Levofolinate

Phase 2Small molecule

Levofolinate is one of 169 small molecule programs targeting Gastroesophageal Junction Adenocarcinoma. It is currently in Phase 2.

Indications

Total Trials

Active Trials

168

Competitors

Pipeline

Status by Indication[3][1]

Indication

Gastroesophageal Junction AdenocarcinomaRecruiting

Colorectal CancerActive, not recruiting

Pancreatic CancerCompleted

Gastric CancerActive, not recruiting

Gastroesophageal Junction AdenocarcinomaPhase 2

Recruiting

Colorectal CancerPhase 1

Active, not recruiting

Pancreatic CancerPhase 1

Completed

Gastric CancerPhase 2

Active, not recruiting

Competition

Competitive Landscape

335 competitors in Pancreatic Cancer

#DrugCompanyPhaseTrials

Levofolinate

Ono Pharmaceutical Co. Ltd

Phase 2

2 2

Medrol

Pfizer

Preclinical

1 3

Byetta

AstraZeneca

Preclinical

1 4

Feraheme

AAzurity Pharmaceuticals

Preclinical

1 5

MS Contin

HHikma Pharmaceuticals LLC

Preclinical

1 6

Ayvakit Sprinkle

MMemorial Sloan Kettering Cancer Center

Preclinical

1 7

Xylocaine

MMEDRx USA, Inc.

Preclinical

1 8

Sulfonylureas

Eli Lilly

Preclinical

1 9

Active Comparator

Moderna

Preclinical

1 10

Cyclophosphamid

EEssen Biotech

Preclinical

Ranked by pipeline maturity and clinical activity. Current drug highlighted in teal.

Timeline

Expected Milestones

Q4 2026

Phase 1Active, not recruiting

Pancreatic Cancer

NCT06532344

Q3 2027

Phase 2Active, not recruiting

Gastric Cancer

NCT04745988

Q4 2027

Phase 1Active, not recruiting

Colorectal Cancer

NCT06540261

Q2 2031

Phase 2Recruiting

Gastroesophageal Junction Adenocarcinoma

NCT07018570

Clinical

Trials by Indication[1]

Metastatic Colorectal Cancer2 trials

A Study of BBI608 Administrated With FOLFIRI + Bevacizumab in Adult Patients With Metastatic Colorectal Cancer

Completed·SSumitomo Pharma Co., Ltd.·Phase 1·NCT02641873·4 enrolled

A Study of Aflibercept in Combination With FOLFIRI in Patients With Second-Line Metastatic Colorectal Cancer in Japan

Completed· Sanofi logo

Sanofi·Phase 2·NCT01882868·62 enrolled

Pancreatic Cancer2 trials

An Open-label, Uncontrolled Study of ONO-7913 and ONO-4538 in Combination With Modified FOLFIRINOX Therapy, the Standard of Care, as First-line Treatment in Patients With Metastatic Pancreatic Cancer

Active, not recruiting· Ono Pharmaceutical Co. Ltd logo

Ono Pharmaceutical Co. Ltd·Phase 1·NCT06532344·32 enrolled

An Open-label, Uncontrolled Study of ONO-4578 and ONO-4538 in Combination With Standard-of-care Modified FOLFIRINOX (mFFX) or Gemcitabine Plus Nab-paclitaxel (GnP) Therapy as First-line Treatment in Patients With Metastatic Pancreatic Cancer

Completed· Ono Pharmaceutical Co. Ltd logo

Ono Pharmaceutical Co. Ltd·Phase 1·NCT06538207·46 enrolled

Colorectal Cancer1 trial

The Study of ONO-7913, ONO-4538 and the Standard of Care as First-line Treatment in Patients Colorectal Cancer

Active, not recruiting· Ono Pharmaceutical Co. Ltd logo

Ono Pharmaceutical Co. Ltd·Phase 1·NCT06540261·65 enrolled

Gastroesophageal Junction Adenocarcinoma1 trial

An Open Label Phase 2 Study of Total Neoadjuvant Therapy (TNT) Consisting of FLOT With Pembrolizumab and Short Radiation for Patients With Locally Advanced Gastroesophageal Junction Adenocarcinoma

Recruiting·NNational Cancer Center Hospital East·Phase 2·NCT07018570·26 enrolled

Gastric Cancer1 trial

An Open Label Phase 2 Study to Evaluate the Safety and Efficacy of Lenvatinib with Pembrolizumab or Lenvatinib, Pembrolizumab and FLOT in the Neoadjuvant / Adjuvant Treatment for Patients with Gastric Cancer

Active, not recruiting·NNational Cancer Center Hospital East·Phase 2·NCT04745988·43 enrolled

1 more indication

Fluorouracil1 trial

A Study of Irinotecan, Levofolinate, and 5-Fluorouracil (FOLFIRI) Plus Ramucirumab (IMC-1121B)

Completed· Eli Lilly logo

Eli Lilly·Phase 1·NCT01286818·6 enrolled

Sources

References

[1]
ClinicalTrials.gov — 8 trial records for Levofolinate. U.S. National Library of Medicine, National Institutes of Health.
[2]
ChEMBL — Levofolinate compound record. European Bioinformatics Institute (EMBL-EBI).
[3]
Open Targets Platform — Drug–disease associations for Levofolinate. EMBL-EBI & Wellcome Sanger Institute.
[4]
SEC EDGAR — Ono Pharmaceutical Co. Ltd company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Modality: Small molecule[2]
Highest Phase: Phase 2[1]
Company: Ono Pharmaceutical Co. Ltd

Levofolinate

Status by Indication[3][1]

Competitive Landscape

Expected Milestones

Q4 2026

Q3 2027

Q4 2027

Q2 2031

Trials by Indication[1]

Metastatic Colorectal Cancer2 trials

Pancreatic Cancer2 trials

Colorectal Cancer1 trial

Gastroesophageal Junction Adenocarcinoma1 trial

Gastric Cancer1 trial

Fluorouracil1 trial

References

Drug Info

Quick Facts

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