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Tixagevimab Cilgavimab
Tixagevimab Cilgavimab is a Monoclonal antibody Small molecule drug developed by Azienda Ospedaliera Universitaria Integrata Verona. It is currently in Phase 3 development for Prevention of COVID-19 in individuals 12 years of age and older.
Tixagevimab and cilgavimab are monoclonal antibodies that bind to the SARS-CoV-2 spike protein, preventing viral entry into host cells.
Tixagevimab Cilgavimab is a monoclonal antibody that blocks the spike glycoprotein, classified as a blocker. It is being studied for the treatment of COVID-19, among other conditions, in clinical trials such as NCT05780437.
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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 | Tixagevimab Cilgavimab |
|---|---|
| Sponsor | Azienda Ospedaliera Universitaria Integrata Verona |
| Drug class | Monoclonal antibody |
| Target | SARS-CoV-2 spike protein |
| Modality | Small molecule |
| Therapeutic area | Infectious disease |
| Phase | Phase 3 |
Mechanism of action
Tixagevimab and cilgavimab are designed to provide long-lasting protection against SARS-CoV-2 infection by targeting the spike protein, which is essential for the virus to enter host cells. By binding to the spike protein, these antibodies prevent the virus from attaching to and entering host cells, thereby reducing the risk of infection.
Approved indications
- Prevention of COVID-19 in individuals 12 years of age and older
Common side effects
- Injection site pain
- Fatigue
- Headache
Key clinical trials
- REAl LIfe" Observational Study on the Effectiveness of Evusheld Prophylaxis Against SARS-CoV-2 Omicron Variants in Vaccine Non-responder Immunocompromised Patients
- Finding Treatments for COVID-19: A Trial of Antiviral Pharmacodynamics in Early Symptomatic COVID-19 (PLATCOV) (PHASE2)
- AZD7442 Pharmacokinetics, Pharmacodynamics, and Safety Evaluation in Pediatrics (PHASE1)
- Study Understanding Pre-Exposure pRophylaxis of NOVel Antibodies (SUPERNOVA) Sub-study: Study Understanding Pre-Exposure pRophylaxis of NOVel Antibodies (SUPERNOVA) Sub-study (PHASE2, PHASE3)
- AZD7442 for Inpatients With COVID-19 (An ACTIV-3/TICO Treatment Trial) (PHASE3)
- eVusheld Assessment reaL wORld Effectiveness in Israel Clalit Health Services
- Phase III Double-blind, Placebo-controlled Study of AZD7442 for Pre-exposure Prophylaxis of COVID-19 in Adult. (PHASE3)
- Study to Evaluate Pharmacokinetic Comparability Between AZD7442 Co-formulation (AZD8895 + AZD1061) vs AZD8895 and AZD1061 Individually in Adult Healthy Participants (PHASE1)
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:
- Tixagevimab Cilgavimab CI brief — competitive landscape report
- Tixagevimab Cilgavimab updates RSS · CI watch RSS
- Azienda Ospedaliera Universitaria Integrata Verona portfolio CI
Frequently asked questions about Tixagevimab Cilgavimab
What is Tixagevimab Cilgavimab?
How does Tixagevimab Cilgavimab work?
What is Tixagevimab Cilgavimab used for?
Who makes Tixagevimab Cilgavimab?
What drug class is Tixagevimab Cilgavimab in?
What development phase is Tixagevimab Cilgavimab in?
What are the side effects of Tixagevimab Cilgavimab?
What does Tixagevimab Cilgavimab target?
Related
- Drug class: All Monoclonal antibody drugs
- Target: All drugs targeting SARS-CoV-2 spike protein
- Manufacturer: Azienda Ospedaliera Universitaria Integrata Verona — full pipeline
- Therapeutic area: All drugs in Infectious disease
- Indication: Drugs for Prevention of COVID-19 in individuals 12 years of age and older
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing