Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
INXN-4001 · 1 trial · 3 indications
As assessed by incidence of all study intervention-related adverse events occurring up to 6 months post- treatment intervention-related adverse events
| Arm | Type | Description |
|---|---|---|
| Group 1 | EXPERIMENTAL | Single infusion of INXN-4001, Dose 1 |
| Group 2 | EXPERIMENTAL | Single infusion of INXN-4001, Dose 2 |
| Name | Type | Description |
|---|---|---|
| INXN-4001 | BIOLOGICAL | Retrograde coronary sinus infusion of triple effector plasmid (INXN-4001) |
Inclusion Criteria: * Male and female adult patients with a stable LVAD implanted for end-stage heart failure * Must be managed in an outpatient setting and on stable medication regimen Exclusion Criteria: * Women who are pregnant or nursing * Patients who have been on another clinical trial for ...
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INXN-4001 is an investigational therapy being studied for heart failure. It is a triple effector plasmid designed to deliver three therapeutic factors to the heart. The drug is being evaluated in patients with heart failure, including those with a heart-assist device. It is currently in Phase 1 clinical development.
INXN-4001 is being developed by Precigen, Inc., a biopharmaceutical company traded on the Nasdaq under the ticker symbol PGEN. Precigen is conducting clinical research on this investigational therapy for heart failure. The company is responsible for the ongoing development and potential future commercialization of INXN-4001.
INXN-4001 is in Phase 1 clinical development. It is an investigational drug, meaning it has not been approved by regulatory authorities and is still being studied for safety and efficacy. The Phase 1 trial for INXN-4001 has been completed, and the drug remains in early-stage clinical research.
INXN-4001 has one completed Phase 1 clinical trial, identified as NCT03409627. This study, titled "Novel INXN-4001 Triple Effector Plasmid in Heart Failure," enrolled 12 participants in the United States. The trial included patients with heart failure, cardiovascular diseases, and those with a heart-assist device. The study was controlled but not randomized or double-blinded.
INXN-4001 is not FDA approved. It is an investigational drug currently in Phase 1 clinical development. The completed Phase 1 trial (NCT03409627) was designed to evaluate the therapy in heart failure patients, but the drug has not yet received regulatory approval. Further clinical studies would be needed to support any future approval.