Last edition
News about "BTK inhibitor"
Novartis' Remibrutinib Shows Positive Phase III Results in Chronic Inducible Urticaria
Pivotal RemIND trial meets primary endpoint across three major CIndU subtypes, positioning oral remibrutinib as a potential first targeted therapy for inducible chronic hives.
BTK Inhibitor | 19/02/2026 | By News Bureau | 124
Roche's Fenebrutinib Matches Ocrevus in Slowing Disability Progression in PPMS Phase III Trial
Phase III FENtrepid study shows oral BTK inhibitor fenebrutinib achieved non-inferiority to Ocrevus in primary progressive multiple sclerosis, reducing disability progression risk by 12 percent with consistent subgroup benefit.
BTK Inhibitor | 10/02/2026 | By News Bureau | 148
Roche reported positive late-breaking Phase III ACTRIMS data showing fenebrutinib reduced disability progression in Primary Progressive Multiple Sclerosis (PPMS), demonstrating non-inferiority to OCREVUS and reinforcing its potential as a first-in-class oral BTK inhibitor.
BTK Inhibitor | 09/02/2026 | By News Bureau | 131
EU Approves Sanofi's Wayrilz as First BTK Inhibitor for Immune Thrombocytopenia
Sanofi has received EU approval for Wayrilz, the first Bruton’s Tyrosine Kinase (BTK) inhibitor indicated for immune thrombocytopenia, offering a novel multi-immune modulation approach. The approval is based on positive results from LUNA 3 study, which demonstrated rapid and durable platelet responses.
BTK Inhibitor | 24/12/2025 | By News Bureau | 119
In the pivotal FENtrepid trial, Roche’s BTK inhibitor fenebrutinib demonstrated a meaningful reduction in disability progression in Primary Progressive Multiple Sclerosis (PPMS), performing at least on par with OCREVUS—the current standard and only approved treatment for PPMS.
BTK Inhibitor | 15/11/2025 | By Dineshwori | 237
FDA Approves Novartis's Rhapsido as First Oral BTK Inhibitor for Chronic Spontaneous Urticaria
The US Food and Drug Administration (FDA) has approved Novartis’ Rhapsido (remibrutinib) as an oral treatment for adult patients with chronic spontaneous urticaria (CSU) who continue to experience symptoms despite H1 antihistamine therapy.
BTK Inhibitor | 03/10/2025 | By Dineshwori | 365
US FDA Clears Sanofi's Wayrilz, First BTK Inhibitor for ITP
The US FDA approval was based on the pivotal LUNA 3 phase-III study, in which Sanofi’s Wayrilz met the primary and secondary endpoints, showing a positive impact on sustained platelet counts and other ITP symptoms.
BTK Inhibitor | 30/08/2025 | By Dineshwori | 232
Sanofi Reveals Positive Results of Tolebrutinib in HERCULES Phase 3 Study
In the HERCULES study, nrSPMS was defined at baseline as having an SPMS diagnosis with an expanded disability status scale (EDSS) score between 3.0 and 6.5, no clinical relapses for the previous 24 months and documented evidence of disability accumulation in the previous 12 months.
BTK Inhibitor | 03/09/2024 | By Aishwarya | 637
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