The Medicines and Healthcare products Regulatory Agency (MHRA) recognises the risks associated with the promotion and sale of ivermectin and other unauthorised or unproven products as treatments for cancer. Ivermectin is not authorised in the United Kingdom for the treatment or prevention of cancer, and claims that it can treat, prevent or cure cancer may mislead patients and risk them delaying or foregoing proven medical treatment.

The MHRA takes robust enforcement action against the illegal promotion, advertising and supply of unauthorised medicines, including online. Through its Criminal Enforcement Unit, the MHRA investigates suspected breaches of the Human Medicines Regulations 2012, and has the power to seize illicit medicines and, where appropriate, pursue prosecution.

Ivermectin has been a controversial drug throughout the pandemic, with many clinicians prescribing globally with no clear evidence to demonstrate there is a benefit. Taking this into consideration and the need to generate evidence on ivermectin’s efficacy in the treatment for COVID-19, the PRINCIPLE trial investigators determined that its inclusion would provide further information. Many of the outcomes of clinical trials, such as RECOVERY, have shown that such treatments are ineffective, which informs our understanding.

Should the ivermectin arm of the PRINCIPLE trial produce positive outcomes, an application may be submitted to the Medicines and Healthcare products Regulatory Agency (MHRA). The MHRA must assess the company’s compliance with Human Medicines Regulation requirements, including pre-clinical and clinical trials, manufacturing and pharmacovigilance legislation requirements and the manufacture of a product to determine its safety, quality, or efficacy, including input from the Commission on Human Medicines. A marketing authorisation application for the license of a medicinal product must be submitted by a legal entity registered with Companies House, as holding a marketing authorisation includes legal responsibilities.

Ivermectin was entered into the PRINCIPLE clinical trial in the United Kingdom in June 2021. The trial aims to generate robust evidence to determine its effectiveness as a treatment against COVID-19.

To date, there is no conclusive evidence for the efficacy of ivermectin in treating and preventing COVID-19, as there have been no supportive randomised control trials in the United Kingdom. The United States Food and Drug Administration (FDA), the European Medicines Agency and the World Health Organization have concluded that the evidence in support of ivermectin as a COVID-19 treatment is insufficient to warrant a marketing authorisation. The FDA has issued warnings against the use of ivermectin whilst it remains in trials, as it can have dangerous interactions with other medicines. Currently, there is no firm deadline set for the publication of trial results. However, the Therapeutics Taskforce continues to monitor any emerging evidence for ivermectin’s use as a treatment for COVID-19.

For a product to be granted a licensing authorisation, a company must apply to the Medicines and Healthcare products Regulatory Agency (MHRA) for authorisation. The MHRA has not received an application for use of Ivermectin in the treatment of patients with COVID-19. If received, the application will undergo a safety, efficacy and quality review, including consultation with Commission on Human Medicines.

Ivermectin was entered into the large-scale PRINCIPLE clinical trial in the United Kingdom in June 2021. To date, there is no conclusive evidence for efficacy of Ivermectin in treating and preventing COVID-19, as there are no supportive randomised control trials. Currently, there is no firm deadline set for the publication of trial results. However, the Therapeutics Taskforce continues to monitor any emerging evidence for ivermectin’s use as a treatment for COVID-19.

Evidence from clinical trials of ivermectin as a treatment for COVID-19 is inconclusive at this stage. We will continue to monitor the data from clinical trials continuing worldwide, including the Government-funded PRINCIPLE trial, to expand the evidence base for ivermectin. We recognise the need to make treatments for COVID-19 available to patients once proven as safe and effective. The RAPID-C19 group was established to accelerate the process between the completion of clinical trials and patient access. Ivermectin will be considered for marketing authorisation in the United Kingdom as a treatment for COVID-19 should an application be received from a manufacturer.

The Therapeutics Taskforce is monitoring data from clinical trials taking place worldwide to assess whether ivermectin is a safe and effective treatment for COVID-19. Ivermectin is not currently a licensed treatment for COVID-19 and evidence from clinical trials as a treatment for COVID-19 is inconclusive. This assessment is based on the views of the Therapeutics Taskforce, the UK COVID-19 Therapeutics Advisory Panel and the Research to access pathway for investigational drugs for COVID-19. This assessment is also consistent with the views of the World Health Organization, the Food and Drug Administration and the European Medicines Agency. We will continue to keep this assessment under review as more data becomes available from clinical trials, including the Government-funded PRINCIPLE clinical trial.

Protease inhibitors have an important role in the treatment of COVID-19. Therefore, the United Kingdom recently secured 250,000 patient courses of the Pfizer PAXLOVID protease inhibitor, as well as 480,000 patient courses of Merck Sharp Dohme’s polymerase inhibitor Lagevrio. Evidence for ivermectin as a treatment of COVID-19 is inconclusive at this stage. However, the Therapeutic Taskforce continues to monitor any emerging evidence for ivermectin as a COVID-19 treatment from clinical trials worldwide. This includes clinical trials considering ivermectin’s potential application as a protease inhibitor.

The Department continues to monitor any new evidence for ivermectin as a treatment for COVID-19. While we are aware that although some clinical trials have shown positive signals for the potential efficacy of ivermectin, there are no supportive randomised control trials and insufficient evidence to support use for COVID-19. Results from the PRINCIPLE clinical trial platform, launched in June, are expected in early 2022 and we will monitor data from worldwide clinical trials on the efficacy of ivermectin.

Ivermectin is not a licensed treatment for COVID-19 and evidence from clinical trials of ivermectin as a treatment for COVID-19 is inconclusive at this stage. We have included ivermectin in the United Kingdom (UK) Government funded PRINCIPLE clinical trial to help generate conclusive data on its effectiveness in treating patients with COVID-19 who have not been hospitalised. We will continue to monitor the data from this trial and other trials completed worldwide, to expand the evidence base for Ivermectin. There are no plans to permit healthcare professionals to supply Ivermectin to UK patients for treatment of COVID-19 unless the Medicines and Healthcare products Regulatory Agency approves ivermectin as a licensed treatment for COVID-19 in future.

The Department continues to closely monitor the evidence on ivermectin as a treatment for COVID-19 from clinical trials taking place worldwide. On 23 June 2021, ivermectin was entered into the University of Oxford’s United Kingdom PRINCIPLE clinical trial as a potential treatment for COVID-19 in the community. We await the outcome from this trial early next year.

The Department is closely monitoring the evidence on the case for using ivermectin for the treatment and prevention of COVID-19. Licensing of ivermectin is dependent on application to the Medicines and Healthcare products Regulatory Agency for authorisation. We are continuing to monitor for new data from trials worldwide, including the UK PRINCIPLE clinical trial platform, which announced on 23 June that ivermectin would be investigated to generate robust data on its effectiveness in treating adults aged 18 years old and over who are at higher risk of serious illness from COVID-19.

On 23 June, the PRINCIPLE clinical trial platform in the United Kingdom announced that ivermectin would be investigated to generate robust data on its effectiveness in treating adults aged 18 years old and over with mild COVID-19 who are at higher risk of developing serious illness. We will closely monitor the data from this trial, as well as emerging clinical trials worldwide to expand our evidence-base on the efficacy of ivermectin in treating COVID-19.

The Department is closely monitoring the evidence on the case for ivermectin as a treatment for COVID-19. On 23 June, the PRINCIPLE clinical trial platform announced that ivermectin would be investigated to generate robust data on its effectiveness in treating adults aged 18 years old and over who are at higher risk of serious illness from COVID-19. We will closely monitor the data from this trial, as well as emerging clinical trials worldwide to expand our evidence-base on the efficacy of ivermectin. We expect that data will become available from trials throughout 2021 and 2022 and will be reviewed by the Medicines and Healthcare products Regulatory Agency.

The Department is closely monitoring the evidence on the case for ivermectin as a treatment for COVID-19. On 23 June, the PRINCIPLE clinical trial platform announced that ivermectin would be investigated to generate robust data on its effectiveness in treating adults aged 18 years old and over who are at higher risk of serious illness from COVID-19. We will closely monitor the data from this trial, as well as emerging evidence from the large number of clinical trials worldwide to expand our evidence-base on the efficacy of ivermectin.

The Department has been closely monitoring the evidence on the case for ivermectin as a treatment for COVID-19. A recent collection of small studies show some positive indications that ivermectin may act as a treatment for COVID-19. However, further high quality, larger-scale studies are still needed to confirm the safety and efficacy of this treatment. We will continue to closely monitor the data from further emerging clinical trials worldwide to expand our evidence-base on the efficacy of ivermectin in treating COVID-19.

The Department is closely monitoring the evidence on the use of ivermectin as a treatment for COVID-19. A recent collection of small studies show some positive indications. However, further high quality, larger-scale studies are still needed to confirm the efficacy of this treatment. The Therapeutics Taskforce will keep the position on ivermectin under review as more data becomes available.

Currently, ivermectin for oral use is not a licensed human medicine in the United Kingdom. The Medicines and Healthcare products Regulatory Agency is aware that ivermectin, administered orally, is being studied for safety and efficacy in numerous clinical trials worldwide, including in the UK. While some studies have reported findings, other large studies are still on-going.

The Department continues to monitor evidence on the use of ivermectin both as a prophylactic and treatment for COVID-19. A recent collection of small studies shows some positive indications that ivermectin may act as a treatment for COVID-19. However, further high quality, larger-scale studies are still needed to confirm the safety and efficacy of this treatment. The Therapeutics Taskforce will keep the position on ivermectin under review as more data becomes available.

Currently, ivermectin for oral use is not a licensed human medicine in the United Kingdom. For ivermectin to be granted a marketing authorisation in the UK, an application must be submitted to the Medicines and Healthcare products Regulatory Agency (MHRA) for review. The MHRA has processes in place to expedite such an application, and assess this for quality, efficacy and safety.

The MHRA is aware that ivermectin, administered orally, is being studied for safety and efficacy in numerous clinical trials worldwide and is used in some countries in the treatment of COVID-19. While some studies have reported findings, other large studies are still on-going.