Rhapsido (remibrutinib) / Novartis - LARVOL DELTA

P072 Improvement across work productivity and quality of life with remibrutinib treatment in patients with chronic spontaneous urticaria in the REMIX-1/2 trials. (PubMed, Br J Dermatol) - "REMIX-2: n = 297 remibrutinib and n = 153 placebo. DLQI, Dermatology Life Quality Index; WPAI, Work Productivity and Activity Impairment."

Clinical • HEOR • Journal • Chronic Spontaneous Urticaria • Dermatology • Immunology • Urticaria

Emerging IgE and non-IgE targeted therapies for chronic urticaria. (PubMed, Ann Allergy Asthma Immunol) - "Dupilumab received FDA approval for antihistamine refractory chronic spontaneous urticaria (CSU) supporting the targeting of type-2 cytokines, IL-4 and IL-13, in this disease. Bruton's tyrosine kinase (BTK) inhibitors show promise, with remibrutinib receiving FDA approval and demonstrating significant reductions in UAS7 in Phase 3 trials. c-Kit (c-Kit or KIT) inhibition with barzolvolimab shows robust efficacy with sustained effects post-treatment...Although some programs have been discontinued due to safety concerns or lack of efficacy such as fenebrutinib (BTK inhibitor), THB001 (c-Kit inhibitor), EP262 (MRGPRX2 antagonist), tezepelumab (anti- TSLP), as well as lirentelimab and AK006 (Siglec-targeting agents), these studies have informed many of the other positive studies. In summary, over the last year, we have seen the CU pipeline mature with multiple Phase 3 programs and new approvals representing diverse mechanisms of action. Nevertheless, significant..."

Journal • Review • Chronic Spontaneous Urticaria • Dermatology • Immunology • Urticaria • IL13 • IL4 • TSLP

REMASTER: A Study to Evaluate the Efficacy and Safety of Remibrutinib in Secondary Progressive Multiple Sclerosis (clinicaltrials.gov) - P3 | N=1275 | Not yet recruiting | Sponsor: Novartis Pharmaceuticals

New P3 trial • CNS Disorders • Multiple Sclerosis

Better Improvement For Omalizumab Versus Dupilumab/Remibrutinib for CSU: Week 12 Disease Activity Matched-Adjusted Indirect Comparison (ACAAI 2025) - P3 | "Conclusions In patients with CSU, omalizumab 300 mg demonstrated superior efficacy versus dupilumab and remibrutinib: significantly greater improvements in placebo-adjusted disease activity were observed with matching-adjusted indirect comparison analyses. These data highlight that omalizumab remains an effective treatment option for patients with CSU, with the potential for early improvement of quality of life."

Chronic Spontaneous Urticaria • Dermatology • Immunology • Urticaria

Efficacy Of Remibrutinib Versus Dupilumab In Chronic Spontaneous Urticaria: US Phase 3b Study Design (RECLAIM) (ACAAI 2025) - P3 | "Study design details will be presented at congress. Conclusion This study will evaluate the early efficacy and safety of remibrutinib versus dupilumab in patients with CSU."

Clinical • P3 data • Cardiovascular • Chronic Spontaneous Urticaria • Dermatology • Immunology • Pruritus • Urticaria • IL4R

Remibrutinib Versus Placebo After Antihistamine Failure In Adolescent CSU Patients: A Phase 3 Study Design (ACAAI 2025) - P3 | "Primary completion of the study is expected by Q2 2026. Conclusion The results of this phase 3 study will provide evidence of the efficacy and safety of remibrutinib in adolescents with CSU."

Clinical • P3 data • Chronic Spontaneous Urticaria • Dermatology • Immunology • Urticaria

Early And Sustained Efficacy Of Remibrutinib In Adult Patients with CSU: Pooled Analysis Of REMIX-1/-2 (ACAAI 2025) - "Remibrutinib showed greater improvement versus placebo over 24 weeks that was sustained through week 52 in all remibrutinib-treated patients (including those transitioned from placebo). Conclusion Remibrutinib showed improvements in urticaria symptoms as early as week 1, with over 50% improvement by week 2, which improved further and was sustained through week 52, suggesting its potential as an oral treatment option for patients with CSU."

Retrospective data • Chronic Spontaneous Urticaria • Dermatology • Immunology • Urticaria

Remibrutinib Improves Urticaria Symptoms Quality of Life and Sleep: An Analysis From REMIX-1/-2 Studies (ACAAI 2025) - "Remibrutinib-treated patients showed strong correlation between UAS7 and DLQI (0.80), SIS7 (0.84), and AIS7 (0.86). Conclusion Remibrutinib leads to fast improvements in UAS7, as early as week 1, which corresponds to fast improvements in QoL, sleep, and activity."

HEOR • Dermatology • Immunology • Urticaria

Efficacy Of Remibrutinib In Anti-IgE Biologic-Naïve Biologic-Experienced and Biologic-Refractory Patients With CSU: REMIX-1/-2 Studies (ACAAI 2025) - "Subgroups were analyzed by prior exposure to omalizumab, an anti-IgE biologic: no (naïve) and yes (experienced). Similarly, remibrutinib showed comparable reductions in CFB-ISS7 and CFB-HSS7 across all subgroups. Conclusion Remibrutinib showed greater efficacy versus placebo, irrespective of prior exposure to and treatment failure with anti-IgE biologics, in patients with CSU."

Clinical • Late-breaking abstract • Chronic Spontaneous Urticaria • Dermatology • Immunology • Urticaria

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=364 | Active, not recruiting | Sponsor: Novartis Pharmaceuticals | Recruiting ➔ Active, not recruiting | Trial completion date: Dec 2028 ➔ Aug 2028

Enrollment closed • Pan tumor • Trial completion date • Dermatology • Immunology • Urticaria

Comparative efficacy of omalizumab, dupilumab, and remibrutinib in chronic spontaneous urticaria: a network meta-analysis of randomized control trials. (PubMed, J Dermatolog Treat) - "Omalizumab 300 mg, followed by remibrutinib, exhibited the highest effect sizes across major outcomes for CSU. Newer therapies such as remibrutinib and dupilumab appear generally effective, offering promising tools for CSU patients who may not respond to standard treatments."

Clinical • Journal • Retrospective data • Chronic Spontaneous Urticaria • Dermatology • Immunology • Urticaria

Remibrutinib: Data readout from P3 RELIEVE trial (NCT06744920) for myasthenia gravis in 2028 (Novartis) - Q3 2025 Results

P3 data • Immunology • Myasthenia Gravis

Remibrutinib in chronic spontaneous urticaria: 52-Week results from two phase 3 studies. (PubMed, J Allergy Clin Immunol) - P3 | "Remibrutinib may offer a novel, effective oral treatment option that provides fast (as early as week 1) and sustained symptom relief for patients with chronic spontaneous urticaria remaining symptomatic despite H1-antihistamines."

Journal • P3 data • Chronic Spontaneous Urticaria • Dermatology • Immunology • Urticaria

RemiSeven: A Study of Remibrutinib Using MR Imaging in Relapsing or Progressive MS (clinicaltrials.gov) - P2 | N=20 | Not yet recruiting | Sponsor: Moein Amin

New P2 trial • CNS Disorders • Multiple Sclerosis

Remibrutinib: Regulatory submission in Japan for chronic spontaneous urticaria in H2 2025 (Novartis) - Q3 2025 Results

Filing • Chronic Spontaneous Urticaria • Immunology

Remibrutinib: Primary completion of P3 REMODEL-1 trial (NCT05147220) for multiple sclerosis in 2026 (Novartis) - Q3 2025 Results: Primary completion of P3 REMODEL-2 trial (NCT05156281) for multiple sclerosis in 2026

Trial primary completion date • Immunology • Multiple Sclerosis

Remibrutinib: Regulatory submission for multiple sclerosis in 2027 (Novartis) - Q3 2025 Results: Regulatory submission for Hidradenitis suppurativa in 2028 or later; Regulatory submission for myasthenia gravis in 2028 and later

Filing • Hidradenitis Suppurativa • Immunology • Multiple Sclerosis • Myasthenia Gravis

Remibrutinib: Data readout from P3 RECHARGE1 trial (NCT06799000) for Hidradenitis suppurativa in 2028 (Novartis) - Q3 2025 Results: Data readout from P3 RECHARGE2 trial (NCT06840392) for Hidradenitis suppurativa in 2028

P3 data • Hidradenitis Suppurativa • Immunology

Efficacy and Safety of Remibrutinib in Chronic Spontaneous Urticaria: A Systematic Review and Meta-Analysis. (PubMed, Am J Ther) - "Remibrutinib demonstrates significant efficacy and an overall favorable short-term safety profile for refractory CSU, though increased mild infections warrant monitoring. Larger, long-term studies and direct comparisons with omalizumab are needed."

Journal • Retrospective data • Cardiovascular • Chronic Spontaneous Urticaria • Dermatology • Immunology • Infectious Disease • Urticaria

Next-Generation Therapies for Hidradenitis Suppurativa: Recent FDA Approvals and a Look at Clinical Trial Landscape (EADV 2025) - "Over the past decade, numerous immunotherapies have been developed for a wide range of dermatologic conditions, including two recently FDA-approved treatments for HS within the last year (bimekizumab and secukinumab)2,3...Sonelokimab, another IL-17A/F inhibitor, is currently in a recruiting phase 3 trial...Other cytokine-targeting agents are lutikizumab (IL-1α/IL-1β inhibitor), spesolimab (anti-IL-36R), and anifrolumab (type I interferon receptor antagonist)...Agents targeting the JAK-STAT pathway include the JAK1 inhibitors povorcitinib, upadacitinib, and ruxolitinib, as well as deucravacitinib, a tyrosine kinase 2 inhibitor; all are currently under investigation for HS...Remibrutinib, a Bruton's tyrosine kinase (BTK) inhibitor, also showed promising results, with 72.7% of patients reaching the HiSCR endpoint at week 167. Brensocatib, a dipeptidyl-peptidase 1 inhibitor, is currently being evaluated in a recruiting phase 3 trial... The last decade has brought a wave..."

Clinical • Dermatology • Hidradenitis Suppurativa • Immunology • Inflammation • IFNAR2 • IL17A • IL1B • TYK2

Novartis receives FDA approval for Rhapsido (remibrutinib), the only oral, targeted BTKi treatment for chronic spontaneous urticaria (CSU) (PRNewswire) - "The FDA approval of Rhapsido in CSU is based on results from the Phase III REMIX-1 (NCT05030311) and REMIX-2 (NCT05032157) clinical trials in patients who remained symptomatic on second-generation H1 antihistamines."

FDA approval • Chronic Spontaneous Urticaria

Comparative Efficacy of Omalizumab, Dupilumab, and Remibrutinib in Chronic Spontaneous Urticaria: A Network Meta-Analysis of Randomized Control Trials (EADV 2025) - No abstract available

Retrospective data • Chronic Spontaneous Urticaria • Dermatology • Immunology • Urticaria

Efficacy and safety of remibrutinib in chronic spontaneous urticaria : a systematic review and meta-analysis (EADV 2025) - "This meta-analysis shows that remibrutinib provides early and sustained efficacy with an acceptable safety profile in chronic spontaneous urticaria, with the 25mg twice daily regimen seems to be more beneficial."

Retrospective data • Review • Cardiovascular • Chronic Spontaneous Urticaria • Dermatology • Immunology • Pruritus • Urticaria

Remibrutinib in patients with moderate to severe hidradenitis suppurativa: International Hidradenitis Suppurativa Severity Scoring System (IHS4) outcomes from a randomised, phase 2, double-blind, placebo-controlled platform study (EADV 2025) - P2 | "Remibrutinib showed improvements in clinical response through 16 weeks, as measured by IHS4 and IHS4-55, with reductions in disease severity observed. BTK inhibition may emerge as a promising therapeutic intervention in HS."

Clinical • P2 data • Dermatology • Hidradenitis Suppurativa • Immunology • Inflammation

Efficacy of remibrutinib in patients with CSU by demographics and baseline characteristics: Pooled analysis from REMIX-1/-2 studies (EADV 2025) - "This pooled analysis from REMIX-1/-2 studies showed that remibrutinib consistently improved CSU symptoms, regardless of demographics and baseline characteristics, indicating that remibrutinib could be an effective oral treatment option across a wide range of CSU patient profiles."

Retrospective data • Cardiovascular • Chronic Spontaneous Urticaria • Dermatology • Immunology • Urticaria