Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
ibuzatrelvir · 4 trials · 4 indications
The difference in the proportion of participants with the composite endpoint of a) Progression to severe COVID-19 or all-cause mortality by Day 38, or b) Evidence of recurrent or persistent SARS-CoV-2 infection
The difference in proportions of patients requiring COVID 19 related emergency department visits with administration of supplemental oxygen, COVID-19 antiviral or IV treatment (eg hydration, antibiotics, or corticosteroids), all-cause hospitalization, or all-cause death through Day 28 between ibuzatrelvir and placebo, among patients who were treated ≤5 days after COVID-19 symptom onset and who were not receiving background SoC treatment for their COVID-19 infection at baseline.
if data permits
| Arm | Type | Description |
|---|---|---|
| Ibuzatrelvir + Remdesivir | EXPERIMENTAL | Participants will receive ibuzatrelvir orally twice a day + IV remdesivir |
| Ibuzatrelvir | EXPERIMENTAL | Participants will receive ibuzatrelvir orally twice a day + IV placebo for remdesivir |
| Remdesivir | EXPERIMENTAL | Participants will receive placebo for ibuzatrelvir orally twice a day + IV remdesivir |
| placebo | PLACEBO_COMPARATOR | placebo administered orally every 12 hours (twice daily) for 5 days. |
| Period 1 | EXPERIMENTAL | ibuzatrelvir single oral dose on Day 1. |
| Period 2 | EXPERIMENTAL | carbamazepine BID oral doses on Day 1-15. ibuzatrelvir single oral dose on Day 14. |
| Name | Type | Description |
|---|---|---|
| ibuzatrelvir | DRUG | tablet |
| remdesivir | DRUG | injection, for intravenous use |
| placebo for ibuzatrelvir | DRUG | tablet |
| placebo for remdesivir | DRUG | injection, for intravenous use |
| placebo | DRUG | placebo tablets |
| carbamazepine ER | DRUG | 100 mg BID (Day 1-3) 200 mg BID (Day 4-7) 300 mg BID (Day 8-15) |
Inclusion Criteria: 1. 18 years of age or older at screening who are non-hospitalized or hospitalized with mild to moderate COVID-19 2. Confirmed SARS-CoV-2 infection as determined by RAT (or other locally approved test) collected within 2 days prior to randomization. Initial onset of symptoms attr...
Ibuzatrelvir is an investigational small molecule being studied for the treatment of COVID-19 infection, including COVID-19 SARS-CoV-2 infection. It is being evaluated in adult and adolescent patients who are not hospitalized but are at risk for severe disease, as well as in adults who are severely immunocompromised.
Ibuzatrelvir is being developed by Pfizer, Inc. (NYSE: PFE). The company is conducting clinical trials to evaluate the drug's safety and efficacy in treating COVID-19 infection.
Ibuzatrelvir is in Phase 1 and Phase 3 clinical trials. Phase 1 studies are investigating how the drug is processed in healthy adults, while Phase 3 studies are evaluating its efficacy in patients with COVID-19 who are at risk for severe disease or are severely immunocompromised.
Ibuzatrelvir is being studied in four clinical trials. NCT06646042 and NCT07235137 are Phase 1 studies in healthy adults, including a study in Chinese participants. NCT06679140 is a Phase 3 trial in non-hospitalized COVID-19 patients at risk for severe disease, and NCT07013474 is a Phase 3 trial in severely immunocompromised adults with COVID-19.
Ibuzatrelvir is not FDA approved. It is an investigational drug currently in clinical development, with ongoing Phase 3 trials for COVID-19. The drug has not completed the regulatory approval process.
Ibuzatrelvir is a small molecule being studied for COVID-19. Its specific molecular target has not been disclosed in the available clinical trial information. The drug is being evaluated for its ability to treat COVID-19 infection in various patient populations.