Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Vupanorsen · 3 trials · 4 indications
Fasting was required at least 10 hours before blood sample collection. Baseline was calculated using the average of all values obtained at Screening and on Day 1 prior to dosing.
AUC24h is the area under the concentration-time profile from time 0 to 24 hour post-dose
AUC48h is the area under the plasma concentration-time profile from time zero to the quantifiable concentration 48 hours post-dose
AUClast is the area under the plasma concentration-time profile from time zero to the time of the last quantifiable concentration (Clast)
Maximum plasma concentration observed from data
AUCinf is area under the plasma concentration-time profile from time zero extrapolated to infinite time
Time for Cmax (Tmax) for vupanorsen
terminal elimination half life (t½) for vupanorsen
Apparent clearance for vupanorsen
Apparent volume of distribution for vupanorsen
| Arm | Type | Description |
|---|---|---|
| Placebo | PLACEBO_COMPARATOR | No drug |
| Vupanorsen 80 mg every 4 weeks | EXPERIMENTAL | 80 milligrams (mg) given subcutaneously every 4 weeks. |
| Vupanorsen 60 mg every 2 weeks | EXPERIMENTAL | 60 mg given subcutaneously every 2 weeks. |
| Vupanorsen 120 mg every 4 weeks | EXPERIMENTAL | 120 mg given subcutaneously every 4 weeks. |
| Vupanorsen 80 mg every 2 weeks | EXPERIMENTAL | 80 mg given subcutaneously every 2 weeks. |
| Vupanorsen 160 mg every 4 weeks | EXPERIMENTAL | 160 mg given subcutaneously every 4 weeks. |
| Vupanorsen 120 mg every 2 weeks | EXPERIMENTAL | 120 mg given subcutaneously every 2 weeks. |
| Vupanorsen 160 mg every 2 weeks | EXPERIMENTAL | 160 mg given subcutaneously every 2 weeks. |
| Vupanorsen 80 milligram (mg) | EXPERIMENTAL | Participants will receive one, 0.8 milliliter (mL) subcutaneous injection with vupanorsen 100 mg/mL solution |
| Vupanorsen 160 milligram (mg) | EXPERIMENTAL | Participants will receive two, 0.8 mL subcutaneous injections with vupanorsen 100 mg/mL solution |
| Vupanorsen 160 mg | EXPERIMENTAL | Participants will receive two, 0.8 mL subcutaneous injections with vupanorsen 100 mg/mL solution |
| Name | Type | Description |
|---|---|---|
| Vupanorsen | DRUG | Vupanorsen and placebo will be provided as prefilled syringes packaged and dispensed in cartons with tamper-evident seals. Only single-use syringes will be used. |
| Placebo | DRUG | Vupanorsen and placebo will be provided as prefilled syringes packaged and dispensed in cartons with tamper-evident seals. Only single-use syringes will be used. |
Inclusion Criteria: 1. Male or female participants aged ≥40 years at Screening. 2. Fasting non-HDL-C at Screening ≥100 mg/dL. 3. Fasting TG at Screening of 150 to 500 mg/dL, inclusive, which may be repeated once if deemed necessary. 4. Participants must be on a stable dose of a statin for at least ...
Vupanorsen is an investigational drug being studied for dyslipidemias, including hyperlipidemias and hyperlipoproteinemias, as well as in healthy volunteers. It is being developed by Pfizer, Inc. (NYSE: PFE) and is currently in Phase 2 clinical development for cardiovascular conditions.
Vupanorsen is being developed by Pfizer, Inc., which is publicly traded on the New York Stock Exchange under the ticker symbol PFE. The drug is an investigational small molecule being studied for the treatment of dyslipidemias and related cardiovascular conditions.
Vupanorsen is in Phase 2 clinical development. It has completed two trials, including a Phase 2 dose-ranging study known as TRANSLATE-TIMI 70. The drug is investigational and has not been approved by regulatory authorities for any indication.
Vupanorsen has completed three clinical trials. NCT04459767 was a Phase 1 study in Japanese healthy adults with elevated triglycerides. NCT04516291, the TRANSLATE-TIMI 70 study, was a Phase 2 dose-ranging trial in patients with dyslipidemias. NCT04916795 was a Phase 1 study in healthy Chinese adults.
No, Vupanorsen is not FDA approved. It is an investigational drug currently in clinical development, having completed Phase 1 and Phase 2 trials. The drug has not yet received regulatory approval for any use and remains under investigation for dyslipidemias and related conditions.