NDAORALTABLETPriority Review
Approved
Jan 1964
Lifecycle
LOE Approaching
Competitive Pressure
30/100
Clinical Trials
22
Data completeness
3/8 — Basic
Priority Review
ALKERAN (melphalan) by Acrotech Biopharma is clinical pharmacology: melphalan is an alkylating agent of the bischloroethylamine type. First approved in 1964.
Drug data last refreshed 8h ago · AI intelligence enriched 3d ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
ALKERAN (melphalan) is an alkylating agent that cross-links DNA in tumor cells, active against both resting and rapidly dividing malignancies. It is primarily indicated for multiple myeloma treatment, with historical use in ovarian cancer and other hematologic malignancies. The drug works by binding to guanine bases in DNA, causing irreversible interstrand cross-links that prevent cell replication.
LOE Approaching
ALKERAN is approaching loss of exclusivity with a legacy market position; team size and growth investment are likely minimal as the franchise prepares for generic competition.
Mechanism of Action
CLINICAL PHARMACOLOGY: Melphalan is an alkylating agent of the bischloroethylamine type. As a result, its cytotoxicity appears to be related to the extent of its interstrand cross-linking with DNA, probably by binding at the Nposition of guanine. Like other bifunctional alkylating agents, it is…
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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.