ANANDA PHARMA LTD ("Ananda" or the "Company") : MHRA and NHS Ethics Approval Received for ENDOCAN Phase 2 Clinical Trial for Endometriosis

LONDON, March 4, 2026 /PRNewswire/ -- Ananda Pharma, a UK-based biopharmaceutical company developing regulatory approved cannabidiol medicines to treat complex, chronic conditions, is pleased to announce that NHS Health Research Authority (HRA) and MHRA approval have been received for the ENDOCAN Phase 2 clinical trial investigating the safety and efficacy of its proprietary MRX1 CBD oral solution, for the management of endometriosis-associated pain.

https://investors.anandapharma.co.uk/link/7eXB3PThe Phase 2 trial, led by Dr Lucy Whitaker as Principal Investigator, Prof Andrew Horne and Prof Phillipa Saunders of The University of Edinburgh and funded by the Chief Scientist Office, is a double-blind, placebo controlled pilot study to assess the effectiveness of MRX1 CBD oral solution to alleviate pain and improve quality of life for women with endometriosis. The study will randomise up to 100 women diagnosed with endometriosis over a treatment period of 12 weeks. The trial will be conducted through NHS Lothian and NHS Grampian in Scotland.

Endometriosis is a chronic condition affecting ~190 million women. It is defined by the presence of endometrial-like tissue outside the uterus ('lesions'), commonly within the pelvis. Endometriosis costs the UK ~£8.2 billion per year in NHS costs and lost income. The cost of endometriosis in the US is estimated at more than $100 billion per year when taking into account treatment, lost productivity and wider family and societal costs. Current treatment options include surgical excision of the lesions, treatment with hormone suppressing drugs, various analgesics and anti depressants. These treatments are often ineffective and come with harmful side effects.  Symptoms recur within five years following surgery in 40-50% of women. There is an urgent unmet need for new medical treatments for endometriosis and optimal treatment for endometriosis was a key strategic priority of the 2021 Scottish Government's Women's Health Plan.

The dosing in this trial will go as high as 12.5mg/kg/day of CBD which for a 70kg woman would be 875mg of CBD per day.  For comparison, the UK Food Standards Authority recommends a maximum daily dose of 10mg per person and other clinical trials investigating CBD for the treatment of endometriosis pain considered much lower doses.  It is important to note that MRX1 CBD oral solution is effectively THC free meaning it can be dosed at high levels without concerns of intoxication.

Approval from the MHRA and HRA Ethics Committee is a key regulatory milestone, enabling the trial to proceed to patient recruitment and site initiation activities. Further updates will be provided as the study progresses.

Ananda's CEO, Melissa Sturgess commented: "The personal and societal burden of endometriosis is staggering and it is appalling that more is not being done to find useful treatments for this debilitating condition.  We are determined to be part of finding a solution to this area of extreme unmet need in women's health.

Many women use CBD to help manage their endometriosis pain symptoms: we need to know how much CBD is needed, in a standardised regulatory approved solution, to enable prescribing by a specialist as part of a woman's health care plan. We also need this treatment to be cost effective and available to every woman who needs it. 

We are honoured to be working with global endometriosis key opinion leaders at The University of Edinburgh and I am beyond proud of our small and mighty team which now has 3 in-human clinical trials to its name."

About Ananda Pharma

Ananda Pharma is a UK-based biopharmaceutical company providing its cannabidiol formulation, MRX1, to two Phase 2 clinical trials, The ENDOCAN trial, MRX1 for  endometriosis pain (funded by NHS Scotland) and the ACTION trial MRX1 for CIPN (chemotherapy induced peripheral neuropathy)(funded by an NIHR EME grant) . The Company is led by successful entrepreneurs and is working with a team of world-class scientists, including globally respected Key Opinion Leaders at the University of Edinburgh.

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