Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
XRP0038 · 5 trials · 3 indications
| Arm | Type | Description |
|---|---|---|
| placebo | EXPERIMENTAL | 4 administrations at 2-week interval of placebo solution |
| NV1FGF 16 mg | EXPERIMENTAL | 4 administrations at 2-week interval of 4mg at each administration |
| NV1FGF 32 mg | EXPERIMENTAL | 4 administrations at 2-week interval of 8mg at each administration |
| NV1FGF 500 μg | EXPERIMENTAL | 8 intramuscular injections for a total of 500 μg administered in one single administration 3 to 8 days before major amputation |
| NV1FGF 2000 μg | EXPERIMENTAL | 8 intramuscular injections for a total of 2000 μg administered in one single administration 3 to 8 days before major amputation |
| NV1FGF 4000 μg | EXPERIMENTAL | 8 intramuscular injections for a total of 4000 μg administered in one single administration 3 to 8 days before major amputation |
| Name | Type | Description |
|---|---|---|
| XRP0038 (NV1FGF) | DRUG | Pharmaceutical form:solution Route of administration: intramuscular |
| placebo | DRUG | Pharmaceutical form:solution Route of administration: intramuscular |
Inclusion criteria: * Age\>40 years * History of typical intermittent claudication lasting for at least 3 months, showing no improvement and consistent with treadmill test findings * Objective evidence of Peripheral Arterial Occlusive Disease. After 10 minutes of rest, either by Ankle brachial inde...
XRP0038 is an investigational small molecule being developed for severe peripheral artery occlusive disease, peripheral arterial disease, and peripheral arterial occlusive disease. It is in Phase 2 clinical development and has not been approved by the FDA.
XRP0038 is being developed by Sanofi, a multinational pharmaceutical company listed on the stock exchange under the ticker SNY. The drug is currently in Phase 2 clinical trials for peripheral arterial disease.
XRP0038 is in Phase 2 clinical development. It is an investigational drug and has not received FDA approval. Clinical trials have been completed for Phase 1 and Phase 2 studies.
XRP0038 has completed three clinical trials: NCT00368797, a Phase 2 study in severe peripheral artery occlusive disease with 125 patients; NCT01157143, a Phase 1 study in peripheral arterial occlusive disease; and NCT01157156, a Phase 1 study in severe peripheral artery occlusive disease.
Yes, XRP0038 is also known as NV1FGF. Clinical trial records for XRP0038 reference NV1FGF in study titles, indicating the two names refer to the same investigational drug.