Fusilev

(Levoleucovorin)

Phase 3Small molecule

AActavis Inc.

Fusilev is one of 125 small molecule programs targeting Esophageal Squamous Cell Carcinoma. It is currently in Phase 3.

Indications

Total Trials

Active Trials

124

Competitors

FDA Applications

NDA/BLA/ANDA regulatory filings

Patents

Pipeline

Status by Indication[3][1]

Indication

Esophageal Squamous Cell CarcinomaRecruiting

Colorectal NeoplasmsRecruiting

Gastroesophageal AdenocarcinomaRecruiting

Locally Advanced Unresectable or Metastatic Solid Tumors Including Esophageal CancerActive, not recruiting

Acute Lymphoblastic LeukemiaActive, not recruiting

Esophageal Squamous Cell CarcinomaPreclinical

Recruiting

Colorectal NeoplasmsPhase 3

Recruiting

Gastroesophageal AdenocarcinomaPreclinical

Recruiting

Locally Advanced Unresectable or Metastatic Solid Tumors Including Esophageal CancerPhase 2

Active, not recruiting

Acute Lymphoblastic LeukemiaPhase 3

Active, not recruiting

Competition

Competitive Landscape

163 competitors in Acute Lymphoblastic Leukemia

#DrugCompanyPhaseTrials

Oncovin

Eli Lilly

Phase 3

75 2

Adriamycin

Pfizer

Phase 3

40 3

Oncaspar

SServier

Phase 3

48 4

Wellcovorin

EEastern Cooperative Oncology Group

Phase 3

40 5

Elspar

DDutch Childhood Oncology Group

Phase 3

45 6

Cerubidine

EEastern Cooperative Oncology Group

Phase 3

43 7

Fludara

Sanofi

Phase 3

15 8

Iclusig

Takeda

Phase 3

12 9

Neoral

Tepadina

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

Timeline

Expected Milestones

Q1 2027

Phase 2Active, not recruiting

Locally Advanced Unresectable or Metastatic Solid Tumors Including Esophageal Cancer

NCT05945823

Q3 2027

Phase 3Active, not recruiting

Acute Lymphoblastic Leukemia

NCT03007147

Q4 2028

Phase 2Recruiting

Acute Leukemia of Ambiguous Lineage

NCT06317662

Q3 2029

PreclinicalRecruiting

Gastroesophageal Adenocarcinoma

NCT06469944

Clinical

Trials by Indication[1]

First Line Therapy1 trial

Phase II Trial of FOLFOXIGIL Versus FOLFOXIRI as First-line Therapy in Patients With mCRC

Withdrawn·FFujian Cancer Hospital·Phase 2·NCT03222089

Liver Metastases1 trial

Treatment of Colorectal Liver Metastases With Immunotherapy and Bevacizumab

Completed·—·Phase 2·NCT03698461·20 enrolled

Esophageal Squamous Cell Carcinoma1 trial

A Phase 1/2 Open-Label, Umbrella Platform Design Study of Investigational Agents in Combination With Pembrolizumab (MK-3475) With or Without Chemotherapy in Participants With 1L Locally Advanced Unresectable/Metastatic Esophageal Cancer: KEYMAKER-U06 Substudy 06E

Recruiting· Merck & Co. logo

Merck & Co.·Preclinical·NCT06780111·298 enrolled

Acute Leukemia of Ambiguous Lineage1 trial

A Phase 2 Study of Blinatumomab in Combination With Chemotherapy for Infants With Newly Diagnosed Acute Lymphoblastic Leukemia With Randomization of KMT2A-Rearranged Patients to Addition of Venetoclax

Recruiting·NNational Cancer Institute (NCI)·Phase 2·NCT06317662·153 enrolled

Gastric Cancer1 trial

A Phase 3, Randomized, Multicenter, Double-blind Study of the Efficacy and Safety of ONO-4578 Versus Placebo in Combination With Nivolumab and Chemotherapy in Participants With HER2-negative, PD-L1-Positive Advanced or Metastatic Gastric Cancer, Esophagogastric Junction Cancer, or Esophageal Adenocarcinoma

Not yet recruiting· Ono Pharmaceutical Co. Ltd logo

Ono Pharmaceutical Co. Ltd·Phase 3·NCT07818070·600 enrolled

6 more indications

Gastroesophageal Adenocarcinoma1 trial

A Phase 1/2 Open-Label, Umbrella Platform Design Study of Investigational Agents With Pembrolizumab (MK-3475) and Chemotherapy in Participants With 1L Locally Advanced Unresectable/Metastatic Gastroesophageal Adenocarcinoma (Gastric Adenocarcinoma, Gastroesophageal Junction Adenocarcinoma, and Esophageal Adenocarcinoma): Substudy 06C

Recruiting· Merck & Co. logo

Merck & Co.·Preclinical·NCT06469944·160 enrolled

Locally Advanced Unresectable or Metastatic Solid Tumors Including Esophageal Cancer1 trial

A Phase 2 Study of Futibatinib in Combination With PD-1 Antibody-based Standard of Care Therapy in Patients With Solid Tumors.

Active, not recruiting· Taiho Oncology, Inc. logo

Taiho Oncology, Inc.·Phase 2·NCT05945823·53 enrolled

Metastatic Esophageal Squamous Cell Carcinoma1 trial

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.

Terminated· Merck & Co. logo

Merck & Co.·Phase 3·NCT04949256·863 enrolled

Acute Lymphoblastic Leukemia1 trial

International Phase 3 Trial in Philadelphia Chromosome-Positive Acute Lymphoblastic Leukemia (Ph+ALL) Testing Imatinib in Combination With Two Different Cytotoxic Chemotherapy Backbones

Active, not recruiting·CChildren's Oncology Group·Phase 3·NCT03007147·352 enrolled

Esophageal Squamous Cell Carcinoma (ESCC)1 trial

A Randomized, Double-blind, Placebo-controlled Phase 3 Trial of Pembrolizumab (MK-3475) Versus Placebo in Participants With Esophageal Carcinoma Receiving Concurrent Definitive Chemoradiotherapy (KEYNOTE 975)

Completed· Merck & Co. logo

Merck & Co.·Phase 3·NCT04210115·703 enrolled

Colorectal Neoplasms1 trial

An Open-label Randomized Phase 3 Study of Tucatinib in Combination With Trastuzumab and mFOLFOX6 Versus mFOLFOX6 Given With or Without Either Cetuximab or Bevacizumab as First-line Treatment for Subjects With HER2+ Metastatic Colorectal Cancer

Recruiting· Pfizer logo

Pfizer·Phase 3·NCT05253651·400 enrolled

Regulatory

FDA Approval Timeline[4]

Mar 7, 2008

FUSILEV

NDA NDA020140

Sep 29, 2016

LEVOLEUCOVORIN CALCIUM

NDA NDA208723

Oct 19, 2018

KHAPZORY

NDA NDA211226

Sources

References

[1]
ClinicalTrials.gov — 11 trial records for Levoleucovorin. U.S. National Library of Medicine, National Institutes of Health.
[2]
ChEMBL — Levoleucovorin compound record. European Bioinformatics Institute (EMBL-EBI).
[3]
Open Targets Platform — Drug–disease associations for Levoleucovorin. EMBL-EBI & Wellcome Sanger Institute.
[4]
OpenFDA — FDA approval records (NDA NDA211226). U.S. Food & Drug Administration.
[5]
FDA Orange Book — Patent and exclusivity data for Fusilev. U.S. Food & Drug Administration.
[6]
SEC EDGAR — Actavis Inc. company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Modality: Small molecule[2]
Highest Phase: Phase 3[1]
Company: AActavis Inc.

Patent Landscape[5]

Patent Cliff

Mar 25, 2039

Earliest patent expiration — generic entry possible after this date

Patent #Expires

11541012Mar 25, 2039

Fusilev

Status by Indication[3][1]

Competitive Landscape

Expected Milestones

Q1 2027

Q3 2027

Q4 2028

Q3 2029

Trials by Indication[1]

First Line Therapy1 trial

Liver Metastases1 trial

Esophageal Squamous Cell Carcinoma1 trial

Acute Leukemia of Ambiguous Lineage1 trial

Gastric Cancer1 trial

Gastroesophageal Adenocarcinoma1 trial

Locally Advanced Unresectable or Metastatic Solid Tumors Including Esophageal Cancer1 trial

Metastatic Esophageal Squamous Cell Carcinoma1 trial

Acute Lymphoblastic Leukemia1 trial

Esophageal Squamous Cell Carcinoma (ESCC)1 trial

Colorectal Neoplasms1 trial

FDA Approval Timeline[4]

References

Drug Info

Quick Facts

Patent Landscape[5]

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