NDAORALTABLETPriority Review
Approved
Mar 1957
Lifecycle
LOE Approaching
Competitive Pressure
30/100
Clinical Trials
20
Data completeness
5/8 — Partial
Priority Review
LEUKERAN (chlorambucil) by Viatris (2) is alkylating activity [moa]. First approved in 1957.
Drug data last refreshed 7h ago · AI intelligence enriched 1w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
LEUKERAN (chlorambucil) is an oral alkylating agent approved in 1957 for hematologic malignancies, primarily chronic lymphocytic leukemia and lymphomas. It works by cross-linking DNA, disrupting cell division and triggering apoptosis in rapidly dividing cells.
$0.023BPart D
LOE ApproachingDeclining
Product is in late lifecycle stage with minimal market presence (35 Part D claims in 2023), indicating a small, shrinking commercial footprint with limited team expansion opportunity.
Mechanism of Action
Alkylating Activity
Pharmacologic Class:
Alkylating Drug
Indications
Indication data is being enriched from DailyMed and FDA labeling. Check back soon for approved therapeutic uses.
Clinical Trials (20)
ICP-022 Versus Chlorambucil Combined With Rituximab in the Treatment of Untreated CLL/SLL
Started Jan 2021
218 enrolled
Chronic Lymphocytic LeukemiaSmall Lymphocytic Lymphoma
Study of Acalabrutinib Versus Chlorambucil Plus Rituximab in Adult Subjects With Previously Untreated Chronic Lymphocytic Leukemia
Started Jan 2020
155 enrolled
Untreated Chronic Lymphocytic Leukemia
A Prospective Cohort of Obinutuzumab and Chlorambucil (GC) Chemotherapy for the Treatment of Elderly Patients With Chronic Lymphocytic Leukemia Including Next- Generation Sequencing (NGS)-Based Assessment
Started Jul 2019
31 enrolled
Chronic Lymphocytic Leukemia
A Study of the Combination of Ibrutinib Plus Venetoclax Versus Chlorambucil Plus Obinutuzumab for the First-line Treatment of Participants With Chronic Lymphocytic Leukemia (CLL)/Small Lymphocytic Lymphoma (SLL)
Started Apr 2018
211 enrolled
Leukemia, Lymphocytic, Chronic, B-Cell
Ublituximab + TGR-1202 Compared to Obinutuzumab + Chlorambucil in Participants With Untreated and Previously Treated Chronic Lymphocytic Leukemia
Started Nov 2015
603 enrolled
Chronic Lymphocytic Leukemia
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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.