TheraRadar
Data updated: May 26, 2026

FUSILEV (levoleucovorin calcium)

Trial Activity: Stable 2 active trials
Oncology Approved 2008-03-07
Jump to: Indications Approvals Trials Competitors Safety Patents

Development Insights

Southwest Autism Research & Resource Center conducting 2 trials (50%)
4 indications explored (Focused)
→ autism spectrum disorder (2 trials)
→ language disorders (2 trials)
→ non hodgkin's lymphoma (1 trials)
2
Indications
--
Phase 3 Trials
18
Years on Market

Details

Status
Discontinued
First Approved
2008-03-07
Routes
INTRAVENOUS
Dosage Forms
SOLUTION, POWDER

Companies

ACROTECH BIOPHARMA
Active Ingredient: LEVOLEUCOVORIN CALCIUM

FUSILEV Approval History

2009
2010
2011
2012
2013
2014
2015
2016
2017
2018
2019
2020
2021
2022
2023
2024
2025
2026
Original
New Indication
New Form
Label Update
24 FDA actions from 2008 to 2020 · 1 indication expansions
Nov 2020 SUPPL
Label · Labeling
FDA Letter Label
Feb 2020 SUPPL
Label · Labeling
FDA Letter Label
Jan 2020 SUPPL
Label · Labeling
FDA Letter Label

What FUSILEV Treats

2 FDA approvals

Originally approved for its first indication in 2008 . Covers 2 distinct patient populations.

  • Other (2)
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Clinical Trial Registry

4 trials
Trial Sponsor ID Phase Status Title
NCT04060017 DOD Leucovorin Ph 2 active not recruiting Early Treatment of Language Impairment in Young Children With Autism Spectrum Disorder With Leucovorin Calcium
NCT04060030 AS Leucovorin Ph 2 recruiting Treatment of Social and Language Deficits With Leucovorin for Young Children With Autism
NCT01820091 SPI-FUS-12-103 Ph 1 withdrawn Phase 1 Study of Fusilev® to Prevent or Reduce Mucositis in Patients With Non-Small Cell Lung Cancer Receiving Folotyn®
NCT01789723 SPI-FUS-12-102 Ph 1 withdrawn Phase 1 Study of Fusilev to Prevent or Reduce Mucositis in Patients With Non-Hodgkin's Lymphoma Receiving Folotyn
🔬

Active Pipeline

Pro

Ongoing clinical trials by development phase

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Key Completed Trials

Pro

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.

FUSILEV FDA Label Details

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Data Sources

FDA Approval: NDA020140 → 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