NDAORALCAPSULE
Approved
Aug 1976
Lifecycle
LOE Approaching
Competitive Pressure
30/100
Clinical Trials
20
Data completeness
5/8 — Partial
GLEOSTINE (lomustine) by R-Pharm US is alkylating activity [moa]. First approved in 1976.
Drug data last refreshed 3h ago · AI intelligence enriched 1mo ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
GLEOSTINE (lomustine) is an oral alkylating agent chemotherapy drug approved in 1976 for treating certain cancers through DNA cross-linking. It is administered as a capsule and works by preventing cancer cell division. The drug is now in late-stage lifecycle with loss of exclusivity approaching.
$0.003BPart D
LOE ApproachingDeclining commercial potential with minimal current spending and claim volume indicates a legacy product with shrinking team resources and limited career growth 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)
VorAsidenib With Lomustine In Patients With rEcurrent IDH-mutaNT Glioma Harboring IDH1 and/or IDH2 Mutations
Started Nov 2026
36 enrolled
Recurrent GliomaIDH-mutant Gliomas
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
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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.