Drugs / Molnupiravir
Molnupiravir
Regulatory milestones approvals, filings & regulatory actions · 1 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Refused (EMA) | EU (EMA) | LAGEVRIO | COVID-19 | 2023-02-24 | “CHMP of the European Medicines Agency (EMA) has recommended the refusal of the marketing authorization for LAGEVRIO™ (molnupiravir)” merck.com ↗ |
Trials 21
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 16 trials · 1 met primary · 1 missed | ||||||
| Phase 1 | NCT05818124 | Aug 2023 → Jun 2024 | influenza | Merck Sharp & Dohme LLC | Completed | Missed primary |
| Phase 1 | NCT06816030 | Jun → Aug 2023 | — | Merck Sharp & Dohme LLC | Completed | No outcome recorded |
| Phase 1 | NCT06615869 | Jan → Feb 2023 | — | Merck Sharp & Dohme LLC | Completed | Met primary |
| Phase 1 | NCT05386758 | Jun 2022 → Feb 2023 | impaired renal function disease | Merck Sharp & Dohme LLC | Completed | No outcome recorded |
| Phase 1 | NCT05386589 | Jun → Dec 2022 | — | Merck Sharp & Dohme LLC | Completed | No outcome recorded |
| Phase 1 | NCT04392219 | Apr → Aug 2020 | Coronaviridae infectious disease | Ridgeback Biotherapeutics, LP | Completed | No outcome recorded |
| Phase 1/21 trial · 1 missed | ||||||
| Phase 1/2 | NCT04746183 | Jul 2020 → Mar 2027 expected | COVID-19 | University of Liverpool | Recruiting | Missed primary |
| Phase 27 trials · 1 met primary · 1 missed | ||||||
| Phase 2 | NCT06551844 | Apr 2026 → Dec 2029 expected | dengue disease | Oxford University Clinical Research Unit, Vietnam | Recruiting | No outcome recorded |
| Phase 2 | NCT06488300 | Jul 2024 → Jan 2027 expected | respiratory syncytial virus infectious disease | University of Oxford | Recruiting | No outcome recorded |
| Phase 2 | NCT05648448 | Feb 2023 → Jan 2027 expected | influenza | University of Oxford | Recruiting | No outcome recorded |
| Phase 2 | NCT05559905 | Nov 2022 → Apr 2023 | respiratory syncytial virus infectious disease | Merck Sharp & Dohme LLC | Completed | Missed primary |
| Phase 2 | NCT05041907 | Sep 2021 → Jan 2027 expected | COVID-19 | University of Oxford | Recruiting | Mixed |
| Phase 2 | NCT04405570 | Jun 2020 → Feb 2021 | COVID-19 | Ridgeback Biotherapeutics, LP | Completed | Met primary |
| Phase 2 | NCT04405739 | Jun 2020 → Feb 2022 | COVID-19 | Ridgeback Biotherapeutics, LP | Completed | No outcome recorded |
| Phase 2/33 trials · 1 met primary · 1 missed | ||||||
| Phase 2/3 | NCT05459532 | Aug 2022 → Jul 2023 | COVID-19 | University of Witwatersrand, South Africa | Completed | No outcome recorded |
| Phase 2/3 | NCT04575597 | Oct 2020 → May 2022 | COVID-19 | Merck Sharp & Dohme LLC | Completed | Met primary |
| Phase 2/3 | NCT04575584 | Oct 2020 → Aug 2021 | COVID-19 | Merck Sharp & Dohme LLC | Terminated | Missed primary Stop: Business |
| Phase 34 trials · 1 missed | ||||||
| Phase 3 | NCT06667700 | Dec 2024 → Jan 2031 expected | COVID-19 | Merck Sharp & Dohme LLC | Recruiting | No outcome recorded |
| Phase 3 | NCT05595824 | Dec 2021 → Mar 2022 | COVID-19 | Promomed, LLC | Completed | No outcome recorded |
| Phase 3 | NCT04939428 | Aug 2021 → Nov 2022 | COVID-19 | Merck Sharp & Dohme LLC | Completed | Missed primary |
| Phase 3 | NCT04730206 | Jun 2021 → Jul 2022 | COVID-19 | KU Leuven | Terminated | No outcome recorded Stop: Enrollment |
| Comparator or background therapy2 trials | ||||||
| Phase 3 | NCT05271929 Background | Apr 2022 → Jan 2024 | COVID-19 | German Red Cross Blood Transfusion Service Baden-Württemberg-Hessen | Terminated | Met primary Stop: Enrollment |
| Phase 3 | NCT04381936 Comparator | Mar 2020 → Sep 2028 expected | pneumonia | University of Oxford | Recruiting | No outcome recorded |
News releases announcing trial results or a regulatory action · 33
| Date | Issuer | Release |
|---|---|---|
| 2023-06-27 | Merck Sharp & Dohme LLC | Regulatory Merck and Ridgeback Provide Update on EU Marketing Authorization Application for LAGEVRIO™ (molnupiravir) merck.com ↗
The withdrawal is based on the CHMP’s view that the data submitted are not sufficient to satisfy EU regulatory requirements for marketing authorization of LAGEVRIO. |
| 2023-02-28 | MSD R&D (China) Co., Ltd. | Results 新型コロナウイルス感染症の曝露後予防としてラゲブリオ®（モルヌピラビル）を評価する 第3相MOVe-AHEAD試験の新たなデータを公表 msd.co.jp ↗
ラゲブリオ ® （モルヌピラビル）が、新型コロナウイルス感染症患者の家庭内接触者における新型コロナウイルス感染症の発症リスクについて、統計学的に有意な減少を示さなかったことを発表しました。 |
| 2023-02-24 | Merck Sharp & Dohme LLC | Regulatory Merck and Ridgeback Provide Update on EU Marketing Authorization Application for LAGEVRIO™ (Molnupiravir) merck.com ↗
Merck and Ridgeback will appeal the decision and request a re-examination of the CHMP’s opinion. |
| 2023-02-21 | Merck Sharp & Dohme LLC | Results Merck Provides Update on Phase 3 MOVe-AHEAD Trial Evaluating LAGEVRIO™ (molnupiravir) for Post-exposure Prophylaxis for Prevention of COVID-19 merck.com ↗
Merck (NYSE: MRK), known as MSD outside the United States and Canada, today announced that LAGEVRIO™ (molnupiravir) did not demonstrate a statistically significant reduction in the risk of COVID-19 following household exposure to another individual with COVID-19. |
| 2022-10-06 | Merck Sharp & Dohme LLC | Results Merck and Ridgeback Biotherapeutics Provide Update on New Clinical and Non-Clinical Studies of LAGEVRIO™ (molnupiravir) merck.com ↗
Results from a separate, non-clinical 6-month carcinogenicity study in mice demonstrated that LAGEVRIO was not carcinogenic. |
| 2022-06-13 | MSD R&D (China) Co., Ltd. | Results Merck & Co., Inc., Rahway, N.J., USAとRidgeback Biotherapeutics、 ラゲブリオ®（モルヌピラビル）の第3相MOVe-OUT試験の新たなデータを公表 事前に設定された探索的評価項目に基づき、ラゲブリオ®を投与した患者では プラセボを投与した患者より急性期治療のための来院の割合が低く 事後解析では呼吸療法（侵襲的人工呼吸管理など）が必要な患者がより少ない結果に msd.co.jp ↗
事前に設定された探索的評価項目の解析で、modified intent-to-treat（MITT）解析対象集団においてラゲブリオ ® を投与した患者では急性期治療のための来院または新型コロナウイルス感染症関連の急性期治療のための来院の割合がMITT解析対象集団でプラセボを投与した患者と比較して低くなりました。 |
| 2022-06-07 | Merck Sharp & Dohme LLC | Results Merck and Ridgeback Announce New Data For Investigational LAGEVRIO™ (molnupiravir) From Phase 3 MOVe-OUT Study merck.com ↗
Merck, known as MSD outside the United States and Canada, and Ridgeback Biotherapeutics today announced the Annals of Internal Medicine has published additional data from the Phase 3 MOVe-OUT trial evaluating LAGEVRIO™ (molnupiravir), an investigational oral antiviral medicine, in non-hospitalized adults with mild to moderate COVID-19 who were at high risk for progressing to severe disease. |
| 2022-04-28 | Merck Sharp & Dohme LLC | Results Merck Announces First-Quarter 2022 Financial Results merck.com ↗
Results showed that among patients with infectious virus isolated at baseline and for whom post-baseline infectivity data were available, LAGEVRIO was associated with more rapid elimination of infectious SARS-CoV-2 than placebo. |
| 2022-04-11 | MSD R&D (China) Co., Ltd. | Results Merck & Co., Inc., Kenilworth, N.J., U.S.A.とRidgeback Biotherapeutics、 ラゲブリオ®（モルヌピラビル）がプラセボと比較して 感染性SARS-CoV-2をより速やかに消失させたことを示すデータを公表 msd.co.jp ↗
ベースライン時に感染性ウイルスを分離し、ベースライン後の感染力のデータを得られた被験者において、ラゲブリオ ® はプラセボより感染性ウイルスの消失が速やかでした。 |
| 2022-04-01 | Merck Sharp & Dohme LLC | Results Merck and Ridgeback to Present Data Demonstrating That Treatment With LAGEVRIO™ (molnupiravir) Was Associated With More Rapid Elimination of Infectious SARS-CoV-2 Than Placebo merck.com ↗
In participants with infectious virus isolated at baseline and for whom post-baseline infectivity data were available, molnupiravir was associated with more rapid elimination of infectious virus than placebo. |
| 2022-02-19 | Merck Sharp & Dohme LLC | Results Merck and Ridgeback Statement on Clinical Trial of Hetero’s Generic Molnupiravir merck.com ↗
We are excited to see that in this clinical trial in more than 1,200 patients in India, generic molnupiravir significantly reduced hospitalizations compared to standard of care alone in patients with mild COVID-19. |
| 2022-02-01 | MSD R&D (China) Co., Ltd. | Results Merck & Co., Inc., Kenilworth, N.J., U.S.A.とRidgeback Biotherapeuticsが開発する新型コロナウイルス感染症の経口抗ウイルス薬モルヌピラビル、オミクロン株に対する活性がin vitro試験で示される msd.co.jp ↗
Merck & Co., Inc., Kenilworth, N.J., U.S.A.（米国とカナダ以外ではMSD）およびRidgeback Biotherapeuticsは本日、経口抗ウイルス薬として開発しているモルヌピラビルについて、6件の非臨床試験のデータにより、SARS-CoV-2の変異株であるオミクロン株（B1.1.529）に対する活性が in vitro 試験で示されたと発表しました。 |
| 2022-01-28 | Merck Sharp & Dohme LLC | Results Merck and Ridgeback’s Molnupiravir, an Investigational Oral Antiviral COVID-19 Medicine, Demonstrated Activity Against Omicron Variant in In Vitro Studies merck.com ↗ |
| 2021-12-24 | Merck Sharp & Dohme LLC | Regulatory Merck and Ridgeback’s Molnupiravir, an Investigational Oral Antiviral COVID-19 Treatment, Receives Special Approval for Emergency in Japan merck.com ↗
Merck (NYSE: MRK), known as MSD outside the United States and Canada, and Ridgeback Biotherapeutics today announced that Japan’s Ministry of Health, Labor and Welfare has granted Special Approval for Emergency in Japan for molnupiravir, an investigational oral antiviral medicine, for infectious disease caused by SARS-CoV-2. |
| 2021-12-23 | Merck Sharp & Dohme LLC | Regulatory Merck and Ridgeback’s Molnupiravir Receives U.S. FDA Emergency Use Authorization for the Treatment of High-Risk Adults With Mild to Moderate COVID-19 merck.com ↗
Merck (NYSE: MRK), known as MSD outside the United States and Canada, and Ridgeback Biotherapeutics today announced that the U.S. Food and Drug Administration (FDA) has granted Emergency Use Authorization (EUA) for molnupiravir, an investigational oral antiviral (MK-4482, EIDD-2801). |
| 2021-12-16 | Merck Sharp & Dohme LLC | Results MSD and Ridgeback Announce Publication of Phase 3 Study of Molnupiravir, an Investigational Oral Antiviral COVID-19 Treatment, in the New England Journal of Medicine msd.com ↗
Data from MOVe-OUT demonstrated that early treatment with molnupiravir significantly reduced the risk of hospitalization or death in high risk, unvaccinated adults with COVID-19. |
| 2021-12-16 | Merck Sharp & Dohme LLC | Results Merck and Ridgeback Announce Publication of Phase 3 Study of Molnupiravir, an Investigational Oral Antiviral COVID-19 Treatment, in the New England Journal of Medicine merck.com ↗
Data from MOVe-OUT demonstrated that early treatment with molnupiravir significantly reduced the risk of hospitalization or death in high risk, unvaccinated adults with COVID-19. |
| 2021-11-30 | Merck Sharp & Dohme LLC | Regulatory MSD and Ridgeback Statement on Positive FDA Advisory Committee Vote for Investigational Oral Antiviral Molnupiravir for Treatment of Mild to Moderate COVID-19 in High Risk Adults msd.com ↗
The Advisory Committee voted 13-10 that the known and potential benefits of molnupiravir outweigh its known and potential risks for the treatment of mild to moderate COVID-19 in high risk adult patients who are within five days of symptom onset. |
| 2021-11-30 | Merck Sharp & Dohme LLC | Regulatory Merck and Ridgeback Statement on Positive FDA Advisory Committee Vote for Investigational Oral Antiviral Molnupiravir for Treatment of Mild to Moderate COVID-19 in High Risk Adults merck.com ↗
The Advisory Committee voted 13-10 that the known and potential benefits of molnupiravir outweigh its known and potential risks for the treatment of mild to moderate COVID-19 in high risk adult patients who are within five days of symptom onset. |
| 2021-11-26 | Merck Sharp & Dohme LLC | Results MSD and Ridgeback Biotherapeutics Provide Update on Results from MOVe-OUT Study of Molnupiravir, an Investigational Oral Antiviral Medicine, in At Risk Adults With Mild-to-Moderate COVID-19 msd.com ↗
Nine deaths were reported in the placebo group, and one in the molnupiravir group. |
| 2021-11-26 | Merck Sharp & Dohme LLC | Results Merck and Ridgeback Biotherapeutics Provide Update on Results from MOVe-OUT Study of Molnupiravir, an Investigational Oral Antiviral Medicine, in At Risk Adults With Mild-to-Moderate COVID-19 merck.com ↗
Nine deaths were reported in the placebo group, and one in the molnupiravir group. |
| 2021-11-04 | Merck Sharp & Dohme LLC | Regulatory MSD and Ridgeback’s Molnupiravir, an Oral COVID-19 Antiviral Medicine, Receives First Authorization in the World msd.com ↗ |
| 2021-11-04 | Merck Sharp & Dohme LLC | Regulatory Merck and Ridgeback’s Molnupiravir, an Oral COVID-19 Antiviral Medicine, Receives First Authorization in the World merck.com ↗
U.K.’s Medicines and Healthcare Products Regulatory Agency Authorizes Molnupiravir for the Treatment of Mild-to-Moderate COVID-19 in Adults With a Positive SARS-CoV-2 Diagnostic Test and Who Have at Least One Risk Factor for Developing Severe Illness |
| 2021-10-25 | Merck Sharp & Dohme LLC | Regulatory MSD and Ridgeback Announce Initiation of a Rolling Review by the European Medicines Agency for Molnupiravir, an Investigational Oral Antiviral Medicine, for the Treatment of COVID-19 in Adults msd.com ↗
MSD (NYSE:MRK), a trade name of Merck & Co., Inc, Kenilworth, NJ, USA, today announced that the European Medicines Agency (EMA) has initiated a rolling review for molnupiravir, an investigational oral antiviral medicine, for the treatment of COVID-19 in adults. |
| 2021-10-25 | Merck Sharp & Dohme LLC | Regulatory Merck and Ridgeback Announce Initiation of a Rolling Review by the European Medicines Agency for Molnupiravir, an Investigational Oral Antiviral Medicine, for the Treatment of COVID-19 in Adults merck.com ↗
Merck (NYSE: MRK), known as MSD outside the United States and Canada, and Ridgeback Biotherapeutics today announced that the European Medicines Agency (EMA) has initiated a rolling review for molnupiravir, an investigational oral antiviral medicine, for the treatment of COVID-19 in adults. |
| 2021-10-11 | Merck Sharp & Dohme LLC | Regulatory MSD and Ridgeback Announce Submission of Emergency Use Authorization Application to the U.S. FDA for Molnupiravir, an Investigational Oral Antiviral Medicine, for the Treatment of Mild-to-Moderate COVID-19 in At Risk Adults msd.com ↗
MSD (NYSE:MRK), a trade name of Merck & Co., Inc, Kenilworth, NJ, USA, today announced that MSD has submitted an Emergency Use Authorization (EUA) application to the U.S. Food and Drug Administration (FDA) for molnupiravir, an investigational oral antiviral medicine, for the treatment of mild-to-moderate COVID-19 in adults who are at risk for progressing to severe COVID-19 and/or hospitalization. |
| 2021-10-11 | Merck Sharp & Dohme LLC | Regulatory Merck and Ridgeback Announce Submission of Emergency Use Authorization Application to the U.S. FDA for Molnupiravir, an Investigational Oral Antiviral Medicine, for the Treatment of Mild-to-Moderate COVID-19 in At Risk Adults merck.com ↗
Merck (NYSE: MRK), known as MSD outside the United States and Canada, and Ridgeback Biotherapeutics today announced that Merck has submitted an Emergency Use Authorization (EUA) application to the U.S. Food and Drug Administration (FDA) for molnupiravir, an investigational oral antiviral medicine, for the treatment of mild-to-moderate COVID-19 in adults who are at risk for progressing to severe COVID-19 and/or hospitalization. |
| 2021-10-01 | Merck Sharp & Dohme LLC | Results MSD and Ridgeback’s Investigational Oral Antiviral Molnupiravir Reduced the Risk of Hospitalization or Death by Approximately 50 Percent Compared to Placebo for Patients with Mild or Moderate COVID-19 in Positive Interim Analysis of Phase 3 Study msd.com ↗
At the interim analysis, molnupiravir reduced the risk of hospitalization or death by approximately 50%; 7.3% of patients who received molnupiravir were either hospitalized or died through Day 29 following randomization (28/385), compared with 14.1% of placebo-treated patients (53/377); p=0.0012. |
| 2021-10-01 | Merck Sharp & Dohme LLC | Results Merck and Ridgeback’s Investigational Oral Antiviral Molnupiravir Reduced the Risk of Hospitalization or Death by Approximately 50 Percent Compared to Placebo for Patients with Mild or Moderate COVID-19 in Positive Interim Analysis of Phase 3 Study merck.com ↗
At the Interim Analysis, 7.3 Percent of Patients Who Received Molnupiravir Were Hospitalized Through Day 29, Compared With 14.1 Percent of Placebo-Treated Patients Who were Hospitalized or Died |
| 2021-07-09 | Merck Sharp & Dohme LLC | Results MSD Statement on Clinical Data for Molnupiravir Generated by Hetero in India msd.com ↗
One of these generics manufacturers, Hetero, has announced that it has accumulated positive data from an open label clinical study of molnupiravir and has submitted these data to the Drug Controller General of India (DCGI). |
| 2021-04-15 | Merck Sharp & Dohme LLC | Results MSD and Ridgeback Biotherapeutics Provide Update on Progress of Clinical Development Program for Molnupiravir, an Investigational Oral Therapeutic for the Treatment of Mild-to-Moderate COVID-19 msd.com ↗
Data from MOVe-IN indicate that molnupiravir is unlikely to demonstrate a clinical benefit in hospitalized patients, who generally had a longer duration of symptoms prior to study entry; therefore, the decision has been made not to proceed to Phase 3. |
| 2021-04-15 | Merck Sharp & Dohme LLC | Results Merck and Ridgeback Biotherapeutics Provide Update on Progress of Clinical Development Program for Molnupiravir, an Investigational Oral Therapeutic for the Treatment of Mild-to-Moderate COVID-19 merck.com ↗
Data from MOVe-IN indicate that molnupiravir is unlikely to demonstrate a clinical benefit in hospitalized patients, who generally had a longer duration of symptoms prior to study entry; therefore, the decision has been made not to proceed to Phase 3. |
| 2021-03-06 | Merck Sharp & Dohme LLC | Results Ridgeback Biotherapeutics and Merck Announce Preliminary Findings from a Phase 2a Trial of Investigational COVID-19 Therapeutic Molnupiravir merck.com ↗
These preliminary findings were presented today during Science Spotlights TM at the 2021 Conference on Retroviruses and Opportunistic Infections (CROI 2021). |
All press releases naming this drug 52 releases
Evidence & citations 8 cited values
Every value below carries the sentence it was read from. 27 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Molnupiravir | “Molnupiravir (MK-4482)” NCT05271929 ↗ |
| Known as | EIDD-1931 ISOPROPYL ESTER | ChEMBL registry synonym — accepted as the source's own label CHEMBL4650320 ↗ |
| Known as | EIDD-2801 | “This was a phase IIa, double-blind, placebo-controlled, randomized trial, designed to compare the safety, tolerability, and antiviral activity of EIDD-2801 (molnupiravir)...” NCT04405570 ↗ |
| Known as | Esperavir | “Molnupiravir (Esperavir)” NCT05595824 ↗ |
| Known as | MK-4482 | “Efficacy and Safety of Molnupiravir (MK-4482) in Hospitalized Adult Participants With COVID-19 (MK-4482-001)” NCT04575584 ↗ |
| Action | Inhibit | “an orally efficacious ribonucleoside analogue inhibitor of influenza viruses” PMID 33273742 ↗ Dec 2020 |
| Modality | Small molecule | “Molnupiravir is an orally administered, small-molecule ribonucleoside prodrug shown to inhibit replication of severe acute respiratory syndrome coronavirus 2” PMID 38319179 ↗ Dec 2021 |
| Route | Oral | “oral antivirals” PMID 40383127 ↗ May 2025 |