• 06 Mar 2026
• Admin
• News Article

Ananda Pharma Receives Regulatory Approval for Phase 2 CBD Trial in Endometriosis

A new clinical study is set to explore whether cannabidiol (CBD) could help women manage endometriosis-related pain.

Ananda Pharma has received approval from the Medicines and Healthcare products Regulatory Agency and the NHS Health Research Authority to begin its Phase 2 ENDOCAN clinical trial.

The study will evaluate the safety and effectiveness of MRX1 CBD oral solution for women suffering from pain linked to Endometriosis.

The ENDOCAN Trial: Study Design and Goals

The Phase 2 ENDOCAN trial is designed as a double-blind, placebo-controlled pilot study.

The trial will:

• Enroll up to 100 women diagnosed with endometriosis
• Run over a 12-week treatment period
• Evaluate whether MRX1 CBD oral solution reduces pain and improves quality of life

The study will be conducted through:

• NHS Lothian
• NHS Grampian

Both are part of the UK’s National Health Service network in Scotland.

The trial is funded by Scotland’s Chief Scientist Office and led by a research team from The University of Edinburgh.

Key investigators include:

• Lucy Whitaker (Principal Investigator)
• Andrew Horne
• Phillipa Saunders

Understanding Endometriosis and Its Impact

Endometriosis is a chronic inflammatory condition affecting around 190 million women worldwide. It occurs when tissue similar to the lining of the uterus grows outside the uterus, forming lesions that commonly develop in the pelvis.

The condition can cause:

• Severe pelvic pain
• Pain during menstruation
• Infertility
• Reduced quality of life

The economic burden is substantial.

• In the United Kingdom, the condition costs roughly £8.2 billion annually in healthcare expenses and lost productivity.
• In the United States, estimates exceed $100 billion per year when factoring in treatment costs, lost work, and wider societal impacts.

Limitations of Current Treatment Options

Current treatment strategies for endometriosis are often limited or temporary.

Typical approaches include:

• Surgical removal of lesions
• Hormone-suppressing medications
• Painkillers and antidepressants

However, these treatments frequently have drawbacks.

• Side effects can limit long-term use.
• Symptoms return in 40–50% of women within five years after surgery.

As a result, developing better therapies has become a major healthcare priority.

In fact, improving treatment options for endometriosis was identified as a key focus in the 2021 Scottish Government Women’s Health Plan.

High-Dose CBD Therapy Under Investigation

The ENDOCAN trial will test relatively high doses of CBD compared with most consumer products. The study will use doses up to 12.5 mg/kg/day.

For a 70 kg woman, that equals approximately 875 mg of CBD per day.

For comparison:

• The UK Food Standards Agency recommends a maximum daily intake of 10 mg for consumer CBD products.

Researchers emphasize that the investigational product, MRX1, is effectively THC-free, meaning it should not produce intoxicating effects even at higher doses.

A Key Regulatory Milestone

Approval from both the Medicines and Healthcare products Regulatory Agency and the NHS Health Research Authority allows the study to move forward.

The next steps include:

• Site initiation
• Patient recruitment
• Trial launch

Further updates will be shared as the study progresses.

Leadership Perspective: Addressing an Unmet Need

According to Melissa Sturgess, CEO of Ananda Pharma, the trial targets a major gap in women’s healthcare.

She noted that the personal and societal burden of endometriosis is enormous, yet treatment innovation has been limited.

Sturgess added that while many women already use CBD to manage symptoms, clinical trials are needed to determine:

• Effective dosing levels
• Safety in standardized pharmaceutical formulations
• Potential for prescription use by specialists

The goal is to develop a treatment that is clinically validated, affordable, and widely accessible.

Expanding the MRX1 Clinical Program

The ENDOCAN study is one of several trials involving MRX1, Ananda’s proprietary CBD formulation.

The company is currently supporting two Phase 2 clinical trials:

1. ENDOCAN Trial – MRX1 for endometriosis pain (funded by NHS Scotland)
2. ACTION Trial – MRX1 for chemotherapy-induced peripheral neuropathy

Both programs aim to evaluate whether pharmaceutical-grade CBD can address chronic pain conditions with limited treatment options.