Ananda Pharma Doses First Patient in NIHR-Backed CIPN Trial

Trial Design and Patient Enrollment

The double-blind, placebo-controlled trial will enroll approximately 120 patients across UK oncology centers over 18 months. Participants must have completed chemotherapy for solid tumors within the past 12 months and present with Grade 2 or higher peripheral neuropathy on the Common Terminology Criteria for Adverse Events scale. The primary endpoint? Change in neuropathic pain intensity on an 11-point numerical rating scale at 12 weeks.

Ananda's investigational product, APL-1001, delivers a 1:1 ratio of CBD and THC via sublingual oil. Dosing starts at 2.5 mg of each cannabinoid twice daily. Titration's permitted up to 10 mg per dose based on tolerability. The formulation uses full-spectrum cannabis extract standardized to contain minor cannabinoids including CBG (0.8-1.2%) and CBC (0.4-0.7%), plus terpenes myrcene and β-caryophyllene at concentrations exceeding 2 mg/mL combined.

Secondary endpoints include:

• Change in tactile sensitivity measured by monofilament testing
• Patient-reported quality of life via EORTC QLQ-CIPN20 questionnaire
• Reduction in concomitant analgesic medication use
• Safety profile and adverse event frequency

NIHR Funding and Regulatory Pathway

The trial received £2.1 million in NIHR funding through the Efficacy and Mechanism Evaluation Programme, which prioritizes interventions addressing unmet clinical needs. CIPN affects 30-40% of patients receiving platinum-based or taxane chemotherapy regimens, according to a 2024 meta-analysis in The Lancet Oncology. Current treatment options are limited. Gabapentinoids and duloxetine show modest efficacy—fewer than 50% of patients achieve meaningful pain reduction.

Ananda holds a Schedule 1 Home Office license permitting clinical use of controlled cannabis extracts. The trial operates under Medicines and Healthcare products Regulatory Agency (MHRA) approval granted in March 2026. If Phase 2 data demonstrate statistical significance on the primary endpoint, Ananda plans to file for Phase 3 by Q2 2027, targeting a UK marketing authorization application by 2029.

Cannabinoid Mechanism in Neuropathic Pain

Preclinical models suggest CBD and THC modulate neuropathic pain through distinct but synergistic mechanisms. THC acts as a partial agonist at CB1 receptors in dorsal root ganglia, reducing excitatory neurotransmitter release. CBD demonstrates activity at TRPV1 channels and enhances endocannabinoid tone by inhibiting FAAH enzyme activity, according to pharmacology data Ananda published in British Journal of Pharmacology in 2025.

The company's formulation includes β-caryophyllene, a sesquiterpene that selectively binds CB2 receptors with anti-inflammatory properties. A 2023 study in Pain found that β-caryophyllene co-administration reduced mechanical allodynia in paclitaxel-treated mice by 38% compared to cannabinoids alone. Myrcene, present at 3.2 mg/mL in APL-1001, may potentiate cannabinoid activity by modulating blood-brain barrier permeability. The trial will explore this via optional PK sampling.

Competing Cannabis CIPN Programs

Ananda's trial joins at least three other cannabis-based CIPN studies recruiting patients globally. Israel's Panaxia Pharmaceuticals is enrolling 80 patients in a Phase 2 trial of its orally disintegrating tablet containing 10 mg CBD and 1 mg THC. Results expected Q4 2026. In Australia, Zelira Therapeutics completed a 60-patient pilot study in March showing a 2.3-point reduction in pain scores versus 0.9 for placebo, though the difference didn't reach statistical significance (p=0.08).

For context on the broader cannabis clinical-trials landscape, see the CannIntel topic hub on cannabis clinical trials.

The NIHR backing signals a shift in how UK regulators view cannabinoid medicine—not as alternative therapy, but as a legitimate pharmaceutical development pathway for conditions with poor treatment options.

Commercial and Reimbursement Outlook

If approved, APL-1001 would enter a UK oncology market where CIPN treatment costs the NHS an estimated £47 million annually in failed therapies and pain-management referrals. Ananda hasn't disclosed pricing strategy, but comparable neuropathic-pain medications carry NHS list prices of £64.40 for Lyrica (pregabalin) and £27.72 for Cymbalta (duloxetine) per 28-day supply. Cannabis-based medicines in the UK currently face reimbursement challenges. Epidyolex (cannabidiol oral solution) required three years of real-world evidence before securing routine NHS funding for Dravet syndrome in 2021.

Ananda's CEO, Dr. Mira Desai, noted in a July 17 statement that the trial's pragmatic design aims to generate health-economic data suitable for NICE appraisal, permitting concomitant analgesics and using patient-reported outcomes as secondary endpoints. The company's also exploring partnerships with US oncology networks to support a parallel FDA Investigational New Drug application, contingent on UK Phase 2 readouts.