^
    2d
    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)
    3d
    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)
    16d
    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
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    Rhapsido (remibrutinib) • Ocrevus (ocrelizumab)
    21d
    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)
    21d
    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)
    24d
    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)
    26d
    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
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    NLRP3 (NLR Family Pyrin Domain Containing 3)
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    Imbruvica (ibrutinib) • Brukinsa (zanubrutinib) • Calquence (acalabrutinib) • Jaypirca (pirtobrutinib) • Rhapsido (remibrutinib) • fenebrutinib (RG7845)
    1m
    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)
    1m
    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)
    1m
    A Study to Investigate the Pharmacokinetics and Safety of Remibrutinib in Participants With Severe Renal Impairment Compared to Matched Healthy Participants. (clinicaltrials.gov)
    P1, N=16, Completed, Novartis Pharmaceuticals | Recruiting --> Completed
    Trial completion
    |
    Rhapsido (remibrutinib)
    1m
    Properties of FDA-approved small molecule protein kinase inhibitors: a 2026 update. (PubMed, Pharmacol Res)
    The following ten drugs received FDA approval in 2025 - avutometinib (inhibiting MEK1/2 in serous ovarian carcinomas), defactinib (blocking FAK in low grade serous ovarian carcinomas), delgocitinib (antagonizing the JAK family in hand eczema), mirdametinib (inhibiting MEK1/2 in type I neurofibromatosis), remibrutinib (blocking BTK in chronic spontaneous urticaria), rilzabrutinib (antagonizing BTK in chronic immune thrombocytopenia), sunvozertinib (blocking mutant exon 21 insertion EGFR NSCLC), taletrectinib (inhibiting mutant ROS1 in NSCLC), vimseltinib (blocking CSF1R in tenosynovial giant cell tumors), and zongertinib (antagonizing mutant HER2 in NSCLC). This article summarizes the physicochemical properties of all 94 FDA-approved small molecule protein kinase inhibitors including the molecular weight, number of hydrogen bond donors/acceptors, ligand efficiency, lipophilic efficiency, polar surface area, and solubility. A total of 45 of the 94 FDA-approved drugs have a least one Lipinski rule of five violation.
    FDA event • Review • Journal
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    EGFR (Epidermal growth factor receptor) • HER-2 (Human epidermal growth factor receptor 2) • ROS1 (Proto-Oncogene Tyrosine-Protein Kinase ROS) • CSF1R (Colony stimulating factor 1 receptor)
    |
    EGFR mutation
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    Gomekli (mirdametinib) • Avmapki (avutometinib) • Hernexeos (zongertinib) • Fakzynja (defactinib) • Ibtrozi (taletrectinib) • Zegfrovy (sunvozertinib) • Rhapsido (remibrutinib) • Romvimza (vimseltinib)
    1m
    REASSERT: Remibrutinib in Real-world Clinical Practice - a US Sub-study (clinicaltrials.gov)
    P=N/A, N=505, Not yet recruiting, Novartis Pharmaceuticals
    New trial • Real-world evidence
    |
    Rhapsido (remibrutinib)