RHAPSIDO (remibrutinib)
Rhapsido is a kinase inhibitor used to manage chronic spontaneous urticaria in adult patients. It helps those who still experience symptoms despite previous treatment with H1 antihistamines. This medication is specifically used for the spontaneous form of the condition rather than other types of urticaria.
How RHAPSIDO Works
Remibrutinib works by inhibiting Bruton’s tyrosine kinase (BTK), an intracellular protein found in mast cells, basophils, and other immune cells. By blocking this protein and related kinases, the drug prevents the release of histamine and other proinflammatory mediators. This action stops the cell degranulation process that is typically triggered by pathogenic antibodies.
Development Insights
Details
- Status
- Prescription
- First Approved
- 2025-09-30
- Patent Cliff
- 2043
- Routes
- ORAL
- Dosage Forms
- TABLET
RHAPSIDO Approval History
What RHAPSIDO Treats
1 indicationsRHAPSIDO is approved for 1 conditions since its original approval in 2025. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Chronic Spontaneous Urticaria
RHAPSIDO Target & Pathway
ProTarget
A kinase essential for B-cell development and signaling. BTK inhibitors block B-cell receptor signaling, making them highly effective in B-cell malignancies like chronic lymphocytic leukemia and mantle cell lymphoma.
RHAPSIDO Competitive Set
ProThree rings of competition based on shared molecular targets and treated indications.
MoA expansion candidates
Same target(s), different indications — where else is this mechanism being explored?
Indication competitors
Same indication, different mechanism — what else might this patient receive?
Filters applied: drops same-active-ingredient (505(b)(2) reformulations), route-mismatch (topical vs systemic), and cross-therapeutic-area matches in same-indication rings.
Drugs Similar to RHAPSIDO
FDA-approved drugs for similar conditions. Compare mechanisms and indications to understand treatment alternatives.
Clinical Trial Registry
10 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT07456891 | CLOU064A2306B | Ph 3 | recruiting | Remibrutinib Open Label Roll-over Post-trial Access Protocol |
| NCT06865651 | CLOU064M12101 2024-516355-41 | Ph 2 | recruiting | Study of Remibrutinib (LOU064) Efficacy and Safety and Exploration of Its Mechanism of Action in Participants With Chronic Urticaria |
| NCT05156281 REMODEL-2 | CLOU064C12302 2023-509372-41-00 | Ph 3 | active not recruiting | Efficacy and Safety of Remibrutinib Compared to Teriflunomide in Participants With Relapsing Multiple Sclerosis (RMS) |
| NCT07032272 | CLOU064A2105 | Ph 1 | completed | A Study to Investigate the Pharmacokinetics and Safety of Remibrutinib in Participants With Severe Renal Impairment Compared to Matched Healthy Participants. |
| NCT06042478 | CLOU064A2304 2022-502161-19-00 | Ph 3 | active not recruiting | 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. |
| NCT06868212 RECLAIM | CLOU064AUS02 | Ph 3 | recruiting | 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 |
| NCT05147220 REMODEL-1 | CLOU064C12301 2020-005899-36 | Ph 3 | active not recruiting | Efficacy and Safety of Remibrutinib Compared to Teriflunomide in Participants With Relapsing Multiple Sclerosis (RMS) |
| NCT05976243 | CLOU064M12301 2023-505739-12-00 | Ph 3 | active not recruiting | A Study to Investigate Efficacy, Safety, and Tolerability of Remibrutinib Compared With Placebo in Adults With CINDU Inadequately Controlled by H1-antihistamines |
| NCT05432388 | CLOU064I12201 2021-006950-30 | Ph 2 | completed | Study of Efficacy, Safety and Tolerability of Remibrutinib in Adult Participants With an Allergy to Peanuts |
| NCT04035668 LOUiSSe results posted | CLOU064E12201 2018-004387-54 | Ph 2 | terminated | A Phase 2 Study to Evaluate the Safety and Efficacy of LOU064 in Patients With Moderate to Severe Sjögren's Syndrome |
Active Pipeline
Ongoing clinical trials by development phase
Key Completed Trials
Completed studies with published results, ranked by significance
Trial Timeline
Full development history with FDA approval milestones
Understanding FDA Approval Types
| Count | Type | What it means |
|---|---|---|
| - | ORIG | Original approval - drug first enters market |
| - | SUPPL - Efficacy | New indication (new disease/condition approved) |
| - | SUPPL - Labeling | Label text changes (warnings, dosing updates) |
| - | SUPPL - Manufacturing | Production changes (new facility) |
| - | SUPPL - Chemistry | Formulation changes (new dosage strength) |
Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.
RHAPSIDO FDA Label Details
Indications & Usage
FDA Label (PDF)RHAPSIDO is indicated for the treatment of Chronic Spontaneous Urticaria.
RHAPSIDO Patents & Exclusivity
Patents (3 active)
Exclusivity
Pro Intelligence Preview
Deep insights for RHAPSIDO
Revenue Insights
- • Quarterly revenue tracking
- • Historical trend analysis
Patent Timeline
- • Cliff: 2043
- • 3 active patents
Trial Analysis
- • 10 total trials
- • Stage: Expansion
Competitive Landscape
- • 2 similar drugs
- • Same target/indication analysis
Full approval history • All patents • Revenue trends • Competitor analysis
Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.
How We Calculate These Metrics
Trial Activity Stage
Measures the current development activity pattern based on trial phases, status, and trends. Important: This measures R&D activity, not commercial lifecycle.
Trial statuses: "Active" means recruiting or ongoing. "Completed" means reached planned endpoint. "Terminated" means stopped early—often due to safety, efficacy, or business reasons.
- Growth: High proportion of early-phase trials (Phase 1/2), active development
- Expansion: Significant Phase 3 activity, approaching or pursuing approvals
- Mature: Substantial Phase 4 post-marketing studies
- Stable: Mixed phase distribution, steady development
- Declining: Low active trial ratio, reduced R&D investment