Ananda Reports Clean Phase 1 Safety Data for CBD Pain Drug

Ananda Pharma has published the full results of an early-stage safety study of MRX1, its cannabidiol-based pain medicine, reporting that the drug was well tolerated in healthy volunteers and triggered no concerning changes in liver function. The company-issued clinical study report, released on June 17, 2026, closes out the preparatory phase of the program and clears the way for two pain trials due to begin in the second half of the year. What it does not do is show that the drug relieves pain; that question is still ahead.

What the safety study showed

The trial was a Phase 1 pharmacokinetic study run in Australia, the kind of first-in-human work designed to map how a drug moves through the body and whether healthy people tolerate it. Twenty adults — 10 men and 10 women, a deliberate split given known sex differences in how the body processes CBD — each received at least one dose. Ten took 2.5 mg/kg twice daily and ten took 7.5 mg/kg twice daily over six days; a subset also took a single dose alongside a high-fat meal to test whether food changes absorption.

Ananda reported that every treatment-related side effect was mild, with no moderate or severe events, no participants stopping the drug, and no deaths. It also reported no clinically significant changes in laboratory measures, including liver function. That last point carries more weight than it might first appear. High doses of CBD are known to raise liver enzymes in some patients — a signal regulators watch closely, and one documented in the labeling of Epidyolex, the cannabidiol medicine already approved for rare childhood epilepsies. Clean liver readings at a daily dose as high as 15 mg/kg are the kind of result that makes regulators comfortable letting a larger trial proceed. The company described the profile as consistent with the established record of approved CBD therapies.

A safety read-out, not an efficacy one

Here the methodological caveats matter. The study was open-label, meaning there was no placebo group and no blinding; it enrolled healthy volunteers rather than pain patients; it ran for days, not weeks; and it involved 20 people. Those features are normal and appropriate for a Phase 1 study, whose job is to establish safety, tolerability and dosing — not to measure whether a drug works. They also mean the data say nothing about whether MRX1 eases endometriosis pain or chemotherapy-related nerve pain, the two conditions Ananda is pursuing.

It is also worth being clear about the source. The findings come from Ananda’s own clinical study report, not from a peer-reviewed journal or an independent analysis. Companies routinely disclose their own trial data at this stage, but it means the results have not yet passed external scientific review. The company said the data will support regulatory filings in the UK, US and EU, and underpin its planned use of the U.S. Food and Drug Administration’s 505(b)(2) pathway — a route that lets a developer lean on existing safety evidence for an approved drug class, here CBD, rather than building a full dossier from scratch.

Ananda is not the only company steering a cannabinoid toward a pain indication. German developer Vertanical recently won U.S. breakthrough-therapy status for a cannabis-based pain drug, a reminder that several groups are now testing whether cannabinoids can clear the bar for regulated medicines rather than wellness products.

The trials that will test the pain claim

The efficacy questions fall to two randomized controlled trials at the University of Edinburgh, both funded by the NHS and UK government research bodies rather than by the company. The ENDOCAN trial will test MRX1 against a placebo in up to 100 women with endometriosis-associated pain across NHS Lothian and NHS Grampian over a 12-week treatment period. The ACTION trial will study the drug in chemotherapy-induced peripheral neuropathy, a nerve-pain condition where CBD has shown early promise. Both are double-blind and placebo-controlled — the design that can actually separate a drug effect from the strong placebo response common in pain research — with dosing on track for the second half of 2026.

The endometriosis study is notable for its dose. It will give some participants up to 12.5 mg/kg of CBD a day, far above the 10 mg daily limit the UK Food Standards Agency sets for over-the-counter CBD products. Ananda says MRX1 is effectively free of THC, which allows high dosing without intoxication. That distinction matters for interpretation, because different cannabis compounds appear to act on different types of pain, and isolating CBD removes the confound of THC’s central effects.

MRX1 now carries the company’s clinical hopes on its own. Ananda had supplied two other formulations for government-backed epilepsy trials at University College London and Great Ormond Street Hospital, but in September 2025 was told its product was no longer needed after a manufacturing contractor fell short. The safety data are now in hand. Whether MRX1 actually controls pain is the question the Edinburgh trials are built to answer.

References:

^{1. Ananda Pharma Limited, “Phase 1 MRX1 Study Delivers Strong Headline Data” (June 17, 2026), PR Newswire. https://www.prnewswire.com/news-releases/phase-1-mrx1-study-delivers-strong-headline-data-302802999.html}