TheraRadar
Data updated: May 26, 2026

VYKOURA (leucovorin calcium)

Trial Activity: Stable 43 active trials
Oncology Approved 2026-02-03

Vykoura is a folate analog used to help adult and pediatric patients recover from high-dose methotrexate therapy. It also helps patients who have experienced an overdose of folic acid antagonists or who have trouble clearing methotrexate from their systems. Additionally, it treats certain types of anemia caused by folic acid deficiency and is used alongside fluorouracil to manage metastatic colorectal cancer.

Source: FDA Label • AVYXA HOLDINGS
Jump to: Indications Approvals Trials Competitors Similar Safety Patents

How VYKOURA Works

This drug works by providing a source of reduced folates that does not require the enzyme dihydrofolate reductase to function, allowing it to bypass the block caused by methotrexate. When used with fluorouracil, it converts into a molecule that stabilizes the binding of the chemotherapy to its target enzyme, thymidylate synthase. This stabilization enhances the drug's ability to inhibit DNA repair and replication in cancer cells.

Source: FDA Label

Development Insights

National Cancer Institute (NCI) conducting 23 trials (19%)
399 indications explored (Broad Platform)
→ colorectal cancer (14 trials)
→ acute lymphoblastic leukemia (9 trials)
→ recurrent rectal cancer (9 trials)
1
Indication
--
Phase 3 Trials
0
Years on Market

Details

Status
Prescription
First Approved
2026-02-03
Patent Cliff
2044

Pro Metrics

Patent cliff and revenue data

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Routes
INTRAMUSCULAR, INTRAVENOUS
Dosage Forms
SOLUTION

Companies

AVYXA HOLDINGS
Active Ingredient: LEUCOVORIN CALCIUM

VYKOURA Approval History

Original
New Indication
New Form
Label Update
3 FDA actions from 2026 to 2026
Feb 2026 ORIGINAL
Update · Type 5 - New Formulation or New Manufacturer
FDA Letter Label

What VYKOURA Treats

5 indications

VYKOURA is approved for 5 conditions since its original approval in 2026. These indications span multiple therapeutic areas including oncology, immunology, and more.

  • Methotrexate Toxicity
  • Folic Acid Antagonist Toxicity
  • Dihydrofolate Reductase Inhibitor Toxicity
  • Megaloblastic Anemia
  • Metastatic Colorectal Cancer
Source: FDA Label

VYKOURA Competitive Set

Pro

Three rings of competition based on shared molecular targets and treated indications.

Direct competitors

2

Same target(s) AND same indication — head-to-head.

LEVOLEUCOVORIN CALCIUM
GLAND
2015 4 indic.
CAPECITABINE
AMNEAL PHARMS
2013 9 indic.

MoA expansion candidates

10

Same target(s), different indications — where else is this mechanism being explored?

AXTLE
AVYXA HOLDINGS
2024 2 indic.
JYLAMVO
SHORLA
2022 6 indic.

Indication competitors

10

Same indication, different mechanism — what else might this patient receive?

QUIOFIC
SOLUBIOMIX
2026 2 indic.
JOBEVNE
BIOCON BIOLOGICS
2025 8 indic.
Unlock 16 more competitors across all three rings.
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Filters applied: drops same-active-ingredient (505(b)(2) reformulations), route-mismatch (topical vs systemic), and cross-therapeutic-area matches in same-indication rings.

What's emerging in VYKOURA's indications

See all emerging drugs →

Phase 3 candidates targeting molecules with no FDA-approved drug, in indications VYKOURA treats. First-in-class if their pivotal trials read out positive.

Tiragolumab MTIG7192A / RG6058 ~ Mixed — Ph3 readout
Hoffmann-La Roche
TIGIT · monoclonal antibody (anti-TIGIT) · 10 Phase 3 trials
Ceralasertib AZD6738 ~ Mixed — Ph3 readout
AstraZeneca
ATR · small-molecule ATR kinase inhibitor · 2 Phase 3 trials

Drugs Similar to VYKOURA

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FDA-approved drugs for similar conditions. Compare mechanisms and indications to understand treatment alternatives.

ALYMSYS
BEVACIZUMAB-MALY
1 shared
AMNEAL PHARMS LLC
Shared indications:
Metastatic Colorectal Cancer
AVASTIN
BEVACIZUMAB
1 shared
Roche
Shared indications:
Metastatic colorectal cancer
AVZIVI
BEVACIZUMAB-TNJN
1 shared
BIO-THERA SOLUTIONS LTD
Shared indications:
Metastatic Colorectal Cancer
View all 11 similar drugs Pro
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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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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.

VYKOURA FDA Label Details

Indications & Usage

FDA Label (PDF)

VYKOURA is indicated for the treatment of Methotrexate Toxicity; Folic Acid Antagonist Toxicity; Dihydrofolate Reductase Inhibitor Toxicity; Megaloblastic Anemia; Metastatic Colorectal Cancer.

VYKOURA Patents & Exclusivity

Latest Patent: Dec 2044

Patents (1 active)

US12564592 Expires Dec 23, 2044
Source: FDA Orange Book

Pro Intelligence Preview

Deep insights for VYKOURA

Revenue Insights

  • • Quarterly revenue tracking
  • • Historical trend analysis

Patent Timeline

  • • Cliff: 2044
  • • 9 active patents

Trial Analysis

  • • 123 total trials
  • • Stage: Stable

Competitive Landscape

  • • 11 similar drugs
  • • Same target/indication analysis
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Full approval history • All patents • Revenue trends • Competitor analysis

Data Sources

FDA Approval: NDA220406 → 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