Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
VYD2311-SD · 1 trial · 1 indication
| Arm | Type | Description |
|---|---|---|
| VYD2311-SD (single dose) | ACTIVE_COMPARATOR | VYD2311 administered via IM injection on Day 1, followed by placebo injection (0.9% sodium chloride \[normal saline\]) on Day 30 and Day 60 |
| VYD2311-MD (multidose) | ACTIVE_COMPARATOR | VYD2311 administered via IM injection on Day 1, Day 30, and Day 60 |
| Placebo | PLACEBO_COMPARATOR | Normal saline administered by IM injection on Day 1, Day 30, and Day 60 |
| Name | Type | Description |
|---|---|---|
| VYD2311-SD | DRUG | VYD2311-SD (single-dose arm): Intramuscular injection dosing on Day 1 with VYD2311 and Intramuscular injection dosing Placebo (normal saline) on Day 30 and Day 60 |
| VYD2311-MD | DRUG | VYD2311-MD (multi-dose): Intramuscular injection dosing on Day 1, Day 30, and Day 60 with VYD2311 |
| Placebo | DRUG | Intramuscular injection dosing on Day 1, Day 30, and Day 60 with Placebo (Normal Saline) |
Inclusion Criteria: Participants are eligible to be included in the study only if all the following criteria apply: 1. Is an adult aged ≥18 years or an adolescent aged 12 to \<18 years weighing at least 40 kg at the time of Screening. Note: Adolescent enrollment is allowed only if permitted by the...
VYD2311-SD is an investigational small molecule being studied for the prevention of COVID-19. It is currently in Phase 3 clinical development and has not been approved by the FDA. The drug is being evaluated in a randomized, double-blind, placebo-controlled trial.
VYD2311-SD is being developed by Invivyd, Inc., a biopharmaceutical company traded on the Nasdaq under the ticker symbol IVVD. The company is conducting a Phase 3 clinical trial to evaluate the drug for the prevention of COVID-19.
VYD2311-SD is currently in Phase 3 clinical development. It is an investigational drug and has not been approved by the FDA. The Phase 3 trial is active but not recruiting participants, and the drug has received Fast Track designation from the FDA.
VYD2311-SD is being studied in a Phase 3 clinical trial with the identifier NCT07298434. This trial is titled 'Study of VYD2311 for the Prevention of COVID-19' and is enrolling 1,770 participants aged 12 years and older in the United States. The trial is randomized, double-blind, and placebo-controlled.
No, VYD2311-SD is not FDA approved. It is an investigational drug currently in Phase 3 clinical development for the prevention of COVID-19. The FDA has granted Fast Track designation to the drug, which is intended to expedite its development and review process.