NDAORALCAPSULEPriority Review
Approved
Jul 1969
Lifecycle
LOE Approaching
Competitive Pressure
30/100
Clinical Trials
1
Data completeness
6/8 — Strong
Priority Review
MATULANE (procarbazine hydrochloride) by Leadiant Biosciences is clinical pharmacology the precise mode of cytotoxic action of procarbazine has not been clearly defined. Approved for lymphoma, brain and central nervous system tumors. First approved in 1969.
Drug data last refreshed 19h ago · AI intelligence enriched 2w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
MATULANE (procarbazine hydrochloride) is an oral alkylating agent approved in 1969 for lymphoma and brain/CNS tumors. It works through multiple mechanisms including inhibition of protein, RNA, and DNA synthesis, as well as direct DNA damage via hydrogen peroxide formation during auto-oxidation. The drug is rapidly absorbed and crosses the blood-brain barrier, making it particularly useful for CNS malignancies.
$2MPart D
LOE ApproachingDeclining
Minimal commercial activity with only $2M in Part D spending and declining patient volumes signals a small legacy product with limited team headcount and promotional focus.
Mechanism of Action
CLINICAL PHARMACOLOGY The precise mode of cytotoxic action of procarbazine has not been clearly defined. There is evidence that the drug may act by inhibition of protein, RNA and DNA synthesis. Studies have suggested that procarbazine may inhibit transmethylation of methyl groups of methionine into…
Indications (2)
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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.