Data updated: May 26, 2026
ORALTAG (iohexol)
Trial Activity: Declining 3 active trials
Other
Approved 2015-03-26
Development Insights
Eli Lilly and Company conducting 5 trials (24%)
19 indications explored (Broad Platform)
→ healthy (4 trials)
→ heart failure (2 trials)
→ bacterial infection (1 trials)
1
Indication
--
Phase 3 Trials
11
Years on Market
Details
- Status
- Discontinued
- First Approved
- 2015-03-26
- Routes
- ORAL
- Dosage Forms
- FOR SOLUTION
ORALTAG Approval History
2016
2017
2018
2019
2020
2021
2022
2023
2024
2025
2026
Original
New Indication
New Form
Label Update
1 FDA actions from 2015 to 2015
What ORALTAG Treats
1 FDA approvalsOriginally approved for its first indication in 2015 .
- Other (1)
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Clinical Trial Registry
20 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT06709521 | 23-0013 5UM1AI104681-12 | Ph 4 | recruiting | Optimization of Beta-lactam Dosing in Critically Ill Patients With Cystatin C (OPTIMIZE-GNI) |
| NCT03997370 | NRG-GY022 NCI-2019-04008, NRG-GY022 | Ph 1 | active not recruiting | Evaluation of Dosing Procedures of Chemotherapy Treatment (Carboplatin) With the Contrast Agent Iohexol |
| NCT04649229 | 2000028712 | Ph 4 | completed | Mechanisms Underlying Hypotensive Response to ARB/NEP Inhibition - Aim 3 |
| NCT02050269 IoxRea | PHAO13-SE / IoxRea 2013-003936-65, 2013-R49 | Ph 3 | completed | Measuring the Plasma Clearance of Iohexol to Estimate Glomerular Filtration Rate in Intensive Care Unit Patients: Preliminary Feasibility Study |
| NCT04113109 | #191228 | Ph 4 | completed | Mechanisms Underlying Hypotensive Response to ARB/NEP Inhibition - Aim 2 |
| NCT05105009 | 19-1131 | Ph 1 | completed | Furosemide and Creatinine Tubular Stress Test in Order to Measure Proximal Tubule Residual Function |
| NCT02772276 results posted | ORFM-2 | Ph 2 | completed | Pharmacokinetics of MB-102 and Use of the Non-invasive Optical Renal Function Monitor (ORFM) Device in Subjects With Normal and Impaired Renal Function and a Range of Skin Color Types |
| NCT05615467 | 18629 J2P-MC-LXBE | Ph 1 | completed | A Study of Effect of LY3556050 on Metformin in Healthy Participants |
| NCT05580250 | 18353 J2D-JE-CVAD | Ph 1 | withdrawn | A Study of LY3526318 in Healthy Male Japanese Participants |
| NCT03631771 | GE-012-103/19476/OPY-44-002 | Ph 4 | withdrawn | Pediatric Risk of Hypothyroidism With Iodinated Contrast Media |
| NCT04627831 | CE-Iohexol - Study 201 Ligand 201, CAP201 | Ph 2 | withdrawn | Comparison of Captisol-Enabled™ Iohexol and Omnipaque™ in Patients With Impaired Renal Function Undergoing Coronary Angiography |
| NCT04742816 | CCTG 605s | Ph 4 | completed | Renal Effects of Hormones/Biomarkers in Transgender PrEP Recipients |
| NCT01839526 | AGAL19110 2012-001966-14, MSC 12711 | Ph 1 | terminated | A Study of Renal Function in Treatment-naïve, Young Male Patients With Fabry Disease |
| NCT04156750 | 17612 J2P-MC-LXBA | Ph 1 | completed | A Study of LY3556050 in Healthy Participants |
| NCT03826602 | SGNTUC-020 | Ph 1 | completed | A Drug-Drug Interaction Study in Healthy Volunteers of the Effects of Tucatinib on Metformin |
| NCT03415997 | NSHA REB 1023119 | Ph 4 | completed | Dosing Iodinated Contrast Media According to Lean vs. Total Body Weight |
| NCT02884089 results posted | 16536 I3Y-MC-JPCK | Ph 1 | completed | A Study of the Effect of Abemaciclib on Metformin and Iohexol in Healthy Participants |
| NCT03545087 | 16007 I8D-MC-AZEN | Ph 1 | withdrawn | A Study of Lanabecestat in Participants With Severe Kidney Impairment Compared to Healthy Participants |
| NCT02246998 results posted | GS-US-236-0140 2014-002095-93 | Ph 4 | completed | Renal Effect of Stribild or Other Tenofovir DF-containing Regimens Compared to Ritonavir-boosted Atazanavir Plus Abacavir/Lamivudine in Antiretroviral Treatment-naive HIV-1 Infected Adults |
| NCT02522338 HIVOL | 1008078 2010-022272-31 | Ph 4 | completed | Measurement of Glomerular Filtration Rate (GFR) in HIV Patients: Single-center Study Comparing the Accuracy of Estimators of GFR Versus Iohexol Plasma Clearance |
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Pro Active Pipeline
Ongoing clinical trials by development phase
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Pro Key Completed Trials
Completed studies with published results, ranked by significance
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Trial Timeline
Full development history with FDA approval milestones
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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.
ORALTAG FDA Label Details
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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