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 28m ago · AI intelligence enriched 2w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
HEPZATO is melphalan hydrochloride injection, a DNA-alkylating agent administered via intra-arterial route that creates interstrand cross-links with guanine residues. It is active against both resting and rapidly dividing tumor cells, making it suitable for regional chemotherapy delivery. The product was approved by the FDA in August 2023 and represents a novel formulation and delivery approach for an established cytotoxic mechanism.
Growth8.1 years to LOE
Early-stage growth product with no direct competitors presents opportunity for brand-building and market development, though team size and investment level are currently undefined.
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 Aug 2026
15 enrolled
Metastatic MelanomaLiver Metastases
Career Relevance
HEPZATO's early growth stage and niche intra-arterial delivery mechanism create targeted career opportunities in specialized medical affairs and field roles focused on high-complexity accounts (interventional radiologists, hepatic oncologists). The lack of current linked job postings suggests brand is still establishing infrastructure, making early-career entry potentially high-impact but requiring tolerance for ambiguity.
Brand Manager
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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.