Head-to-head evidence

fingolimod (Gilenya) vs ozanimod

Same mechanism, same race: design-graded trial evidence for both assets, with the grading rationale shown. Grades describe the quality of the evidence, never the merits of either security.

Multiple Sclerosis

Shared mechanism: S1P receptor · full Multiple Sclerosis pipeline

fingolimod (Gilenya)

Marketed by Novartis

Approved in Multiple Sclerosissmall molecule
Reliable signal

NCT00289978 · Phase 3 · completed

This was a large randomized, triple-blind, placebo-controlled Phase 3 trial in 1,272 people with multiple sclerosis, using the annualized relapse rate as its primary measure. Both fingolimod doses roughly halved that rate against placebo: 0.16 relapses per year (95% CI 0.13 to 0.19) on 1.25 mg and 0.18 (95% CI 0.15 to 0.22) on 0.5 mg, against 0.40 (95% CI 0.34 to 0.47) on placebo. The registry posts these rates without a statistical test, but the intervals do not overlap, so the direction of the effect is not in doubt.

Next expected readout: September 2027 · NCT04480853 (registry estimate)

Unlock with Research ↗

ozanimod · Zeposia

Marketed by Bristol-Myers Squibb

Approved in Multiple SclerosisSmall molecule (S1P1,5 modulator)
Partial signal

NCT01628393 · Phase 2/3 · completed

The trial was randomized, placebo-controlled and fully blinded in 258 participants, and both ozanimod doses significantly reduced new brain lesions on MRI versus placebo. Because the primary measure was an imaging biomarker rather than a clinical outcome such as relapse rate or disability, this trial supports but does not on its own confirm a clinical benefit.

Next expected readout: August 2028 · NCT06529406 (registry estimate)

Unlock with Research ↗

The full competitive landscape for each asset (every same-race competitor with aligned evidence, sortable) is on the asset pages: fingolimod (Gilenya)'s landscape · ozanimod's landscape