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, including SARS-CoV-2 infection in adults and adolescents who are not hospitalized but at risk for severe disease, and in adults who are severely immunocompromised. It is also being studied in healthy participants for pharmacokinetic purposes.
Ibuzatrelvir is being developed by Pfizer, Inc. (NYSE: PFE). The company is conducting clinical trials to evaluate the drug's safety, tolerability, and efficacy in various populations, including healthy adults and patients with COVID-19.
Ibuzatrelvir is in Phase 1 and Phase 3 clinical trials. Phase 1 studies are investigating how the drug is absorbed and how it interacts with other medications in healthy adults. Phase 3 studies are evaluating its efficacy and safety in patients with COVID-19 who are at risk for severe disease or are severely immunocompromised.
Ibuzatrelvir is being studied in several clinical trials, including NCT06646042 (Phase 1, drug interaction in healthy adults), NCT06679140 (Phase 3, non-hospitalized COVID-19 patients at risk for severe disease), NCT07013474 (Phase 3, severely immunocompromised adults with COVID-19), and NCT07235137 (Phase 1, pharmacokinetics in healthy Chinese adults).
Ibuzatrelvir is not FDA approved. It is an investigational drug currently in clinical development. Pfizer is conducting Phase 1 and Phase 3 trials to assess its safety and efficacy for treating COVID-19, but it has not yet received regulatory approval for any use.
Ibuzatrelvir is a small molecule being developed as an antiviral treatment for COVID-19. While its specific molecular target has not been disclosed in the available information, it is being studied for its ability to treat SARS-CoV-2 infection in various patient populations.