Oleander extract PBI-05204 for metastatic pancreatic cancer

MS-N141 · Cancer control · Early-phase negative evidence · Safety · Human evidence · Appraised 26 October 2026

Does the standardized Nerium oleander extract PBI-05204 help people with heavily pretreated metastatic pancreatic adenocarcinoma?

Evidence at a glance

Evidence label: Investigational botanical drug; single-arm phase II study missed its survival target
Benefit: One partial response occurred, but the prespecified overall-survival benchmark was not met.
Certainty: Low for efficacy because there was no randomized comparator; moderate that monotherapy did not meet the study’s own target in this population.
Risk: Oleandrin is a cardiac glycoside. Gastrointestinal toxicity was common, and unregulated oleander products can be severely or fatally toxic.

What was studied

Formulation and route: PBI-05204 is a standardized supercritical-carbon-dioxide extract of Nerium oleander containing oleandrin. It is not equivalent to raw oleander, homemade preparations or products adulterated with yellow oleander.

Design and population: A multicenter, open-label, single-arm phase II study enrolled 42 people with stage IV metastatic pancreatic adenocarcinoma refractory to standard therapy; 38 were analyzed. Participants received oral PBI-05204 daily until progression, unacceptable toxicity or withdrawal. More than 80% had received at least two prior chemotherapy lines. The study sought a 50% probability of survival beyond 4.5 months.

What the evidence found

Ten of 38 analyzed participants (26.3%) were alive beyond 4.5 months. Median overall survival was 112 days and median progression-free survival 56 days. One partial response (2.6%) lasted 162 days. The study therefore did not meet its primary overall-survival endpoint.

Drug-related events most often included vomiting (23.7%), nausea (18.4%), decreased appetite (18.4%) and diarrhea (15.8%). Across all causes, 55.3% experienced at least one grade 3 or higher treatment-emergent event in this very ill population.

A preceding phase I study in 46 advanced-solid-tumor patients established a recommended phase II dose of 0.2255 mg/kg/day; seven had stable disease beyond 4 months. Stable disease in an uncontrolled dose-finding study does not establish efficacy.

How to interpret it

The phase II result is not evidence that oleander cures pancreatic cancer. A single response without a control group can reflect selection, disease biology, prior treatment or chance.

Preclinical activity in cell and animal models remains investigational. It must not be presented as proof of tumor control in people.

Practical safety context

Do not ingest raw oleander or products of uncertain identity. Cardiac glycosides can cause nausea, vomiting, dangerous heart rhythms and death. In September 2026, FDA again warned about supplements found to contain toxic yellow oleander; those alerts concern adulterated consumer products, not the standardized trial formulation, but they underscore the hazard of uncertain identity.

Questions for the care team

Is the proposed product the exact clinical-trial formulation, or an unregulated preparation?
Did the study meet its prespecified endpoint, and was there a randomized comparator?
What cardiac monitoring, electrolyte review and interaction screening would be required?

Funding and conflicts

The phase II trial was sponsored in part by Phoenix Biotechnology. One author disclosed being the company’s chief scientific officer with consulting, intellectual-property and ownership interests; other industry relationships were also disclosed. These ties heighten the need for independent randomized confirmation.

Sources

Last literature search: 26 October 2026. Record appraisal: 26 October 2026. This page is educational and does not replace individualized medical advice. Laboratory effects, biomarkers, symptom changes or an uncontrolled response must not be interpreted as proof of tumor control, delayed recurrence or longer survival.