Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as ibuzatrelvir
PF-07817883 · 5 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.
Change from baseline in SARS-CoV-2 RNA level at Day 5 was analyzed using Mixed Effects Repeated Measures (MMRM) model with fixed effects including treatment, visit, visit by treatment interaction, and baseline viral load. Covariates included days from baseline since symptom onset (\<=3 versus \[vs.\] \>3 days), vaccination status (complete or partial vs. unvaccinated), baseline anti-N serology status and age at screening (years). Participants were excluded from the analysis if baseline viral load was less than 4\*log10 copies/milliliter, missing, or not detected.
Plasma PF-07817883 PK parameters
Plasma PF-07817883 PK parameters
Plasma PF-07817883 parameters
| 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. |
| Arm 1: low dose | EXPERIMENTAL | - |
| Arm 2: medium dose | EXPERIMENTAL | - |
| Arm 3: high dose | EXPERIMENTAL | - |
| Arm 4: Placebo | PLACEBO_COMPARATOR | - |
| Cohort 1 | EXPERIMENTAL | No renal impairment |
| Cohort 2 | EXPERIMENTAL | Severe renal impairment |
| Cohort 3 | EXPERIMENTAL | Moderate renal impairment |
| Cohort 4 | EXPERIMENTAL | Severe hepatic impairment |
| 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 |
| PF-07817883 | DRUG | Arm 1: low dose Arm 2: medium dose Arm 3: high dose |
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...
Top 19 of 30 competitors
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| Pfizer Inc. | PFE | 7 | PHASE3 | VLA15, Prevenar 20, 13vPnC, ATM-AVI, PG4 |
| Sanofi SA Sponsored ADR | SNY | 1 | PHASE3 | PCV21 |
| GSK plc Sponsored ADR | GSK | 4 | PHASE2 | Penmenvy, iNTS-TCV, Strep A vaccine, Pan-Salmonella vaccine |
| Grifols, S.A. Sponsored ADR Class B | GRFS | 1 | PHASE3 | Xembify |
| CorMedix Inc. | CRMD | 1 | PHASE3 | DefenCath |
| Sinovac Biotech Ltd. | SVA | 4 | PHASE3 | Sinovac PCV24, Group ACYW135X Meningococcal Conjugate Vaccine, Group ACYW135 Meningococcal Conjugate Vaccine |
| Novartis AG Sponsored ADR | NVS | 2 | PHASE2 | EDI048 |
| Innoviva, Inc. | INVA | 3 | PHASE2 | Eravacycline, Sulbactam-durlobactam |
| BiomX Inc. | PHGE | 1 | PHASE2 | BX004 |
| Hoffmann-La Roche | RHHBY | 1 | PHASE3 | Baloxavir Marboxil |
| Merck & Co., Inc. | MRK | 2 | PHASE1 | V118C |
| AstraZeneca PLC | AZN | 1 | PHASE1 | AZD7760 |
| BioNTech SE Sponsored ADR | BNTX | 1 | PHASE1 | BNT163 |
| 60 Degrees Pharmaceuticals, Inc. | SXTP | 1 | PHASE2 | Tafenoquine |
| Tarsus Pharmaceuticals, Inc. | TARS | 1 | PHASE2 | TP-05 |
| Moderna, Inc. | MRNA | 1 | PHASE2 | mRNA-1982 |
| AN2 Therapeutics, Inc. | ANTX | 1 | PHASE2 | Epetraborole |
| Emergent BioSolutions Inc. | EBS | 4 | - | AIGIV/kg |
| Phathom Pharmaceuticals, Inc. | PHAT | 1 | - | Vonoprazan |
PF-07817883 is an investigational oral small molecule being studied for the treatment of COVID-19 and SARS-CoV-2 infection. It is being developed by Pfizer for adults with symptomatic COVID-19 who are not hospitalized. It has not been approved by any regulatory agency and remains in clinical development.
PF-07817883 is being developed by Pfizer, Inc., which trades on the New York Stock Exchange under the ticker PFE. Pfizer is the sole sponsor listed for the clinical trials of this compound.
PF-07817883 is in Phase 1 clinical development, with a Phase 2 study also completed. It is an investigational drug and has not received FDA approval. The completed studies include two Phase 1 pharmacokinetic trials and one Phase 2 trial in adults with symptomatic COVID-19.
PF-07817883 has been evaluated in three completed clinical trials: NCT06586216, a Phase 1 study of renal impairment effects; NCT05884554, a Phase 1 study of hepatic impairment effects; and NCT05799495, a Phase 2 study in adults with symptomatic COVID-19 who were not hospitalized. All trials were conducted in the United States.
PF-07817883 is also referred to simply as PF-07817883. No other alternative names have been established for this investigational compound.