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 1h ago · AI intelligence enriched 1w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
ALKERAN (melphalan) is a bischloroethylamine alkylating agent that induces cytotoxicity through interstrand DNA cross-linking, primarily at guanine N-positions. It is indicated for multiple myeloma and has been a foundational chemotherapy standard since 1964. The drug is active against both resting and rapidly dividing tumor cells.
LOE Approaching
Product is approaching loss of exclusivity, signaling potential team consolidation and transition focus toward legacy management or pipeline support roles.
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 Acrotech Biopharma? 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.