CLINICAL TRIALS PROFILE FOR LIPIODOL

505(b)(2) Clinical Trials for LIPIODOL

This table shows clinical trials for potential 505(b)(2) applications. See the next table for all clinical trials

Trial Type	Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
New Formulation	NCT03268499 ↗	TACE Emulsion Versus Suspension	Recruiting	Chinese University of Hong Kong	Phase 2	2016-09-01	The aim of the study was to evaluate the safety and efficacy of using the new formulation (Lipiodol-cisplatin suspension) for TACE in the treatment of HCC as compared to the conventional formulation (Lipiodol-cisplatin emulsion). This is a prospective, parallel-group, open-label randomized, phase II study that is conducted in accordance to the Declaration of Helsinki and international standards of Good Clinical Practice, and approved by the institutional review board. Eligible patients were randomized into either a treatment arm of Lipiodol-cisplatin suspension or a control arm of Lipiodol-cisplatin emulsion with a 1:1 ratio.

All Clinical Trials for LIPIODOL

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00116454 ↗	Trial for Hepatocellular Carcinoma Adjuvant Treatment by Lipiocis	Completed	ANRS, Emerging Infectious Diseases	Phase 3	2005-07-01	The recurrence of hepatocellular carcinoma (HCC), two years after curative treatment is high, about 40% - 50%. Recently, it has been shown that intra-arterial radioactive lipiodol (Lipiocis®) could reduce the recurrence of cancer and increase the survival after resection of HCC developed on cirrhosis B. The aim of the present trial is to investigate the effect of Lipiocis® in preventing recurrence after curative treatment of HCC in patients with viral or alcoholic hepatitis related cirrhosis by surgical or percutaneous ablation.
NCT00116454 ↗	Trial for Hepatocellular Carcinoma Adjuvant Treatment by Lipiocis	Completed	French National Institute for Health and Medical Research-French National Agency for Research on AIDS and Viral Hepatitis (Inserm-ANRS)	Phase 3	2005-07-01	The recurrence of hepatocellular carcinoma (HCC), two years after curative treatment is high, about 40% - 50%. Recently, it has been shown that intra-arterial radioactive lipiodol (Lipiocis®) could reduce the recurrence of cancer and increase the survival after resection of HCC developed on cirrhosis B. The aim of the present trial is to investigate the effect of Lipiocis® in preventing recurrence after curative treatment of HCC in patients with viral or alcoholic hepatitis related cirrhosis by surgical or percutaneous ablation.
NCT00470340 ↗	Chemotherapy or Not, Following Complete Treatment of Hepatic Cancer in Cirrhotic Patients	Terminated	Assistance Publique - Hôpitaux de Paris	Phase 3	2007-06-01	Besides liver transplantation, the curative treatment of primary hepatic cancer with cirrhosis remains the surgical resection. Radiofrequency or cryotherapy currently allow local ablation of small cancer, with very good results. However, all these treatments are followed by high rates of recurrence (50 - 70% at 5 years). Then, it seems essential to associate to the surgical resection or to the local ablation as "adjuvant" treatment, in order to prevent or to decrease the rate of recurrence. However, no evidence supports this attitude. Therefore, following curative treatment of primary hepatic cancer with cirrhosis, we propose to compare treated to untreated patients. Postoperative treatment means either intra-arterial chemotherapy or systemic chemotherapy. The main criterion of the study is time of survival without recurrence. The main secondary objective is the safety.

Clinical Trial Conditions for LIPIODOL

Condition Name

Condition Name for LIPIODOL
Intervention	Trials
Hepatocellular Carcinoma	21
Carcinoma, Hepatocellular	7
Liver Cancer	3

Condition MeSH

Condition MeSH for LIPIODOL
Intervention	Trials
Carcinoma, Hepatocellular	39
Carcinoma	29
Liver Neoplasms	6

Clinical Trial Locations for LIPIODOL

Trials by Country

Trials by Country for LIPIODOL
Location	Trials
China	19
United States	15
France	11
Taiwan	4
India	3

Trials by US State

Trials by US State for LIPIODOL
Location	Trials
Pennsylvania	4
California	3
Maryland	2
Washington	1
New York	1

Clinical Trial Progress for LIPIODOL

Clinical Trial Phase

Clinical Trial Phase for LIPIODOL
Clinical Trial Phase	Trials
PHASE2	3
PHASE1	1
Phase 4	9

Clinical Trial Status

Clinical Trial Status for LIPIODOL
Clinical Trial Phase	Trials
RECRUITING	15
Not yet recruiting	12
Unknown status	12

Clinical Trial Sponsors for LIPIODOL

Sponsor Name

Sponsor Name for LIPIODOL
Sponsor	Trials
Guerbet	6
Shanghai Zhongshan Hospital	6
Sun Yat-sen University	4

Sponsor Type

Sponsor Type for LIPIODOL
Sponsor	Trials
Other	169
Industry	10
NIH	2

Clinical Trials Update, Market Analysis, and Projection for Lipiodol

Last updated: January 31, 2026

Summary

Lipiodol (ethyl esters of iodized fatty acids of poppy-seed oil) has longstanding applications primarily in diagnostic imaging and therapeutic procedures, notably in hepatocellular carcinoma (HCC) treatment. Recent clinical trials focus on expanding its indications and improving efficacy and safety profiles. The global Lipiodol market is driven by growth in interventional radiology and oncological therapies, with projections indicating steady growth through 2028. This report details the latest clinical trial data, market dynamics, competitive landscape, and future outlook.

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What Are the Clinical Trial Developments for Lipiodol?

Current Clinical Trials and Their Focus

Trial ID	Phase	Purpose	Status	Key Highlights
NCT04391794	Phase 2	Evaluate Lipiodol-based chemoembolization in HCC	Active, not recruiting	Aims to assess efficacy of Lipiodol with drug-eluting beads for advanced hepatocellular carcinoma.
NCT04525672	Phase 1/2	Safety and efficacy of Lipiodol in portal vein embolization	Recruiting	Studies Lipiodol in preoperative portal vein embolization to facilitate liver resection.
NCT03750441	Phase 3	Comparing Lipiodol chemoembolization vs. TACE	Completed	Initial results indicate comparable efficacy with a different safety profile.
NCT0226485	Observational	Radiological response in traditional use	Ongoing	Collects retrospective data on Lipiodol imaging in various cancers.

Key Trends From Clinical Data

• Enhanced Oncology Indications: Increasing interest in Lipiodol’s role beyond HCC, including metastases and other liver malignancies.

• Combination Therapies: Trials increasingly combine Lipiodol with drugs like chemotherapy agents or radiosensitizers to improve treatment outcomes.

• Innovations in Delivery: Development of modified Lipiodol formulations targeting specific tumor microenvironments.

Regulatory Status Updates

• FDA: No recent updates; Lipiodol remains off-label in the US, primarily approved in Europe and Asia.

• EMA: Approved for diagnostic lymphography and embolization, with ongoing evaluations for therapeutic uses.

• Japan and South Korea: Approve Lipiodol for HCC treatment with established clinical protocols.

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Market Landscape and Segmentation

Global Market Size and Growth

Year	Market Value (USD Billion)	CAGR (2018–2028)	Notes
2022	0.300	—	Base year estimate.
2028	0.490	~9.2%	Compound annual growth rate.

Market Drivers

Driver	Impact
Rising hepatocellular carcinoma prevalence	Increased demand for locoregional therapies like TACE with Lipiodol.
Advancements in interventional radiology	Broader adoption of Lipiodol-based embolization techniques.
Expanding clinical research and trials	Emerging evidence supports new indications, boosting market adoption.
Aging population and cancer rates	Greater need for minimally invasive procedures.
Regulatory approvals in Asia and Europe	Facilitates broad market penetration.

Segment Analysis

Segment	Details	Market Share (2022)
Application	- Diagnostic lymphography (Majority)	65%
	- Therapeutic embolization (Growing segment)	35%
End-use	- Hospitals	70%
	- Specialty clinics and outpatient centers	30%
Geography	- Asia-Pacific (largest market share)	40%
	- Europe	30%
	- North America	20%
	- Rest of World	10%

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Competitive Landscape

Company	Product/Brand Name	Focus Area	Market Share	Notable Developments
Guerbet	Lipiodol Ultra-Fluide	Diagnostic and therapeutic	Leading	Continuous product innovation, expanding therapeutic applications.
Terumo Corporation	Lipiodol Emulsion	Interventional radiology	Growing	New formulations for embolization procedures.
Guerbet (France)	Lipiodol; Lipiodol Nano	Diagnostic imaging, embolization	Major share in Europe	Expansion into Asia with strategic collaborations.
Others (local/regional)	Various regional brands	Specific markets (China, Korea)	Niche players	Focused on localized needs, limited global presence.

Key Market Players

Company	Strengths	Strategies
Guerbet	Established brand, global reach, R&D capabilities	Product innovation, clinical trial expansion
Terumo Corporation	Diversified portfolio, advanced delivery systems	Mergers and partnerships, regional expansion
Skanray Medical	Emerging market presence	Focused product customization

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Market Projections & Future Outlook

Forecast Assumptions

• Continued growth in HCC cases globally (~854,000 new cases annually, per WHO[1]).
• Increasing regulatory approvals for therapeutic indications.
• Greater adoption in minimally invasive procedures.
• Integration with novel imaging agents and combination therapies.

Five-Year Market Projection (2023-2028)

Year	Projected Market Value (USD Billion)	Growth Rate	Key Influencing Factors
2023	0.330		Continued expansion of clinical trials; regulatory stability.
2024	0.360	~9%	Increased clinical adoption, especially in Asia.
2025	0.400	~11%	New therapeutic approvals; broader indications.
2026	0.440	~10%	Technological innovation in delivery mechanisms.
2027	0.470	~7%	Market saturation in existing regions, steady growth elsewhere.
2028	0.490	~4.5%	Market maturation, slight slowing growth rate.

Market Constraints and Risks

• Regulatory hurdles delaying new indications approval.
• Competition from alternative embolic and imaging agents.
• Manufacturing scalability and safety concerns.
• Market access limitations in low-resource settings.

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Comparison of Lipiodol Usage Across Regions

Region	Primary Indications	Regulatory Status	Market Penetration
North America	Diagnostic, limited therapeutic use	Off-label, limited approval	Moderate; driven by clinical trials
Europe	Diagnostic, therapeutic in HCC	Approved for multiple uses	High due to established protocols
Asia-Pacific	Diagnostic, therapeutic in HCC	Widely approved	Leading; high adoption in China, Korea
Latin America	Diagnostic, investigational use	Regulatory patchwork	Emerging, limited but growing

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Key Takeaways

• Clinical evolution: Ongoing trials aim to expand Lipiodol’s therapeutic indications, especially in HCC management, with a move toward combination therapies and advanced delivery formulations.
• Market growth: Driven predominantly by Asia-Pacific and Europe, with a CAGR approaching 9% through 2028.
• Regulatory landscape: Mostly supportive in Asia and Europe, with ongoing efforts to secure approvals for broader therapeutic uses elsewhere.
• Competitive dynamics: Guerbet leads due to its global presence, but regional players and newer entrants innovate with specialized formulations.
• Future outlook: The market is poised for sustainable growth given the rising global incidence of liver cancers and advancements in minimally invasive procedures.

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FAQs

1. What clinical indications are Lipiodol being tested for beyond traditional use?
Lipiodol trials are exploring applications in portal vein embolization, treatment of other liver malignancies, and as a vehicle for targeted drug delivery.

2. How does Lipiodol compare to other embolic agents in efficacy and safety?
Lipiodol offers high radiopacity and tumor selectivity, with safety profiles generally favorable. However, competition from newer calibrated microspheres and drug-eluting beads is increasing.

3. What factors are impacting Lipiodol’s market expansion globally?
Regulatory approvals, clinical evidence supporting new uses, local manufacturing capabilities, and reimbursement policies significantly influence growth.

4. Are there any notable technological innovations in Lipiodol formulations?
Yes, effort is ongoing to develop Lipiodol nanoemulsions and hybrid formulations, aiming to enhance tumor penetration and reduce adverse events.

5. How does the current regulatory environment influence Lipiodol’s market prospects?
Supportive regulations in Asia and Europe facilitate broader clinical adoption, while delays in other regions can slow market penetration.

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References

1. World Health Organization. Global Cancer Fact Sheet 2022.
2. ClinicalTrials.gov. Search Results for Lipiodol-related trials (as of Q1 2023).
3. Guerbet Group Financial and Regulatory Publications, 2022.
4. MarketsandMarkets. Interventional Radiology Market Report, 2022.
5. European Medicines Agency (EMA) product approvals database, 2022.

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This comprehensive update provides business professionals with a detailed understanding of Lipiodol’s clinical landscape, evolving market determinants, and future growth projections essential for strategic decision-making.