Lagevrio (molnupiravir) is a direct-acting oral, broad-spectrum antiviral agent in clinical development as a treatment for COVID-19. Ridgeback has completed Phase 1 and Phase 2 studies. The program has advanced into Phase 3 development as a therapeutic for COVID-19 and Lagevrio was found to significantly reduce the risk of hospitalization or death in an interim analysis of the Phase 3 MOVe-OUT trial. In December 2021, the U.S. Food and Drug Administration granted Emergency Use Authorization for Lagevrio to treat mild to moderate COVID-19 in adults who are at high risk for progression to severe COVID-19.
Administered as an oral capsule, Lagevrio has also shown activity in animal models of Ebola, Equine Encephalitis (VEEV and EEEV), Influenza (seasonal, pandemic and avian), and Respiratory Syncytial Virus.
Lagevrio is being developed under a collaboration agreement with Merck (known as MSD outside the U.S. and Canada).
- Press Release / HHS 10.27.2023
- Press Release / HHS – ASPR 09.29.2023
- Media / Bloomberg 09.21.2023
(molnupiravir; MK-4482; EIDD-2801)
* Partnered with Merck
** The U.S. FDA has granted EUA for Lagevrio (molnupiravir)
Ridgeback would like to acknowledge and thank our collaborators on the Lagevrio (molnupiravir; EIDD-2801) development program:
Lagevrio (molnupiravir) Timeline
Dr. George Painter’s lab at DRIVE (Drug Innovation Ventures at Emory) starts screening targets for active pharmaceutical agents against pandemic threats.
Dr. George Painter, CEO of DRIVE, and Wendy Holman, CEO of Ridgeback Biotherapeutics, meet to discuss Ridgeback licensing Lagevrio from DRIVE.
DRIVE files an Investigational New Drug (IND) application with the FDA to study Lagevrio in seasonal flu.
Ridgeback and DRIVE sign definitive agreement for a license and collaboration to develop Lagevrio.
Ridgeback in collaboration with DRIVE commences planning and implementation of large-scale manufacturing of Lagevrio, onboards staff of external experts and DRIVE consultants and plans a phase 1 clinical trial to support an expedited path to COVID-19 development.
Ridgeback files Investigational New Drug (IND) application with the FDA to study Lagevrio in COVID-19. Ridgeback files application with UK’s MHRA to study Lagevrio in COVID-19.
Ridgeback begins Phase 1 clinical trials – single ascending dose, multiple ascending dose and fed/fasted studies of Lagevrio.
Ridgeback begins manufacturing run of Lagevrio.
Ridgeback initiates Phase II trial evaluating Lagevrio in patients with COVID-19 in the outpatient setting (2003 study).
Ridgeback initiates second and third manufacturing run of Lagevrio.
Ridgeback and Merck finalize partnership agreement for Lagevrio.
Ridgeback initiates Phase II trial evaluating Lagevrio in patients with COVID-19 in the inpatient setting (2004 study).
Ridgeback and the AGILE Clinical Trials Platform announce initiation of the AGILE study which evaluates the treatment effect of Lagevrio in patients with COVID-19 in the outpatient setting in the United Kingdom.
Merck and Ridgeback Biotherapeutics announce initiation of Pivotal Phase 2/3 MOVe-OUT and MOVe-IN studies evaluating Lagevrio in patients with COVID-19 both in the hospital and out of the hospital setting.
Merck and Ridgeback Biotherapeutics announce initiation of pivotal phase 3 MOVe-AHEAD study evaluating Lagevrio for post-exposure prophylaxis of COVID-19 infection.
Merck and Ridgeback Biotherapeutics announce Lagevrio significantly reduced the risk of hospitalization or death in an interim analysis of the Phase 3 MOVe-OUT trial, and that recruitment into the study is being stopped early due to these positive results, at the recommendation of an independent Data Monitoring Committee and in consultation with the FDA.
The United Kingdom Medicines and Healthcare products Regulatory Agency (MHRA) granted authorization in the United Kingdom for Lagevrio.
The U.S. Food and Drug Administration granted Emergency Use Authorization for Lagevrio to treat mild to moderate COVID-19 in adults with positive results of direct SARS-CoV-2 viral testing, and who are at high risk for progression to severe COVID-19, including hospitalization or death, and for whom alternative COVID-19 treatment options authorized by the FDA are not accessible or clinically appropriate.
Authorizations for Lagevrio are proceeding in a number of countries worldwide.