^
    3d
    Remibrutinib Open Label Roll-over Post-trial Access Protocol (clinicaltrials.gov)
    P3, N=212, Recruiting, Novartis Pharmaceuticals | Not yet recruiting --> Recruiting
    Enrollment open
    |
    Rhapsido (remibrutinib)
    10d
    Phase 3b Study to Assess the Efficacy, Safety, and Tolerability of Remibrutinib in Comparison to Placebo, With Omalizumab as Active Control, in Adult CSU Patients, Followed by an Open-label 52-week Optional Extension. (clinicaltrials.gov)
    P3, N=470, Active, not recruiting, Novartis Pharmaceuticals | N=218 --> 470
    Enrollment change
    |
    Rhapsido (remibrutinib)
    10d
    RECHARGE-1: A Phase 3 Study to Assess Efficacy Safety and Tolerability of Remibrutinib in Adult and Adolescent Patients With Moderate to Severe Hidradenitis Suppurativa (RECHARGE 1) (clinicaltrials.gov)
    P3, N=555, Recruiting, Novartis Pharmaceuticals | Active, not recruiting --> Recruiting | N=205 --> 555
    Enrollment open • Enrollment change
    |
    Rhapsido (remibrutinib)
    10d
    RECHARGE 2: A Phase 3 Study to Assess Efficacy Safety and Tolerability of Remibrutinib in Adult and Adolescent Patients With Moderate to Severe Hidradenitis Suppurativa (clinicaltrials.gov)
    P3, N=555, Recruiting, Novartis Pharmaceuticals | N=250 --> 555
    Enrollment change
    |
    Rhapsido (remibrutinib)
    10d
    Efficacy and Safety of Remibrutinib After Switching From Ocrelizumab in Participants Living With Relapsing Multiple Sclerosis. (clinicaltrials.gov)
    P3, N=360, Recruiting, Novartis Pharmaceuticals | N=215 --> 360
    Enrollment change • Head-to-Head
    |
    Rhapsido (remibrutinib) • Ocrevus (ocrelizumab)
    13d
    A New Drug Target in Allergic Diseases: Bruton Tyrosine Kinase. (PubMed, J Investig Allergol Clin Immunol)
    Development of the first-generation BTK inhibitor (BTKi), ibrutinib, revolutionized the treatment of B-cell malignancies. Based on limited available data, BTK does not seem to have a prominent role in the pathogenesis of AD, and its role in asthma is unclear, thus necessitating further clinical research. Remibrutinib and rilzabrutinib have shown the most promise in allergic and autoimmune diseases to date; remibrutinib is approved in adults with CSU, and rilzabrutinib is approved in adults with persistent or chronic immune thrombocytopenia.
    Review • Journal
    |
    BTK (Bruton Tyrosine Kinase)
    |
    Imbruvica (ibrutinib) • Rhapsido (remibrutinib)
    13d
    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, Recruiting, Novartis Pharma AG | Not yet recruiting --> Recruiting
    Enrollment open
    |
    Rhapsido (remibrutinib)
    20d
    RECHARGE-1: A Phase 3 study to assess efficacy, safety and tolerability of remibrutinib in adult and adolescent patients with moderate to severe hidradenitis suppurativa (clinicaltrials.gov)
    P3, N=238, Active, not recruiting, Novartis Pharmaceuticals | Recruiting --> Active, not recruiting
    Enrollment closed
    |
    Rhapsido (remibrutinib)
    25d
    24 Weeks Double-blind Randomized Placebo-controlled Trial to Evaluate Efficacy, PK, Safety of LOU064 in Adolescents (12 - <18) With CSU and Inadequate Response to H1-antihistamine Followed by Optional 3 Years Open-label Extension and an Optional 3 Years Safety Long-term Treatment-free Follow-up (clinicaltrials.gov)
    P3, N=100, Recruiting, Novartis Pharmaceuticals | Trial primary completion date: Apr 2026 --> Nov 2026
    Trial primary completion date
    |
    Rhapsido (remibrutinib)
    1m
    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)
    2ms
    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)
    2ms
    Remibrutinib Open Label Roll-over Post-trial Access Protocol (clinicaltrials.gov)
    P3, N=212, Not yet recruiting, Novartis Pharmaceuticals
    New P3 trial
    |
    Rhapsido (remibrutinib)