NDAINTRA-ARTERIALPOWDER
Approved
Aug 2023
Lifecycle
Peak
Competitive Pressure
0/100
Clinical Trials
1
Data completeness
5/8 — Partial
HEPZATO (melphalan hydrochloride injection, powder, lyophilized, for solution) by Delcath is type. First approved in 2023.
Drug data last refreshed 26m ago · AI intelligence enriched 2w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
HEPZATO is a lyophilized powder formulation of melphalan hydrochloride administered via intra-arterial injection as a cytotoxic chemotherapy agent. It works by forming interstrand DNA cross-links at the N7 position of guanine, exerting cytotoxicity against both resting and rapidly dividing tumor cells. The product was approved in August 2023 and represents a specialized delivery approach for an established alkylating agent mechanism.
Peak7.9 years to LOE
Early-stage peak lifecycle product with zero competitive pressure indicates opportunity for rapid market capture, though team sizing data is unavailable.
Mechanism of Action
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 N7 position of guanine. It is active against both resting and rapidly dividing tumor cells.
Indications
Indication data is being enriched from DailyMed and FDA labeling. Check back soon for approved therapeutic uses.
Clinical Trials (1)
Hepzato Kit and Opdualag for Metastatic Melanoma and Liver Metastasis
Started Nov 2026
15 enrolled
Metastatic MelanomaLiver Metastases
Career Relevance
Working on HEPZATO offers early-career opportunity in a newly approved, uncontested oncology niche with 7.9 years of patent protection and zero linked job postings, suggesting a lean, specialized team model. This position favors professionals seeking to build expertise in rare/specialized cancer delivery mechanisms before facing generic competition.
Brand Manager
Worked on HEPZATO at Delcath? 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.