Ananda Pharma has cleared the ultimate regulatory hurdle wanted to start its ENDOCAN Part 2 scientific trial, receiving approval from the MHRA and NHS Well being Analysis Authority to begin dosing of its proprietary MRX1 CBD oral answer in ladies with endometriosis-associated ache.
The milestone marks a major step ahead for a trial that has been in improvement for a number of years. The double-blind, placebo-controlled examine, led by international endometriosis specialists on the College of Edinburgh and funded by the Chief Scientist Workplace, will embody as much as 100 ladies throughout NHS Lothian and NHS Grampian in Scotland over a 12-week remedy interval.
Melissa Sturgess, CEO of Ananda Pharma, informed Enterprise of Hashish: “The explanation this examine is completely different is that we’re utilizing a product that would go right through to regulatory approval and be capable of be prescribed by a health care provider on the NHS.”
Years within the making
Ananda has been working in the direction of the Endocan trial since early 2023, when it acquired MRX Medical Restricted, the car for MRX1, for £2 million, with the College of Edinburgh trials already recognized as a goal software.
By February 2024, Ananda had signed a proper Drug Provide Settlement with the College of Edinburgh and NHS Lothian, securing not solely the framework for MRX1’s use in ENDOCAN but additionally full IP possession of the medication and an choice to licence any arising IP for industrial functions
Since then, Ananda spent the rest of 2024 and into 2025 finishing the steadiness testing and regulatory pharmaceutical necessities wanted earlier than it may start dosing people, work Sturgess described as important groundwork for any future MHRA licensing software.
Ethics approvals had been focused earlier than the tip 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 Part 1 pharmacokinetic examine, performed in Australia between July and October 2025 throughout 19 individuals. Preliminary information revealed in November 2025 confirmed MRX1 demonstrated a beneficial security profile, with all reported antagonistic occasions delicate and no discontinuations. The total scientific examine report is predicted in Q2 2026.
It’s that groundwork, round £1.5 million value of labor, that gave the corporate the arrogance to dose on the ranges ENDOCAN requires.
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The ENDOCAN trial
The trial is led by Dr Lucy Whitaker as Principal Investigator, alongside Professor Andrew Horne and Professor Phillipa Saunders of the College of Edinburgh, researchers whom Sturgess described as globally revered key opinion leaders in endometriosis.
The ENDOCAN trial stands aside from a lot of the prevailing analysis into CBD and endometriosis in a number of essential respects, Sturgess informed Enterprise of Hashish.
The examine is placebo-controlled and double-blind, a major methodological step up from the observational research which have dominated this house so far. Contributors shall be randomly allotted to both lively remedy or placebo.
Eligibility for the trial can also be strictly outlined. The individuals should have a confirmed endometriosis analysis by way of laparoscopy, the one globally accepted gold customary for the situation, somewhat than merely presenting with pelvic ache.
Sturgess mentioned this distinction is prime to the trial’s regulatory potential. “The label on a bottle will say, take X quantity of this for the remedy of ache related to endometriosis. So for the regulator to approve a drug, it might’t simply be random ache, it must be related to a situation.”
These on the lively arm could have their dose of MRX1 escalated over the 12 weeks, reaching as excessive as 12.5mg per kilogram of physique weight per day, equal to round 875mg of CBD day by day for a 70kg lady. To place that in context, the UK Meals Requirements Authority recommends a most day by day dose of simply 10mg for over-the-counter CBD merchandise.
“We’re speaking about dosing 80 occasions increased than the Meals Requirements Authority permits,” Sturgess continued. That stage of dosing is made doable by MRX1’s formulation, which is successfully THC-free.
“You may give a lady 870 milligrams of CBD a day with out having to fret about how a lot THC she’s getting, which suggests there’s no danger of intoxication,” Sturgess defined.
The trial can even transcend quality-of-life measures. Blood and serum samples shall be taken 3 times in the course of the examine and analysed for inflammatory markers, giving researchers a biochemical window into whether or not MRX1 is producing measurable modifications within the physique. All patient-reported final result measures will use validated questionnaires already accepted by the MHRA and FDA for regulatory approval trials.
The trial’s high-dose design can also have secondary implications past endometriosis. The FSA’s 10mg day by day restrict for over-the-counter CBD has lengthy been contested by trade, with regulators citing an absence of strong scientific security information at increased doses as a key justification.
Whereas the ENDOCAN trial will not be designed to handle that query immediately, the protection information generated, together with antagonistic occasion monitoring all through the programme and blood evaluation at three factors, may contribute meaningfully to the proof base.
A lot-needed scientific trials
The approval additionally arrives at a notable second in Ananda’s broader scientific story. In September 2025, the corporate was formally notified by UCL that its formulation was not required for the government-backed epilepsy trials at UCL and Nice Ormond Road Hospital, trials that had been in planning since way back to 2019 and had been introduced in October 2024.
The acknowledged motive was that Ananda’s manufacturing contractor had failed to fulfill its obligations, although Sturgess informed Enterprise of Hashish that the corporate was given little additional clarification. “We had been merely knowledgeable that our formulation was not required. We simply by no means heard something after that,” she mentioned.
Sturgess added that she intends to inform the UCL group of the ENDOCAN approval, noting that the MRX1 formulation now heading into the endometriosis trial is near-identical to the one which was dropped.
For Ananda, ENDOCAN is one in every of two Part 2 randomised managed trials now underway on the College 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 analysis group in place, and years of preparatory work behind it, ENDOCAN represents an actual likelihood to see the primary cannabis-based remedy since GW-Pharma to be made out there on the NHS.
