Last reviewed 2026-05-31 · How we verify

dimethyl fumarate - Reference form

Biogen · Phase 1 active Small molecule ✓ Verified May 2026 Quality 0/100

dimethyl fumarate - Reference form is a Small molecule drug developed by Biogen. It is currently in Phase 1 development. Also known as: BG00012 Tecfidera®.

Dimethyl fumarate is a reference form of the compound that has been studied in healthy volunteers to establish its bioequivalence with a test form. The study, conducted by Biogen, aimed to compare the bioavailability of dimethyl fumarate supplied by two different commercial manufacturers.

Likelihood of approval

12.6% vs 9.6% industry baseline

If approved by FDA: likely 2033–2036

Steps remaining: Phase 2 → Phase 3 → NDA/BLA submission

Confidence: Medium

Why this estimate

Baseline phase 1 → approval rate +9.6pp
Industry-wide phase 1 drugs reach approval ~9.6% of the time (BIO/Informa 2023 industry benchmark across all therapeutic areas).
Big-pharma sponsor +3.0pp
Biogen is a top-20 pharma sponsor — historical approval rates run ~3pp above average due to scale, regulatory experience, and trial-design quality.

Predicted approval windows by jurisdiction (conditional on FDA approval)

Regulator	Country	Likely year	Lag vs FDA
FDA	US	2033–2036	—
EMA	EU	2034–2037	+0.7 yr
MHRA	GB	2034–2037	+0.7 yr
Health Canada	CA	2034–2038	+0.9 yr
TGA	AU	2034–2038	+1.2 yr
PMDA	JP	2034–2038	+1.5 yr
NMPA	CN	2035–2039	+2.3 yr
MFDS	KR	2034–2038	+1.4 yr
CDSCO	IN	2034–2039	+1.8 yr
ANVISA	BR	2035–2039	+2.3 yr

Hover any row for the lag rationale. Lag estimates are reduced when the drug has FDA Breakthrough or EMA PRIME designation (sponsors file globally in parallel).

Estimate based on the BIO/Informa industry phase transition rates plus per-drug modifiers for therapeutic area, sponsor type, FDA designations, mechanism, and trial design. Per-jurisdiction lags from Tufts CSDD international approval studies. Not investment, clinical or regulatory advice. Methodology: /methodology#likelihood.

At a glance

Generic name	dimethyl fumarate - Reference form
Also known as	BG00012 Tecfidera®
Sponsor	Biogen
Modality	Small molecule
Phase	Phase 1

Approved indications

No approved indications tracked.

Common side effects

No common side effects on file.

Key clinical trials

A Healthy Volunteer Study to Establish the Bioequivalence of BG00012 Supplied by 2 Different Commercial Manufacturers (PHASE1)

Primary sources

Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.

Source	Used for
ClinicalTrials.gov	Trial enrolment, design, endpoints, results

Competitive intelligence

For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:

dimethyl fumarate - Reference form CI brief — competitive landscape report
dimethyl fumarate - Reference form updates RSS · CI watch RSS
Biogen portfolio CI

Frequently asked questions about dimethyl fumarate - Reference form

What is dimethyl fumarate - Reference form?

dimethyl fumarate - Reference form is a Small molecule drug developed by Biogen.

Who makes dimethyl fumarate - Reference form?

dimethyl fumarate - Reference form is developed by Biogen (see full Biogen pipeline at /company/biogen).

Is dimethyl fumarate - Reference form also known as anything else?

dimethyl fumarate - Reference form is also known as BG00012 Tecfidera®.

What development phase is dimethyl fumarate - Reference form in?

dimethyl fumarate - Reference form is in Phase 1.

Manufacturer: Biogen — full pipeline
Also known as: BG00012 Tecfidera®

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing