CNBX Eyes 2026 Trials for Cannabinoid-Based Cancer Therapies

The company is targeting two oncology drug candidates while navigating funding gaps and regulatory hurdles.

December 02, 2025

CNBX Pharmaceuticals Moves Forward With Cancer-Focused Cannabinoid Drugs

CNBX Pharmaceuticals is making a focused push toward clinical trials for two cannabinoid-based therapies aimed at oncology. Based in Bethesda, the company is preparing for first-in-human studies of two lead candidates— Cannabics SR and RCC-33 —with the goal of launching Phase I/II trials in 2026.

Cannabics SR is designed to treat Cancer Anorexia Cachexia Syndrome (CACS), a condition marked by rapid, involuntary weight loss in advanced cancer patients. RCC-33 targets colorectal cancer, one of the most common and deadly cancers worldwide. Both drug candidates are oral capsules that use standardized cannabinoid formulations for consistent dosing and a steady therapeutic effect.

The pilot data for Cannabics SR showed appetite improvements and weight stabilization in patients. RCC-33, currently in preclinical development, has demonstrated tumor volume reduction in animal studies and cytotoxicity in colon cancer cell lines. The company plans to advance both candidates under the FDA’s Investigational New Drug (IND) process, pending capital.

A Capital-Dependent Plan

CNBX isn’t self-funding these trials. The company is clear about needing additional investment to move forward. The projected cost for RCC-33’s Phase I/II trial is $6.5 million, which includes preclinical safety studies and work with contract research organizations.

Manufacturing is fully outsourced. CNBX plans to source GMP-grade active ingredients from Purisys, a U.S.-based supplier with FDA-facing experience. Purisys would also assist with Chemistry, Manufacturing, and Controls (CMC) documentation for the IND application.

The commercialization strategy doesn’t include direct product sales. Instead, CNBX intends to complete early-stage trials and license its therapies to established pharmaceutical companies. That structure allows the company to stay lean while focusing on its core—R&D and regulatory advancement.

Regulatory Dynamics and Market Access

The regulatory path is more complex for CNBX than for most small biotechs. Because the therapies are cannabinoid-based, the company must navigate FDA approval and U.S. Drug Enforcement Administration (DEA) restrictions. Cannabinoids remain Schedule I substances under federal law. That means additional approvals, handling protocols, and scheduling adjustments may be required before commercial activity can begin in the U.S.

International markets, particularly Israel and parts of the European Union, may offer faster pathways. CNBX is exploring licensing options in jurisdictions where the regulatory environment is more permissive for cannabinoid-based medicines.

Market Need and Strategic Fit

There’s clear white space in both therapeutic areas CNBX is targeting. The market for CACS treatments is limited, with only one FDA-approved drug available—and it comes with side effects that restrict long-term use. Cannabics SR aims to deliver a more tolerable alternative, using a sustained-release formulation to minimize peaks and drops in cannabinoid levels.

RCC-33 addresses a much larger market. Colorectal cancer affects more than 2 million people globally each year, and current treatments can have significant side effects. RCC-33 is being positioned for use in the neoadjuvant and adjuvant settings—either before surgery to shrink tumors or afterward to reduce recurrence risk.

If the company can demonstrate a favorable safety profile and early signs of efficacy in humans, it may find traction with partners who have the infrastructure to take these programs forward.

What Comes Next

For now, CNBX’s focus is on preclinical development and preparing for IND submissions. Trial site selection, contract manufacturing, and regulatory prep are all underway—but contingent on funding.

The science is in place. The path is clear. The next step is execution.