Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as Oral Ifetroban, Ifetroban Oral Capsule, Ifetroban Injection, 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 drug developed by Cumberland Pharmaceuticals Inc. (ticker CPIX). It is being studied in Phase 2 clinical trials for several conditions, including aspirin exacerbated respiratory disease (AERD), aspirin-induced asthma, cardiovascular diseases, Duchenne muscular dystrophy cardiomyopathy, hepatorenal syndrome, and idiopathic pulmonary fibrosis.
Ifetroban targets TBXA2R, the thromboxane A2 receptor. By acting on this receptor, Ifetroban is designed as a thromboxane receptor antagonist. This mechanism is being explored across respiratory and cardiovascular conditions, including aspirin exacerbated respiratory disease and idiopathic pulmonary fibrosis.
Ifetroban is being developed by Cumberland Pharmaceuticals Inc., which trades under the ticker CPIX. The company is the sponsor of the clinical trial program evaluating oral Ifetroban across respiratory, cardiovascular, and neuromuscular indications.
Ifetroban is in Phase 2 clinical development. It is investigational and has not been approved by the FDA. Cumberland Pharmaceuticals is running Phase 2 trials in idiopathic pulmonary fibrosis, aspirin exacerbated respiratory disease, Duchenne muscular dystrophy cardiomyopathy, and cardiovascular disease.
Ifetroban has been studied in several Phase 2 trials, including NCT05571059 in idiopathic pulmonary fibrosis, which is currently recruiting 128 patients in the United States. Other trials include NCT03962855 in cardiovascular diseases, NCT03340675 in Duchenne muscular dystrophy cardiomyopathy, and NCT03028350 in aspirin exacerbated respiratory disease.
Yes. Oral Ifetroban, Ifetroban Oral Capsule, Ifetroban Injection, and Ifetroban Sodium are alternative names for the same drug, Ifetroban. The oral capsule formulation is the one used in the Phase 2 trials for idiopathic pulmonary fibrosis, aspirin exacerbated respiratory disease, and Duchenne muscular dystrophy cardiomyopathy.