Confirmed

One controlled phase 3 trial met its main goal, and tolebrutinib is approved for this use.

Trial timeline

Phase 320202026

Trial start year. Dot size reflects participants where reported. Only trials that count towards the status are shown.

secondary progressive MS · BTK inhibition (B cells and microglia)

Two or more controlled phase 3 trials met their main goal, or one did and a medicine of this approach is approved for this use.

Trials
3
Running now
2
Controlled phase 2/3 trials
3
People in controlled trials
3396

Deciding trials (phase 3): 1 met, 0 did not.

Other linked trials: 2

Dose comparisons, trials against another medicine, add-on trials, phase 1 and uncontrolled studies. They are listed below but do not set the status.

Trials

  • ZB020-03-002decides the statusOngoing

    Phase 3 · 2026 · Placebo-controlled · MSFT-NCT07299019

  • REMASTERdecides the statusOngoing

    Phase 3 · 2025 · Placebo-controlled · MSFT-NCT07225504

  • HERCULESdecides the statusMet main goal

    Phase 3 · 2020 · Placebo-controlled · MSFT-NCT04411641

The deciding phase and counts come from the Trial Bank’s fixed rules.

Lab evidence

Lab studies in animals or cells. Results in animals often do not hold in people, and these studies never change the status of an idea.

Loading lab studies…

Loading reviews and guidelines…

History

  • 2026-10-28Trials: 2 → 3
  • 2026-10-27First listed as Confirmed

Related hypotheses

Assembled by software from public sources and not checked by people. Each record links to its source. Report an error