Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
riferminogene pecaplasmid · 1 trial · 1 indication
| Arm | Type | Description |
|---|---|---|
| Riferminogene pecaplasmid | EXPERIMENTAL | 4 administrations of riferminogene pecaplasmid 4 mg at 2-week intervals |
| Placebo | PLACEBO_COMPARATOR | 4 administrations of placebo (for riferminogene pecaplasmid) at 2-week intervals |
| Name | Type | Description |
|---|---|---|
| riferminogene pecaplasmid | BIOLOGICAL | Formulation: 5 ml glass vials containing 2,5 ml riferminogene pecaplasmid Route: intramuscular (IM) injection of 2.5 mL in the ischemic leg to be treated |
| Placebo (for riferminogene pecaplasmid) | BIOLOGICAL | Formulation: 5 ml glass vials containing 2,5 ml placebo Route: IM injection of 2.5 mL in the ischemic leg to be treated |
Inclusion Criteria: * Having peripheral artery disease at the stage of Critical Limb Ischemia (CLI) with skin lesions (either ulcer(s) or gangrene); * With objective evidence of CLI such as ankle systolic pressure \<70 mmHg and/or toe systolic pressure \<50 mmHg or transcutaneous oxygen pressure (T...
Riferminogene pecaplasmid is an investigational therapy being studied for peripheral vascular diseases, specifically critical limb ischemia with skin lesions. It is a monoclonal antibody modality being developed by Sanofi. The drug is currently in Phase 3 clinical development, meaning it has not yet been approved and remains investigational.
Riferminogene pecaplasmid is being developed by Sanofi, a global biopharmaceutical company listed on the stock exchange under the ticker SNY. The drug is in Phase 3 clinical development for peripheral vascular diseases, specifically critical limb ischemia with skin lesions.
Riferminogene pecaplasmid is in Phase 3 clinical development. It is an investigational drug being studied for peripheral vascular diseases, specifically critical limb ischemia with skin lesions. The drug has not been approved by regulatory authorities and remains in clinical trials.
Riferminogene pecaplasmid has one completed Phase 3 clinical trial with the identifier NCT00566657. The trial, titled 'Efficacy and Safety of XRP0038/NV1FGF in Critical Limb Ischemia Patients With Skin Lesions,' enrolled 525 participants across multiple countries. The trial was randomized, double-blind, and placebo-controlled.
Riferminogene pecaplasmid is also known as XRP0038 and NV1FGF. These names refer to the same investigational drug being developed by Sanofi for peripheral vascular diseases, specifically critical limb ischemia with skin lesions. The Phase 3 clinical trial NCT00566657 used the name XRP0038/NV1FGF.
Riferminogene pecaplasmid is a monoclonal antibody modality being developed for peripheral vascular diseases. The specific molecular target of this drug has not been disclosed in available information. It is currently in Phase 3 clinical development for critical limb ischemia with skin lesions.