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Ifetroban

Phase 2

Portal Hypertension | Small molecule | Gastrointestinal |Cumberland Pharmaceuticals Inc.|Last Updated: Apr 15, 2026

Success Probability
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Trial Design
RandomizedDouble-BlindPLACEBO_CONTROLLED
Total Trials1
Total Enrollment30
FDA Designations
ORPHAN_DRUGRARE_PEDIATRIC_DISEASEFAST_TRACK
Clinical trial landscape

Ifetroban · 7 trials · 17 indications

Phase 2 7
NCT03962855Thromboxane Receptor Antagonist to Improve Endothelial FunctionCardiovascular Diseases
COMPLETED57 Analytics
NCT05571059Oral Ifetroban in Patients With Idiopathic Pulmonary Fibrosis (IPF)Idiopathic Pulmonary Fibrosis
RECRUITING128 Analytics
NCT03340675Oral Ifetroban in Subjects With Duchenne Muscular DystrophyDuchenne Muscular Dystrophy Cardiomyopathy
COMPLETED46 Analytics
NCT03028350Oral Ifetroban to Treat Aspirin Exacerbated Respiratory Disease (AERD)Asthma, Aspirin-Induced
COMPLETED54 Analytics
NCT02802228Study to Assess Safety and Efficacy of Ifetroban for Treatment of Portal Hypertension in Cirrhotic PatientsPortal Hypertension
COMPLETED30 Analytics
NCT02682511Oral Ifetroban to Treat Diffuse Cutaneous Systemic Sclerosis (SSc) or SSc-associated Pulmonary Arterial HypertensionScleroderma, Diffuse
ACTIVE NOT_RECRUITING34 Analytics
NCT01436500Safety and Pharmacokinetics of Ifetroban in Hepatorenal Syndrome PatientsHepatorenal Syndrome
COMPLETED55 Analytics
PHASE2COMPLETED
Thromboxane Receptor Antagonist to Improve Endothelial Function
Cardiovascular DiseasesUnlock trial analytics
PHASE2RECRUITING
Oral Ifetroban in Patients With Idiopathic Pulmonary Fibrosis (IPF)
Idiopathic Pulmonary FibrosisUnlock trial analytics
PHASE2COMPLETED
Oral Ifetroban in Subjects With Duchenne Muscular Dystrophy
Duchenne Muscular Dystrophy CardiomyopathyUnlock trial analytics
PHASE2COMPLETED
Oral Ifetroban to Treat Aspirin Exacerbated Respiratory Disease (AERD)
Asthma, Aspirin-InducedUnlock trial analytics
PHASE2COMPLETED
Study to Assess Safety and Efficacy of Ifetroban for Treatment of Portal Hypertension in Cirrhotic Patients
Portal HypertensionUnlock trial analytics
PHASE2ACTIVE NOT_RECRUITING
Oral Ifetroban to Treat Diffuse Cutaneous Systemic Sclerosis (SSc) or SSc-associated Pulmonary Arterial Hypertension
Scleroderma, DiffuseUnlock trial analytics
PHASE2COMPLETED
Safety and Pharmacokinetics of Ifetroban in Hepatorenal Syndrome Patients
Hepatorenal SyndromeUnlock trial analytics
Study Endpoints
Primary Endpoints
Change in Reactive Hyperemia Index (RHI)
Baseline to 4 weeks

The change in Reactive Hyperemia Peripheral Index (RHI) as measured by Arterial Tonometry. The Reactive Hyperemia Index (RHI) is calculated as the ratio of post- to pre-occlusion peripheral arterial tone signals on the occluded side, normalized to the control side, and further adjusted for baseline vascular tone. RHI is automatically measured by the EndoPAT 2000 software. According to the manufacturer, an RHI value greater than 1.67 is considered normal, while a lower value indicates endothelial dysfunction and is associated with an increased risk of cardiovascular events.

Change from baseline in Forced Vital Capacity (FVC) in mL
Baseline through 12 months

To demonstrate a reduction in lung function decline for ifetroban compared to placebo over 52 weeks.

Incidence of Treatment-Emergent Adverse Events
Baseline through 12 months

Percentage of subjects with one or more treatment emergent adverse event

Change From Baseline in Sinonasal Outcome Test-22 Score
Baseline and 8 weeks

Sinonasal Outcome Test-22 (SNOT-22) score is a scale with a minimum score of 0 and a maximum score of 110 based on the presence and severity of symptoms and outcomes of rhinosinusitis. Higher scores indicate worse symptoms and/or outcomes.

Safety (Incidence and Severity of Adverse Events)
Through 97 days (90 days treatment and 7 days follow-up)

Incidence is measured as the total number of adverse events reported during the treatment and follow-up period for each treatment group.

Safety (Severity of Adverse Events)
Through 90 days treatment and 7 days follow-up

The severity of each event is reported by the investigator according to the following protocol/CTCAE definitions: Grade 1-Mild; asymptomatic or mild symptoms; clinical or diagnostic observations only; intervention not indicated; Grade 2-Moderate; minimal, local or noninvasive intervention indicated; limiting age-appropriate instrumental activities of daily living; Grade 3-Severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; limiting self-care activities of daily living; Grade 4-Life-threatening consequences; urgent intervention indicated; Grade 5-Death related to adverse event.

Incidence of adverse events (AEs) and Serious AEs (SAEs)
56 weeks

Safety is measured using AEs, including clinical significant changes in vital signs, laboratory test abnormalities and clinical tolerability of ifetroban.

Half-life (T-1/2) of Ifetroban and Ifetroban Acylglucuronide
3 days

Plasma concentrations of ifetroban and its major active metabolite were measured at Baseline and Study Hours 1, 2, 4, 8, 12, 24, 48, 49, 50, 52, 56, 60, and 72 to determine the Pharmacokinetic parameters.

Pharmacokinetic Parameters (Exposure) of Ifetroban and Ifetroban Acylglucuronide After Three Days of Treatment
3 days

Plasma concentrations of ifetroban and its primary active metabolite were measured at Baseline and Study Hours 1, 2, 4, 8, 12, 24, 48, 49, 50, 52, 56, 60, and 72 to determine the Pharmacokinetic parameters.

Pharmacokinetic Parameters (Concentration) of Ifetroban and Ifetroban Acylglucuronide After Three Days of Treatment
3 days

Plasma concentrations of ifetroban and it's major active metabolite were measured at Baseline and Study Hours 1, 2, 4, 8, 12, 24, 48, 49, 50, 52, 56, 60, and 72 to determine the Pharmacokinetic parameters.

Secondary Endpoints
Change in Percent Flow-mediated Vasodilation (FMD)
Baseline to 4 weeks
Change in Urinary TXB2-M
Baseline to 4 weeks
Time to the first occurrence of any of the components of the composite endpoint: time to first acute IPF exacerbation, first hospitalization for respiratory cause, or death
Baseline through 12 months
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Study Design & Arms
AllocationRANDOMIZED
MaskingQUADRUPLE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
IfetrobanACTIVE_COMPARATORIfetroban 250 mg oral capsule administered once daily for a minimum of 4 weeks.
PlaceboPLACEBO_COMPARATORMatching placebo administered once daily for a minimum of 4 weeks.
Ifetroban SodiumEXPERIMENTALDrug: Ifetroban Oral capsule, 250 mg, once daily for 12 months
Oral Ifetroban - Low DoseEXPERIMENTALWeight based, once daily oral ifetroban
Oral Ifetroban - High DoseEXPERIMENTALWeight based, once daily oral ifetroban
PlacebosPLACEBO_COMPARATORMatching Placebo
Ifetroban Oral CapsuleEXPERIMENTALOral ifetroban, 200 mg daily for 8 weeks
Placebo Oral CapsulePLACEBO_COMPARATOROral placebo daily for 8 weeks
Patients with dcSScEXPERIMENTALPatients with dcSSc will be randomized to receive either oral ifetroban or oral placebo daily for 365 days
Patients with SSc-PAHEXPERIMENTALPatients with SSc-PAH will be randomized to receive either oral ifetroban or oral placebo daily for 365 days
5 mg ifetroban, Type 1EXPERIMENTAL60-minute intravenous infusion of 5 mg ifetroban given once daily for 3 days to subjects with Type 1 HRS.
Placebo, Type 1PLACEBO_COMPARATOR60-minute intravenous infusion of 5% dextrose in sterile water given once daily for 3 days to subjects with Type 1 HRS.
5 mg ifetroban, Type 2EXPERIMENTAL60-minute intravenous infusion of 5 mg ifetroban given once daily for 3 days to subjects with Type 1 HRS.
15 mg ifetroban, Type 1EXPERIMENTAL60-minute intravenous infusion of 15 mg ifetroban given once daily for 3 days to subjects with Type 1 HRS.
15 mg ifetroban, Type 2EXPERIMENTAL60-minute intravenous infusion of 15 mg ifetroban given once daily for 3 days to subjects with Type 2 HRS.
50 mg ifetroban, Type 1EXPERIMENTAL60-minute intravenous infusion of 50 mg ifetroban given once daily for 3 days to subjects with Type 1 HRS.
50 mg ifetroban, Type 2EXPERIMENTAL60-minute intravenous infusion of 50 mg ifetroban given once daily for 3 days to subjects with Type 2 HRS.
150 mg ifetroban, Type 2EXPERIMENTAL60-minute intravenous infusion of 150 mg ifetroban given once daily for 3 days to subjects with Type 2 HRS.
Placebo, Type 2PLACEBO_COMPARATOR60-minute intravenous infusion of 5% dextrose in sterile water given once daily for 3 days to subjects with Type 2 HRS.
Interventions
NameTypeDescription
Ifetroban SodiumDRUGIfetroban sodium 250 mg capsule once daily for 4 weeks
PlaceboDRUGPlacebo arm to match Ifetroban Sodium once daily for 4 weeks.
IfetrobanDRUGWeight based, once daily oral ifetroban
Ifetroban Oral CapsuleDRUGSubjects will be treated with oral ifetroban daily for 8 weeks
Placebo Oral CapsuleDRUGSubjects will be treated with oral placebo daily for 8 weeks
Oral IfetrobanDRUGSubjects will be treated with oral ifetroban or placebo daily for 365 days
Oral PlaceboDRUGSubjects will be treated with oral ifetroban or placebo daily for 365 days
Ifetroban InjectionDRUGIfetroban sodium injectable, diluted in sterile water with 5% dextrose
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Eligibility Criteria
Age Range18 Years to 80 Years
SexALL
Healthy VolunteersNo
Study Sites1

Inclusion Criteria: * Males and females 18-80 years of age with established cardiovascular disease * Take \>=81 mg daily of aspirin as part of their daily medical regimen * Urine thromboxane B2 metabolites \>1145 pg/mg creatinine on screening. * Able to provide written consent and comply with proto...

Countries:United StatesIndia
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Recent Changes (Last 90 Days)
LOWMay 26, 2026NCT05571059primaryCompletionDate: changed
MEDIUMMay 26, 2026NCT02682511primaryCompletionDate: changed
LOWMay 24, 2026NCT05571059studyFirstPostDate: changed
LOWMay 24, 2026NCT02682511studyFirstPostDate: changed
MEDIUMMay 21, 2026NCT03340675TRIAL_REMOVED: changed
MEDIUMMay 21, 2026NCT03340675TRIAL_REMOVED: changed