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- || Paxlovid (nirmatrelvir/ritonavir) / Pfizer
Enrollment open: Study to Estimate the Effects of Hepatic Impairment on the Pharmacokinetics (PK) of PF-07321332 (clinicaltrials.gov) - Oct 27, 2021
P1, N=16, Recruiting, Sponsor: Pfizer
Not yet recruiting --> Recruiting
- || PF-07321332 / Pfizer, molnupiravir (MK-4482) / Emory University, Ridgeback Biotherap, Merck (MSD)
Also watching molnupiravir and PF-07321332 closely (Twitter) - Oct 22, 2021
- ||| ritonavir / Generic mfg., PF-07321332 / Pfizer
الحكومة البريطانية @GOVUK تتعاقد لشراء أدوية قيد الاعتماد والبحث لعلاج كوفيد ✍دواء ميرك @Merck 💊مولنوبيرافير (480ألف كورس علاجي) ✍دواء فايزر @pfizer 💊PF-07321332+Ritonavirرايتونافير (250ألف كورس علاجي) https://t.co/mHBk43nWvB (840) (Twitter) - Oct 22, 2021
- |||| ritonavir / Generic mfg., PF-07321332 / Pfizer, molnupiravir (MK-4482) / Emory University, Ridgeback Biotherap, Merck (MSD)
Clinical: This summer? 🤔 Obviously the Molnupiravir supply is some way off and @sajidjavid has not pointed out to people that PF-07321332/ritonavir *HAS NOT COMPLETED CLINICAL TRIALS* #Covid19UK #Antivirals (Twitter) - Oct 20, 2021
- || Paxlovid (nirmatrelvir/ritonavir) / Pfizer
Enrollment open: PF-07321332/Ritonavir and Ritonavir on Dabigatran Study in Healthy Participants (clinicaltrials.gov) - Oct 19, 2021
P1, N=24, Recruiting, Sponsor: Pfizer
Not yet recruiting --> Recruiting Not yet recruiting --> Recruiting
- || Paxlovid (nirmatrelvir/ritonavir) / Pfizer
Enrollment open: Drug-Drug Interaction Study to Estimate the Effect of PF-07321332/Ritonavir and Ritonavir on Midazolam in Healthy Participants (clinicaltrials.gov) - Oct 19, 2021
P1, N=12, Recruiting, Sponsor: Pfizer
Not yet recruiting --> Recruiting Not yet recruiting --> Recruiting
- || Paxlovid (nirmatrelvir/ritonavir) / Pfizer
Trial completion: Drug-Drug Interaction Study Assessing Effect of Carbamazepine on PF-07321332 Boosted With Ritonavir (clinicaltrials.gov) - Oct 19, 2021
P1, N=12, Completed, Sponsor: Pfizer
Not yet recruiting --> Recruiting Active, not recruiting --> Completed
- ||| Paxlovid (nirmatrelvir/ritonavir) / Pfizer
Trial completion: STUDY OF PF-07321332 IN HEALTHY PARTICIPANTS (clinicaltrials.gov) - Oct 13, 2021
P1, N=70, Completed, Sponsor: Pfizer
Active, not recruiting --> Completed Recruiting --> Completed
- || Paxlovid (nirmatrelvir/ritonavir) / Pfizer
Trial completion: Drug-Drug Interaction Study Assessing Effect of Itraconazole on PF-07321332/Ritonavir in Healthy Participants (clinicaltrials.gov) - Oct 12, 2021
P1, N=12, Completed, Sponsor: Pfizer
Recruiting --> Completed Recruiting --> Completed
- | Enrollment open: Finding Treatments for COVID-19: A Trial of Antiviral Pharmacodynamics in Early Symptomatic COVID-19 (PLATCOV) (clinicaltrials.gov) - Oct 7, 2021
P2, N=750, Recruiting, Sponsor: University of Oxford
Recruiting --> Completed Not yet recruiting --> Recruiting
- || Paxlovid (nirmatrelvir/ritonavir) / Pfizer
New P1 trial: PF-07321332/Ritonavir and Ritonavir on Dabigatran Study in Healthy Participants (clinicaltrials.gov) - Sep 30, 2021
P1, N=24, Not yet recruiting, Sponsor: Pfizer
- ||||| ritonavir / Generic mfg., PF-07321332 / Pfizer
@Pfizer begins study of oral #SARSCOV2 3CL protease inhibitor (PF-07321332) boosted w Ritonavir for post-exposure prophylaxis of COVID-19 in n=2660 household contacts. https://t.co/MpvxSEGXw4 (Twitter) - Sep 28, 2021
- || remdesivir / Generic mfg.
PK/PD data, Journal: Rethinking Remdesivir: Synthesis, Antiviral Activity and Pharmacokinetics of Oral Lipid Prodrugs. (Pubmed Central) - Sep 24, 2021
We focused on making simple, orally bioavailable lipid analogs of remdesivir nucleoside (RVn; GS-441524) that are processed to RVn monophosphate, the precursor of the active RVn triphosphate, by a single-step intracellular cleavage...In Syrian hamsters oral treatment with ODBG-P-RVn was well tolerated and achieved therapeutic levels in plasma above the EC for SARS-CoV-2. The results suggest further evaluation as an early oral treatment for SARS-CoV-2 infection to minimize severe disease and reduce hospitalizations.
- |||||| Paxlovid (nirmatrelvir/ritonavir) / Pfizer
Enrollment open: A Study of a Potential Oral Treatment to Prevent COVID-19 in Adults Who Are Exposed to Household Member(s) With a Confirmed Symptomatic COVID-19 Infection (clinicaltrials.gov) - Sep 23, 2021
P3, N=2634, Recruiting, Sponsor: Pfizer
The results suggest further evaluation as an early oral treatment for SARS-CoV-2 infection to minimize severe disease and reduce hospitalizations. Not yet recruiting --> Recruiting
- | PF-07321332 / Pfizer
Journal: Computational simulations on the binding and reactivity of a nitrile inhibitor of the SARS-CoV-2 main protease. (Pubmed Central) - Sep 22, 2021
Alchemical free energy calculations suggest that positions P3 and P4 could be susceptible to improvement in order to get a larger binding strength. QM/MM simulations unveil the reaction mechanism for covalent inhibition, showing that the nitrile warhead facilitates the recruitment of a water molecule for the proton transfer step.
- | PF-07321332 / Pfizer
Journal: Exploring the Binding Mechanism of PF-07321332 SARS-CoV-2 Protease Inhibitor through Molecular Dynamics and Binding Free Energy Simulations. (Pubmed Central) - Sep 19, 2021
Our study elucidated in detail the binding mechanism of the potent PF-07321332 to 3CL along with the low potency of lopinavir and ritonavir due to weak binding affinity demonstrated by the binding energy data. This study will be helpful for the development and optimization of more specific compounds to combat coronavirus disease.
- |||||| Paxlovid (nirmatrelvir/ritonavir) / Pfizer
Enrollment open, Phase classification: Evaluation of Protease Inhibition for COVID-19 in Standard-Risk Patients (EPIC-SR). (clinicaltrials.gov) - Sep 17, 2021
P3, N=1140, Recruiting, Sponsor: Pfizer
This study will be helpful for the development and optimization of more specific compounds to combat coronavirus disease. Not yet recruiting --> Recruiting | Phase classification: P2/3 --> P3
- |||||||||| Paxlovid (nirmatrelvir/ritonavir) / Pfizer
New P3 trial: A Study of a Potential Oral Treatment to Prevent COVID-19 in Adults Who Are Exposed to Household Member(s) With a Confirmed Symptomatic COVID-19 Infection (clinicaltrials.gov) - Sep 17, 2021
P3, N=2634, Not yet recruiting, Sponsor: Pfizer
- || Paxlovid (nirmatrelvir/ritonavir) / Pfizer
Enrollment open: Renal Impairment Study of PF-07321332 Boosted With Ritonavir in Adult Participants With Renal Impairment and in Healthy Participants With Normal Renal Function. (clinicaltrials.gov) - Sep 16, 2021
P1, N=36, Recruiting, Sponsor: Pfizer
Not yet recruiting --> Recruiting | Phase classification: P2/3 --> P3 Not yet recruiting --> Recruiting
- | New P2 trial: Finding Treatments for COVID-19: A Trial of Antiviral Pharmacodynamics in Early Symptomatic COVID-19 (PLATCOV) (clinicaltrials.gov) - Sep 12, 2021
P2, N=750, Not yet recruiting, Sponsor: University of Oxford
- || Paxlovid (nirmatrelvir/ritonavir) / Pfizer
New P1 trial: Drug-Drug Interaction Study to Estimate the Effect of PF-07321332/Ritonavir and Ritonavir on Midazolam in Healthy Participants (clinicaltrials.gov) - Sep 1, 2021
P1, N=12, Not yet recruiting, Sponsor: Pfizer
- || Paxlovid (nirmatrelvir/ritonavir) / Pfizer
Enrollment closed: Drug-Drug Interaction Study Assessing Effect of Carbamazepine on PF-07321332 Boosted With Ritonavir (clinicaltrials.gov) - Aug 30, 2021
P1, N=12, Active, not recruiting, Sponsor: Pfizer
Not yet recruiting --> Recruiting Recruiting --> Active, not recruiting
- || Paxlovid (nirmatrelvir/ritonavir) / Pfizer
Phase classification: Evaluation of Protease Inhibition for COVID-19 in Standard-Risk Patients (EPIC-SR). (clinicaltrials.gov) - Aug 29, 2021
P2/3, N=1140, Not yet recruiting, Sponsor: Pfizer
Recruiting --> Active, not recruiting Phase classification: P3 --> P2/3
- || Paxlovid (nirmatrelvir/ritonavir) / Pfizer
Phase classification: EPIC-HR: Study of Oral PF-07321332/Ritonavir Compared With Placebo in Nonhospitalized High Risk Adults With COVID-19 (clinicaltrials.gov) - Aug 26, 2021
P3, N=3000, Recruiting, Sponsor: Pfizer
Phase classification: P3 --> P2/3 Phase classification: P2/3 --> P3
- |||||| Paxlovid (nirmatrelvir/ritonavir) / Pfizer
Enrollment open, Enrollment change: EPIC-HR: Study of Oral PF-07321332/Ritonavir Compared With Placebo in Nonhospitalized High Risk Adults With COVID-19 (clinicaltrials.gov) - Aug 22, 2021
P2/3, N=3000, Recruiting, Sponsor: Pfizer
Phase classification: P2/3 --> P3 Not yet recruiting --> Recruiting | N=2260 --> 3000
- |||||||||| Paxlovid (nirmatrelvir/ritonavir) / Pfizer
New P2/3 trial, New P3 trial: Evaluation of Protease Inhibition for COVID-19 in Standard-Risk Patients (EPIC-SR). (clinicaltrials.gov) - Aug 17, 2021
P3, N=1140, Not yet recruiting, Sponsor: Pfizer
- || Review, Journal: Considerations for the discovery and development of 3-chymotrypsin-like cysteine protease inhibitors targeting SARS-CoV-2 infection. (Pubmed Central) - Aug 15, 2021
A key challenge to the development of novel 3CLpro inhibitors is the poor understanding of the predictive value of in vitro potency toward clinical efficacy, an issue complicated by the involvement of host proteases in virus entry. Further preclinical and clinical validation will be key to establishing 3CLpro inhibitors as a bona fide class for future SARS-CoV-2 therapeutics for both hospitalized and outpatient populations.
- || Paxlovid (nirmatrelvir/ritonavir) / Pfizer
New P1 trial: Study to Estimate the Effects of Hepatic Impairment on the Pharmacokinetics (PK) of PF-07321332 (clinicaltrials.gov) - Aug 12, 2021
P1, N=16, Not yet recruiting, Sponsor: Pfizer
- || Paxlovid (nirmatrelvir/ritonavir) / Pfizer
Enrollment open: Drug-Drug Interaction Study Assessing Effect of Itraconazole on PF-07321332/Ritonavir in Healthy Participants (clinicaltrials.gov) - Jul 30, 2021
P1, N=12, Recruiting, Sponsor: Pfizer
Further preclinical and clinical validation will be key to establishing 3CLpro inhibitors as a bona fide class for future SARS-CoV-2 therapeutics for both hospitalized and outpatient populations. Not yet recruiting --> Recruiting
- | PF-07321332 / Pfizer
Journal: Supervised Molecular Dynamics (SuMD) Insights into the mechanism of action of SARS-CoV-2 main protease inhibitor PF-07321332. (Pubmed Central) - Jul 30, 2021
In the present work, we exploited Supervised Molecular Dynamics (SuMD) simulations to elucidate the key features that characterise the interaction between this drug candidate and the protease, emphasising similarities and differences with other structurally related inhibitors such as Boceprevir and PF-07304814. The structural insights provided by SuMD will hopefully be able to inspire the rational discovery of other potent and selective protease inhibitors.
- || Paxlovid (nirmatrelvir/ritonavir) / Pfizer
Enrollment open: Drug-Drug Interaction Study Assessing Effect of Carbamazepine on PF-07321332 Boosted With Ritonavir (clinicaltrials.gov) - Jul 28, 2021
P1, N=12, Recruiting, Sponsor: Pfizer
The structural insights provided by SuMD will hopefully be able to inspire the rational discovery of other potent and selective protease inhibitors. Not yet recruiting --> Recruiting
- || Paxlovid (nirmatrelvir/ritonavir) / Pfizer
New P1 trial: Drug-Drug Interaction Study Assessing Effect of Itraconazole on PF-07321332/Ritonavir in Healthy Participants (clinicaltrials.gov) - Jul 13, 2021
P1, N=12, Not yet recruiting, Sponsor: Pfizer
- || Paxlovid (nirmatrelvir/ritonavir) / Pfizer
New P1 trial: Drug-Drug Interaction Study Assessing Effect of Carbamazepine on PF-07321332 Boosted With Ritonavir (clinicaltrials.gov) - Jul 13, 2021
P1, N=12, Not yet recruiting, Sponsor: Pfizer
- |||| PF-07321332 / Pfizer
Preclinical: Thank you for this summary. I’m watching therapeutics development closely. Any thoughts on Pfizer’s PF-07321332? I haven’t seen preclinicals on animal models…have you over chance? (Twitter) - Jul 13, 2021
- |||||||||| Paxlovid (nirmatrelvir/ritonavir) / Pfizer
New P2/3 trial, New P3 trial: EPIC-HR: Study of Oral PF-07321332/Ritonavir Compared With Placebo in Nonhospitalized High Risk Adults With COVID-19 (clinicaltrials.gov) - Jul 12, 2021
P2/3, N=2260, Not yet recruiting, Sponsor: Pfizer
- || Paxlovid (nirmatrelvir/ritonavir) / Pfizer
Enrollment change, Trial completion date, Trial primary completion date: STUDY OF PF-07321332 IN HEALTHY PARTICIPANTS (clinicaltrials.gov) - Jul 1, 2021
P1, N=78, Recruiting, Sponsor: Pfizer
Not yet recruiting --> Recruiting N=60 --> 78 | Trial completion date: May 2021 --> Sep 2021 | Trial primary completion date: May 2021 --> Sep 2021
- || Paxlovid (nirmatrelvir/ritonavir) / Pfizer
New P1 trial: Renal Impairment Study of PF-07321332 Boosted With Ritonavir in Adult Participants With Renal Impairment and in Healthy Participants With Normal Renal Function. (clinicaltrials.gov) - Jun 2, 2021
P1, N=32, Not yet recruiting, Sponsor: Pfizer
- ||||| PF-07321332 / Pfizer
Clinical: How about giving #Longcovid patients access to antivirals? Would love to participate in a RCT with #Pfizer new PF-07321332 drug. It is in humane to let us suffer and not give us these options for treatment. It could be a test for clinical improvement (Twitter) - May 29, 2021
- | PF-07321332 / Pfizer
Ha superato con buoni risultati i test di #sperimentazioneanimale l'antivirale di @pfizeritalia in pillola PF-07321332. #EARA https://t.co/oknwcldoZF https://t.co/VQV5XOel6V (Twitter) - May 4, 2021
- | Enrollment change, Trial completion date, Trial primary completion date: AGILE (Early Phase Platform Trial for COVID-19) (clinicaltrials.gov) - Apr 22, 2021
P1/2, N=600, Recruiting, Sponsor: University of Liverpool
N=60 --> 78 | Trial completion date: May 2021 --> Sep 2021 | Trial primary completion date: May 2021 --> Sep 2021 N=200 --> 600 | Trial completion date: Dec 2021 --> Apr 2022 | Trial primary completion date: Jun 2021 --> Nov 2021
- | PF-07321332 / Pfizer
Great article. Also, got a nice chuckle from "Catchily named PF-07321332". (Twitter) - Apr 9, 2021
- ||| Paxlovid (nirmatrelvir/ritonavir) / Pfizer
Enrollment open: STUDY OF PF-07321332 IN HEALTHY PARTICIPANTS (clinicaltrials.gov) - Mar 2, 2021
P1, N=60, Recruiting, Sponsor: Pfizer
N=200 --> 600 | Trial completion date: Dec 2021 --> Apr 2022 | Trial primary completion date: Jun 2021 --> Nov 2021 Not yet recruiting --> Recruiting
- ||| Paxlovid (nirmatrelvir/ritonavir) / Pfizer
New P1 trial: STUDY OF PF-07321332 IN HEALTHY PARTICIPANTS (clinicaltrials.gov) - Feb 15, 2021
P1, N=60, Not yet recruiting, Sponsor: Pfizer
- | Enrollment change: RECOVERY: Randomised Evaluation of COVID-19 Therapy (clinicaltrials.gov) - Feb 10, 2021
P2/3, N=40000, Recruiting, Sponsor: University of Oxford
Not yet recruiting --> Recruiting N=20000 --> 40000
- | New P1/2 trial: AGILE (Early Phase Platform Trial for COVID-19) (clinicaltrials.gov) - Feb 8, 2021
P1/2, N=200, Recruiting, Sponsor: University of Liverpool
- | Fragmin (dalteparin sodium) / Pfizer, Eisai, Innohep (tinzaparin) / LEO Pharma, Paxlovid (nirmatrelvir/ritonavir) / Pfizer
Trial completion date, Trial primary completion date: Australasian COVID-19 Trial (ASCOT) ADAptive Platform Trial (clinicaltrials.gov) - Nov 22, 2020
P3, N=2400, Recruiting, Sponsor: University of Melbourne
N=20000 --> 40000 Trial completion date: Jun 2022 --> Dec 2022 | Trial primary completion date: Jun 2021 --> Dec 2021
- | Enrollment change: RECOVERY: Randomised Evaluation of COVID-19 Therapy (clinicaltrials.gov) - Nov 12, 2020
P2/3, N=20000, Recruiting, Sponsor: University of Oxford
Trial completion date: Jun 2022 --> Dec 2022 | Trial primary completion date: Jun 2021 --> Dec 2021 N=15000 --> 20000
- | Fragmin (dalteparin sodium) / Pfizer, Eisai, Innohep (tinzaparin) / LEO Pharma, Paxlovid (nirmatrelvir/ritonavir) / Pfizer
New P3 trial: Australasian COVID-19 Trial (ASCOT) ADAptive Platform Trial (clinicaltrials.gov) - Jul 22, 2020
P3, N=2400, Recruiting, Sponsor: University of Melbourne
- | Trial completion date, Trial primary completion date: RECOVERY: Randomised Evaluation of COVID-19 Therapy (clinicaltrials.gov) - Jul 6, 2020
P2/3, N=15000, Recruiting, Sponsor: University of Oxford
N=15000 --> 20000 Trial completion date: Jun 2021 --> Dec 2031 | Trial primary completion date: Dec 2020 --> Dec 2021
- | New P2/3 trial: RECOVERY: Randomised Evaluation of COVID-19 Therapy (clinicaltrials.gov) - May 10, 2020
P2/3, N=12000, Recruiting, Sponsor: University of Oxford