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 studied for the treatment of progressive forms of multiple sclerosis, specifically primary progressive multiple sclerosis (PPMS) and secondary progressive multiple sclerosis (SPMS). It is currently in Phase 3 clinical development and has not been approved by regulatory authorities.
Orelabrutinib targets Bruton's tyrosine kinase (BTK), an enzyme involved in B cell and microglial signaling. By inhibiting BTK, Orelabrutinib is designed to modulate immune responses that contribute to neurodegeneration in progressive multiple sclerosis. It is being evaluated as a potential disease-modifying therapy for PPMS and SPMS.
Orelabrutinib is being developed by Zenas BioPharma, Inc., a biopharmaceutical company traded on the NASDAQ under the ticker symbol ZBIO. The company is conducting Phase 3 clinical trials to evaluate the drug's safety and efficacy in patients with progressive forms of multiple sclerosis.
Orelabrutinib is currently in Phase 3 clinical development. Two Phase 3 trials are actively recruiting participants: one for primary progressive multiple sclerosis (NCT07067463) and one for secondary progressive multiple sclerosis (NCT07299019). The drug is investigational and has not received FDA approval.
Orelabrutinib is being studied in two Phase 3 trials. NCT07067463 is evaluating the drug in 705 patients with primary progressive multiple sclerosis across multiple countries. NCT07299019 is evaluating the drug in 990 patients with secondary progressive multiple sclerosis. Both trials are randomized, double-blind, and placebo-controlled.
Orelabrutinib is a specific BTK inhibitor developed by Zenas BioPharma. While it shares a mechanism of action with other BTK inhibitors, it is a distinct investigational compound. No alternative names for Orelabrutinib have been disclosed, and it is being studied specifically for progressive forms of multiple sclerosis.