NDAORALTABLET
Approved
Mar 2019
Lifecycle
Peak
Competitive Pressure
0/100
Clinical Trials
20
Data completeness
6/8 — Strong
MAVENCLAD (cladribine) by Fresenius Kabi is synthesis, resulting in depletion of lymphocytes. First approved in 2019.
Drug data last refreshed 18h ago · AI intelligence enriched 1mo ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
MAVENCLAD (cladribine) is an oral purine antimetabolite approved in 2019 for multiple sclerosis, working by depleting lymphocytes to reduce immune-mediated disease activity. It represents the first oral short-course immunosuppressive therapy for relapsing-remitting MS, offering a convenient dosing schedule compared to traditional DMTs. The drug targets patients with active relapsing disease who require rapid disease control.
$0.156BPart D
Peak14.8 years to LOEThe product is at peak revenue stage with 2,078 Part D claims in 2023; commercial teams are focused on maximizing market penetration and managing a stable, profitable franchise.
Mechanism of Action
synthesis, resulting in depletion of lymphocytes.
Pharmacologic Class:
Purine Antimetabolite
Indications
Indication data is being enriched from DailyMed and FDA labeling. Check back soon for approved therapeutic uses.
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
10 enrolled
Acute Myeloid Leukemia
Cladribine Tablets Level of Response Predictors in Clinical Practice (CLODINA)
Started Aug 2023
366 enrolled
Multiple Sclerosis
Worked on MAVENCLAD at Fresenius Kabi? Share your interview experience or compensation data (+7 days Pro)
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.