Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as PF-07321332 Dose 1, nirmatrelvir, PF-07321332
Nirmatrelvir/ ritonavir · 7 trials · 3 indications
Baseline was defined as the latest measurement between Day -1 and Day 1, but post-dose samples that were collected within 1 hour post start of dosing were also treated as baseline. Samples with result "\< lower limit of quantification (LLOQ)" were imputed as 1.7 log10 copies/milliliter (mL), and samples with result "Not Detected" were imputed as 0.0 log10 copies/mL.
NP swab was collected by healthcare professional (HCP) from participants and were sent to the central laboratory for viral RNA level testing real-time reverse transcriptase-polymerase chain reaction(RT-PCR). Sustained was defined as NP swab SARS-CoV-2 RNA level not \>=2.0 log10 per milliliter (copies/mL) at any study visit (through Day 44) following the first study visit where the participant's NP swab SARS-CoV-2 RNA level \<LLOQ (\<2.0 log10 copies/mL).
Percentage of participants who developed symptomatic Reverse Transcriptase Polymerase Chain Reaction (RT-PCR) or Rapid Antigen Test (RAT) confirmed SARS-Cov-2 infection were reported in this outcome measure. Index case was defined as participants with symptomatic COVID-19.
Percentage of participants with COVID-19 related hospitalization or death from any cause during the first 28 days of the study was estimated using the Kaplan-Meier (KM) method. Using KM method, survival probability for each time interval was calculated as the number of participants surviving divided by the number of participants at risk. Participants who had the event, dropped out, or moved out were not counted as "at risk" i.e., participants who were lost were considered "censored" and were not counted in the denominator.
Cmax was the maximum observed plasma concentration and was directly observed from data. Concentration values below the lower limit of quantification (LLQ) were set to zero. Geometric mean analysis was on the log scale. Zero values were not included in geometric mean and geometric coefficient of variation calculation. The geometric coefficient of variation was expressed in percentage.
AUClast was area under the plasma concentration time-curve from zero (pre-dose) to the last measured concentration. The geometric coefficient of variation was expressed in percentage.
AUCinf was defined as area under the plasma concentration-time curve from time zero to infinity. The geometric coefficient of variation was expressed in percentage.
AUCinf was calculated by AUClast + (Clast/kel). AUClast was the area under the plasma concentration-time profile from time 0 to the time of Clast. Clast was the predicted plasma concentration at the last quantifiable time point estimated from the log-linear regression analysis and kel was the terminal phase rate constant calculated by a linear regression of the log-linear concentration-time curve.
Total amount of unchanged drug excreted in the urine over 48 hours.
Renal clearance was calculated as total amount of unchanged drug excreted in the urine over 48 hours (Ae48) divided by area under the plasma concentration-time profile from time 0 to 48 hours post dose.
| Arm | Type | Description |
|---|---|---|
| Cohort 1 nirmatrelvir/ritonavir | EXPERIMENTAL | nirmatrelvir/ritonavir will be given by tablets or powder by mouth twice a day for 5 days (10 doses total). Weight ≥40 kg 1. ≥12 to \<18 years 2. ≥6 to \<12 years |
| Cohort 2 nirmatrelvir/ritonavir | EXPERIMENTAL | nirmatrelvir/ritonavir will be given as powder by mouth twice a day for 5 days (10 doses total) Weight ≥20 to \<40 kg, ≥6 to \<18 years |
| Cohort 3 nirmatrelvir/ritonavir | EXPERIMENTAL | nirmatrelvir/ritonavir ≥2 to \<6 years |
| Cohort 4 nirmatrelvir/ritonavir | EXPERIMENTAL | nirmatrelvir/ritonavir ≥1 month (≥28 days) to \<2 years |
| Cohort 5 nirmatrelvir/ritonavir | EXPERIMENTAL | nirmatrelvir/ritonavir \<1 month (\<28 days) old |
| nirmatrelvir plus ritonavir for 5 days | EXPERIMENTAL | Nirmatrelvir (2 tablets) plus ritonavir (1 capsule) will be given by mouth every 12 hours for 5 days |
| placebo plus ritonavir for 5 days | OTHER | placebo (2 tablets) plus ritonavir (1 capsule) will be given by mouth every 12 hours for 5 days |
| Nirmatrelvir plus ritonavir for 10 days | EXPERIMENTAL | Nirmatrelvir (2 tablets) plus ritonavir (1 capsule) will be given by mouth every 12 hours for 10 days followed by placebo for nirmatrelvir (2 tablets) plus placebo for ritonavir (1 capsule) every 12 hours for 5 days |
| Nirmatrelvir plus ritonavir for 15 days | EXPERIMENTAL | Nirmatrelvir (2 tablets) plus ritonavir (1 capsule) will be given by mouth every 12 hours for 15 days. |
| PF-07321332/ritonavir (5 days) | EXPERIMENTAL | Participants will receive PF-07321332/ritonavir every 12 hours from Day 1 through Day 5 followed by Placebo every 12 hours from Day 6 through Day 10 |
| PF-07321332/ritonavir (10-Day) | EXPERIMENTAL | Participants will receive PF-07321332/ritonavir every 12 hours from Day 1 through Day 10. |
| Placebo | PLACEBO_COMPARATOR | Participants will receive placebo every 12 hours from Day 1 through Day 10. |
| PF-07321332/ritonavir | EXPERIMENTAL | Orally administered PF-07321332+ritonavir |
| Cohort 1 | EXPERIMENTAL | Healthy Volunteer |
| Cohort 2 | EXPERIMENTAL | Hepatic Impairment |
| PF-07321332 | EXPERIMENTAL | PF 07321332/ritonavir |
| Name | Type | Description |
|---|---|---|
| nirmatrelvir | DRUG | PF-07321332 |
| ritonavir | DRUG | ritonavir |
| placebo for nirmatrelvir | DRUG | Participants will receive 2 tablets of placebo for nirmatrelvir every 12 hours. A placebo does not have any medicine in it but looks just like the medicine being studied. |
| Placebo for ritonavir | DRUG | Participants will receive 1 capsule of placebo for ritonavir every 12 hours. A placebo does not have any medicine in it but looks just like the medicine being studied. |
| PF-07321332 | DRUG | PF-07321332 |
| Placebo for PF-07321332 | DRUG | Placebo |
| Placebo | DRUG | Placebo (tablet or capsule) |
| PF-07321332/ritonavir | DRUG | PF-07321332 in combination with the PK boosting agent, ritonavir, being developed for the treatment of COVID-19 |
Inclusion criteria: * Male and female, age 0 to \< 18 years, able to swallow for some participants * Confirmed SARS-CoV-2 infection within 72 hours prior to enrollment * Initial onset of COVID-19 signs/symptoms within 5 days prior to the day of enrollment and at least 1 of the specified COVID-19 si...
Top 9 of 11 competitors
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| Pfizer Inc. | PFE | 7 | PHASE3 | ibuzatrelvir, Nirmatrelvir/ ritonavir, BNT162b2/RIV |
| Merck & Co., Inc. | MRK | 2 | PHASE3 | Molnupiravir |
| Invivyd, Inc. | IVVD | 2 | PHASE3 | VYD2311 |
| Vanda Pharmaceuticals Inc. | VNDA | 1 | PHASE3 | Tradipitant |
| Moderna, Inc. | MRNA | 2 | PHASE2 | mRNA-1283, mRNA-1273 |
| ImmunityBio Inc | IBRX | 2 | PHASE2 | Nogapendekin alfa inbakicept |
| Traws Pharma, Inc. | TRAW | 1 | PHASE2 | Ratutrelvir |
| GeoVax Labs, Inc. | GOVX | 1 | PHASE2 | GEO-CM04S1 |
| Gilead Sciences, Inc. | GILD | 1 | PHASE2 | Remdesivir |
Nirmatrelvir/ritonavir is an investigational oral small molecule antiviral being developed by Pfizer for COVID-19, and it is also being studied in people with hepatic impairment and renal impairment. It combines nirmatrelvir with ritonavir and is given as an oral treatment in clinical trials.
Nirmatrelvir/ritonavir targets Mpro, the SARS-CoV-2 main protease. Nirmatrelvir is the component that acts on this viral enzyme, while ritonavir is included as a pharmacokinetic booster. This mechanism is designed to interfere with viral replication in COVID-19.
Pfizer, Inc. is developing nirmatrelvir/ritonavir. Pfizer trades on the New York Stock Exchange under the ticker PFE. The company sponsors the clinical trial program for the asset across COVID-19 and related impairment populations.
Nirmatrelvir/ritonavir is in Phase 3 development and is investigational. It has not been established as approved based on this program information. The clinical program includes five trials overall, with one currently active and four completed.
Nirmatrelvir/ritonavir has been studied in trials including NCT05567952, NCT05438602, NCT05261139, and NCT05047601. These cover COVID-19 rebound, immunocompromised patients, pediatric patients, and post-exposure prevention. NCT05261139, the EPIC-Peds Phase 3 trial, is currently recruiting participants.
Yes. Nirmatrelvir is also known as PF-07321332, and the combination is referred to as nirmatrelvir/ritonavir or PF-07321332/ritonavir. Other listed names include PF-07321332 Dose 1 and combinations with dabigatran or midazolam used in study settings.