NDAORALCAPSULE
Approved
Aug 1976
Lifecycle
LOE Approaching
Competitive Pressure
30/100
Clinical Trials
19
Data completeness
5/8 — Partial
GLEOSTINE (lomustine) by R-Pharm US is alkylating activity [moa]. First approved in 1976.
Drug data last refreshed 14h ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
GLEOSTINE (lomustine) is an oral alkylating chemotherapy agent approved in 1976 for treatment of brain tumors, CNS lymphomas, and other solid malignancies. It works by alkylating DNA, causing cross-linking and cell death across a broad range of tumor types. The drug is indicated for glioblastoma, anaplastic astrocytoma, medulloblastoma, lymphomas, melanoma, and multiple solid tumors.
$3MPart D
LOE ApproachingDeclining
Mature, declining-revenue product with minimal market presence and limited team expansion opportunity; brand management focus is on retention rather than growth.
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 (19)
A Study With L19TNF in Combination With Lomustine in Patients With Glioblastoma at Progression or Recurrence
Started May 2024
90 enrolled
Glioblastoma
Phase II Trial of Romiplostim for Thrombocytopenia Induced by Lomustine at First Progression of MGMT Promoter-meth Glioblastoma
Started Sep 2022
0First Progression of MGMT Promoter-methylated Glioblastoma
Safety and Efficacy of Different Administration Sequences of L19TNF With Lomustine in Glioblastoma at First Progression
Started Jun 2022
0Glioblastoma
A Study to Evaluate Safety and Efficacy of L19TNF Plus Lomustine in Patients With Glioblastoma at First Progression
Started Feb 2021
142 enrolled
Glioblastoma
Study to Evaluate Eflornithine + Lomustine vs Lomustine in Recurrent Anaplastic Astrocytoma (AA) Patients
Started Jul 2016
343 enrolled
Anaplastic AstrocytomaRecurrent Anaplastic Astrocytoma
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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.