Bioequivalence Study of Tegomil Fumarate in Healthy Humans
In a Phase 1 study, 70 healthy participants received either tegomil fumarate or dimethyl fumarate. The pharmacokinetic analysis showed that the amounts of MMF released from both drugs were bioequivalent, meeting the accepted ratio range. Both medications were well tolerated without serious side effects reported.
- Tags
- #MSResearch
- Most relevant to
- —
- Human efficacy
- Not yet assessed
- Mechanism
- Not yet assessed
- Evidence strength
- Not yet assessed
- Outcome
- Not yet assessed
Why it matters
This study supports that tegomil fumarate can be considered a bioequivalent alternative to dimethyl fumarate, which is significant for relapsing-remitting multiple sclerosis treatment options.
What this does not prove
The study does not confirm treatment efficacy in MS patients, as it was conducted only in healthy volunteers.
Next milestone
No next milestone was established from the available source.
Study facts
- Study design
- Interventional
- Participants / samples
- 70 · basis not reported
- Randomised
- Yes
- Controlled
- Not reported
- Primary endpoint met
- Yes
- Relevant MS type
- RRMS
- Publication date
- 2026-09-29
- Evidence reviewed
- Abstract only
- Regulatory approval
- Yes
- Research areas
- Not classified
Original sources
Supporting passages (13)
study phaseThese were single-center, open-label, randomized, crossover (full replicate design), phase I studies.
study designThese were single-center, open-label, randomized, crossover (full replicate design), phase I studies.
subjectsRESULTS: In total, 70 participants were enrolled (Study 1, N = 40; Study 2, N = 30).
sample sizeIn total, 70 participants were enrolled (Study 1, N = 40; Study 2, N = 30).
randomizedParticipants were randomized to one of two treatment sequences (test-reference-test-reference or reference-test-reference-test), with 7 days between each drug administration.
primary endpoint metIn both studies, pharmacokinetic parameters for MMF were similar between drugs.
regulatory approvalTegomil fumarate is a newly approved treatment for relapsing-remitting multiple sclerosis.
relevant ms typesTegomil fumarate is a newly approved treatment for relapsing-remitting multiple sclerosis.
interventionIn both studies, healthy individuals aged 18-55 years received a single dose of tegomil fumarate (348.4 mg gastro-resistant hard capsule; "test") or an equimolar dose of dimethyl fumarate based on monomethyl fumarate (MMF) release (240.0 mg gastro-resistant hard capsule; "reference").
primary endpointGeometric least-squares mean test/reference ratios for Cmax, AUC0-t, and AUC0-inf (and associated 90% confidence intervals for each) all fell within the accepted range of 80.00-125.00%, thereby demonstrating the bioequivalence of tegomil fumarate versus dimethyl fumarate.
findingsPharmacokinetic analyses showed that a single dose of 348.4 mg tegomil fumarate released the same amount of MMF as an equimolar dose of 240 mg dimethyl fumarate under both low-fed (low-calorie, low-fat) and fed (high-calorie, high-fat) dietary conditions.
publication datePublication date: 2026-09-29
limitationsTitle: Bioequivalence of tegomil fumarate gastro-resistant capsules versus dimethyl fumarate gastro-resistant capsules under different fed conditions: two randomized, crossover, phase I studies.
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