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 23m ago · AI intelligence enriched 1w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
GLIADEL is a carmustine-impregnated biodegradable implant administered intracranially for brain tumors, operating via alkylating mechanism to cross-link DNA and inhibit tumor cell growth. Approved in 1996, it represents a pioneering localized chemotherapy approach for glioblastoma and other malignant gliomas. The implant delivers high drug concentrations directly to the tumor microenvironment while minimizing systemic exposure.
LOE Approaching
Product approaching loss of exclusivity with moderate competitive pressure (30/100), suggesting contracted brand team and potential workforce rightsizing.
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.