NDAINJECTIONINJECTABLEPriority Review
Approved
Nov 1992
Lifecycle
LOE Approaching
Competitive Pressure
30/100
Clinical Trials
2
Data completeness
4/8 — Partial
Priority Review
ALKERAN (melphalan hydrochloride) by Hetero is clinical pharmacology: melphalan is an alkylating agent of the bischloroethylamine type. Approved for multiple myeloma. First approved in 1992.
Drug data last refreshed Yesterday · AI intelligence enriched 2w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
ALKERAN (melphalan hydrochloride) is a bifunctional alkylating agent used to treat multiple myeloma by cross-linking DNA and inducing cytotoxicity in both resting and rapidly dividing tumor cells. Administered intravenously, melphalan undergoes rapid plasma clearance with a terminal half-life of approximately 75 minutes and is metabolized through chemical hydrolysis to inactive monohydroxy and dihydroxy metabolites.
LOE Approaching
As a legacy alkylating agent with approaching loss of exclusivity, ALKERAN team size is likely modest and focused on lifecycle management rather than expansion.
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…
Worked on ALKERAN at Hetero? Share your interview experience or compensation data (+7 days Pro)
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.