Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Orelabrutinib · 2 trials · 2 indications
* Expanded disability status scale (EDSS) score increase ≥ 1.0 point from baseline when the baseline score is ≤ 5.0, or ≥ 0.5 points from baseline when the baseline score is \> 5.0, OR * ≥ 20% increase in the Timed 25-Foot Walk Test (T25FWT), OR * ≥ 20% increase in the 9-hole Peg Test (9HPT)
Expanded disability status scale (EDSS) score increase ≥ 1.0 point from baseline when the baseline score is ≤ 5.0, or ≥ 0.5 points from baseline when the baseline score is \> 5.0
| Arm | Type | Description |
|---|---|---|
| Orelabrutinib Group | EXPERIMENTAL | - |
| Placebo Group | PLACEBO_COMPARATOR | - |
| Name | Type | Description |
|---|---|---|
| Orelabrutinib | DRUG | Orally |
| Placebo | DRUG | Orally |
Inclusion Criteria: * 18 to 60 years of age, inclusive * Diagnosed with Primary Progressive MS (PPMS) according to 2017 McDonald criteria * Participant must have documented evidence of disability progression observed during the 24 months before screening. * Expanded disability status scale (EDSS) s...
Orelabrutinib is an investigational small molecule BTK inhibitor being developed by Zenas BioPharma, Inc. (ticker ZBIO) for neurological indications. It is in Phase 3 clinical development for primary progressive and secondary progressive multiple sclerosis, a neurology therapeutic area. It is a placebo-controlled, randomized, double-blind study program in adults 18 years and older.
Orelabrutinib is being studied for primary progressive multiple sclerosis and secondary progressive multiple sclerosis. Both are progressive forms of MS, and the Phase 3 program enrolls adults 18 years and older. The trials are randomized, double-blind, and placebo-controlled, and neither study includes healthy volunteers.
Orelabrutinib targets BTK, Bruton's tyrosine kinase, and acts as a BTK inhibitor. BTK inhibition is the mechanism under study in its multiple sclerosis program. It is a small molecule administered as an oral agent in clinical development for progressive forms of MS.
Zenas BioPharma, Inc., which trades under the ticker ZBIO, is developing orelabrutinib. The company is running the Phase 3 program in primary progressive and secondary progressive multiple sclerosis across sites in the United States, Europe, and other countries.
Orelabrutinib is in Phase 3 clinical development for progressive multiple sclerosis. It is investigational and is not described as approved for any indication. The Phase 3 studies are randomized, double-blind, and placebo-controlled, with enrollment targets of 990 and 705 participants respectively.
Orelabrutinib is being studied in two recruiting Phase 3 trials: NCT07299019 in secondary progressive multiple sclerosis, targeting 990 participants, and NCT07067463 in primary progressive multiple sclerosis, targeting 705 participants. Both enroll adults 18 years and older of all sexes and are conducted across multiple countries including the United States and sites in Europe.