CBD Drug MRX1 Completes Phase 1 Pharmacokinetic Study

Ananda Pharma Limited (London, UK) has successfully completed a Phase 1 pharmacokinetic (PK) clinical trial of its in-house developed cannabidiol (CBD) oral solution, MRX1, achieving all primary endpoints. The study involved 20 healthy adult volunteers who received 2.5 mg/kg and 7.5 mg/kg twice daily for six days, with an additional nine participants receiving a single 2.5 mg/kg dose after a high-fat meal (food-effect study). All adverse events (AEs) were mild (Grade 1), with no moderate or severe AEs, treatment discontinuations, or liver function abnormalities. The absence of hepatotoxicity, a common risk associated with CBD drugs, is a strong positive safety signal from a regulatory perspective.

Targeting Two Unmet Needs Simultaneously

MRX1 will enter Phase 2 trials for two indications: endometriosis and chemotherapy-induced peripheral neuropathy (CIPN). Currently, there are no FDA-approved dedicated treatments for CIPN, and the market relies on off-label prescriptions of drugs like duloxetine and gabapentin. The endometriosis treatment market is estimated at $2.2 to $3.9 billion in 2026 and is projected to grow to $6.6 billion by 2036 (CAGR of 5.4%). The CIPN market is expected to expand from $900 million in 2023 to $1.6 billion in 2033 (CAGR of 6.1%). Both areas have a growing need for non-opioid pain management, creating a significant opportunity for CBD-based approaches.

Phase 2 ENDOCAN and ACTION Trial Designs

Two Phase 2 trials will be conducted in collaboration with the University of Edinburgh. The ENDOCAN trial, targeting endometriosis, is funded by NHS Scotland, while the ACTION trial, targeting CIPN, is funded by NIHR EME. This public funding significantly reduces the clinical financial risk for the small biotech company. Dosing is expected to begin in the second half of 2026.

Competitive Landscape and 505(b)(2) Regulatory Strategy

Currently, the only FDA-approved plant-derived CBD drug is Jazz Pharmaceuticals' (JAZZ) Epidiolex, which generated $1.1 billion in sales in 2025, but its indications are limited to Lennox-Gastaut syndrome, Dravet syndrome, and tuberous sclerosis. MRX1's entry into the pain indication market should be viewed as an expansion of the CBD drug class rather than direct competition. Ananda is adopting the FDA 505(b)(2) pathway, leveraging existing CBD safety data, and is pursuing a simultaneous regulatory strategy in the US, UK, and EU.

Transition to Private Status and Focus on R&D

Ananda Pharma was delisted from the AQSE Growth Market (formerly ticker ANA) on December 22, 2025, and transitioned to a private limited company. This will save approximately £500,000 per year in listing maintenance fees, which will be reinvested in MRX1 R&D. The Executive Chairman has already invested over £10 million of personal funds, and existing shareholders will have the opportunity to participate in future funding rounds under the same terms.