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Journal: Discovery of potential RSV fusion protein inhibitors from benzimidazole derivatives using QSAR, molecular docking, and ADMET evaluation methods. (Pubmed Central) - Sep 25, 2025 Furthermore, we used the optimal toxicity model to assess their cytotoxicity, and identified 23 derivatives with predicted cytotoxicity lower than that of JNJ-53718678. Finally, through drug-likeness evaluation, ADMET analysis and molecular dynamics simulation, we obtained eight potential RSV inhibitors with higher inhibitory activity, lower cytotoxicity, and better pharmacokinetic properties compared to JNJ-53718678.
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Clinical data, P2a data, Journal: A pilot phase 2a, randomised, double-blind, placebo-controlled study to explore the antiviral activity, clinical outcomes, safety, and tolerability of rilematovir at two dose levels in non-hospitalised adults with respiratory syncytial virus (RSV) infection. (Pubmed Central) - Sep 26, 2023 P2a Safe and effective therapeutic options for RSV in infants and young children remain an unmet need. Rilematovir use, initiated early, suggests a potential clinical benefit in RSV-infected adults, with data supporting development of RSV therapeutic options.
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Enrollment change, Trial completion date, Trial termination: A Study of JNJ-53718678 in Participants With Hepatic Impairment (clinicaltrials.gov) - Jun 13, 2022 P1, N=25, Terminated, N=52 --> 25 | Trial completion date: Dec 2022 --> Mar 2022 | Recruiting --> Terminated; A strategic decision was made to discontinue the study. The decision was not based on a safety concern.
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Journal: Probing In Silico the Benzimidazole Privileged Scaffold for the Development of Drug-like Anti-RSV Agents. (Pubmed Central) - Dec 29, 2021 A deepen comparison of the related electrostatic features and H-bonding motifs allowed us to pave the way for the following molecular dynamic simulation of JNJ-53718678 and then to perform docking studies of the in-house library of potent benzimidazole-containing anti-RSV agents...Along with this, in silico prediction of absorption, distribution, metabolism, excretion (ADME) properties, and also of possible off-target events was performed. The results highlighted once more that the benzimidazole ring represents a privileged scaffold whose properties deserve to be further investigated for the rational design of novel and orally bioavailable anti-RSV agents.
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Enrollment change, Trial completion date, Trial primary completion date: A Study of JNJ-53718678 in Participants With Hepatic Impairment (clinicaltrials.gov) - Nov 8, 2021 P1, N=52, Recruiting, Not yet recruiting --> Recruiting N=32 --> 52 | Trial completion date: Nov 2021 --> Apr 2022 | Trial primary completion date: Jun 2021 --> Apr 2022
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Trial completion date, Trial primary completion date: A Study of JNJ-53718678 in Participants With Hepatic Impairment (clinicaltrials.gov) - Apr 22, 2021 P1, N=32, Recruiting, Target exposures were reached and antiviral activity was observed. Trial completion date: Jun 2021 --> Nov 2021 | Trial primary completion date: Mar 2021 --> Jun 2021
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Trial completion date: A Study of JNJ-53718678 in Participants With Hepatic Impairment (clinicaltrials.gov) - Mar 17, 2021 P1, N=32, Recruiting, Trial completion date: Jun 2021 --> Nov 2021 | Trial primary completion date: Mar 2021 --> Jun 2021 Trial completion date: Mar 2021 --> Jun 2021
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Enrollment open: A Study of JNJ-53718678 in Participants With Hepatic Impairment (clinicaltrials.gov) - Sep 1, 2020 P1, N=32, Recruiting, By integrating duodenal sampling, N-glucuronidation was confirmed as another metabolic pathway despite the low amount of M8 excreted in urine and feces. Not yet recruiting --> Recruiting
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