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Vaxart (VXRT) Drug Pipeline
| Drug Name | Condition | Stage | Status | Study Name | Trial Start Date | Article |
|---|---|---|---|---|---|---|
| Vxa-G1.1-Nn, Vxa-G2.4-Ns, Vxa G1.1 Nn-T, Vxa G2.4 Ns-T | Norovirus Infections | Phase I | Active Not Recruiting | A Trial of a Norovirus G1.1 and G2.4 Vaccine Administered Orally to Healthy Participants Aged ≥ 18 Years and ≤ 80 Years Old | Apr 17, 2025 | ― |
| Vxa-Cov2-3.1, Comirnaty®, Vxa-Cov2-3.3 | Covid-19, Sars-Cov2 | Phase II | Recruiting | A Study to Evaluate VXA-CoV2-3.3 COVID-19 Vaccine Against Currently Approved/Authorized mRNA COVID-19 Injectable Booster Vaccine in Adults Previously Immunized Against COVID-19 Infection | Nov 01, 2024 | ― |
| Open Label Bivalent Gii.4/Gi.1 High Dose Vaccine 2×10 To The Power 11 Iu/Dose, Bivalent Gii.4/Gi.1 High Dose Vaccine 2×10 To The Power 11 Iu/Dose, Bivalent Gii.4/Gi.1 Medium Dose Vaccine 1×10 To The Power 11 Iu/Dose | Norovirus Infections | Phase II | Completed | A Study to Determine the Safety and Immunogenicity of Bivalent GI.1 and GII.4 Vaccines in Healthy Volunteers | Nov 15, 2022 | ― |
| Vxa-G1.1-Nn, Norovirus Gi.1 Norwalk Virus Inoculum | Norovirus Infections | phase1AndPhase2 | Completed | Norovirus Challenge Study | Jan 25, 2022 | ― |
| Vxa-G1.1-Nn | Norovirus Infections | Phase I | Completed | A Phase 1, Open-label, Safety and Immunogenicity Study of an Oral Multi-dose Administration Regimen With an Adenoviral-vector Based Tablet Norovirus Vaccine (VXA-G1.1-NN) Administered to Healthy Adult Volunteers | Jan 18, 2022 | ― |
| Vxa-Cov2-1.1-S | Covid-19 | Phase II | Terminated | A Ph 2 Trial With an Oral Tableted COVID-19 Vaccine | Sep 16, 2021 | ― |
| Vxa-Gi.1.Nn | Norovirus Infections | Phase I | Completed | Ph 1b: Safety & Immunogenicity of Ad5 Based Oral Norovirus Vaccine | Apr 19, 2021 | ― |
| Vxa-G1.1-Nn | Norovirus Infections | phase1AndPhase2 | Completed | Immunogenicity & Safety Study of Adenovirus Type 5 (AD5) Based Oral Norovirus Vaccines | Apr 19, 2021 | ― |
| Vxa-Cov2-1 | COVID19 | Phase I | Completed | Safety and Immunogenicity Trial of an Oral SARS-CoV-2 Vaccine (VXA-CoV2-1) for Prevention of COVID-19 in Healthy Adults and Boost (VXA-CoV2-1.1-S) at 1 Year Post Initial Vaccination in Subset of Subjects | Sep 21, 2020 | ― |
| Vxa-G1.1-Nn, Vxa-G2.4-Ns | Norovirus Infection | Phase I | Completed | Safety & Immunogenicity Study of Ad5 Based Oral Norovirus Vaccines | Mar 28, 2019 | ― |
| Drug Name | Stage | Condition | Status | Study Name | Trial Start Date | Article |
|---|---|---|---|---|---|---|
| Vxa-G1.1-Nn, Vxa-G2.4-Ns, Vxa G1.1 Nn-T, Vxa G2.4 Ns-T | Phase I | Norovirus Infections | Active Not Recruiting | A Trial of a Norovirus G1.1 and G2.4 Vaccine Administered Orally to Healthy Participants Aged ≥ 18 Years and ≤ 80 Years Old | Apr 17, 2025 | ― |
| Vxa-Cov2-3.1, Comirnaty®, Vxa-Cov2-3.3 | Phase II | Covid-19, Sars-Cov2 | Recruiting | A Study to Evaluate VXA-CoV2-3.3 COVID-19 Vaccine Against Currently Approved/Authorized mRNA COVID-19 Injectable Booster Vaccine in Adults Previously Immunized Against COVID-19 Infection | Nov 01, 2024 | ― |
| Open Label Bivalent Gii.4/Gi.1 High Dose Vaccine 2×10 To The Power 11 Iu/Dose, Bivalent Gii.4/Gi.1 High Dose Vaccine 2×10 To The Power 11 Iu/Dose, Bivalent Gii.4/Gi.1 Medium Dose Vaccine 1×10 To The Power 11 Iu/Dose | Phase II | Norovirus Infections | Completed | A Study to Determine the Safety and Immunogenicity of Bivalent GI.1 and GII.4 Vaccines in Healthy Volunteers | Nov 15, 2022 | ― |
| Vxa-G1.1-Nn, Norovirus Gi.1 Norwalk Virus Inoculum | phase1AndPhase2 | Norovirus Infections | Completed | Norovirus Challenge Study | Jan 25, 2022 | ― |
| Vxa-G1.1-Nn | Phase I | Norovirus Infections | Completed | A Phase 1, Open-label, Safety and Immunogenicity Study of an Oral Multi-dose Administration Regimen With an Adenoviral-vector Based Tablet Norovirus Vaccine (VXA-G1.1-NN) Administered to Healthy Adult Volunteers | Jan 18, 2022 | ― |
| Vxa-Cov2-1.1-S | Phase II | Covid-19 | Terminated | A Ph 2 Trial With an Oral Tableted COVID-19 Vaccine | Sep 16, 2021 | ― |
| Vxa-Gi.1.Nn | Phase I | Norovirus Infections | Completed | Ph 1b: Safety & Immunogenicity of Ad5 Based Oral Norovirus Vaccine | Apr 19, 2021 | ― |
| Vxa-G1.1-Nn | phase1AndPhase2 | Norovirus Infections | Completed | Immunogenicity & Safety Study of Adenovirus Type 5 (AD5) Based Oral Norovirus Vaccines | Apr 19, 2021 | ― |
| Vxa-Cov2-1 | Phase I | COVID19 | Completed | Safety and Immunogenicity Trial of an Oral SARS-CoV-2 Vaccine (VXA-CoV2-1) for Prevention of COVID-19 in Healthy Adults and Boost (VXA-CoV2-1.1-S) at 1 Year Post Initial Vaccination in Subset of Subjects | Sep 21, 2020 | ― |
| Vxa-G1.1-Nn, Vxa-G2.4-Ns | Phase I | Norovirus Infection | Completed | Safety & Immunogenicity Study of Ad5 Based Oral Norovirus Vaccines | Mar 28, 2019 | ― |
FAQ
What are the FDA phases for drug approval?
The FDA approval process for new drugs is divided into several phases: a. Preclinical testing b. Phase 1 – Safety and dosage c. Phase 2 – Effectiveness and side effects d. Phase 3 – Confirmation of effectiveness, monitoring of adverse reactions, and comparison with existing treatments e. Phase 4 – Post-marketing studies to track long-term safety and effectiveness
What is a clinical trial?
A clinical trial is a carefully designed study in which researchers test a drug, treatment, or medical device in people to evaluate its safety, effectiveness, and potential side effects. These trials are essential for determining whether a new treatment should be approved for widespread use.
What drugs does Vaxart (VXRT) have in its pipeline
Vaxart VXRT is currently developing the following drugs: Vxa-G1.1-Nn, Vxa-G2.4-Ns, Vxa G1.1 Nn-T, Vxa G2.4 Ns-T, Vxa-Cov2-3.1, Comirnaty®, Vxa-Cov2-3.3, Open Label Bivalent Gii.4/Gi.1 High Dose Vaccine 2×10 To The Power 11 Iu/Dose, Bivalent Gii.4/Gi.1 High Dose Vaccine 2×10 To The Power 11 Iu/Dose, Bivalent Gii.4/Gi.1 Medium Dose Vaccine 1×10 To The Power 11 Iu/Dose, Vxa-G1.1-Nn, Norovirus Gi.1 Norwalk Virus Inoculum, Vxa-G1.1-Nn, Vxa-Cov2-1.1-S, Vxa-Gi.1.Nn, Vxa-Cov2-1, Vxa-G1.1-Nn, Vxa-G2.4-Ns, Norwalk Gi.1 Virus, Vxa-A1.1 H1 Tablet Vaccine (Small), Vxa-A1.1 H1 Tablet Vaccine (Large), Vxa-G1.1-Nn Oral Vaccine, Vapendavir, Fluzone®, Vxa-A1.1, Vxa-G1.1-Nn (High Dose) Oral Vaccine Tablet, Vxa-G1.1-Nn (Low Dose) Oral Vaccine Tablet, Vxa-Rsv-F Tablets (High Dose), Vxa-Rsv-F Tablets (Low Dose), Ap611074 5% Gel, Vxa-Byw.10 (Low Dose) Oral Vaccine, Vxa-Byw.10 (High Dose) Oral Vaccine, Vxa-A1.1 Oral Vaccine. These drug candidates are in various stages of clinical development as the company works toward FDA approval.
