Organization (Industry)
DELCATH SYSTEMS, INC.
ClinicalTrials.gov lists DELCATH SYSTEMS, INC. as lead sponsor of 11 trials. It has 8 active development programs and 2 approved assets.
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Trials started per year with this organization as sponsor or collaborator, 1990 onward. The series also counts trials where the organization is a collaborator; the lead-sponsor trial count does not.
2026 is partial: 2 registered with a 2026 start date. The dashed outline is the pace from the 1 registered with a start date through September, planned starts included, not adjusted; not a forecast. No forecast is made for this organization: it averages 0.8 trial starts a year over the five years to September, under the 5 a year the method needs.
This page covers DELCATH SYSTEMS, INC.: 11 lead-sponsored trials and 2 legal-entity registrations.
Disease areas (26)
Shown in this order: most trials first.
| Disease area | Trials |
|---|---|
| Melanoma | 7 |
| Uveal Melanoma | 6 |
| Liver Neoplasms | 4 |
| Carcinoma, Hepatocellular | 3 |
| Bile Duct Neoplasms | 2 |
Showing 5 of 26 disease areas.
Trials by start year as sponsor or collaborator (8)
Shown in this order: most recent first. 2026 is partial: trials registered with a 2026 start date so far, not a full year.
Show the table of trials by start year as sponsor or collaborator
| Year | Trials started |
|---|---|
| 2026 (partial year) | 2 |
| 2025 | 2 |
| 2022 | 1 |
| 2018 | 1 |
| 2016 | 2 |
| 2014 | 2 |
| 2006 | 1 |
| 2004 | 1 |
Recruitment duration, a model prediction: 2 trials still running at the 2026-10-09 snapshot, fewer than the 5 needed for a median. Source: ClinicalTrials.gov / AACT (CTTI), public domain.
Active development programs (8)
Shown in this order: max phase, then active trials.
| Drug | Disease area | Max phase | Trials |
|---|---|---|---|
| Melphalan/HDS (Percutaneous Hepatic Perfusion) | Melanoma | Phase 3 | 1 |
| Melphalan/HDS (Percutaneous Hepatic Perfusion) | Uveal Melanoma | Phase 3 | 1 |
| Melphalan/HDS Followed by Consolidation Treatment with Trifluridine-tipiracil plus Bevacizumab | Rectal Neoplasms | Phase 2 | 1 |
| Melphalan/HDS Followed by Consolidation Treatment with Trifluridine-tipiracil plus Bevacizumab | Colorectal Neoplasms | Phase 2 | 1 |
| Trifluridine-tipiracil plus Bevacizumab Alone | Rectal Neoplasms | Phase 2 | 1 |
Showing 5 of 8 active programs.
Approved assets (2)
Shown in this order: max phase first.
| Drug | Trials |
|---|---|
| Melphalan | 4 |
| Sorafenib | 1 |
Sponsor delivery record (1)
Enrollment hit target: the share of this sponsor's lead-sponsored trials whose actual enrollment reached the planned enrollment. On time: the share whose actual primary completion date was no later than the planned date. Each share counts only trials where we observed an estimated figure before the actual one, and n is that number of trials. Below 5 trials the count is shown as a fraction, not a percentage.
| Enrollment | Timeline |
|---|---|
| 0 of 1 hit target (n=1) | 1 of 2 on time (n=2) |
Journals published in (1)
| Journal | Publications |
|---|---|
| Annals of surgical oncology | 1 |
US granted patents (1)
Patents are not classified by disease area in the source, so this is the organization's overall portfolio, not a split by disease.
| US patents granted | Granted in the last 5 years | Most recent grant |
|---|---|---|
| 19 | 5 | 2025-07-22 |
SEC-reported annual financials (11)
Shown in this order: newest fiscal year first; SEC EDGAR XBRL companyfacts, USD as reported.
| Fiscal year | Revenue (USD) | Net income (USD) | R&D (USD) |
|---|---|---|---|
| 2025 | 85,231,000 | 2,700,000 | 29,246,000 |
| 2024 | 37,205,000 | -26,386,000 | 13,874,000 |
| 2023 | 2,065,000 | -47,678,000 | 17,502,000 |
| 2022 | 2,719,000 | -36,508,000 | 18,583,000 |
| 2021 | 3,555,000 | -25,649,000 | 13,778,000 |
| 2020 | not reported | -24,156,000 | 11,201,000 |
| 2019 | not reported | -8,879,000 | 9,490,000 |
| 2018 | not reported | -19,222,000 | 19,650,000 |
| 2017 | not reported | -45,117,000 | 10,495,000 |
| 2016 | not reported | -17,971,000 | 8,448,000 |
Showing 10 of 11 fiscal years.
Financing and grant events (50)
Shown in this order: most recent first.
| Date | Round type | Amount (USD) | Source |
|---|---|---|---|
| 2025-12-31 | Other financing | not disclosed | Sec extracted |
| 2025-11-19 | Other financing | not disclosed | Sec extracted |
| 2024-12-24 | Other financing | 16,300,000 | Sec extracted |
| 2024-12-23 | Other financing | not disclosed | Sec extracted |
| 2024-09-26 | Other financing | not disclosed | Edgar offerings |
Showing 5 of 50 events.
FDA inspection record (1)
| Latest classification | Inspections |
|---|---|
| NAI | 6 |
Manufacturing and distribution sites (2)
Shown in this order: severity rank then name.
| Facility | Location | Regulators | Member organization |
|---|---|---|---|
| Delcath Systems, Inc. | Queensbury, US | FDA | |
| Delcath Systems, Inc. | Queensbury, US | FDA |
Climate targets, as filed (1)
| Reporting year | Net-zero target |
|---|---|
| 2025 | not disclosed |
Workforce and board diversity, as filed (1)
| Reporting year | Workforce % women | Board % women |
|---|---|---|
| 2025 | not disclosed | not disclosed |
Organization relationships (5)
Shown in this order: most evidence first.
| Related organization | Relationship | Evidence |
|---|---|---|
| Government of the United States of America | Co sponsors trial with | 2 |
| Iqvia Holdings Inc. | Co sponsors trial with | 1 |
| Iqvia Holdings Inc. | Uses vendor | 1 |
| Moffitt Cancer Center | Co sponsors trial with | 1 |
| University of Wisconsin System | Co sponsors trial with | 1 |
Latest dated events (91)
Shown in this order: newest first.
| Date | Event | Source |
|---|---|---|
| 2026-10 | Trial started | Clinical trials (ClinicalTrials.gov) (ClinicalTrials.gov, U.S. National Library of Medicine; AACT database, Clinical Trials Transformation Initiative (CTTI)) |
| 2026-03-31 | PDUFA decision date | Regulatory decision dates extracted from SEC filings |
| 2026-01-29 | Trial started | Clinical trials (ClinicalTrials.gov) (ClinicalTrials.gov, U.S. National Library of Medicine; AACT database, Clinical Trials Transformation Initiative (CTTI)) |
| 2025-12-31 | Financing | Funding rounds and grants (NIH RePORTER + SEC EDGAR) |
| 2025-12-31 | Trial started | Clinical trials (ClinicalTrials.gov) (ClinicalTrials.gov, U.S. National Library of Medicine; AACT database, Clinical Trials Transformation Initiative (CTTI)) |
Showing 5 of 91 events.
Biomarker capability evidence (60)
Shown in this order: tier desc, then gene symbol.
| Gene | Role | Evidence |
|---|---|---|
| BRAF | Trial collaborator | Named in trial inclusion criteria |
| CDK4 | Trial sponsor | Named in trial inclusion criteria |
| DHDDS | Trial sponsor | Named in trial inclusion criteria |
| EGFR | Trial sponsor | Named in trial inclusion criteria |
| ERBB2 | Trial sponsor | Named in trial inclusion criteria |
Showing 5 of 60 evidence rows.
Not on this page
Checked, with nothing recorded for this organization: companies grouped under this page, related companies not grouped here, fda warning letters, fda untitled letters, fda recalls, fda import refusals, clia clinical laboratory certificates, and biomarkers this organization publishes on.