Drugs / lipiodol
lipiodol
Regulatory milestones approvals, filings & regulatory actions · 2 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Label expansion | US (FDA) | LIPIODOL | — | 2014-04-04 | fda.gov ↗ |
| Approved | US (FDA) | LIPIODOL | — | 1954-03-31 | fda.gov ↗ |
Trials 8
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| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 12 trials | ||||||
| Phase 1 | NCT05490381 | Dec 2023 → Jan 2025 | head and neck cancer | University of Washington | Withdrawn | No outcome recorded Stop: Enrollment |
| Phase 1 | NCT04733092 | Mar 2021 → Jun 2022 | osteoarthritis, knee | Assistance Publique - Hôpitaux de Paris | Completed | No outcome recorded |
| Phase 22 trials · 1 met primary | ||||||
| Phase 2 | NCT05340231 | May → Dec 2022 | colorectal cancer | Gang Wu | Unknown | No outcome recorded |
| Phase 2 | NCT01877187 | Apr 2013 → Feb 2020 | liver cancer | Yale University | Completed | Met primary |
| Phase 32 trials | ||||||
| Phase 3 | NCT06497140 | Sep 2024 → Jan 2028 expected | osteoarthritis, knee | Assistance Publique - Hôpitaux de Paris | Recruiting | No outcome recorded |
| Phase 3 | NCT03542331 | Mar 2018 → Jan 2020 | female infertility | University Hospital Brussels | Unknown | No outcome recorded |
| Phase not applicable2 trials | ||||||
| — | NCT03277716 | Dec 2017 → Dec 2019 | hepatocellular carcinoma | Fan Weijun | Unknown | No outcome recorded |
| — | NCT02180568 | May 2014 → Dec 2016 | lung disorder | Severance Hospital | Completed | No outcome recorded |
| Comparator or background therapy33 trials | ||||||
| Phase 0 | NCT07295262 Background | Jan 2026 → Jul 2028 expected | adult hepatocellular carcinoma | West China Hospital | Recruiting | No outcome recorded |
| Phase 0 | NCT04753918 Background | Mar → Sep 2021 | non-small cell lung carcinoma | Taoyuan General Hospital | Unknown | No outcome recorded |
| Phase 0 | NCT04048317 Comparator | Sep 2019 → Sep 2020 | hepatocellular carcinoma | Assiut University | Unknown | No outcome recorded |
| Phase 1 | NCT07132541 Background | Aug 2025 → Nov 2026 expected | ampulla of vater cancer, malignant pancreatic neoplasm | Minia University | Recruiting | No outcome recorded |
| Phase 1 | NCT04200417 Background | Dec 2019 → Apr 2022 | bronchial neoplasm, mediastinal cancer, pleural neoplasm, respiratory system cancer | Memorial Sloan Kettering Cancer Center | Completed | No outcome recorded |
| Phase 1 | NCT03865563 Background | Jul 2019 → Jun 2021 | pancreatic adenocarcinoma | Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins | Withdrawn | No outcome recorded |
| Phase 1/2 | NCT05842174 Background | Apr 2026 → Sep 2029 expected | hepatocellular carcinoma | VA Office of Research and Development | Recruiting | No outcome recorded |
| Phase 1/2 | NCT05435014 Comparator | Sep 2022 → Jun 2026 | hepatocellular carcinoma | T-ACE Medical Co., Ltd | Suspended | No outcome recorded |
| Phase 1/2 | NCT02638857 Background | Sep 2015 → Mar 2017 | hepatocellular carcinoma | Second Military Medical University | Unknown | No outcome recorded |
| Phase 2 | NCT07380633 Comparator | Jan 2026 → Dec 2027 expected | hepatocellular carcinoma | Sun Yat-sen University | Active not recruiting | No outcome recorded |
| Phase 2 | NCT07230509 Background | Dec 2025 → Dec 2027 expected | ampulla of vater cancer, malignant pancreatic neoplasm | Minia University | Recruiting | No outcome recorded |
| Phase 2 | NCT05672108 Background | May 2023 → Oct 2027 expected | bronchial neoplasm, colon carcinoma, neoplasm of mediastinum, non-small cell lung carcinoma +2 | City of Hope Medical Center | Recruiting | No outcome recorded |
| Phase 2 | NCT05361161 Background | Jun → Dec 2022 | gastric cancer | Gang Wu | Unknown | No outcome recorded |
| Phase 2 | NCT04728633 Background | Sep 2021 → Jan 2027 expected | metastatic malignant neoplasm, uveal melanoma | Thomas Jefferson University | Active not recruiting | No outcome recorded |
| Phase 2 | NCT03727633 Background | Jul 2018 → Jun 2025 | hepatocellular carcinoma | University Hospital, Montpellier | Terminated | No outcome recorded Stop: Enrollment |
| Phase 2 | NCT03048123 Comparator | Oct 2015 → Oct 2016 | hepatocellular carcinoma | Sun Yat-sen University | Completed | No outcome recorded |
| Phase 2 | NCT00820053 Background | Jan → Dec 2009 | hepatocellular carcinoma | Eastern Hepatobiliary Surgery Hospital | Completed | No outcome recorded |
| Phase 2/3 | NCT02585479 Comparator | Oct 2015 → Oct 2017 | hepatocellular carcinoma | Guangxi Medical University | Withdrawn | No outcome recorded |
| Phase 2/3 | NCT02584556 Background | Oct 2015 → Oct 2017 | hepatocellular carcinoma | Guangxi Medical University | Withdrawn | No outcome recorded |
| Phase 2/3 | NCT01861912 Background | Jun 2013 → Jun 2016 | hepatocellular carcinoma | Guangdong Provincial People's Hospital | Unknown | No outcome recorded |
| Phase 3 | NCT06130072 Comparator | Nov 2023 → Mar 2024 | — | Ain Shams University | Unknown | No outcome recorded |
| Phase 3 | NCT05647954 Background | Dec 2022 → Dec 2024 | neuroendocrine neoplasm | Taizhou Hanzhong Biomedical Co., Ltd. | Unknown | No outcome recorded |
| Phase 3 | NCT03192644 Comparator | Jul 2017 → Dec 2022 | hepatocellular carcinoma | Sun Yat-sen University | Unknown | No outcome recorded |
| Phase 3 | NCT02762266 Comparator | Feb 2016 → Dec 2022 | hepatocellular carcinoma | Stanford University | Terminated | No outcome recorded Stop: Business |
| Phase 3 | NCT02109146 Background | Mar 2014 → May 2023 | hepatocellular carcinoma | Zhejiang University | Completed | No outcome recorded |
| Phase 3 | NCT02755311 Comparator | Mar 2014 → Jun 2016 | hepatocellular carcinoma | Sun Yat-sen University | Unknown | No outcome recorded |
| Phase 3 | NCT00470340 Background | Jun 2007 → Nov 2008 | cirrhosis of liver, hepatocellular carcinoma | Assistance Publique - Hôpitaux de Paris | Terminated | No outcome recorded |
| Phase 4 | NCT02631499 Background | Dec 2015 → Dec 2018 | hepatocellular carcinoma | Fudan University | Unknown | No outcome recorded |
| Phase 4 | NCT01959061 Background | Sep 2013 → Dec 2017 | colorectal cancer | Nanjing Chia-tai Tianqing Pharmaceutical | Unknown | No outcome recorded |
| — | NCT03617029 Comparator | Jan → Oct 2019 | lung cancer | National Taiwan University Hospital Hsin-Chu Branch | Unknown | No outcome recorded |
| — | NCT01923064 Comparator | Oct → Dec 2013 | portal hypertension | Shanghai Zhongshan Hospital | Completed | No outcome recorded |
| — | NCT01489410 Comparator | Oct 2012 → Mar 2014 | hepatocellular carcinoma | University of Minnesota | Withdrawn | No outcome recorded |
| — | NCT00825669 Comparator | Dec 2008 → Dec 2009 | hepatocellular carcinoma | Eastern Hepatobiliary Surgery Hospital | Completed | No outcome recorded |
News releases announcing trial results or a regulatory action · 7
| Date | Issuer | Release |
|---|---|---|
| 2026-04-24 | Guerbet | Regulatory Guerbet announces an important milestone achievement in the “Vascular Embolization” indication for Lipiodol® Ultra Fluid (Iodinated ethyl esters of fatty acids of poppy seed oil) guerbet.com ↗
Guerbet, a global leader in medical imaging, announces a positive outcome from a worksharing procedure, involving several EU member states, for a new Lipiodol ® indication in interventional radiology. |
| 2020-12-08 | Guerbet | Regulatory UK approves Lipiodol ® Ultra Fluid for hysterosalpingography in women undergoing infertility workup guerbet.com ↗
Guerbet (GBT) has been granted approval for an indication extension in the United Kingdom, where Lipiodol ® Ultra Fluid is the only oil-based contrast medium indicated for hysterosalpingography (HSG) in women undergoing infertility workup. |
| 2020-07-29 | Guerbet | Regulatory Lipiodol® Ultra Fluid indicated for hysterosalpingography (HSG) for tubal flushing in women undergoing infertility workup in Denmark guerbet.com ↗
Guerbet (GBT) announced today that the Danish Medicines Agency has granted approval for an extension of the indication of Lipiodol ® Ultra Fluid in Denmark, where it is now indicated for hysterosalpingography (HSG) for tubal flushing in women undergoing infertility workup. |
| 2020-03-23 | Guerbet | Regulatory Hungary and the Netherlands approve Lipiodol ® Ultra Fluid for hysterosalpingography in women undergoing infertility workup guerbet.com ↗
Guerbet (GBT), a global leader in medical imaging, has announced that it has received indication approval in Hungary and the Netherlands where Lipiodol ® Ultra Fluid is now indicated for hysterosalpingography (HSG) in women undergoing infertility workup. |
| 2020-02-12 | Guerbet | Regulatory Lipiodol ® Ultra Fluid indicated for hysterosalpingography (HSG) in women undergoing infertility workup in Ireland guerbet.com ↗
Guerbet (GBT) has announced that it has been granted approval for an indication extension in Ireland, where Lipiodol ® Ultra Fluid is now indicated for hysterosalpingography (HSG) in women undergoing infertility workup. |
| 2018-09-11 | Guerbet | Regulatory New indication approved for Guerbet’s Lipiodol® Ultra Fluid guerbet.com ↗
New indication approved for Guerbet’s Lipiodol® Ultra Fluid |
| 2017-05-18 | Guerbet | Results H2Oil Trial using Lipiodol® UF for hysterosalpingography published in the New England Journal of Medicine guerbet.com ↗
Guerbet announced that a clinical study, published today in the New England Journal of Medicine and presented at the 13 th World Congress on Endometriosis in Vancouver, Canada, shows interesting clinical data about hysterosalpingography examination with Lipiodol ® Ultra-Fluide. |
All press releases naming this drug 7 releases
Evidence & citations 5 cited values
Every value below carries the sentence it was read from. 41 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | lipiodol | “Then the left and right hepatic arteries were accessed by a microcatheter and intraarterial epirubicin (40 mg) and oxaliplatin (150 mg) in a mixture of lipiodol (3～5 mL) were injected.” NCT02109146 ↗34“Arterial infusion chemotherapy (THP + oxaliplatin + raltitrexed) and THP combined with lipiodol embolization for 2 times, with an interval of 1 month.” NCT05361161 ↗ “fotemustine 100 mg/sqm, day2, every 6 weeks; lipiodol is usually 5-10 ml (According to the location and number of lesions)” NCT05647954 ↗ “Lipiodol 5-10ml,Pirarubicin17mg/m2 and Oxaliplatin 30mg/m2 are infused through the right and left hepatic arteries” NCT02584556 ↗ “Injection of Histoacryl® (n-butyl-2-cyanoacrylate) mixed with Lipiodol® (1:1 ratio) into the pancreatic parenchyma” NCT07230509 ↗ “Injection of Histoacryl® (n-butyl-2-cyanoacrylate) mixed with Lipiodol® (1:1 ratio) into the pancreatic parenchyma” NCT07132541 ↗ “The chemotherapeutic drugs and 2 to 10 ml lipiodol are given via hepatica propria artery.” NCT00825669 ↗ “Self-assembled nanoprobes of Indocyanine Green (ICG) and Cisplatin mixed with lipiodol” NCT07295262 ↗ “Chemoembolization: Lipiodol emulsion (lipiodol 10ml+ Oxaliplatin 85mg +Lidocaine 1ml)” NCT05340231 ↗ “300mg/m2 carb mixed with 2-5 mL lipiodol, followed by pure lipiodol” NCT07380633 ↗ “lipiodol mixed with chemotherapy drugs (EADM, lobaplatin, and MMC)” NCT03048123 ↗ |
| Known as | Ethiodized Oil | ClinicalTrials.gov intervention name — accepted as the source's own label NCT05490381 ↗ |
| Known as | Lipidol | “iso-amyl- 2-cyanoacrylate mixed with Ethiodized oil (Lipidol)” NCT06130072 ↗ |
| Known as | Lipiodol Ultra-Fluide | “Chemolipiodolization was performed mixed with 5 ml of lipiodol (Lipiodol Ultra-Fluide; André Guerbet Laboratories, Aulnay-sous-Bois, France).” NCT02755311 ↗ |
| Route | Intrathecal | “intra-arterial chemotherapy (CIAL = cisplatin 75 mg + lipiodol 10 ml)” NCT00470340 ↗ |