^
    1d
    Bruton protein-tyrosine kinase (BTK) FDA-approved small molecule inhibitors used for the management of neoplastic and inflammatory disorders. (PubMed, Pharmacol Res)
    Aberrant B cell receptor signaling occurs in several B cell neoplasms including follicular lymphoma (treated with zanubrutinib, a BTK inhibitor), mantle cell lymphoma (acalabrutinib, pirtobrutinib, zanubrutinib), marginal zone lymphoma (zanubrutinib), chronic lymphocytic leukemia and small lymphocytic lymphoma (ibrutinib, acalabrutinib, zanubrutinib, pirtobrutinib), and Waldenström macroglobulinemia (ibrutinib, zanubrutinib)...Pirtobrutinib fails to form a covalent bond and is a reversible BTK inhibitor. The FDA-approvals of rilzabrutinib and remibrutinib (2025) represent the first nononcologic authorizations for BTK antagonists.
    FDA event • Review • Journal
    |
    BTK (Bruton Tyrosine Kinase) • PLCG2 (Phospholipase C Gamma 2) • LYN (LYN Proto-Oncogene Src Family Tyrosine Kinase) • SYK (Spleen tyrosine kinase)
    |
    Imbruvica (ibrutinib) • imatinib • cyclophosphamide • Brukinsa (zanubrutinib) • Calquence (acalabrutinib) • vincristine • prednisone • Jaypirca (pirtobrutinib) • Rhapsido (remibrutinib)
    27d
    CLOU064P12301: A clinical trial to find out how well LOU064 (remibrutinib) works and how safe it is for people with secondary progressive multiple sclerosis (2025-521546-23-00)
    P2/3, N=635, Not yet recruiting, Novartis Pharma AG
    New P2/3 trial
    |
    Rhapsido (remibrutinib)
    29d
    Remibrutinib Open Label Roll-over Post-trial Access Protocol (clinicaltrials.gov)
    P3, N=212, Not yet recruiting, Novartis Pharmaceuticals
    New P3 trial
    |
    Rhapsido (remibrutinib)
    1m
    CLOU064P12301: A clinical trial to find out how well LOU064 (remibrutinib) works and how safe it is for people with secondary progressive multiple sclerosis (2025-521546-23-00)
    P2/3, N=279, Not yet recruiting, Novartis Pharma AG
    New P2/3 trial
    |
    Rhapsido (remibrutinib)
    1m
    A Study to Investigate Efficacy, Safety, and Tolerability of Remibrutinib Compared With Placebo in Adults With CINDU Inadequately Controlled by H1-antihistamines (clinicaltrials.gov)
    P3, N=362, Active, not recruiting, Novartis Pharmaceuticals | Trial completion date: Aug 2028 --> Jun 2029
    Trial completion date • Pan tumor
    |
    Rhapsido (remibrutinib)
    2ms
    Efficacy and Safety of Remibrutinib After Switching From Ocrelizumab in Participants Living With Relapsing Multiple Sclerosis. (clinicaltrials.gov)
    P3, N=360, Recruiting, Novartis Pharmaceuticals | Trial completion date: Dec 2031 --> Jun 2031 | Trial primary completion date: Jan 2030 --> Jul 2029
    Trial completion date • Trial primary completion date • Head-to-Head
    |
    Rhapsido (remibrutinib) • Ocrevus (ocrelizumab)
    2ms
    RELIEF: A Real-world Study of Remibrutinib in Chronic Spontaneous Urticaria Patients (clinicaltrials.gov)
    P=N/A, N=350, Recruiting, Novartis Pharmaceuticals
    New trial • Real-world evidence
    |
    Rhapsido (remibrutinib)
    2ms
    REASSERT: Remibrutinib in Real-world Clinical Practice - a US Sub-study (clinicaltrials.gov)
    P=N/A, N=505, Recruiting, Novartis Pharmaceuticals | Not yet recruiting --> Recruiting
    Enrollment open • Real-world evidence
    |
    Rhapsido (remibrutinib)
    2ms
    REASSERT: Remibrutinib in Real-world Clinical Practice (clinicaltrials.gov)
    P=N/A, N=3280, Recruiting, Novartis Pharmaceuticals | Not yet recruiting --> Recruiting | Trial completion date: Aug 2030 --> Oct 2031 | Trial primary completion date: Aug 2030 --> Oct 2031
    Enrollment open • Trial completion date • Trial primary completion date • Real-world evidence
    |
    Rhapsido (remibrutinib)
    2ms
    Involvement of Btk in Cardiovascular Disease and Its Therapeutic Targeting. (PubMed, Circulation)
    First-generation BTKi such as ibrutinib demonstrate antithrombotic efficacy but are limited by off-target effects, including bleeding and atrial fibrillation. Second- and third-generation inhibitors (eg, acalabrutinib, zanubrutinib, and pirtobrutinib) show enhanced selectivity, reducing cardiovascular toxicity in patients with B-cell malignancies. Highly selective BTKi (fenebrutinib and remibrutinib) do not show bleeding in clinical trials of various autoimmune disorders, and covalent selective BTKi applied at low dosage are expected to selectively inhibit Btk in platelets without bleeding side effects. Preclinical data and early observations from compassionate use in patients with atypical autoimmune thrombosis highlight the potential of BTKi as selective antithrombotic agents beyond traditional therapies. This review conceptualizes and underscores Btk's pivotal role at immune-thrombosis interfaces in atherothrombosis, advocating for precision medicine approaches and innovative platforms to unlock its full therapeutic potential in cardiovascular disease management.
    Review • Journal
    |
    NLRP3 (NLR Family Pyrin Domain Containing 3)
    |
    Imbruvica (ibrutinib) • Brukinsa (zanubrutinib) • Calquence (acalabrutinib) • Jaypirca (pirtobrutinib) • Rhapsido (remibrutinib) • fenebrutinib (RG7845)
    2ms
    REMODEL-2: Efficacy and Safety of Remibrutinib Compared to Teriflunomide in Participants With Relapsing Multiple Sclerosis (RMS) (clinicaltrials.gov)
    P3, N=1011, Active, not recruiting, Novartis Pharmaceuticals | Recruiting --> Active, not recruiting
    Enrollment closed
    |
    Rhapsido (remibrutinib)
    2ms
    REMODEL-1: Efficacy and Safety of Remibrutinib Compared to Teriflunomide in Participants With Relapsing Multiple Sclerosis (RMS) (clinicaltrials.gov)
    P3, N=1001, Active, not recruiting, Novartis Pharmaceuticals | Recruiting --> Active, not recruiting
    Enrollment closed
    |
    Rhapsido (remibrutinib)