ENJAYMO (sutimlimab-jome) · RECORDATI RARE DISEASES, INC.
ENJAYMO (sutimlimab-jome) is a classical complement inhibitor indicated for the treatment of hemolysis in adult patients with cold agglutinin disease (CAD). The medication is specifically designed to address the premature destruction of red blood cells that characterizes this autoimmune condition. It serves as a targeted therapeutic option for managing the clinical manifestations of hemolysis in this specific patient population.
How ENJAYMO Works
Sutimlimab-jome is a monoclonal antibody that binds to C1s, a serine protease responsible for cleaving the C4 protein. By inhibiting C1s, the drug prevents the deposition of complement opsonins on the surface of red blood cells, which stops the classical complement pathway from triggering hemolysis. This mechanism is specific to the classical pathway and does not inhibit the lectin or alternative complement pathways.
Details
- Status
- Prescription
- First Approved
- 2022-02-04
- Patent Cliff
- 2029
- Revenue
- $24M (Q4-2024)
- Routes
- INJECTION
- Dosage Forms
- INJECTABLE
ENJAYMO Approval History
What ENJAYMO Treats
2 indicationsENJAYMO is approved for 2 conditions since its original approval in 2022. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Cold Agglutinin Disease
- Hemolysis
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.
ENJAYMO FDA Label Details
Indications & Usage
FDA Label (PDF)ENJAYMO is a classical complement inhibitor indicated for the treatment of hemolysis in adults with cold agglutinin disease (CAD). Cold Agglutinin Disease ENJAYMO (sutimlimab-jome) is indicated for the treatment of hemolysis in adults with cold agglutinin disease (CAD).
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Deep insights for ENJAYMO
Revenue Insights
- • Q4-2024: $24M
- • Historical trend analysis
Patent Timeline
- • Cliff: 2029
- • Generic/biosimilar risk
Trial Analysis
- • Clinical trial tracking
- • Development stage analysis
Competitive Landscape
- • Competitor tracking
- • 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.