NDAINTRACRANIALIMPLANTPriority Review
Approved
Sep 1996
Lifecycle
LOE Approaching
Competitive Pressure
30/100
Clinical Trials
15
Data completeness
4/8 — Partial
Priority Review
GLIADEL (carmustine) by R-Pharm US is alkylating activity [moa]. First approved in 1996.
Drug data last refreshed 6h ago · AI intelligence enriched 1w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
GLIADEL is a carmustine-based intracranial implant approved in 1996 for brain tumor treatment via direct local delivery. It functions as an alkylating agent that crosses the blood-brain barrier to deliver chemotherapy directly to tumor sites. The implant modality enables sustained intracranial drug concentration while minimizing systemic exposure.
LOE Approaching
Product approaching loss of exclusivity with moderate competitive pressure (30/100) suggests declining team headcount and shift toward lifecycle optimization and managed decline strategies.
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 (15)
A Study of Carmustine With and Without Ethanol in Subjects With Lymphoma
Started Mar 2025
49 enrolled
LymphomaNon-Hodgkin LymphomaHodgkin Lymphoma
Carmustine Wafer in Combination With Retifanlimab and Radiation With/Without Temozolomide in Subjects With Glioblastoma
Started Aug 2022
50 enrolled
Glioblastoma Multiforme
Post-Marketing Surveillance of Long-Term Observation of Gliadel Wafer-Investigation of Vital Prognosis in Patients With High Grade Glioma
Started Jan 2014
507 enrolled
Malignant Glioma
Post-Marketing Surveillance of Gliadel 7.7mg Implant (All-case Observational Study)
Started Jan 2013
561 enrolled
Malignant Glioma
Gliadel, XRT, Temodar, Avastin Followed by Avastin, Temodar for Newly Diagnosed Glioblastoma Multiforme (GBM)
Started Apr 2011
41 enrolled
Glioblastoma MultiformeGliosarcoma
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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.