Asset profile
Tolebrutinib
Small molecule
Evidence outlook · lead readout
HERCULES (NCT04411641) · Non-relapsing Secondary Progressive Multiple Sclerosis
The completed lead evidence has the design features that historically survive confirmatory trials: randomized, controlled, and adequately powered against a prespecified clinically accepted endpoint.
HERCULES (NCT04411641): The trial randomized 1,131 participants in a 2:1 ratio to double-blind tolebrutinib or matching placebo, with participants, investigators, and outcome assessors masked. Its primary clinical endpoint—6-month confirmed disability progression measured by EDSS—was statistically met, with a hazard ratio of 0.693 (95% CI 0.546–0.880; p=0.0026).
How the evidence outlook works ↗
Featured trials
The studies most instrumental to this drug's clinical progression, individually graded on design and result. Pick an indication; Research unlocks the trials, endpoints, key results and grades.
Competitive landscape
44 competitors in this universe: 1 direct rival (same mechanism and indication), 0 same-class, 43 same-indication; 27 further along in development.
| Drug | Stage | Modality | Mechanism | Evidence signal | Reported efficacygraded featured trials |
|---|---|---|---|---|---|
| Tolebrutinib: this drug | Phase 3 | Small molecule | Bruton's tyrosine kinase (BTK) | ||
| BIIB091 | Phase 2 | — | Bruton's tyrosine kinase (BTK) | ||
| Aldesleukin (Proleukin) | Approved | Recombinant Cytokine (il-2) | Interleukin-2 receptor (IL-2R) | ||
| Alemtuzumab | Approved | Monoclonal antibody | CD52 | ||
| Bafiertam | Approved | Small molecule | Nrf2 pathway (fumaric acid ester) | ||
| Cladribine (MAVENCLAD®) | Approved | Small molecule | Adenosine deaminase-resistant purine analog, DNA synthesis machinery in lymphocytes | ||
| Copaxone | Approved | Peptide | Myelin basic protein-mimetic immunomodulation | ||
| Dimethyl Fumarate (Tecfidera) | Approved | Small molecule | Nrf2 pathway (fumaric acid ester) | ||
| Diroximel Fumarate (Vumerity) | Approved | Small molecule | Nrf2 pathway (fumaric acid ester) | ||
| DRF | Approved | Small molecule | Nrf2 pathway (fumaric acid ester) | ||
| Fampridine (Ampyra / Fampyra) | Approved | Small molecule | Potassium Channel Blocker, Voltage-gated potassium channel (Kv), Voltage-gated potassium channels (Kv1/Shaker/KCNA family) | ||
| Fingolimod (Gilenya) | Approved | Small molecule | Sphingosine 1-phosphate receptor (S1PR, specifically S1P1), S1P receptor, Sphingosine-1-phosphate receptors (S1P1, S1P3, S1P4, S1P5) | ||
| Interferon Beta-1a (Avonex) | Approved | Biologic (subtype unspecified) | Type I Interferon receptor (IFNAR) | ||
| Interferon Beta-1b | Approved | Biologic (subtype unspecified) | Interferon beta receptor (type I IFN signaling), Type I interferon receptor | ||
| Interferon-Beta1 | Approved | Biologic (subtype unspecified) | Type I interferon receptor | ||
| Mayzent | Approved | Small molecule | S1P receptor |
…and 29 more. Research shows the complete landscape.
Unlock the full comparison
Research adds each competitor's evidence grade and sourced trial results, aligned per race, so you can see who actually has the data.
Compare head-to-head
Upcoming events
(1 total)
Estimated primary-completion dates from ClinicalTrials.gov. These are registry estimates, never confirmed readout dates; they can move as trials progress.
2029 (1)
April 2029 (1)
What to watch
All registered studies
Every ClinicalTrials.gov study of this drug's own program, grouped by indication and phase. Research unlocks the studies themselves: titles, statuses, dates and featured-trial cross-links.