Remibrutinib is marketed as Rhapsido and was approved by the U.S. FDA on September 30, 2025 for adults with chronic spontaneous urticaria who remain symptomatic despite H1 antihistamines. It is described as an oral targeted BTK inhibitor and the first FDA-approved BTK inhibitor for CSU. The drug works by targeting BTK to inhibit release of histamine and other proinflammatory mediators.
Novartis received EU approval for Rhapsido (remibrutinib) as the first oral targeted treatment for chronic spontaneous urticaria. Phase 3 data also showed significant efficacy in chronic inducible urticaria, with filings underway for additional indications.
Morgan Stanley raised its Novartis price target to $170 from $143 with an Overweight rating, while TD Cowen increased its target to $180 from $160 with a Hold rating. Morgan Stanley sees $23 billion in risk-adjusted potential from nine pipeline assets, with additional upside in success scenarios.
Pfizer's tilrekimig met its primary endpoint in a mid-stage eczema trial and will advance to late-stage testing. Separately, oral remibrutinib demonstrated rapid efficacy in treating peanut allergy in a phase II study.
Novartis announced positive European regulatory opinion for remibrutinib in chronic spontaneous urticaria and reported the drug met its primary endpoint in a Phase 3 trial for chronic inducible urticaria.
Novartis announced positive topline results from its Phase III RemIND trial of remibrutinib in chronic inducible urticaria, meeting the primary endpoint for the three most prevalent types of the condition with significantly higher complete response rates versus placebo.
Novartis announced positive topline results from its Phase III RemIND trial of oral remibrutinib in chronic inducible urticaria, meeting the primary endpoint across three prevalent subtypes with significantly higher complete response rates versus placebo at Week 121.
Novartis announced positive Phase III RemIND trial results for oral remibrutinib in chronic inducible urticaria, marking the first therapy to meet a Phase III primary endpoint in the condition. The company has submitted a supplemental New Drug Application to the FDA.
Novartis reported positive Phase III RemIND trial results showing remibrutinib achieved complete response in three types of chronic inducible urticaria. The company has submitted a supplemental New Drug Application to the FDA for symptomatic dermographism.
Novartis announced positive topline results from its pivotal Phase III RemIND trial of oral remibrutinib in chronic inducible urticaria, meeting the primary endpoint for three prevalent CIndU types with significantly higher complete response rates versus placebo at Week 12.
| NCT ID | Title | Status | Phase |
|---|---|---|---|
| NCT07456891 |
Remibrutinib Open Label Roll-over Post-trial Access Protocol |
RECRUITING | PHASE3 |
| NCT07032272 |
A Study to Investigate the Pharmacokinetics and Safety of Remibrutinib in Participants With Severe Renal Impairment Compared to Matched Healthy Participants. |
COMPLETED | PHASE1 |
| NCT06868212 |
A Study to Evaluate Efficacy of Remibrutinib Compared to Dupilumab at Early Timepoints in Adults With Chronic Spontaneous Urticaria Inadequately Controlled by Second Generation H1-antihistamines |
RECRUITING | PHASE3 |
| NCT06865651 |
Study of Remibrutinib (LOU064) Efficacy and Safety and Exploration of Its Mechanism of Action in Participants With Chronic Urticaria |
RECRUITING | PHASE2 |
| NCT06042478 |
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. |
ACTIVE_NOT_RECRUITING | PHASE3 |
| NCT05976243 |
A Study to Investigate Efficacy, Safety, and Tolerability of Remibrutinib Compared With Placebo in Adults With CINDU Inadequately Controlled by H1-antihistamines |
ACTIVE_NOT_RECRUITING | PHASE3 |
| NCT05432388 |
Study of Efficacy, Safety and Tolerability of Remibrutinib in Adult Participants With an Allergy to Peanuts |
COMPLETED | PHASE2 |
| NCT05170724 |
Global Managed Access Program Cohort for Remibrutinib in Adult Patients With Chronic Spontaneous Urticaria |
AVAILABLE | |
| NCT05156281 |
Efficacy and Safety of Remibrutinib Compared to Teriflunomide in Participants With Relapsing Multiple Sclerosis (RMS) |
ACTIVE_NOT_RECRUITING | PHASE3 |
| NCT05147220 |
Efficacy and Safety of Remibrutinib Compared to Teriflunomide in Participants With Relapsing Multiple Sclerosis (RMS) |
ACTIVE_NOT_RECRUITING | PHASE3 |
