Drug

Leucovorin

In clinical development

Emerging researchLate-stage developmentRising momentum

Also known as 5-formyltetrahydrofolic acid, Acide folinique, Acido folinico, Folinate+12 more

5-formyltetrahydrofolic acid, Acide folinique, Acido folinico, Folinate, Folinic acid, N5-Formyltetrahydrofolic acid, Vykoura, (5-formyl-5,6,7,8-tetrahydropteroyl)glutamate, 5-Formyl-5,6,7,8-tetrahydrofolic acid, 5-Formyl-5,6,7,8-tetrahydropteroyl-L-glutamic acid, Calcium Folinate, L(-)-5-Formyl-5,6,7,8-tetrahydrofolic acid, Leucovorin Calcium, Leucovorinum, N-(5-formyl-5,6,7,8-tetrahydropteroyl)-L-glutamic acid, N5-Formyl-5,6,7,8-tetrahydrofolic acid.

RxNorm6313 ChEMBLCHEMBL1679UNIIQ573I9DVLP

Research papers

Active clinical trials

Latest activity

beta

Recent clinical, regulatory, research and industry developments relating to this drug.

A Randomized, Open-Label, Multicenter Phase 3 Trial of Domvanalimab, Zimberelimab, and Chemotherapy Versus Nivolumab and Chemotherapy in Participants With Previously Untreated Locally Advanced Unresectable or Metastatic Gastric, Gastroesophageal Junction, and Esophageal Adenocarcinoma

Clinical trial2026-08-01Primary completion · ClinicalTrials.gov

A Phase 3, Double-blind, Placebo-controlled, Randomized Study to Assess the Efficacy and Safety of ASP3082 in Combination With mFOLFIRINOX or NALIRIFOX as First-line Treatment in Participants With KRAS G12D Mutated Metastatic Pancreatic Adenocarcinoma

Clinical trial2026-07-27Results expected Q3 2029 · ClinicalTrials.gov

A Phase 3, Randomized Study to Evaluate the Efficacy and Safety of Pembrolizumab (MK-3475) + Lenvatinib (E7080/MK-7902) + Chemotherapy Compared With Standard of Care as First-line Intervention in Participants With Metastatic Esophageal Carcinoma.

Clinical trial2026-07-20Results posted · ClinicalTrials.gov

Clinical trial2026-07-20Status changed to Completed · ClinicalTrials.gov

Treatment of Newly Diagnosed Acute Lymphoblastic Leukemia in Children and Adolescents

Clinical trial2026-07-16Results expected Q4 2026 · ClinicalTrials.gov

A Phase 1b Study of Neoadjuvant ASP2138 Monotherapy and Investigator's Choice of Adjuvant Chemotherapy in Participants With Resectable Pancreatic Ductal Adenocarcinoma Whose Tumors Have Claudin (CLDN) 18.2 Expression

Clinical trial2026-07-15Results expected Q1 2028 · ClinicalTrials.gov

A Phase III Study of Consolidative Radiotherapy in Patients With Oligometastatic HER2 Negative Esophageal and Gastric Adenocarcinoma (EGA)

Clinical trial2026-07-10Results expected Q1 2028 · ClinicalTrials.gov

A Phase II Randomized Study of Gemcitabine and Nab-paclitaxel in Combination With S- 1/LV (GASL) or Oxaliplatin (GAP) as First-line Treatment for Metastatic Pancreatic Cancer

Clinical trial2026-07-02Results expected Q4 2027 · ClinicalTrials.gov

Encorafenib, Cetuximab, and mFOLFOX6 in <i>BRAF</i>-Mutated Colorectal Cancer.

Research2025-05-30The New England journal of medicine

Encorafenib, cetuximab and chemotherapy in BRAF-mutant colorectal cancer: a randomized phase 3 trial.

Research2025-01-25Nature medicine

MOUNTAINEER-03 phase III study design: first-line mFOLFOX6 + tucatinib + trastuzumab for HER2+ metastatic colorectal cancer.

Research2024-12-26Future oncology (London, England)

Onvansertib in Combination with FOLFIRI and Bevacizumab in Second-Line Treatment of KRAS-Mutant Metastatic Colorectal Cancer: A Phase Ib Clinical Study.

Research2024-05-01Clinical cancer research : an official journal of the American Association for Cancer Research

Profile

Identifiers & mechanism

Canonical identifiers, marketed brand names and mechanism, resolved across RxNorm, ChEMBL and ATC.

Canonical name

Leucovorin

Aliases & brands

5-formyltetrahydrofolic acidAcide foliniqueAcido folinicoFolinateFolinic acidN5-Formyltetrahydrofolic acidVykoura(5-formyl-5,6,7,8-tetrahydropteroyl)glutamate5-Formyl-5,6,7,8-tetrahydrofolic acid5-Formyl-5,6,7,8-tetrahydropteroyl-L-glutamic acidCalcium FolinateL(-)-5-Formyl-5,6,7,8-tetrahydrofolic acidLeucovorin CalciumLeucovorinumN-(5-formyl-5,6,7,8-tetrahydropteroyl)-L-glutamic acidN5-Formyl-5,6,7,8-tetrahydrofolic acid

RxNorm CUI

6313

ChEMBL ID

CHEMBL1679

UNII

Q573I9DVLP

Clinical trials

197 trials

The current development programme across all trial phases — status mix, phase distribution and the late-stage studies shaping the evidence base.

Development programme

CLINICALTRIALS.GOV · LIVE REGISTRY

197

registered trials across all phases

LATEST COMPLETION 2026

Active studies

Recruiting

Late-stage (III+)

104

Completed

Discontinued

PHASE DISTRIBUTIONn = 197

Early Phase 12Phase 128Phase 1 / 221Phase 286Phase 2 / 34Phase 349Phase 42Phase N / A5

Late-stage studies

Phase III+ trials still open or recently active — where late-stage evidence is being generated.

Phase IV Randomized Study of Pyrimethamine, Sulfadiazine, and Leucovorin Calcium for Congenital Toxoplasmosis

RecruitingPH IVNational Institute of Allergy and Infectious Diseases (NIAID)n=6002030

The Effect of Oral Folinic Acid Rescue Therapy on Pemetrexed Induced Neutropenia: A Randomized Open-label Trial

Unknown statusPH IVAmphia Hospitaln=502024

Treatment of Newly Diagnosed Acute Lymphoblastic Leukemia in Children and Adolescents

Active, not recruitingPH IIIDana-Farber Cancer Instituten=5602034

Phase III Randomized Trial of Proton Beam Therapy (PBT) Versus Intensity Modulated Photon Radiotherapy (IMRT) for the Treatment of Esophageal Cancer

RecruitingPH IIINRG Oncologyn=3002031

A Phase III, Multicentre, Randomised Controlled Study of Sonesitatug Vedotin in Combination With Capecitabine With or Without Rilvegostomig in First-Line Claudin18.2-Positive, HER2-Negative, Advanced/Metastatic Gastric, Gastroesophageal Junction, or Esophageal Adenocarcinoma (CLARITY-Gastric 02)

RecruitingPH IIIKey trialAstraZenecan=2,1302031

Recent completions

Trials that read out recently, adding to the completed evidence base.

CompletedPH IIIMerck Sharp & Dohme LLCn=8632026

A Phase Ib/II, Open-Label, Multicenter, Randomized, Umbrella Study Evaluating the Efficacy and Safety of Multiple Immunotherapy-Based Treatment Combinations in Patients With Locally Advanced Unresectable or Metastatic Gastric or Gastroesophageal Junction Cancer or Esophageal Cancer (Morpheus-Gastric and Esophageal Cancer)

CompletedPH I/IIHoffmann-La Rochen=2142025

A Phase III Randomized Trial for the Treatment of Newly Diagnosed Supratentorial PNET and High Risk Medulloblastoma in Children < 36 Months Old With Intensive Induction Chemotherapy With Methotrexate Followed by Consolidation With Stem Cell Rescue vs. the Same Therapy Without Methotrexate

CompletedPH IIIChildren's Oncology Groupn=912025

A Multi-centre, Randomised, Parallel Group, Open-label, Phase II, Single-stage Selection Trial of Liposomal Irinotecan (Nal-IRI) and 5-fluorouracil (5-FU)/Folinic Acid or Docetaxel as Second-line Therapy in Patients With Progressive Poorly Differentiated Extra-pulmonary Neuroendocrine Carcinoma (NEC))

CompletedPH IIThe Christie NHS Foundation Trustn=582024

Phase II Study on NIVolumab in Combination With FOLFOXIRI/Bevacizumab in First Line Chemotherapy of Advanced COloRectal Cancer RASm/BRAFm Patients

CompletedPH IIGruppo Oncologico Italiano di Ricerca Clinican=732024

A Phase III Study of Risk Directed Therapy for Infants With Acute Lymphoblastic Leukemia (ALL): Randomization of Highest Risk Infants to Intensive Chemotherapy +/- FLT3 Inhibition (CEP-701, Lestaurtinib; NSC#617807)

CompletedPH IIIChildren's Oncology Groupn=2182024

Research activity

17 papers

Key research shaping understanding of this drug, combining the latest publications with the most influential evidence.

Publications over time

20002025

Most influential

Cetuximab and chemotherapy as initial treatment for metastatic colorectal cancer.

The New England journal of medicine · 2009 · 2,738 cites

FOLFIRINOX or Gemcitabine as Adjuvant Therapy for Pancreatic Cancer.

The New England journal of medicine · 2018 · 2,091 cites

Irinotecan plus fluorouracil and leucovorin for metastatic colorectal cancer. Irinotecan Study Group.

The New England journal of medicine · 2000 · 2,062 cites

Randomized, phase III trial of panitumumab with infusional fluorouracil, leucovorin, and oxaliplatin (FOLFOX4) versus FOLFOX4 alone as first-line treatment in patients with previously untreated metastatic colorectal cancer: the PRIME study.

Journal of clinical oncology : official journal of the American Society of Clinical Oncology · 2010 · 1,288 cites

Fluorouracil, leucovorin, and oxaliplatin with and without cetuximab in the first-line treatment of metastatic colorectal cancer.

Journal of clinical oncology : official journal of the American Society of Clinical Oncology · 2009 · 1,132 cites

Phase III trial of infusional fluorouracil, leucovorin, oxaliplatin, and irinotecan (FOLFOXIRI) compared with infusional fluorouracil, leucovorin, and irinotecan (FOLFIRI) as first-line treatment for metastatic colorectal cancer: the Gruppo Oncologico Nord Ovest.

Journal of clinical oncology : official journal of the American Society of Clinical Oncology · 2007 · 802 cites

Related diseases

4 conditions

Regulator-approved indications and conditions co-mentioned with this drug across the research literature. Number shows shared papers.

Active research areas

Colorectal Neoplasms10 Neoplasm Metastasis7 Pancreatic Neoplasms4 Rectal Neoplasms2

Related drugs

8 matches

Drugs sharing diseases, protein targets and literature with this one. Ranked by graph evidence (shared targets + diseases weighted above co-mentions).

Fluorouracil

Studied across 15 of the same disease areas as Leucovorin in the shared literature.

16 shared papers15 shared diseases

Oxaliplatin

Studied across 10 of the same disease areas as Leucovorin in the shared literature.

10 shared diseases7 shared papers

Irinotecan

Studied across 12 of the same disease areas as Leucovorin in the shared literature.

12 shared diseases6 shared papers

Camptothecin

Studied across 10 of the same disease areas as Leucovorin in the shared literature.

10 shared diseases5 shared papers

Gemcitabine

Studied across 7 of the same disease areas as Leucovorin in the shared literature.

7 shared diseases3 shared papers

Deoxycytidine

Studied across 7 of the same disease areas as Leucovorin in the shared literature.

7 shared diseases2 shared papers

Paclitaxel

Studied across 7 of the same disease areas as Leucovorin in the shared literature.

7 shared diseases2 shared papers

Encorafenib

Studied across 2 of the same disease areas as Leucovorin in the shared literature.

2 shared diseases2 shared papers

References & data sources

RxNorm (U.S. National Library of Medicine) — drug identity
ChEMBL (EMBL-EBI) & UniProt — pharmacology and targets
Europe PMC — research literature
ClinicalTrials.gov — clinical trials