Wednesday, July 8, 2026

Drug profile · INN

dimethyl fumarate

dimethyl fumarate (APO-DIMETHYL FUMARATE) is a kelch-like ech-associated protein 1 inhibitor. Associated with Biogen. Route of administration: oral. Current US regulatory status: approved.

FDA: approved EMA: approved TGA: approved Antineoplastic and immunomodulating agents (L04) L04AX07
US status approved
Patents linked 1
Pipeline programs 9
News articles 1
Drug details — dimethyl fumarate
US status
approved
Class
Antineoplastic and immunomodulating agents (L04)
Route
ORAL
Patents
1
Programs
9
Data quality
0.89

Quick answer

dimethyl fumarate (APO-DIMETHYL FUMARATE) is a kelch-like ech-associated protein 1 inhibitor. Associated with Biogen. Route of administration: oral. Current US regulatory status: approved.

Key facts

INN dimethyl fumarate
Brand APO-DIMETHYL FUMARATE
Mechanism Kelch-like ECH-associated protein 1 inhibitor
Target Kelch-like ECH-associated protein 1
Therapeutic class Antineoplastic and immunomodulating agents (L04)
Route ORAL
Formulation CAPSULE, DELAYED RELEASE
ATC code L04AX07
Originator Biogen

Mechanism of action

Kelch-like ECH-associated protein 1 inhibitor

Primary target: Kelch-like ECH-associated protein 1

Approval history

Authority Status Date
FDA approved
EMA approved
TGA approved

Recent coverage

Pipeline programs

  1. COMB157G3301 Phase 3 · Novartis India · relapsing multiple sclerosis (RMS)
  2. Skilarence gastro-resistant tablets for Adrenomyeloneuropathy Phase 3 · George Institute for · Adrenomyeloneuropathy
  3. TECFIDERA Phase 3 · Biogen · Relapsing-Remitting Multiple Sclerosis
  4. dimethyl fumarate Phase 3 · Biogen · Relapsing-Remitting Multiple Sclerosis
  5. DIMETHYL FUMARATE, DIMETHYL FUMARATE Phase 2 · PARItec · Macular degeneration
  6. Dimethyl fumarate Phase 2 · Xuanwu Hospital · Intracerebral Hemorrhage
  7. deferoxamine Phase 2 · Chinese Academy of · Intracerebral Hemorrhage
  8. NXPTEGO/23/P1-4 Phase 1 · NEURAXPHARM AUSTRALIA PTY · Multiple Sclerosis

Related & competitor drugs

  1. abiraterone acetate Antineoplastic and immunomodulating agents (L02)
  2. anagrelide Antineoplastic and immunomodulating agents (L01)
  3. apremilast Antineoplastic and immunomodulating agents (L04)
  4. arsenic trioxide Antineoplastic and immunomodulating agents (L01)
  5. axitinib Antineoplastic and immunomodulating agents (L01)
  6. azacitidine Antineoplastic and immunomodulating agents (L01)
  1. US 11602515

    Pharmaceutical compositions comprising dimethyl fumarate

    Expires Mon Mar 09 2043 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted

Frequently asked questions

What is dimethyl fumarate?

dimethyl fumarate (APO-DIMETHYL FUMARATE) is a kelch-like ech-associated protein 1 inhibitor. Associated with Biogen. Route of administration: oral. Current US regulatory status: approved.

What is the brand name for dimethyl fumarate?

APO-DIMETHYL FUMARATE is a marketed brand name for dimethyl fumarate. Check FDA Drugs@FDA for the current US label holder and prescribing information.

What is the US approval status of dimethyl fumarate?

dimethyl fumarate has approved status in the United States according to our Drugs@FDA-derived records. Verify on the official FDA label before clinical or commercial decisions.