Last reviewed · How we verify
VYD2311-MD
VYD2311-MD is a monoclonal antibody Small molecule drug developed by Invivyd, Inc.. It is currently in Phase 3 development for Prevention of COVID-19.
VYD2311-MD is a monoclonal antibody that targets the SARS-CoV-2 spike protein.
VYD2311-MD is a small molecule being studied in a Phase 3 clinical trial for the prevention of COVID-19. The trial is a randomized, triple-blind, placebo-controlled study evaluating the efficacy and safety of VYD2311-MD in adults and adolescents.
-
Baseline phase 3 → approval rate
+58.3pp
Industry-wide phase 3 drugs reach approval ~58.3% of the time (BIO/Informa 2023 industry benchmark across all therapeutic areas). -
Anti-infectives pathway favourability
+2.0pp
Microbiological endpoints + non-inferiority designs raise approval rates above baseline.
| Regulator | Country | Likely year | Lag vs FDA |
|---|---|---|---|
| FDA | US | 2028–2030 | — |
| EMA | EU | 2029–2031 | +0.7 yr |
| MHRA | GB | 2029–2031 | +0.7 yr |
| Health Canada | CA | 2029–2032 | +0.9 yr |
| TGA | AU | 2029–2032 | +1.2 yr |
| PMDA | JP | 2029–2032 | +1.5 yr |
| NMPA | CN | 2030–2033 | +2.3 yr |
| MFDS | KR | 2029–2032 | +1.4 yr |
| CDSCO | IN | 2029–2033 | +1.8 yr |
| ANVISA | BR | 2030–2033 | +2.3 yr |
Hover any row for the lag rationale. Lag estimates are reduced when the drug has FDA Breakthrough or EMA PRIME designation (sponsors file globally in parallel).
Estimate based on the BIO/Informa industry phase transition rates plus per-drug modifiers for therapeutic area, sponsor type, FDA designations, mechanism, and trial design. Per-jurisdiction lags from Tufts CSDD international approval studies. Not investment, clinical or regulatory advice. Methodology: /methodology#likelihood.
At a glance
| Generic name | VYD2311-MD |
|---|---|
| Sponsor | Invivyd, Inc. |
| Drug class | monoclonal antibody |
| Target | SARS-CoV-2 spike protein |
| Modality | Small molecule |
| Therapeutic area | Infectious Disease |
| Phase | Phase 3 |
Mechanism of action
It works by binding to the spike protein, preventing the virus from entering host cells. This mechanism of action is similar to other COVID-19 vaccines, but the specific details of VYD2311-MD's mechanism may differ slightly.
Approved indications
- Prevention of COVID-19
Common side effects
- Pain, redness, or swelling at the injection site
- Fatigue
- Headache
Key clinical trials
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- VYD2311-MD CI brief — competitive landscape report
- VYD2311-MD updates RSS · CI watch RSS
- Invivyd, Inc. portfolio CI
Frequently asked questions about VYD2311-MD
What is VYD2311-MD?
How does VYD2311-MD work?
What is VYD2311-MD used for?
Who makes VYD2311-MD?
What drug class is VYD2311-MD in?
What development phase is VYD2311-MD in?
What are the side effects of VYD2311-MD?
What does VYD2311-MD target?
Related
- Drug class: All monoclonal antibody drugs
- Target: All drugs targeting SARS-CoV-2 spike protein
- Manufacturer: Invivyd, Inc. — full pipeline
- Therapeutic area: All drugs in Infectious Disease
- Indication: Drugs for Prevention of COVID-19
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing