NDAINJECTIONINJECTABLEPriority Review
Approved
Nov 1992
Lifecycle
LOE Approaching
Competitive Pressure
30/100
Clinical Trials
2
Data completeness
3/8 — Basic
Priority Review
ALKERAN (melphalan hydrochloride) by Hetero is clinical pharmacology: melphalan is an alkylating agent of the bischloroethylamine type. First approved in 1992.
Drug data last refreshed 12h ago · AI intelligence enriched 3d ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
ALKERAN (melphalan hydrochloride) is an alkylating agent chemotherapy that works by forming interstrand DNA cross-links to kill rapidly dividing tumor cells. It is approved for multiple myeloma treatment, with both oral and intravenous formulations available. The drug has been in use since 1992 and remains a standard-of-care backbone in myeloma regimens.
LOE Approaching
Product is in late-stage lifecycle; commercial teams should anticipate transition planning and focus on retention and line extension strategies.
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.