LIPIODOL (ethiodized oil)
Lipiodol is an oil-based contrast agent used for specialized imaging procedures in both adults and children. It helps patients undergoing hysterosalpingography or lymphography by making internal structures visible on scans. Additionally, it is used in adults with hepatocellular carcinoma to help image tumors through selective hepatic intra-arterial delivery.
How LIPIODOL Works
This agent works by opacifying the vessels and body structures it flows through. By making these areas radiopaque, it allows clinicians to clearly visualize internal structures that would otherwise be difficult to see.
Development Insights
Details
- Status
- Prescription
- First Approved
- 1954-03-31
- Routes
- INTRALYMPHATIC, INTRAUTERINE
- Dosage Forms
- OIL
LIPIODOL Approval History
What LIPIODOL Treats
2 indicationsLIPIODOL is approved for 2 conditions since its original approval in 1954. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Lymphography
- Hepatocellular Carcinoma
LIPIODOL Boxed Warning
FOR INTRALYMPHATIC, INTRAUTERINE AND SELECTIVE HEPATIC INTRA-ARTERIAL USE ONLY Pulmonary and cerebral embolism can result from inadvertent intravascular injection or intravasation of Lipiodol. Inject Lipiodol slowly with radiologic monitoring; do not exceed recommended dose ( 5.1 ). WARNING: FOR INTRALYMPHATIC, INTRAUTERINE AND SELECTIVE HEPATIC INTRA-ARTERIAL USE ONLY See Full Prescribing Information for complete Boxed Warning Pulmonary and cerebral embolism can result from inadvertent intravas...
WARNING: FOR INTRALYMPHATIC, INTRAUTERINE AND SELECTIVE HEPATIC INTRA-ARTERIAL USE ONLY Pulmonary and cerebral embolism can result from inadvertent intravascular injection or intravasation of Lipiodol. Inject Lipiodol slowly with radiologic monitoring; do not exceed recommended dose ( 5.1 ). WARNING: FOR INTRALYMPHATIC, INTRAUTERINE AND SELECTIVE HEPATIC INTRA-ARTERIAL USE ONLY See Full Prescribing Information for complete Boxed Warning Pulmonary and cerebral embolism can result from inadvertent intravascular injection or intravasation of Lipiodol. Inject Lipiodol slowly with radiologic monitoring; do not exceed recommended dose ( 5.1 ).
LIPIODOL Competitive Set
ProThree rings of competition based on shared molecular targets and treated indications.
Indication competitors
Same indication, different mechanism — what else might this patient receive?
Filters applied: drops same-active-ingredient (505(b)(2) reformulations), route-mismatch (topical vs systemic), and cross-therapeutic-area matches in same-indication rings.
What's emerging in LIPIODOL's indications
See all emerging drugs →Phase 3 candidates targeting molecules with no FDA-approved drug, in indications LIPIODOL treats. First-in-class if their pivotal trials read out positive.
Drugs Similar to LIPIODOL
3 of 6FDA-approved drugs for similar conditions. Compare mechanisms and indications to understand treatment alternatives.
GUERBET's other novel FDA approvals
Other CDER-designated drugs from the same sponsor (2016–2025).
Clinical Trial Registry
10 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT04728633 | 20P.1076 JT 15505 | Ph 2 | active not recruiting | Transarterial Chemoembolization for the Treatment of Uveal Melanoma With Liver Metastases |
| NCT05842174 TAQE | ONCC-008-22S IO1CX002542 | Ph 1, Ph 2 | recruiting | Targeting Ischemia-Induced Autophagy Dependence in Hepatocellular Carcinoma |
| NCT05435014 | TACE-OHEP-001 | Ph 1, Ph 2 | suspended | T-ACE Oil by TAE/TACE in Patients With Hepatocellular Carcinoma |
| NCT05672108 | 22067 P30CA033572, NCI-2022-10436 | Ph 2 | recruiting | Phase II Trial of Lung Chemoemobolization |
| NCT04200417 | 19-371 | Ph 1 | completed | Chemoembolization for Lung Tumors |
| NCT02762266 results posted | IRB-35937 NCI-2016-00418, P30CA124435 | Ph 3 | terminated | Transarterial Chemoembolization Compared With Stereotactic Body Radiation Therapy or Stereotactic Ablative Radiation Therapy in Treating Patients With Residual or Recurrent Liver Cancer Undergone Initial Transarterial Chemoembolization |
| NCT05490381 | RG1121599 NCI-2022-05693, STUDY00009998 | Ph 1 | withdrawn | Preoperative Embolization of Hypervascular Head and Neck Tumors to Improve Surgical Outcomes |
| NCT04733092 LipioJoint1 | APHP190891 2020-002206-10 | Ph 1 | completed | Safety and Efficacy of a Lipiodol Emulsion for the Embolization of Hypervascularizations in Patients With Knee Pain (LipioJoint1) |
| NCT01877187 results posted | J12115 NA_00074005, HIC1601017054 | Ph 2 | completed | Lipiodol as an Imaging Biomarker in Patients With Primary and Metastatic Liver Cancer |
| NCT02585479 | TA-C/Ahcc | Ph 2, Ph 3 | withdrawn | Systemic Chemotherapy Versus Transcatheter Arterial Chemoembolization(TACE) for Hepatocellular Carcinoma |
Active Pipeline
Ongoing clinical trials by development phase
Key Completed Trials
Completed studies with published results, ranked by significance
Trial Timeline
Full development history with FDA approval milestones
Understanding FDA Approval Types
| Count | Type | What it means |
|---|---|---|
| - | ORIG | Original approval - drug first enters market |
| - | SUPPL - Efficacy | New indication (new disease/condition approved) |
| - | SUPPL - Labeling | Label text changes (warnings, dosing updates) |
| - | SUPPL - Manufacturing | Production changes (new facility) |
| - | SUPPL - Chemistry | Formulation changes (new dosage strength) |
Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.
LIPIODOL FDA Label Details
Indications & Usage
FDA Label (PDF)LIPIODOL is indicated for the treatment of Lymphography; Hepatocellular Carcinoma.
WARNING: FOR INTRALYMPHATIC, INTRAUTERINE AND SELECTIVE HEPATIC INTRA-ARTERIAL USE ONLY Pulmonary and cerebral embolism can result from inadvertent intravascular injection or intravasation of Lipiodol. Inject Lipiodol slowly with radiologic monitoring; do not exceed recommended dose ( 5.1 ). WARNING...
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.
How We Calculate These Metrics
Trial Activity Stage
Measures the current development activity pattern based on trial phases, status, and trends. Important: This measures R&D activity, not commercial lifecycle.
Trial statuses: "Active" means recruiting or ongoing. "Completed" means reached planned endpoint. "Terminated" means stopped early—often due to safety, efficacy, or business reasons.
- Growth: High proportion of early-phase trials (Phase 1/2), active development
- Expansion: Significant Phase 3 activity, approaching or pursuing approvals
- Mature: Substantial Phase 4 post-marketing studies
- Stable: Mixed phase distribution, steady development
- Declining: Low active trial ratio, reduced R&D investment