Asset profile

BIIB091

Unknown / undisclosed

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Partialdesign only

Evidence outlook · results not reported

FUSION (NCT05798520) · Relapsing Forms of Multiple Sclerosis

The lead study's design has limits that temper confidence (see the rationale below), and its results have not been reported. This tier describes the design, not an outcome.

FUSION (NCT05798520): The study randomized 127 participants and used quadruple blinding with active and matching-placebo comparator arms. Its primary outcomes included adverse events and new MRI lesions, but no results or statistical comparison have been posted, so the primary endpoint cannot be judged as met or missed.

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Competitive landscape

44 competitors in this universe: 1 direct rival (same mechanism and indication), 0 same-class, 43 same-indication; 39 further along in development.

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DrugStageModalityMechanismEvidence signalReported efficacygraded featured trials
BIIB091: this drugPhase 2—Bruton's tyrosine kinase (BTK)
TolebrutinibPhase 3Small moleculeBruton's tyrosine kinase (BTK)
Aldesleukin (Proleukin)ApprovedRecombinant Cytokine (il-2)Interleukin-2 receptor (IL-2R)
AlemtuzumabApprovedMonoclonal antibodyCD52
BafiertamApprovedSmall moleculeNrf2 pathway (fumaric acid ester)
Cladribine (MAVENCLAD®)ApprovedSmall moleculeAdenosine deaminase-resistant purine analog, DNA synthesis machinery in lymphocytes
CopaxoneApprovedPeptideMyelin basic protein-mimetic immunomodulation
Dimethyl Fumarate (Tecfidera)ApprovedSmall moleculeNrf2 pathway (fumaric acid ester)
Diroximel Fumarate (Vumerity)ApprovedSmall moleculeNrf2 pathway (fumaric acid ester)
DRFApprovedSmall moleculeNrf2 pathway (fumaric acid ester)
Fampridine (Ampyra / Fampyra)ApprovedSmall moleculePotassium Channel Blocker, Voltage-gated potassium channel (Kv), Voltage-gated potassium channels (Kv1/Shaker/KCNA family)
Fingolimod (Gilenya)ApprovedSmall moleculeSphingosine 1-phosphate receptor (S1PR, specifically S1P1), S1P receptor, Sphingosine-1-phosphate receptors (S1P1, S1P3, S1P4, S1P5)
Interferon Beta-1a (Avonex)ApprovedBiologic (subtype unspecified)Type I Interferon receptor (IFNAR)
Interferon Beta-1bApprovedBiologic (subtype unspecified)Interferon beta receptor (type I IFN signaling), Type I interferon receptor
Interferon-Beta1ApprovedBiologic (subtype unspecified)Type I interferon receptor
MayzentApprovedSmall moleculeS1P receptor

…and 29 more. Research shows the complete landscape.

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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.

Upcoming events

No upcoming readouts on record for this asset.

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.

Phase 2 (1)
Phase 1 (5)