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- || leritrelvir (RAY1216) / Guangdong Zhongsheng Pharma
P1 data, PK/PD data, Journal: Single- and multiple-dose pharmacokinetics and safety of the SARS-CoV-2 3CL protease inhibitor RAY1216: a phase 1 study in healthy participants. (Pubmed Central) - Mar 5, 2025
P1
RAY1216 was found to be well tolerated and safe in healthy participants. On the basis of preclinical results, PK characteristics, and the safety profile of RAY1216, a dosage of 400 mg three times daily was selected, thereby establishing a foundation for future research and for the clinical application of RAY1216.CLINICAL TRIALSThis study is registered with ClinicalTrials.gov as NCT05829551.
- || leritrelvir (RAY1216) / Guangdong Zhongsheng Pharma
PK/PD data, Journal: Single-dose tolerability and pharmacokinetics of leritrelvir in Chinese patients with hepatic impairment and healthy matched controls. (Pubmed Central) - Feb 13, 2025
P1
Overall, there was no clinically relevant difference in leritrelvir exposure in participants with hepatic impairment compared to normal controls. No dose adjustment is required for leritrelvir in patients with mild or moderate hepatic impairment.CLINICAL TRIALSThis study is registered with ClinicalTrials.gov as NCT06161259.
- | Journal: Identification of novel small-molecule inhibitors of SARS-CoV-2 by chemical genetics. (Pubmed Central) - Sep 23, 2024
Among them, four are nucleotide analogues (remdesivir, JT001, molnupiravir, and azvudine), while the other four are protease inhibitors (nirmatrelvir, ensitrelvir, leritrelvir, and simnotrelvir-ritonavir). In
- | leritrelvir (RAY1216) / Guangdong Zhongsheng Pharma
Journal: Model informed dose regimen optimizing in development of leritrelvir for the treatment of mild or moderate COVID-19. (Pubmed Central) - Sep 12, 2024
Gender and food consumption were identified as significant covariates affecting pharmacokinetic parameters, however, no dose adjustments were deemed necessary. This findings supported by subsequent phase II and phase III trials validated the appropriateness of a 400
- ||| leritrelvir (RAY1216) / Guangdong Zhongsheng Pharma
Trial completion: Drug-durg Interaction of Leritrelvir(RAY1216) With Midazolam, Omeprazole, Rosuvastatin, Verapamil, and Rifampin (clinicaltrials.gov) - Apr 16, 2024
P1, N=56, Completed, Sponsor: Guangdong Raynovent Biotech Co., Ltd
This findings supported by subsequent phase II and phase III trials validated the appropriateness of a 400 Recruiting --> Completed
- || leritrelvir (RAY1216) / Guangdong Zhongsheng Pharma
New P1 trial: Mass Balance Study of [14C]RAY1216 in Healthy Adult Male Subjects in China (clinicaltrials.gov) - Apr 11, 2024
P1, N=6, Completed, Sponsor: Guangdong Raynovent Biotech Co., Ltd
- || leritrelvir (RAY1216) / Guangdong Zhongsheng Pharma, Paxlovid (nirmatrelvir/ritonavir) / Pfizer
PK/PD data, Preclinical, Journal: Preclinical evaluation of the SARS-CoV-2 Mpro inhibitor RAY1216 shows improved pharmacokinetics compared with nirmatrelvir. (Pubmed Central) - Apr 8, 2024
It also shows improved pharmacokinetics in mice and rats, suggesting that RAY1216 could be used without ritonavir, which is co-administered with nirmatrelvir. RAY1216 has been approved as a single-component drug named 'leritrelvir' for COVID-19 treatment in China.
- || Retrospective data, Review, Journal: Small-molecule antivirals treatment for COVID-19: A systematic review and network meta-analysis. (Pubmed Central) - Mar 4, 2024
Additional clinical data are required to confirm the efficacy and safety of simnotrelvir/ritonavir and leritrelvir. The safety profiles of these antivirals were deemed acceptable.
- || Review, Journal: Small-molecule anti-COVID-19 drugs and a focus on China's homegrown mindeudesivir (VV116). (Pubmed Central) - Feb 14, 2024
So far, a few small-molecule antiviral drugs, including nirmatrelvir-ritonavir (Paxlovid), remdesivir, and molnupiravir have been marketed for the treatment of COVID-19...These drugs include azvudine, simnotrelvir-ritonavir (Xiannuoxin), leritrelvir, and mindeudesivir (VV116)...In this review, we discuss the most recent findings regarding the pharmacological mechanism and therapeutic effects focusing on mindeudesivir and other small-molecule antiviral agents for COVID-19. These findings will expand our understanding and highlight the potential widespread application of China's homegrown anti-COVID-19 drugs.
- || leritrelvir (RAY1216) / Guangdong Zhongsheng Pharma
Trial completion, Trial completion date: Pharmacokinetics of Leritrelvir(RAY1216) in Participants With Severe Kidney Disease (clinicaltrials.gov) - Feb 2, 2024
P1, N=16, Completed, Sponsor: Guangdong Raynovent Biotech Co., Ltd
These findings will expand our understanding and highlight the potential widespread application of China's homegrown anti-COVID-19 drugs. Recruiting --> Completed | Trial completion date: Mar 2024 --> Dec 2023
- || Review, Journal: On the origins of SARS-CoV-2 main protease inhibitors. (Pubmed Central) - Jan 29, 2024
Since many series of covalent SARS-CoV-2-M inhibitors owe some of their origins to previous work on other proteases, we first provided a description of various inhibitors of cysteine-bearing human caspase-1 or cathepsin K, as well as inhibitors of serine proteases such as human dipeptidyl peptidase-4 or the hepatitis C protein complex NS3/4A. This is then followed by a description of the results of the approaches adopted (repurposing, structure-based and high throughput screening) to discover coronavirus main protease inhibitors.
- | Sunvepra (asunaprevir) / BMS, leritrelvir (RAY1216) / Guangdong Zhongsheng Pharma
Journal: Computer-Aided Prediction of the Interactions of Viral Proteases with Antiviral Drugs: Antiviral Potential of Broad-Spectrum Drugs. (Pubmed Central) - Jan 15, 2024
As a result, Compounds 1-2, modified based on the structures of Ray1216 and Asunaprevir, indicate potential inhibition of DENV protease according to our computational simulation results. These studies offer ideas and insights for future research in the design of broad-spectrum antiviral drugs.
- || leritrelvir (RAY1216) / Guangdong Zhongsheng Pharma
New P1 trial: Pharmacokinetics of Leritrelvir(Ray1216) in Elder Participants (clinicaltrials.gov) - Dec 12, 2023
P1, N=32, Completed, Sponsor: Guangdong Raynovent Biotech Co., Ltd
- || leritrelvir (RAY1216) / Guangdong Zhongsheng Pharma
New P1 trial: Pharmacokinetics of Leritrelvir(RAY1216) in Participants With Severe Kidney Disease (clinicaltrials.gov) - Dec 7, 2023
P1, N=16, Recruiting, Sponsor: Guangdong Raynovent Biotech Co., Ltd
- || leritrelvir (RAY1216) / Guangdong Zhongsheng Pharma
New P1 trial: Pharmacokinetics of Leritrelvir(RAY1216) in Participants With Hepatic Impairment (clinicaltrials.gov) - Dec 7, 2023
P1, N=24, Completed, Sponsor: Guangdong Raynovent Biotech Co., Ltd
- ||| leritrelvir (RAY1216) / Guangdong Zhongsheng Pharma
Enrollment open: Drug-durg Interaction of Leritrelvir(RAY1216) With Midazolam, Omeprazole, Rosuvastatin, Verapamil, and Rifampin (clinicaltrials.gov) - Nov 22, 2023
P1, N=56, Recruiting, Sponsor: Guangdong Raynovent Biotech Co., Ltd
These studies offer ideas and insights for future research in the design of broad-spectrum antiviral drugs. Not yet recruiting --> Recruiting
- || leritrelvir (RAY1216) / Guangdong Zhongsheng Pharma
P2 data, Journal, Combination therapy, Monotherapy: Antiviral efficacy of RAY1216 monotherapy and combination therapy with ritonavir in patients with COVID-19: a phase 2, single centre, randomised, double-blind, placebo-controlled trial. (Pubmed Central) - Sep 11, 2023
Considering the limited clinical application of RTV, it is recommended to use RAY1216 alone to further verify its efficacy and safety. This study was sponsored by the Key Research and Development Program of China (2022YFC0868700).
- ||| leritrelvir (RAY1216) / Guangdong Zhongsheng Pharma
New P1 trial: Drug-durg Interaction of Leritrelvir(RAY1216) With Midazolam, Omeprazole, Rosuvastatin, Verapamil, and Rifampin (clinicaltrials.gov) - Sep 11, 2023
P1, N=56, Not yet recruiting, Sponsor: Guangdong Raynovent Biotech Co., Ltd
- ||||||| leritrelvir (RAY1216) / Guangdong Zhongsheng Pharma
Trial completion: Study of RAY1216 Tablets Compared With Placebo in Patients With Mild to Moderate COVID-19 (clinicaltrials.gov) - May 24, 2023
P3, N=1359, Completed, Sponsor: Guangdong Raynovent Biotech Co., Ltd
This study was sponsored by the Key Research and Development Program of China (2022YFC0868700). Active, not recruiting --> Completed
- ||| leritrelvir (RAY1216) / Guangdong Zhongsheng Pharma
New P1 trial: The Safety, Tolerability and Pharmacokinetics Study of RAY1216 in Healthy Adult Participants (clinicaltrials.gov) - Apr 25, 2023
P1, N=88, Completed, Sponsor: Guangdong Raynovent Biotech Co., Ltd
- ||||| leritrelvir (RAY1216) / Guangdong Zhongsheng Pharma
Enrollment closed: Study of RAY1216 Tablets Compared With Placebo in Patients With Mild to Moderate COVID-19 (clinicaltrials.gov) - Mar 29, 2023
P3, N=1359, Active, not recruiting, Sponsor: Guangdong Raynovent Biotech Co., Ltd
Active, not recruiting --> Completed Completed --> Active, not recruiting
- ||||||| leritrelvir (RAY1216) / Guangdong Zhongsheng Pharma
Trial completion, Trial completion date, Trial primary completion date: Study of RAY1216 Tablets Compared With Placebo in Patients With Mild to Moderate COVID-19 (clinicaltrials.gov) - Mar 28, 2023
P3, N=1359, Completed, Sponsor: Guangdong Raynovent Biotech Co., Ltd
Completed --> Active, not recruiting Not yet recruiting --> Completed | Trial completion date: Oct 2023 --> Mar 2023 | Trial primary completion date: Sep 2023 --> Jan 2023
- |||||||||| leritrelvir (RAY1216) / Guangdong Zhongsheng Pharma
New P3 trial: Study of RAY1216 Tablets Compared With Placebo in Patients With Mild to Moderate COVID-19 (clinicaltrials.gov) - Nov 17, 2022
P3, N=1070, Not yet recruiting, Sponsor: Guangdong Raynovent Biotech Co., Ltd