NDAORALTABLET
Approved
Mar 2019
Lifecycle
Peak
Competitive Pressure
0/100
Clinical Trials
20
Data completeness
7/8 — Comprehensive
MAVENCLAD (cladribine) by Fresenius Kabi is synthesis, resulting in depletion of lymphocytes. Approved for multiple sclerosis. First approved in 2019.
Drug data last refreshed 22h ago · AI intelligence enriched 3w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
MAVENCLAD (cladribine) is an oral purine antimetabolite approved in March 2019 for relapsing forms of multiple sclerosis, including relapsing-remitting disease and active secondary progressive disease. It works by inhibiting DNA synthesis and depleting lymphocytes, thereby reducing immune-mediated neuroinflammation. As an oral disease-modifying therapy, it offers convenient dosing compared to injectable alternatives and represents a distinct mechanism within the MS treatment armamentarium.
$0.2BPart D
15.4 years to LOEMechanism of Action
synthesis, resulting in depletion of lymphocytes.
Pharmacologic Class:
Purine Antimetabolite
Indications (1)
Clinical Trials (20)
Venetoclax in Combination With Cladribine and Cytarabine Alternating With Azacitidine Plus Venetoclax for the Treatment of Newly Diagnosed Monocytic AML and Active Signaling Mutated AML
Started Jan 2025
40 enrolled
Acute Monocytic LeukemiaAcute Myeloid Leukemia
A Study of Vemurafenib and Obinutuzumab Compared to Cladribine and Rituximab in People With Hairy Cell Leukemia (HCL)
Started Sep 2024
86 enrolled
Hairy Cell Leukemia
Efficacy and Safety of a New Formulation of Oral Cladribine Compared With Placebo in Participants With Generalized Myasthenia Gravis (MyClad)
Started Jun 2024
264 enrolled
Generalized Myasthenia Gravis
Cladribine Venetoclax in Monocytic AML
Started Feb 2024
20 enrolled
Acute Myeloid Leukemia
Cladribine Tablets Level of Response Predictors in Clinical Practice (CLODINA)
Started Aug 2023
367 enrolled
Multiple Sclerosis
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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.