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Discovery, Development, and Patent Trends on Molnupiravir: A Prospective Oral Treatment for COVID-19.

ABSTRACT: The COVID-19 pandemic needs no introduction at present. Only a few treatments are available for this disease, including remdesivir and favipiravir. Accordingly, the pharmaceutical industry is striving to develop new treatments for COVID-19. Molnupiravir, an orally active RdRp inhibitor, is in a phase 3 clinical trial against COVID-19. The objective of this review article is to enlighten the researchers working on COVID-19 about the discovery, recent developments, and patents related to molnupiravir. Molnupiravir was originally developed for the treatment of influenza at Emory University, USA. However, this drug has also demonstrated activity against a variety of viruses, including SARS-CoV-2. Now it is being jointly developed by Emory University, Ridgeback Biotherapeutics, and Merck to treat COVID-19. The published clinical data indicate a good safety profile, tolerability, and oral bioavailability of molnupiravir in humans. The patient-compliant oral dosage form of molnupiravir may hit the market in the first or second quarter of 2022. The patent data of molnupiravir revealed its granted compound patent and process-related patent applications. We also anticipate patent filing related to oral dosage forms, inhalers, and a combination of molnupiravir with marketed drugs like remdesivir, favipiravir, and baricitinib. The current pandemic demands a patient compliant, safe, tolerable, and orally effective COVID-19 treatment. The authors believe that molnupiravir meets these requirements and is a breakthrough COVID-19 treatment.

SUBMITTER: Imran M

PROVIDER: S-EPMC8510125 | biostudies-literature |

REPOSITORIES: biostudies-literature

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Project description:BackgroundNew treatments are needed to reduce the risk of progression of coronavirus disease 2019 (Covid-19). Molnupiravir is an oral, small-molecule antiviral prodrug that is active against severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2).MethodsWe conducted a phase 3, double-blind, randomized, placebo-controlled trial to evaluate the efficacy and safety of treatment with molnupiravir started within 5 days after the onset of signs or symptoms in nonhospitalized, unvaccinated adults with mild-to-moderate, laboratory-confirmed Covid-19 and at least one risk factor for severe Covid-19 illness. Participants in the trial were randomly assigned to receive 800 mg of molnupiravir or placebo twice daily for 5 days. The primary efficacy end point was the incidence hospitalization or death at day 29; the incidence of adverse events was the primary safety end point. A planned interim analysis was performed when 50% of 1550 participants (target enrollment) had been followed through day 29.ResultsA total of 1433 participants underwent randomization; 716 were assigned to receive molnupiravir and 717 to receive placebo. With the exception of an imbalance in sex, baseline characteristics were similar in the two groups. The superiority of molnupiravir was demonstrated at the interim analysis; the risk of hospitalization for any cause or death through day 29 was lower with molnupiravir (28 of 385 participants [7.3%]) than with placebo (53 of 377 [14.1%]) (difference, -6.8 percentage points; 95% confidence interval [CI], -11.3 to -2.4; P = 0.001). In the analysis of all participants who had undergone randomization, the percentage of participants who were hospitalized or died through day 29 was lower in the molnupiravir group than in the placebo group (6.8% [48 of 709] vs. 9.7% [68 of 699]; difference, -3.0 percentage points; 95% CI, -5.9 to -0.1). Results of subgroup analyses were largely consistent with these overall results; in some subgroups, such as patients with evidence of previous SARS-CoV-2 infection, those with low baseline viral load, and those with diabetes, the point estimate for the difference favored placebo. One death was reported in the molnupiravir group and 9 were reported in the placebo group through day 29. Adverse events were reported in 216 of 710 participants (30.4%) in the molnupiravir group and 231 of 701 (33.0%) in the placebo group.ConclusionsEarly treatment with molnupiravir reduced the risk of hospitalization or death in at-risk, unvaccinated adults with Covid-19. (Funded by Merck Sharp and Dohme; MOVe-OUT ClinicalTrials.gov number, NCT04575597.).

Project description:BackgroundThroughout the time of the global pandemic of SARS-CoV-2 virus, there has been a compelling necessity for the development of effective antiviral agents and prophylactic vaccines to limit the virus spread, disease burden, hospitalization, and mortality. Until mid of 2021, the NIH treatment guideline declared no single oral therapy was proven to treat mild to moderate cases. A new hope arose when a repurposed direct acting oral anti-viral agent "Molnupiravir" was shown to be effective in decreasing mortality and need for hospitalization in mild to moderate cases with relatively good safety profile; exhibiting a significant reduction in virus titers only after two days from administration. Molnupiravir recently granted the FDA emergency use authorization to treat mild to moderate COVID-19 patients with at least one risk factor for progression.MethodsWe performed a computer-based literature search of (PubMed, Science direct, MedRxiv, BioRxiv, ClinicalTrials.gov, ISRCTN, Cochrane COVID study register, EU registry, and CTRI registry) till February 15th, 2022. The following keywords were used in our search ("Molnupiravir", "NHC", "EIDD-2807", "MK-4482" or "EIDD-1931").ResultsWe identified from the initial search a total of 279 articles; 246 articles (BioRxiv and MedRxiv N = 186, PubMed N = 33, Science direct N = 27) and 33 Clinical trials from the following registries (ISCTRN (N = 1), Clinical Trials.gov (N = 6), CTRI (N = 12), Cochrane (N = 14)). Through screening phases, 21 records were removed as duplicates and 198 irrelevant records were also excluded. The included studies in this systematic review were (N = 60) included 39 published papers and 21 clinical trials. After Manual addition (N = 4), the qualitative assessment included (N = 64).ConclusionBased on the cumulative evidence from preclinical and clinical studies, Molnupiravir is proven to be a well tolerated, direct acting oral anti-viral agent to halt the disease progression in mild to moderate COVID-19 cases; in terms of mortality and hospitalization rates.

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Discovery, Development, and Patent Trends on Molnupiravir: A Prospective Oral Treatment for COVID-19.

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