Rakuten Medical Starts U.S. Phase 3 Cancer Drug Trials
The San Diego firm moves to scale its light-activated treatment for solid tumors ahead of a planned 2028 FDA submission.
Updated on Oct. 26, 2026 in Biotech
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San Diego-based Rakuten Medical is advancing its photoimmunotherapy platform through Phase 3 clinical trials in the United States. The company uses its light-activated Akalux drug to target and destroy cancer cells.
Why it matters
The firm is prioritizing the U.S. market for its next phase of capital deployment while expanding into regions like Macau to establish data for future commercialization in China.
The Alluminox platform utilizes a light-activated dye to tag cancer cells, which are then destroyed via exposure to red light. Rakuten Medical currently allocates 95% of its resources to the U.S. market.
The players
Rakuten Medical
A San Diego-based biotechnology company focused on photoimmunotherapy and the Alluminox hardware platform.
Hisataka Kobayashi
A researcher at the National Cancer Institute who discovered the core photoimmunotherapy mechanism in 2011.
The details
The treatment process involves binding the drug Akalux to target cancer cells, which then makes the cells vulnerable to physical destruction when illuminated with red light. This photoimmunotherapy method contrasts with traditional systemic chemotherapy by focusing the lethal effect on tagged sites. The company currently installs its hardware platform in hospitals at no cost to the facility, shifting the revenue model to drug sales per treatment cycle.
Timeline
2011: Hisataka Kobayashi identifies the therapeutic potential of the technology.
2028: Rakuten Medical targets this year for its planned FDA submission.
The Tech Race
Rakuten Medical is moving to scale a therapy originating from the National Cancer Institute research program into a global standard for solid tumor treatment. The firm is currently outpacing other light-based oncology efforts by integrating specialized hardware installations directly into hospital workflows.
The treatment is currently available to patients in Japan, but U.S. availability remains subject to successful completion of ongoing clinical trials and FDA approval. Clinicians and patients should monitor 2028 submission milestones for updates on potential domestic access.
The takeaway
Rakuten Medical is betting its future on expanding beyond Japan to capture the U.S. market with its light-activated cancer platform. Watch for the company's scheduled 2028 FDA data submission to see if the platform successfully expands its target range from head and neck cancers to all solid tumors.
Further reading
Learn more about the latest innovations in Biotech to understand how new platforms are entering clinical trials.
Source note: This article includes information reported by Fortune.
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