Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as Oral Ifetroban, Ifetroban Sodium
Ifetroban · 8 trials · 18 indications
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.
To demonstrate a reduction in lung function decline for ifetroban compared to placebo over 52 weeks.
Percentage of subjects with one or more treatment emergent adverse event
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.
Incidence is measured as the total number of adverse events reported during the treatment and follow-up period for each treatment group.
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.
Safety is measured using AEs, including clinical significant changes in vital signs, laboratory test abnormalities and clinical tolerability of ifetroban.
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.
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.
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.
| Arm | Type | Description |
|---|---|---|
| Ifetroban | ACTIVE_COMPARATOR | Ifetroban 250 mg oral capsule administered once daily for a minimum of 4 weeks. |
| Placebo | PLACEBO_COMPARATOR | Matching placebo administered once daily for a minimum of 4 weeks. |
| Ifetroban Sodium | EXPERIMENTAL | Drug: Ifetroban Oral capsule, 250 mg, once daily for 12 months |
| Oral Ifetroban - Low Dose | EXPERIMENTAL | Weight based, once daily oral ifetroban |
| Oral Ifetroban - High Dose | EXPERIMENTAL | Weight based, once daily oral ifetroban |
| Placebos | PLACEBO_COMPARATOR | Matching Placebo |
| Ifetroban Oral Capsule | EXPERIMENTAL | Oral ifetroban, 200 mg daily for 8 weeks |
| Placebo Oral Capsule | PLACEBO_COMPARATOR | Oral placebo daily for 8 weeks |
| Patients with dcSSc | EXPERIMENTAL | Patients with dcSSc will be randomized to receive either oral ifetroban or oral placebo daily for 365 days |
| Patients with SSc-PAH | EXPERIMENTAL | Patients with SSc-PAH will be randomized to receive either oral ifetroban or oral placebo daily for 365 days |
| Ifetroban, Oral Capsule | ACTIVE_COMPARATOR | Ifetroban, Oral Capsule; 200 mg per dose (four - 50 mg capsules), once per day on Study Days 1, 2, and 3. |
| Placebo, Oral Capsule | PLACEBO_COMPARATOR | Placebo, Oral Capsule; matching capsules for oral ifetroban dosing, four capsules once per day on Study Days 1, 2, and 3. |
| 5 mg ifetroban, Type 1 | EXPERIMENTAL | 60-minute intravenous infusion of 5 mg ifetroban given once daily for 3 days to subjects with Type 1 HRS. |
| Placebo, Type 1 | PLACEBO_COMPARATOR | 60-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 2 | EXPERIMENTAL | 60-minute intravenous infusion of 5 mg ifetroban given once daily for 3 days to subjects with Type 1 HRS. |
| 15 mg ifetroban, Type 1 | EXPERIMENTAL | 60-minute intravenous infusion of 15 mg ifetroban given once daily for 3 days to subjects with Type 1 HRS. |
| 15 mg ifetroban, Type 2 | EXPERIMENTAL | 60-minute intravenous infusion of 15 mg ifetroban given once daily for 3 days to subjects with Type 2 HRS. |
| 50 mg ifetroban, Type 1 | EXPERIMENTAL | 60-minute intravenous infusion of 50 mg ifetroban given once daily for 3 days to subjects with Type 1 HRS. |
| 50 mg ifetroban, Type 2 | EXPERIMENTAL | 60-minute intravenous infusion of 50 mg ifetroban given once daily for 3 days to subjects with Type 2 HRS. |
| 150 mg ifetroban, Type 2 | EXPERIMENTAL | 60-minute intravenous infusion of 150 mg ifetroban given once daily for 3 days to subjects with Type 2 HRS. |
| Placebo, Type 2 | PLACEBO_COMPARATOR | 60-minute intravenous infusion of 5% dextrose in sterile water given once daily for 3 days to subjects with Type 2 HRS. |
| Name | Type | Description |
|---|---|---|
| Ifetroban Sodium | DRUG | Ifetroban sodium 250 mg capsule once daily for 4 weeks |
| Placebo | DRUG | Placebo arm to match Ifetroban Sodium once daily for 4 weeks. |
| Ifetroban | DRUG | Weight based, once daily oral ifetroban |
| Ifetroban Oral Capsule | DRUG | Subjects will be treated with oral ifetroban daily for 8 weeks |
| Placebo Oral Capsule | DRUG | Subjects will be treated with oral placebo daily for 8 weeks |
| Oral Ifetroban | DRUG | Subjects will be treated with oral ifetroban or placebo daily for 365 days |
| Oral Placebo | DRUG | Subjects will be treated with oral ifetroban or placebo daily for 365 days |
| Ifetroban, Oral Capsule | DRUG | - |
| Placebo, Oral Capsule | DRUG | - |
| Ifetroban Injection | DRUG | Ifetroban sodium injectable, diluted in sterile water with 5% dextrose |
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...
Ifetroban is an investigational small molecule being studied for cardiovascular diseases, Duchenne muscular dystrophy cardiomyopathy, portal hypertension, hepatorenal syndrome, aspirin-induced asthma, and idiopathic pulmonary fibrosis. It is also being evaluated in scleroderma and scleroderma-associated pulmonary arterial hypertension. The drug is in Phase 2 clinical development.
Ifetroban is a thromboxane receptor antagonist. It works by blocking the action of thromboxane, a molecule that promotes platelet aggregation and vasoconstriction. This mechanism is being studied across multiple conditions, including portal hypertension, aspirin-exacerbated respiratory disease, and Duchenne muscular dystrophy cardiomyopathy.
Ifetroban is being developed by Cumberland Pharmaceuticals Inc., a company traded on NASDAQ under the ticker CPIX. The drug is currently in Phase 2 clinical trials for several indications, including portal hypertension and Duchenne muscular dystrophy.
Ifetroban is in Phase 2 clinical development. It is an investigational drug and has not been approved by the FDA. The drug has received Orphan Drug, Rare Pediatric Disease, and Fast Track designations from the FDA for certain indications.
Ifetroban has been studied in several Phase 2 trials. NCT02682511 evaluated oral ifetroban in diffuse cutaneous systemic sclerosis and scleroderma-associated pulmonary arterial hypertension. NCT02802228 assessed its safety and efficacy for portal hypertension in cirrhotic patients. NCT03028350 studied it in aspirin-exacerbated respiratory disease, and NCT03340675 evaluated it in Duchenne muscular dystrophy.
Yes, Ifetroban is also known as Oral Ifetroban and Ifetroban Sodium. These names refer to the same investigational drug being developed by Cumberland Pharmaceuticals. The oral formulation has been used in clinical trials for conditions such as portal hypertension and Duchenne muscular dystrophy.