Oraltag

(Iohexol)

ApprovedSmall molecule

GGE Healthcare

Oraltag is one of 384 small molecule programs targeting Ascites. It is currently in Approved.

Indications

Total Trials

Active Trials

383

Competitors

FDA Applications

NDA/BLA/ANDA regulatory filings

Pipeline

Status by Indication[3][1]

Indication

AscitesActive, not recruiting

HypothyroidismActive, not recruiting

ToxicityActive, not recruiting

Lung CancerActive, not recruiting

Kidney DiseaseApproved

Myocardial IschemiaApproved

PancreatitisActive, not recruiting

Acute Kidney InjuryApproved

Colorectal CancerActive, not recruiting

Pancreatic CancerActive, not recruiting

AscitesPhase 2

Active, not recruiting

HypothyroidismApproved

Active, not recruiting

ToxicityPreclinical

Active, not recruiting

Lung CancerPreclinical

Active, not recruiting

Kidney DiseaseApproved

Approved

Myocardial IschemiaApproved

Approved

PancreatitisPreclinical

Active, not recruiting

Acute Kidney InjuryApproved

Approved

Colorectal CancerPreclinical

Active, not recruiting

Pancreatic CancerPreclinical

Active, not recruiting

Showing 10 of 15 indications

Competition

Competitive Landscape

1063 competitors in Pancreatic Cancer

#DrugCompanyPhaseTrials

Oraltag

GGE Healthcare

Approved

1 2

MS Contin

Merck & Co.

Preclinical

1 3

Feraheme

AAzurity Pharmaceuticals

Preclinical

1 4

Chemotherapy Agents

Takeda

Preclinical

1 5

Active Comparator

Moderna

Preclinical

1 6

LDE225

Novartis

Preclinical

1 7

Sulfonylureas

Eli Lilly

Preclinical

1 8

Secretin-Ferring

Ferring

Preclinical

1 9

Concurrent Lenvatinib

TTrans Tasman Radiation Oncology Group

Preclinical

2 10

Rybelsus

Pfizer

Preclinical

Ranked by pipeline maturity and clinical activity. Current drug highlighted in teal.

Timeline

Expected Milestones

Q4 2026

ApprovedRecruiting

Bacterial Infection

NCT06709521

Q1 2027

N/ANot yet recruiting

Heart Failure

NCT07349797

N/ARecruiting

Study completion

NCT07174440

Q1 2028

Phase 1Recruiting

Contrast Agent

NCT03997370

Clinical

Trials by Indication[1]

ARB2 trials

Mechanisms Underlying Hypotensive Response to ARB/NEP Inhibition - Aim 3

Completed·YYale University·Phase 4·NCT04649229·46 enrolled

Mechanisms Underlying Hypotensive Response to ARB/NEP Inhibition - Aim 2

Completed·VVanderbilt University Medical Center·Phase 4·NCT04113109·46 enrolled

Impaired Renal Function2 trials

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

Completed·MMediBeacon·Phase 2·NCT02772276·234 enrolled

Comparison of Captisol-Enabled™ Iohexol and Omnipaque™ in Patients With Impaired Renal Function Undergoing Coronary Angiography

Withdrawn·LLigand Pharmaceuticals·Phase 2·NCT04627831

Contrast Agent2 trials

Virtual Colonoscopy Using Omnipaque as a Contrast Agent

Completed·MMontefiore Medical Center··NCT04582500·50 enrolled

Evaluation of Dosing Procedures of Chemotherapy Treatment (Carboplatin) With the Contrast Agent Iohexol

Recruiting·NNRG Oncology·Phase 1·NCT03997370·350 enrolled

ART2 trials

A Study of LY3556050 in Healthy Participants

Completed· Eli Lilly logo

Eli Lilly·Phase 1·NCT04156750·34 enrolled

A Study of LY3526318 in Healthy Male Japanese Participants

Withdrawn· Eli Lilly logo

Eli Lilly·Phase 1·NCT05580250

Biomarkers1 trial

Renal Effects of Hormones/Biomarkers in Transgender PrEP Recipients

Completed·UUniversity of California, San Diego·Phase 4·NCT04742816·42 enrolled

28 more indications

HIV1 trial

Measurement of Glomerular Filtration Rate (GFR) in HIV Patients: Single-center Study Comparing the Accuracy of Estimators of GFR Versus Iohexol Plasma Clearance

Completed·—·Phase 4·NCT02522338·300 enrolled

Interaction1 trial

A Drug-Drug Interaction Study in Healthy Volunteers of the Effects of Tucatinib on Metformin

Completed· Pfizer logo

Pfizer·Phase 1·NCT03826602·18 enrolled

Intensive Care Unit1 trial

Measuring the Plasma Clearance of Iohexol to Estimate Glomerular Filtration Rate in Intensive Care Unit Patients: Preliminary Feasibility Study

Completed·UUniversity Hospital, Tours·Phase 3·NCT02050269·100 enrolled

Hypothyroidism1 trial

Pediatric Risk of Hypothyroidism With Iodinated Contrast Media

Withdrawn·GGE Healthcare·Phase 4·NCT03631771

Vasoconstriction1 trial

Hormone Therapy and Angiotensin-Dependent Arterial and Renal Vasoconstriction in Humans

Recruiting·UUniversity of Calgary··NCT05442463·200 enrolled

Toxicity1 trial

Prediction of Excretion and Toxicity of High Dose Methotrexate in Children and Adolescents With ALL

Completed·—·N/A·NCT02133599·23 enrolled

Pancreatic Cancer1 trial

Prognostic Value of Baseline Computed Tomography (CT) Perfusion Parameters of Pancreatic Cancer for Patients Undergoing Stereotactic Body Radiotherapy or Surgical Resection

Terminated·SStanford University··NCT01326364·6 enrolled

Phase 11 trial

A Phase 1, Open Label, Placebo-Controlled Study to Evaluate the Effect of GSK1349572 on Iohexol and Para-Aminohippurate Clearance in Healthy Subjects

Completed· GSK logo

GSK·Phase 1·NCT01214993·38 enrolled

Ascites1 trial

Oral Iohexol in the Management of Chylous Ascites After After Retroperitoneal or Extended Lymphadenectomy

Completed·—·Phase 2·NCT06820320·42 enrolled

SMA1 trial

Two-Point Measurement of Glomerular Filtration Rate by Iohexol Plasma Disappearance

Completed·UUniversity of Washington··NCT01545531·54 enrolled

Antiretroviral Treatment1 trial

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

Completed· Gilead logo

Gilead·Phase 4·NCT02246998·72 enrolled

Oral1 trial

Uniformity of Oral Contrast Material in the Bowel

Completed·UUniversity of California, San Francisco··NCT02542046·900 enrolled

Fabry Disease1 trial

A Study of Renal Function in Treatment-naïve, Young Male Patients With Fabry Disease

Terminated· Sanofi logo

Sanofi·Phase 1·NCT01839526·39 enrolled

Optical Coherence Tomography1 trial

Iso-Osmolar vs. Low-Osmolar Contrast Agents for Optical Coherence Tomography

Unknown status·MMinneapolis Heart Institute Foundation·Phase 4·NCT05065073·62 enrolled

Tenofovir1 trial

Tenofovir Pharmacology in Older HIV Infected Individuals

Completed·UUniversity of Colorado, Denver··NCT02304263·45 enrolled

CLE1 trial

Development of a Bayesian Estimator for Calculating Plasma Iohexol Clearance

Not yet recruiting·—·Phase 1·NCT05136963·48 enrolled

Heart Failure1 trial

MediBeacon® Transdermal GFR System for the Evaluation of Kidney Function in Adults With Heart Failure

Not yet recruiting·MMediBeacon·N/A·NCT07349797·15 enrolled

Impairment1 trial

A Study of Lanabecestat in Participants With Severe Kidney Impairment Compared to Healthy Participants

Withdrawn· Eli Lilly logo

Eli Lilly·Phase 1·NCT03545087

Function1 trial

Furosemide and Creatinine Tubular Stress Test in Order to Measure Proximal Tubule Residual Function

Completed·IInstituto Nacional de Cardiologia Ignacio Chavez·Phase 1·NCT05105009·50 enrolled

Critically Ill Patients1 trial

Iohexol Clearance in Critically Ill Patients With Augmented Renal Creatinine Clearance

Completed·AAssistance Publique - Hôpitaux de Paris·N/A·NCT04776486·90 enrolled

Body Weight1 trial

Dosing Iodinated Contrast Media According to Lean vs. Total Body Weight

Completed·NNova Scotia Health Authority·Phase 4·NCT03415997·239 enrolled

Lung Cancer1 trial

Pulmonary Interstitial Lymphography in Early Stage Lung Cancer

Terminated·SStanford University·N/A·NCT01188486·12 enrolled

Abemaciclib1 trial

A Study of the Effect of Abemaciclib on Metformin and Iohexol in Healthy Participants

Completed· Eli Lilly logo

Eli Lilly·Phase 1·NCT02884089·40 enrolled

Pancreatitis1 trial

Low-acid Contrast Media for Preventing Post ERCP Pancreatitis

Completed·SShandong University··NCT07391787·3,979 enrolled

Metformin1 trial

A Study of Effect of LY3556050 on Metformin in Healthy Participants

Completed· Eli Lilly logo

Eli Lilly·Phase 1·NCT05615467·18 enrolled

Bacterial Infection1 trial

Optimization of Beta-lactam Dosing in Critically Ill Patients With Suspected or Documented Antimicrobial Resistant Gram-Negative Infections With Cystatin-C (OPTIMIZE-GNI)

Recruiting·NNational Institute of Allergy and Infectious Diseases (NIAID)·Approved·NCT06709521·200 enrolled

Renal Failure1 trial

Measurement of Iohexol Plasma Clearance in Patients Leaving ICU After Acute Renal Failure

Completed·UUniversity Hospital, Angers·Phase 3·NCT02961478·150 enrolled

Unspecified2 trials

Method VALIDation and Evaluation of Non-radioactive Methods to Measure Glomerular Filtration Rate

Not yet recruiting·UUniversity Medical Center Groningen·N/A·NCT06259422·208 enrolled

Contrast and Anesthetic Level With Lumbar Erector Spinae Plan (ESP) Block

Recruiting·UUniversity Hospitals Cleveland Medical Center·N/A·NCT07174440·32 enrolled

Regulatory

FDA Approval Timeline[4]

Nov 30, 1988

OMNIPAQUE 140

NDA NDA018956

Oct 24, 1995

OMNIPAQUE 350

NDA NDA020608

Mar 26, 2015

ORALTAG

NDA NDA205383

Sources

References

[1]
ClinicalTrials.gov — 38 trial records for Iohexol. U.S. National Library of Medicine, National Institutes of Health.
[2]
ChEMBL — Iohexol compound record. European Bioinformatics Institute (EMBL-EBI).
[3]
Open Targets Platform — Drug–disease associations for Iohexol. EMBL-EBI & Wellcome Sanger Institute.
[4]
OpenFDA — FDA approval records (NDA NDA205383). U.S. Food & Drug Administration.
[5]
SEC EDGAR — GE Healthcare company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Modality: Small molecule[2]
Highest Phase: Approved[1]
Company: GGE Healthcare

Oraltag

Status by Indication[3][1]

Competitive Landscape

Expected Milestones

Q4 2026

Q1 2027

Q1 2028

Trials by Indication[1]

ARB2 trials

Impaired Renal Function2 trials

Contrast Agent2 trials

ART2 trials

Biomarkers1 trial

HIV1 trial

Interaction1 trial

Intensive Care Unit1 trial

Hypothyroidism1 trial

Vasoconstriction1 trial

Toxicity1 trial

Pancreatic Cancer1 trial

Phase 11 trial

Ascites1 trial

SMA1 trial

Antiretroviral Treatment1 trial

Oral1 trial

Fabry Disease1 trial

Optical Coherence Tomography1 trial

Tenofovir1 trial

CLE1 trial

Heart Failure1 trial

Impairment1 trial

Function1 trial

Critically Ill Patients1 trial

Body Weight1 trial

Lung Cancer1 trial

Abemaciclib1 trial

Pancreatitis1 trial

Metformin1 trial

Bacterial Infection1 trial

Renal Failure1 trial

Unspecified2 trials

FDA Approval Timeline[4]

References

Drug Info

Quick Facts

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