BLAINJECTIONINJECTABLEPriority Review
Approved
Feb 2019
Lifecycle
Peak
Competitive Pressure
30/100
Clinical Trials
6
Data completeness
6/8 — Strong
Priority Review
CABLIVI (caplacizumab) by Sanofi is caplacizumab-yhdp targets the a1-domain of vwf, and inhibits the interaction between vwf and platelets, thereby reducing both vwf-mediated platelet adhesion and platelet consumption. First approved in 2019.
Drug data last refreshed 14h ago · AI intelligence enriched 1mo ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
CABLIVI (caplacizumab-yhdp) is a monoclonal antibody approved in February 2019 that targets the A1-domain of von Willebrand Factor (vWF) to inhibit vWF-mediated platelet adhesion and consumption. It is indicated for thrombotic thrombocytopenic purpura (TTP), a rare life-threatening blood clotting disorder. The drug works by preventing the interaction between vWF and platelets, thereby reducing platelet consumption and restoring hemostasis.
$0.02BPart D
PeakProduct is at peak maturity with modest spending ($20M) and 96 claims, indicating a niche rare disease franchise with limited but stable team headcount.
Mechanism of Action
Caplacizumab-yhdp targets the A1-domain of vWF, and inhibits the interaction between vWF and platelets, thereby reducing both vWF-mediated platelet adhesion and platelet consumption.
Indications
Indication data is being enriched from DailyMed and FDA labeling. Check back soon for approved therapeutic uses.
Clinical Trials (6)
Caplacizumab and Immunosuppressive Therapy Without Firstline Therapeutic Plasma Exchange in Adults With Immune-mediated Thrombotic Thrombocytopenic Purpura
Started Nov 2022
51 enrolled
Thrombotic Thrombocytopenic Purpura
Retrospective Study on Caplacizumab-treated Pediatric Patients With Immune-mediated Thrombocytopenic Purpura (iTTP)
Started Jun 2022
4 enrolled
Immune-mediated Thrombocytopenic Purpura
A Trial of Caplacizumab in Japanese Patients With Acquired Thrombotic Thrombocytopenic Purpura (aTTP)
Started Oct 2019
21 enrolled
Thrombotic Thrombocytopenic Purpura
Caplacizumab Single and Multiple Dose Study in Healthy Japanese and White Subjects.
Started Jun 2017
60 enrolled
Healthy Volunteers
Phase III Trial With Caplacizumab in Patients With Acquired Thrombotic Thrombocytopenic Purpura
Started Nov 2015
145 enrolled
Acquired Thrombotic Thrombocytopenic Purpura
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Data Sources
- Drug label: DailyMed / FDA
- Clinical trials: ClinicalTrials.gov
- Patent data: FDA Orange Book
- Spending data: CMS Medicare
The information on this page is for informational purposes only and should not be used as a substitute for professional medical advice. Drug information is sourced from FDA, DailyMed, and other government databases. Adverse event data from FAERS does not establish causation. Always consult a healthcare professional for medical decisions.