Has molnupiravir (Lagevrio) passed clinical trials?

Lab technician wearing blue latex gloves and holing a sample tube labelled "Coronavirus"


If you’ve been keeping an eye on the COVID-19 news lately (and let’s be honest, it’s not easy to miss) you’ll have noticed that Lagevrio has been approved by the MHRA as a new treatment for Coronavirus.


So what makes Molnupiravir, the active ingredient in Lagevrio, different to the other COVID-19 medications that have been competing to make it to market?


How has it got here so quickly when other medications require years of testing?


We’ll be answering these questions and more today, so keep reading to find out more.



Has Molnupiravir been through clinical trials?


Molnupiravir has been through a long history of testing and clinical trials, even though it may seem that it’s been developed really quickly from the outside looking in.


It was first patented in 2018, when scientists were looking into it as a possible treatment for the flu, Ebola, and other coronaviruses.


When COVID-19 rocked the globe in 2020, scientists started searching for potential treatment and a natural starting point was looking at drugs they already had available for testing.


Since then Molupiravir has been through more testing and development with an aim of providing an oral medication for COVID-19 patients.


As oral medications (like tablets and capsules) can be taken by a patient with very little supervision, a treatment like this could be essential in relieving the pressure on healthcare services worldwide.



What stages of clinical trials has Lagevrio been through?


Lagevrio has been through Phase 3 of clinical trials, but these ended earlier than they usually would because of how urgently this medication would be needed by patients.


This early finish was approved by the FDA because the trials had reached a suitable stopping point and the results were looking good.


It’s a little unusual for clinical trials to end early, but it’s only happened because the FDA’s monitoring boards agreed it was necessary and that it wouldn’t be ethical to delay the production of this medication further, considering the global effects of the pandemic.


Lab technician wearing blue latex gloves and using a needle to test a blood sample


Has Lagevrio been approved by the MHRA?


Yes, Lagevrio has now been approved by the MHRA (the Medicines and Healthcare products Regulatory Agency) as a safe and effective medication for patients with mild to moderate cases of COVID-19.


They’ve taken into account the data from the clinical trials Molnupiravir have been through so far, which have shown that this medication could reduce the risk of hospitalisation and death in COVID patients by 50%!


This approval means that the UK is the first to approve this medication for Coronavirus, and hopefully, it will be of huge benefit to the NHS, as Lagevrio can be taken at home.



Has Lagevrio been approved by the FDA?


The FDA, also known as the Food and Drug Administration, is a US federal agency that is responsible for the control and regulation of food and medicines.


It’s similar to our MHRA, with the main difference being that it also deals with food.


The FDA has not approved Lagevrio or Molnupiravir at the time of writing, but Merck and Ridgeback have applied for an emergency use authorisation (EUA) that could see this medication approved in the US very soon.


Whether or not the FDA approves Lagevrio for use in the US won’t affect its use here in the UK, but it will be interesting to see what happens when the FDA meet to discuss this medication later this month.


Keep your eyes peeled folks, and we’ll update you here as soon as we know more.



Who is Merck?


Merck is a pharmaceutical company which is also known as MSD (Merck Sharp & Dohme) outside of the US and Canada, and they have been one of the driving forces behind the development and manufacture of Lagevrio.


Alongside a company called Ridgeback Biotherapeutics, they have put Molnupiravir through its paces, administering the testing and clinical trials needed to bring this medication to the public.


This whole process has been pretty quick, especially when you consider how slowly medication trials can run usually, but this is partially due to how urgently we need a medication like this, and the Emergency Use Authorisation that was granted during its development.


Lab technician wearing blue latex gloves and a lab coat signing a form


Why has Molnupiravir been approved for COVID-19 over other treatments?


Molnupiravir hasn’t been approved for COVID-19 instead of other oral medications — it’s just so happened that this medication got to the approval stage first.


It’s like a race, and just because Lagevrio got over the finishing line first in this case, it doesn’t mean others won’t be able to get there too.


Molnupiravir isn’t the first medication that has been approved for COVID-19, a medication called Ronapreve was approved by the MHRA in August, but the main difference is how the medications are used.


As Ronapreve needs to be given by injection or through a drip, it is currently only used in hospitals, on the other hand, Lagevrio is available in capsules that can be taken from home and could reduce the number of patients needing to be hospitalised in the first place.



What happens next?


Now that Lagevrio has been approved for use in COVID-19 patients, the next step is to actually do it!


The medication needs to be produced and rolled out to healthcare teams across the country so they can start to administer it to patients who need it most.


To begin with, Lagevrio will be used in COVID patients who have at least one risk factor for complications of the virus, for example, people who are obese, elderly, or have a condition like diabetes.


This will help to keep these patients out of the hospital so they can self-isolate more effectively while having the added bonus of reducing pressure on the NHS. All in all, it’s a very bright outlook!


Hand wearing a blue latex glove using red medicine capsules to spell out the word "COVID" on a white surface


Well, now you know exactly what’s going on with Lagevrio and a little more about the clinical testing that’s been going into this medication.


If you’ve been worried about whether this medication is safe, we hope that we’ve eased your worries a little bit.


The most important thing you need to know is that the MHRA has approved this medication and as they’re the experts, they’re the ones to listen to.


So watch this space and hopefully we’ll be seeing the effects of this medication really soon.


Laura Henderson - Medical Content Writer
James O'Loan - CEO & Superintendent Pharmacist
James O'Loan , CEO & Superintendent Pharmacist on 15 March 2023
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