Ananda Pharma Confirms Safety of CBD Drug, as Clinical Pain Trials Approach

Ananda Pharma has taken another major step forward in bringing its flagship MRX1 CBD oral solution to market.

Today (June 17), Ananda published the full clinical study report from its Phase I pharmacokinetic trial of its proprietary MRX1 compound, confirming all objectives were met, a clean safety profile across 20 participants, and support for the FDA’s 505(b)(2) development pathway.

Its publication formally closes out the preparatory phase of the MRX1 programme, with Phase II dosing across both trials on track for the second half of 2026.

Clean data

Ananda first dosed participants with MRX1 as part of the Phase I trials in Australia in July 2025, through a trial conducted in partnership with clinical research organisation Southern Star Research. Initial safety data published in November 2025 showed no serious adverse events, and this final report expands on the findings.

Across 20 participants who received at least one dose, all treatment-emergent adverse events were mild (Grade 1). No moderate or severe events, serious adverse events, or discontinuations were recorded.

There were no deaths and no clinically significant changes in liver function, a safety signal regulators examine closely when evaluating high-dose CBD therapies. Ananda described the profile as consistent with the established safety record of CBD-based medicines.

The trial assessed MRX1 at 2.5 mg/kg and 7.5 mg/kg, administered twice daily over six days, with fed and fasted conditions evaluated at the lower dose.

The pharmacokinetic data gathered will support regulatory submissions in the UK, US and EU, and Ananda has confirmed the completed report underpins its application through the FDA 505(b)(2) pathway, which allows developers to build on existing safety data from approved drugs rather than pursuing a full de-novo submission.

Ananda’s CEO, Melissa Sturgess, said in a press release: “This is an important achievement for Ananda and puts us in a strong position as we move into dosing patients in the forthcoming ENDOCAN and ACTION Phase 2 clinical trials.”

The Phase I trial was conducted through the company’s local subsidiary, making the expenditure eligible for Australia’s 43.5% refundable R&D tax rebate. Ananda received an initial repayment of AUD340,166 in November 2025, with a further AUD500,000 expected in the third quarter of 2026, non-dilutive funding that extends the company’s runway without further equity issuance.

Beyond MRX1

MRX1 is one of three drug candidates Ananda has developed, though it is now the sole focus of the company’s clinical programme. The two other formulations, MRX2 and MRX2T, were developed for government-backed epilepsy trials at University College London and Great Ormond Street Hospital, trials announced in October 2024 and co-funded by the NIHR and NHS.

In September 2025, Ananda was formally notified by UCL that its formulation was no longer required, after the company’s manufacturing contractor failed to meet its obligations. The trials are expected to continue with an alternative supplier, but Ananda has no further involvement.

The pivot leaves MRX1 carrying the full weight of the company’s clinical ambitions, and gives extra significance to this latest milestone as a gateway to Phase II clinical trials.

Ananda is now in the final stages of preparation for two randomised controlled trials at the University of Edinburgh, both funded by the NHS and government bodies.

The ENDOCAN trial, which received MHRA and NHS Health Research Authority approval to commence dosing in March 2026, will evaluate MRX1 in up to 100 women with endometriosis-associated pain across NHS Lothian and NHS Grampian, funded by the Chief Scientist Office.

The ACTION trial, funded by the National Institute for Health and Care Research, is investigating MRX1 for chemotherapy-induced peripheral neuropathy. Both trials have the University of Edinburgh‘s research team as principal investigators, with Dr Lucy Whitaker leading ENDOCAN alongside Professors Andrew Horne and Phillipa Saunders. Dosing across both programmes remains on track for the second half of 2026.