RAMAT GAN, Israel, August 12, 2026
Can-Fite BioPharma Ltd. announced an update on the regulatory status of its two lead drug candidates, Namodenoson and Piclidenoson, both of which are advancing through Phase III clinical development programs under regulatory frameworks established with the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA). Namodenoson, an orally administered A3 adenosine receptor (A3AR) agonist, is being evaluated in a pivotal Phase III study for patients with advanced hepatocellular carcinoma (HCC) and underlying Child-Pugh B7 liver cirrhosis. The program benefits from FDA Fast Track designation as well as FDA and European Orphan Drug designations, providing regulatory incentives and support as the company advances the late-stage development program. Piclidenoson, another oral A3AR agonist, is being developed in a Phase III program for moderate-to-severe plaque psoriasis. Can-Fite said the regulatory progress provides defined pathways toward potential future marketing applications in the United States and Europe, although approval remains dependent on successful clinical outcomes and regulatory review.
Namodenoson Advances Pivotal HCC Development
Namodenoson represents Can-Fite’s lead oncology and liver disease candidate and is currently being evaluated in a pivotal Phase III HCC study. The trial is designed to assess the drug in patients with advanced liver cancer and underlying Child-Pugh B7 liver cirrhosis, an area associated with substantial treatment challenges and unmet medical need. The company said the Phase III program is being conducted under guidance from both the FDA and EMA, with the intention of supporting potential regulatory submissions if predefined efficacy and safety endpoints are achieved. Namodenoson’s regulatory position is further supported by FDA Fast Track designation and Orphan Drug designations in the United States and Europe. Fast Track status is intended to facilitate development and regulatory interaction for therapies addressing serious conditions with unmet medical needs, while Orphan Drug status can provide regulatory and development incentives for qualifying rare-disease indications. However, these designations do not represent regulatory approval or establish efficacy, and the ultimate outcome will depend on the Phase III clinical data and subsequent regulatory assessments.
Piclidenoson Progresses in Phase III Psoriasis Program
Piclidenoson is Can-Fite’s oral A3 adenosine receptor agonist being developed for inflammatory diseases, with the company advancing the candidate through a Phase III program targeting moderate-to-severe plaque psoriasis. The development strategy is intended to evaluate Piclidenoson as a potential oral treatment option for patients requiring systemic therapy. Can-Fite said the program is progressing alongside the Namodenoson HCC development effort, creating a late-stage pipeline spanning both oncology and inflammatory disease. The company has previously reported clinical experience involving more than 1,600 patients across its development programs, which it says supports the safety profile of its drug candidates. Nevertheless, the ongoing Phase III programs remain critical because late-stage efficacy and safety data will determine whether the candidates can advance toward regulatory submissions. The company believes the combination of established regulatory pathways and ongoing pivotal studies provides greater clarity for the future development of Piclidenoson and Namodenoson.
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Can-Fite Builds Late-Stage Regulatory Pipeline
The advancement of Namodenoson and Piclidenoson into Phase III development represents a significant stage in Can-Fite’s strategy to develop oral therapies for diseases with significant unmet needs. Beyond the pivotal HCC program, Namodenoson is also being evaluated in a Phase 2b study for metabolic dysfunction-associated steatohepatitis (MASH) and a Phase 2a study in pancreatic cancer, while Can-Fite’s broader development platform has generated exploratory evidence in additional cancer indications. The company’s third drug candidate, CF602, is being investigated for erectile dysfunction. Can-Fite said the regulatory framework surrounding its lead programs could help guide future interactions with authorities and potential marketing applications in the United States and Europe. The current milestones strengthen the company’s late-stage pipeline, but FDA and EMA designations should not be interpreted as approval, and the success of the programs ultimately depends on demonstrating clinically meaningful efficacy and acceptable safety in their respective Phase III studies. Successful outcomes could position Namodenoson and Piclidenoson for the next stage of regulatory development.
Source: Can-Fite BioPharma press release
