NDAINTRA-ARTERIALPOWDER
Approved
Aug 2023
Lifecycle
Growth
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 20h 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. It is an alkylating agent that induces DNA interstrand cross-linking, making it cytotoxic to both resting and rapidly dividing tumor cells. The product was approved in August 2023 and is currently in growth phase.
Growth8.4 years to LOE
Early-stage growth product with limited current market penetration suggests expanding team opportunities in commercial and market access roles.
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 Apr 2026
15 enrolled
Metastatic MelanomaLiver Metastases
Career Relevance
HEPZATO currently shows limited linked job openings (1 position), predominantly in Quality Assurance roles. Growth-phase status suggests opportunities will expand as commercial infrastructure scales, particularly in regulatory, manufacturing, and compliance-focused functions.
Quality Engineer
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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.