Ananda’s lead CBD drug reaches two-year stability milestone
Published: 02:25 02 Jun 2025 EDT
Ananda Pharma Plc (AQSE:ANA, OTCQB:ANANF) said its lead cannabidiol medicine, MRX1, has passed a key regulatory milestone after achieving two years of stability data under internationally recognised pharmaceutical standards.
The UK-based company, which is developing approved CBD treatments for long-term health conditions, said the results meet guidelines set out by the International Council for Harmonisation.
These rules are used by regulators, including the UK’s Medicines and Healthcare products Regulatory Agency, the US Food and Drug Administration, and the European Medicines Agency.
Stability testing is a standard part of drug development and measures how well a product holds its quality over time when stored in different conditions such as heat, humidity and light. In this case, MRX1 has remained stable for 24 months, both under normal and accelerated conditions.
Accelerated testing means the product is stored at temperatures above 30 degrees Celsius. This is particularly important for Ananda’s planned phase I trial in Australia, where storage conditions may vary.
The company said the findings confirm the reliability and consistency of its formulation and highlight a key difference between MRX1 and unlicensed CBD products.
These include items sold in dispensaries or online, as well as those available through UK food supplements legislation or the US Farm Bill, which do not require the same level of quality verification.
Ananda said the absence of intoxicating tetrahydrocannabinol, or THC, also reinforces MRX1’s profile as a pharmaceutical-grade product.
The company is continuing to build its regulatory dossier with data from multiple manufacturing batches to show the process can deliver consistent results.
CEO Melissa Sturgess added: "This achievement shows the level of detail required to ensure we have a formulation that can ultimately become a regulatory-approved medicine. There are no shortcuts."
