Drugs / Iohexol
Iohexol
Regulatory milestones approvals, filings & regulatory actions · 11 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Label expansions (10) | US (FDA) | OMNIPAQUE 140 | — | 1986-11-26 – 1993-07-13 | fda.gov ↗ |
| Approved | US (FDA) | OMNIPAQUE 140 | — | 1985-12-26 | fda.gov ↗ |
Trials 27
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 19 trials | ||||||
| Phase 1 | NCT05136963 | Jun 2024 → Apr 2025 | — | University Hospital of Saint-Etienne | Unknown | No outcome recorded |
| Phase 1 | NCT05615467 | Nov → Dec 2022 | — | Eli Lilly and Company | Completed | No outcome recorded |
| Phase 1 | NCT05065372 | Jul 2022 → Mar 2027 expected | cardiovascular disorder, diabetic kidney disease, type 1 diabetes mellitus | Kalie Tommerdahl | Recruiting | No outcome recorded |
| Phase 1 | NCT05105009 | Mar 2020 → Oct 2023 | chronic renal failure syndrome | Instituto Nacional de Cardiologia Ignacio Chavez | Completed | No outcome recorded |
| Phase 1 | NCT03997370 | Jan 2020 → Feb 2027 expected | cancer | NRG Oncology | Active not recruiting | No outcome recorded |
| Phase 1 | NCT04156750 | Nov 2019 → Aug 2020 | — | Eli Lilly and Company | Completed | No outcome recorded |
| Phase 1 | NCT02884089 | Aug → Dec 2016 | — | Eli Lilly and Company | Completed | No outcome recorded |
| Phase 1 | NCT02098174 | Nov 2013 → Jan 2014 | acute kidney injury | MediBeacon | Completed | No outcome recorded |
| Phase 1 | NCT01839526 | May 2013 → Sep 2016 | Fabry disease | Genzyme, a Sanofi Company | Terminated | No outcome recorded Stop: Enrollment |
| Phase 1/21 trial | ||||||
| Phase 1/2 | NCT03584217 | Oct 2018 → Jun 2023 | diabetic kidney disease, obesity disorder, type 2 diabetes mellitus | University of Colorado, Denver | Unknown | No outcome recorded |
| Phase 22 trials | ||||||
| Phase 2 | NCT06820320 | Feb → Dec 2025 | chylous ascites, metastatic malignant neoplasm in the lymph nodes | Cancer Institute and Hospital, Chinese Academy of Medical Sciences | Completed | No outcome recorded |
| Phase 2 | NCT02772276 | May 2016 → Aug 2021 | acute kidney injury | MediBeacon | Completed | No outcome recorded |
| Phase 32 trials | ||||||
| Phase 3 | NCT02961478 | Feb 2017 → Nov 2022 | acute kidney injury | University Hospital, Angers | Completed | No outcome recorded |
| Phase 3 | NCT02050269 | Jan 2014 → Jun 2016 | — | University Hospital, Tours | Completed | No outcome recorded |
| Phase 46 trials · 1 met primary | ||||||
| Phase 4 | NCT06709521 | Feb 2025 → Jun 2026 overdue | bacterial infectious disease | National Institute of Allergy and Infectious Diseases (NIAID) | Recruiting | No outcome recorded |
| Phase 4 | NCT03631771 | Mar 2022 → Aug 2024 | hypothyroidism | GE Healthcare | Withdrawn | No outcome recorded |
| Phase 4 | NCT04742816 | Sep 2020 → Dec 2021 | — | University of California, San Diego | Completed | No outcome recorded |
| Phase 4 | NCT03769597 | Jan → Aug 2019 | cirrhosis of liver | University Hospital, Limoges | Completed | No outcome recorded |
| Phase 4 | NCT02522338 | Feb 2011 → Dec 2013 | HIV infectious disease | University Hospital of Saint-Etienne | Completed | No outcome recorded |
| Phase 4 | NCT00478556 | Aug 2007 → Mar 2009 | — | University of Alabama at Birmingham | Completed | Met primary |
| Phase not applicable7 trials | ||||||
| — | NCT07174440 | Sep 2025 → Jan 2027 expected | — | University Hospitals Cleveland Medical Center | Recruiting | No outcome recorded |
| — | NCT06846034 | Feb 2025 → Sep 2026 overdue | diabetic kidney disease, type 2 diabetes mellitus | Poitiers University Hospital | Recruiting | No outcome recorded |
| — | NCT06259422 | Jun 2024 → Sep 2025 | chronic kidney disease, impaired renal function disease | University Medical Center Groningen | Unknown | No outcome recorded |
| — | NCT04776486 | Sep 2020 → Jan 2026 | — | Assistance Publique - Hôpitaux de Paris | Completed | No outcome recorded |
| — | NCT03912012 | Jul 2019 → Nov 2020 | type 1 diabetes mellitus | Hospices Civils de Lyon | Completed | No outcome recorded |
| — | NCT02133599 | Jul 2014 → Feb 2019 | — | Ann & Robert H Lurie Children's Hospital of Chicago | Completed | No outcome recorded |
| — | NCT01188486 | Aug 2010 → Apr 2017 | mesothelioma, non-small cell lung carcinoma, small cell lung carcinoma | Stanford University | Terminated | No outcome recorded Stop: Business |
| Comparator or background therapy19 trials | ||||||
| Phase 0 | NCT06220214 Background | Mar 2024 → Jul 2026 overdue | HER2 positive breast carcinoma, triple-negative breast carcinoma | Alison Stopeck | Recruiting | No outcome recorded |
| Phase 0 | NCT05754749 Background | Mar 2023 → Aug 2026 overdue | breast cancer | UNC Lineberger Comprehensive Cancer Center | Recruiting | No outcome recorded |
| Phase 1 | NCT05580250 Background | Nov → Dec 2022 | — | Eli Lilly and Company | Withdrawn | No outcome recorded Stop: Business |
| Phase 1 | NCT03826602 Background | Feb → Mar 2019 | — | Seagen Inc. | Completed | No outcome recorded |
| Phase 1 | NCT07809919 Background | Dec 2018 → Sep 2021 | Chagas disease, visceral leishmaniasis | Novartis Pharmaceuticals | Completed | No outcome recorded |
| Phase 1 | NCT03545087 Background | Jun 2018 → Jan 2019 | impaired renal function disease | Eli Lilly and Company | Withdrawn | No outcome recorded |
| Phase 2 | NCT04627831 Comparator | Jan 2022 → Mar 2023 | — | Ligand Pharmaceuticals | Withdrawn | No outcome recorded |
| Phase 3 | NCT03689946 Background | Mar 2019 → Jan 2023 | cardiovascular disorder, hyperlipidemia | Cedars-Sinai Medical Center | Completed | No outcome recorded |
| Phase 3 | NCT01984411 Background | Jan 2013 | myocardial ischemia | Centro Cardiológico del Caribe, Columbia | Completed | No outcome recorded |
| Phase 4 | NCT07643467 Background | Sep 2026 → May 2028 expected | — | Aaron Cook | Recruiting | No outcome recorded |
| Phase 4 | NCT05967117 Comparator | Nov 2023 → Nov 2024 overdue | lung disorder | Jung Im Jung | Recruiting | No outcome recorded |
| Phase 4 | NCT05065073 Comparator | Sep 2021 → Mar 2023 | coronary artery disorder | Minneapolis Heart Institute Foundation | Unknown | No outcome recorded |
| Phase 4 | NCT04649229 Background | May 2021 → May 2025 | heart failure | Yale University | Completed | No outcome recorded |
| Phase 4 | NCT03415997 Comparator | Feb → Nov 2018 | — | Nova Scotia Health Authority | Completed | No outcome recorded |
| — | NCT07349797 Background | Apr 2026 → Jan 2027 expected | heart failure | MediBeacon | Not yet recruiting | No outcome recorded |
| — | NCT05930236 Background | Apr 2023 → Jun 2024 | chronic pain syndrome, vertebral column disorder | Erasme University Hospital | Unknown | No outcome recorded |
| — | NCT02669784 Comparator | Feb 2016 → May 2017 | acute tubulointerstitial nephritis, aortic aneurysm, arteries, anomalies of | Milton S. Hershey Medical Center | Completed | No outcome recorded |
| — | NCT02928458 Comparator | Sep 2015 → Sep 2017 | intestinal obstruction | The Guthrie Clinic | Withdrawn | No outcome recorded Stop: Enrollment |
| — | NCT00626366 Background | Mar 2008 → Jan 2009 | chronic rhinosinusitis | University of Nebraska | Completed | No outcome recorded |
News releases announcing trial results or a regulatory action · 2
| Date | Issuer | Release |
|---|---|---|
| 2026-07-17 | Impax Laboratories, LLC | Regulatory Amneal Expands Iohexol Injection Portfolio with U.S. FDA Approval of Additional Strengths and Presentations amneal.com ↗
Approval of iohexol injection 350 mg iodine/mL in 50 mL, 75 mL and 100 mL vials, and 300 mg iodine/mL in 50 mL vial, significantly expands Amneal’s injectable contrast portfolio |
| 2025-11-13 | Impax Laboratories, LLC | Regulatory Amneal Receives U.S. FDA Approval for Iohexol Injection amneal.com ↗
Amneal Pharmaceuticals, Inc. (“Amneal” or the “Company”) (Nasdaq: AMRX) today announced the U.S. Food and Drug Administration (FDA) has approved the Company’s iohexol injection (300 mg Iodine/mL), the first generic version of GE Healthcare’s Omnipaque ® (iohexol) injection. |
All press releases naming this drug 5 releases
| Date | Issuer | Release |
|---|---|---|
| 2026-07-17 | Impax Laboratories, LLC | Amneal Expands Iohexol Injection Portfolio with U.S. FDA Approval of Additional Strengths and Presentations amneal.com ↗ |
| 2025-11-13 | Impax Laboratories, LLC | Amneal Receives U.S. FDA Approval for Iohexol Injection amneal.com ↗ |
| 2019-11-08 | Ligand Pharmaceuticals | Ligand Presents Positive Results from Phase 1 Clinical Trial of Captisol-enabled Iohexol ligand.com ↗ |
| 2019-07-10 | Ligand Pharmaceuticals | Ligand Announces Positive Top Line Results from Phase 1 Clinical Trial of Captisol-enabled Iohexol ligand.com ↗ |
| 2019-05-02 | Ligand Pharmaceuticals | Ligand Completes Enrollment of Phase 1 Clinical Trial of Captisol-enabled Iohexol ligand.com ↗ |
Evidence & citations 8 cited values
Every value below carries the sentence it was read from. 46 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Iohexol | “Iohexol Inj 300 MG/ML Diagnostic agent used to measure glomerular filtration rate (GFR)” NCT06846034 ↗37“Iohexol (Omnipaque 300, 5 mL) was administered by IV injection over 2 minutes” NCT02098174 ↗ |
| Known as | Iohexol, Omnipaque 300 | “Iohexol, Omnipaque 300” NCT02133599 ↗ |
| Known as | N,N´ -Bis(2,3-dihydroxypropyl)-5-\[N-(2,3-dihydroxypropyl)-acetamido\]-2,4,6-triiodoisophthalamide | “Iohexol,N,N´ -Bis(2,3-dihydroxypropyl)-5-\[N-(2,3-dihydroxypropyl)-acetamido\]-2,4,6-triiodoisophthalamide, is a non-ionic, water-soluble radiographic contrast medium with a...” NCT06709521 ↗ |
| Known as | Omnipaque | “intravenous injection of Iohexol (Omnipaque 300mg) with blood sampling at 0, 120, 180 and 240 minutes (during Day 1.” NCT03912012 ↗9“5 ml iohexol (Omnipaque) intravenously” NCT05105009 ↗ |
| Known as | Omnipaque (Iohexol) | “Omnipaque™ (Iohexol)” NCT04627831 ↗ |
| Known as | Omnipaque 300 | “Subjects will receive a single bolus of 5 mL of Omnipaque 300 (containing 3235 mg iohexol)” NCT06259422 ↗1“Iohexol (Omnipaque 300, 5 mL) was administered by IV injection over 2 minutes” NCT02098174 ↗ |
| Modality | Diagnostic / imaging agent | “radiographic contrast medium” NCT01188486 ↗ |
| Route | Oral | “Patients will be randomized to receive either a standardized dilution of Gastroview or Omnipaque orally.” NCT00478556 ↗ |