Head-to-head evidence

fingolimod (Gilenya) vs Ponesimod

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)

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Ponesimod

Marketed by Vanda Pharmaceuticals

Approved in Multiple Sclerosissmall molecule
Reliable signal

NCT02425644 · Phase 3 · completed

This large, randomized, double-blind trial compared ponesimod head-to-head against an approved active comparator (teriflunomide) using relapse rate, a core clinical measure of multiple sclerosis activity, and ponesimod met its primary endpoint with a statistically significant roughly 30% relative reduction in relapses.

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