Ananda Pharma Publishes Clean Phase I Safety Data for MRX1 CBD Oral Solution, Paving Way for Phase II Pain Trials
核心洞察
Ananda Pharma (搜索) published the full Phase I clinical study report for its proprietary MRX1 CBD oral solution, confirming all objectives were met with a clean safety profile across 20 participants.
All treatment-emergent adverse events were mild (Grade 1), with no moderate or severe events, no serious adverse events, no discontinuations, and no clinically significant liver function changes.
The completed report supports regulatory submissions in the UK, US, and EU via the FDA 505(b)(2) pathway, which leverages existing safety data from approved drugs.
Ananda Pharma (搜索) has published the full clinical study report from its Phase I pharmacokinetic trial of MRX1, a proprietary cannabidiol (CBD) oral solution, confirming a clean safety profile and meeting all study objectives. The milestone, announced June 17, formally closes the preparatory phase of the MRX1 programme and positions the company to begin dosing patients in two Phase II pain trials during the second half of 2026.
The Phase I trial, conducted in Australia in partnership with clinical research organisation Southern Star Research (搜索), first dosed participants in July 2025. Initial safety data released in November 2025 indicated no serious adverse events, and the final report now provides a comprehensive account of those findings.
Safety and Pharmacokinetic Findings
Across all 20 participants who received at least one dose of MRX1, every treatment-emergent adverse event was classified as mild (Grade 1). The trial recorded no moderate or severe events, no serious adverse events, and no participant discontinuations. There were no deaths, and investigators observed no clinically significant changes in liver function — a safety signal that regulators scrutinise closely when evaluating high-dose CBD therapies.
Ananda described the safety profile as consistent with the established safety record of CBD-based medicines. The trial assessed MRX1 at two dose levels — 2.5 mg/kg and 7.5 mg/kg — administered twice daily over a six-day period, with fed and fasted conditions evaluated at the lower dose.
The pharmacokinetic data gathered will support regulatory submissions in the United Kingdom, United States, and European Union. Ananda confirmed that the completed report underpins its application through the FDA 505(b)(2) development pathway, a regulatory route that allows developers to build on existing safety data from approved drugs rather than pursuing a full de-novo submission.
“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,” said Melissa Sturgess, CEO of Ananda Pharma (搜索), in a press release.
Financial and Operational Context
The Phase I trial was conducted through Ananda's local Australian subsidiary, making the expenditure eligible for the country's 43.5% refundable R&D tax rebate. The company received an initial repayment of AUD 340,166 in November 2025, with a further AUD 500,000 expected in the third quarter of 2026 — non-dilutive funding that extends the company's operational runway without requiring additional equity issuance.
Strategic Focus on MRX1
MRX1 is now the sole focus of Ananda's clinical programme. The company had previously developed two other formulations, MRX2 and MRX2T, 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. However, in September 2025, UCL formally notified Ananda that its formulation was no longer required after the company's manufacturing contractor failed to meet its obligations. Those epilepsy trials are expected to continue with an alternative supplier, leaving Ananda with no further involvement.
This strategic pivot places the full weight of Ananda's clinical ambitions on MRX1, lending additional significance to the completed Phase I report as the gateway to late-stage development.
Upcoming Phase II 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 (搜索)-associated pain across NHS Lothian and NHS Grampian. The trial is funded by the Chief Scientist Office. Details of the second trial, referred to as ACTION, have been referenced alongside ENDOCAN as part of the company's Phase II programme, with both trials on track for dosing in the second half of 2026.