Ananda Pharma has cleared the final regulatory hurdle needed to begin its ENDOCAN Phase 2 clinical trial, receiving approval from the MHRA and NHS Health Research Authority to commence dosing of its proprietary MRX1 CBD oral solution in women with endometriosis-associated pain.
The milestone marks a significant step forward for a trial that has been in development for several years. The double-blind, placebo-controlled study, led by global endometriosis experts at the University of Edinburgh and funded by the Chief Scientist Office, will include up to 100 women across NHS Lothian and NHS Grampian in Scotland over a 12-week treatment period.
Melissa Sturgess, CEO of Ananda Pharma, told our sister publication, Business of Cannabis: “The reason this study is different is that we are using a product that could go all the way through to regulatory approval and be able to be prescribed by a doctor on the NHS.”
Years in the making
Ananda has been working towards the Endocan trial since early 2023, when it acquired MRX Medical Limited, the vehicle for MRX1, for £2 million, with the University of Edinburgh trials already identified as a target application.
By February 2024, Ananda had signed a formal Drug Supply Agreement with the University of Edinburgh and NHS Lothian, securing not only the framework for MRX1’s use in ENDOCAN but also full IP ownership of the medicine and an option to licence any arising IP for commercial purposes
Since then, Ananda spent the remainder of 2024 and into 2025 completing the stability testing and regulatory pharmaceutical requirements needed before it could begin dosing humans, work Sturgess described as essential groundwork for any future MHRA licensing application.
Ethics approvals were targeted before the end of 2025, with recruitment pencilled in for Q1 2026. This week’s announcement confirms that schedule has been met.
Underpinning the trial is Ananda’s Phase 1 pharmacokinetic study, conducted in Australia between July and October 2025 across 19 participants. Initial data published in November 2025 showed MRX1 demonstrated a favourable safety profile, with all reported adverse events mild and no discontinuations. The full clinical study report is expected in Q2 2026.
It is that groundwork, around £1.5 million worth of work, that gave the company the confidence to dose at the levels ENDOCAN requires.
The ENDOCAN trial
The trial is led by Dr Lucy Whitaker as Principal Investigator, alongside Professor Andrew Horne and Professor Phillipa Saunders of the University of Edinburgh, researchers Sturgess described as globally respected key opinion leaders in endometriosis.
The ENDOCAN trial stands apart from much of the existing research into CBD and endometriosis in several important respects, Sturgess told Business of Cannabis.
The study is placebo-controlled and double-blind, a significant methodological step up from the observational studies that have dominated this space to date. Participants will be randomly allocated to either active treatment or placebo.
Eligibility for the trial is also strictly defined. The participants must have a confirmed endometriosis diagnosis via laparoscopy, the only globally accepted gold standard for the condition, rather than simply presenting with pelvic pain.
Sturgess said this distinction is fundamental to the trial’s regulatory potential. “The label on a bottle will say, take X amount of this for the treatment of pain associated with endometriosis. So for the regulator to approve a drug, it can’t just be random pain, it needs to be associated with a condition.”
Those on the active arm will have their dose of MRX1 escalated over the 12 weeks, reaching as high as 12.5mg per kilogram of body weight per day, equivalent to around 875mg of CBD daily for a 70kg woman. To put that in context, the UK Food Standards Authority recommends a maximum daily dose of just 10mg for over-the-counter CBD products.
“We’re talking about dosing 80 times higher than the Food Standards Authority allows,” Sturgess continued. That level of dosing is made possible by MRX1’s formulation, which is effectively THC-free.
“You can give a woman 870 milligrams of CBD a day without having to worry about how much THC she’s getting, which means there’s no risk of intoxication,” Sturgess explained.
The trial will also go beyond quality-of-life measures. Blood and serum samples will be taken three times during the study and analysed for inflammatory markers, giving researchers a biochemical window into whether MRX1 is producing measurable changes in the body. All patient-reported outcome measures will use validated questionnaires already accepted by the MHRA and FDA for regulatory approval trials.
The trial’s high-dose design may also have secondary implications beyond endometriosis. The FSA’s 10mg daily limit for over-the-counter CBD has long been contested by industry, with regulators citing a lack of robust clinical safety data at higher doses as a key justification.
While the ENDOCAN trial is not designed to address that question directly, the safety data generated, including adverse event monitoring throughout the programme and blood analysis at three points, could contribute meaningfully to the evidence base.
Much-needed clinical trials
The approval also arrives at a notable moment in Ananda’s broader clinical story. In September 2025, the company was formally notified by UCL that its formulation was no longer required for the government-backed epilepsy trials at UCL and Great Ormond Street Hospital, trials that had been in planning since as far back as 2019 and were announced in October 2024.
The stated reason was that Ananda’s manufacturing contractor had failed to meet its obligations, though Sturgess told Business of Cannabis that the company was given little further explanation. “We were simply informed that our formulation was no longer required. We just never heard anything after that,” she said.
Sturgess added that she intends to notify the UCL team of the ENDOCAN approval, noting that the MRX1 formulation now heading into the endometriosis trial is near-identical to the one that was dropped.
For Ananda, ENDOCAN is one of two Phase 2 randomised controlled trials now underway at the University of Edinburgh, alongside the ACTION trial investigating MRX1 for chemotherapy-induced peripheral neuropathy, which is funded by the NIHR.
With MHRA approval secured, a world-class research team in place, and years of preparatory work behind it, ENDOCAN represents a real chance to see the first cannabis-based treatment since GW-Pharma to be made available on the NHS.
This article was originally published by Business of Cannabis and is reprinted here with permission.
