NCT05329766 EDGE-Gastric ARC-21 2021-006291-16, 2024-511917-40-00 Ph 2 active not recruiting A Safety and Efficacy Study of Treatment Combinations With and Without Chemotherapy in Adult Participants With Advanced Upper Gastrointestinal Tract Malignancies
NCT06625320 RASolute 302 RMC-6236-302 Ph 3 active not recruiting Phase 3 Study of Daraxonrasib (RMC-6236) in Patients With Previously Treated Metastatic Pancreatic Ductal Adenocarcinoma (PDAC)
NCT05239741 3475-C66 MK-3475-C66 Ph 3 recruiting Study of Pembrolizumab (MK-3475) Versus Chemotherapy in Chinese Participants With Stage IV Colorectal Cancer (MK-3475-C66)
NCT06607185 27237 J5Q-OX-JRDA Ph 1 active not recruiting A Study of the Pan-KRAS Inhibitor LY4066434 in Participants With KRAS Mutant Solid Tumors
NCT04083235 NAPOLI 3 results posted D-US-60010-001 2018-003585-14, 2024-518303-21-00 Ph 3 completed A Study to Assess the Effectiveness and Safety of Irinotecan Liposome Injection, 5-fluorouracil/Leucovorin Plus Oxaliplatin in Patients Not Previously Treated for Metastatic Pancreatic Cancer, Compared to Nab-paclitaxel+Gemcitabine Treatment
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
NCT06586515 MOONRAY-01 27189 J5J-OX-JZZA Ph 1 recruiting MOONRAY-01, A Study of LY3962673 in Participants With KRAS G12D-Mutant Solid Tumors
NCT04615013 2020-0122 NCI-2020-05329, 2020-0122 Ph 1 recruiting NBTXR3, Chemotherapy, and Radiation Therapy for the Treatment of Esophageal Cancer

Showing 50 of 377 trials

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Active Pipeline

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Ongoing clinical trials by development phase

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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 FDA Label Details

Indications & Usage

FDA Label (PDF)

Leucovorin calcium tablets are indicated to diminish the toxicity and counteract the effects of impaired methotrexate elimination and of inadvertent overdosages of folic acid antagonists.

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Data Sources

FDA Approval: ANDA072734 → Label: DailyMed → Patents: FDA Orange Book → Trials: ClinicalTrials.gov →

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

How We Calculate These Metrics

Trial Activity Stage

Measures the current development activity pattern based on trial phases, status, and trends. Important: This measures R&D activity, not commercial lifecycle.

Trial statuses: "Active" means recruiting or ongoing. "Completed" means reached planned endpoint. "Terminated" means stopped early—often due to safety, efficacy, or business reasons.

  • Growth: High proportion of early-phase trials (Phase 1/2), active development
  • Expansion: Significant Phase 3 activity, approaching or pursuing approvals
  • Mature: Substantial Phase 4 post-marketing studies
  • Stable: Mixed phase distribution, steady development
  • Declining: Low active trial ratio, reduced R&D investment