TheraRadar

Pharma Intelligence, Simplified

Data updated: Mar 10, 2026

DIMETHYL FUMARATE

DIMETHYL FUMARATE
Approved 2020-08-17
Jump to: Indications Approvals Trials Competitors Safety Patents
10
Indications
--
Phase 3 Trials
5
Years on Market

Details

Status
Discontinued
First Approved
2020-08-17
Routes
ORAL
Dosage Forms
CAPSULE, DELAYED RELEASE

Companies

SAWAI USA TORRENT SOLA PHARMS ALKEM LABS LTD MACLEODS PHARMS LTD Viatris GLENMARK PHARMS LTD TWI PHARMS AMNEAL ZYDUS PHARMS SHILPA MEDICARE LTD Cipla MSN ACCORD HLTHCARE HETERO LABS LTD III Lupin Aurobindo Pharma PRINSTON INC
Active Ingredient: DIMETHYL FUMARATE

DIMETHYL FUMARATE Approval History

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What DIMETHYL FUMARATE Treats

10 FDA approvals

Originally approved for its first indication in 2020 . Covers 10 distinct patient populations.

  • Other (10)
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Active Pipeline

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Ongoing clinical trials by development phase

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Key Completed Trials

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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.

DIMETHYL FUMARATE FDA Label Details

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Data Sources

FDA Approval: ANDA210285 → Trials: ClinicalTrials.gov →

Data sourced from official FDA and NIH databases. Click links to verify on original sources.