Mesoporous Silica Particles Retain Their Structure and Function while Passing through the Gastrointestinal Tracts of Mice and Humans
Iqbal et al., 2023 · ACS Applied Materials & Interfaces
View publicationSAFETY & TOLERABILITY
Gut-local by design. Generally well tolerated in human research.
SiPore® is designed to perform its function locally in the gastrointestinal tract, where digestion happens. It does not enter the bloodstream. Safety and tolerability have been evaluated across the human SiPore® research program, including dedicated safety research and a large randomized, placebo-controlled clinical trial. Across the evidence base, SiPore® has been generally well tolerated.
FOUR IMMEDIATE FACTS
GUT-LOCALWorks in the gastrointestinal tract.
NON-SYSTEMICDoes not enter the bloodstream.
HUMAN STUDIEDSafety and tolerability evaluated in clinical research.
GENERALLY WELL TOLERATEDAcross the human research program.
LOCAL MODE OF ACTION
Designed to work where digestion happens.
SiPore® is based on precisely engineered porous silica particles. During digestion, the particles remain within the gastrointestinal tract, where their pores interact with digestive enzymes involved in breaking down carbohydrates and fats. SiPore® does not need to enter the bloodstream to perform its function. Its action is physical and local rather than systemic.
GI tract — SiPore® acts here Bloodstream — SiPore® does not enter
MICRON-SIZED BY DESIGN
Why SiPore® remains gut-local.
Micron-sized particles support a gut-local mode of action. SiPore® particles are micron-sized. Research examining mesoporous silica particles as they passed through the gastrointestinal tract found that the particles retained their structure and supported the conclusion that their lack of systemic absorption is related to their micron-scale size.
- Small molecule
- Digestive enzyme
- Micron-sized SiPore® particle
The study examined particle structure and behavior during passage through the gastrointestinal tract and reported that the particles were not degraded during transit.
SCIENTIFIC RIGOR
Safety has been studied separately from the mechanism.
Gut-local action is a property of the technology. Safety is evaluated through evidence.
The fact that SiPore® works locally does not, by itself, establish safety. That is why safety and tolerability have also been evaluated directly in human clinical studies.
Where SiPore® works and how SiPore® has been tolerated are two related but distinct parts of the scientific story.
HUMAN SAFETY RESEARCH
From dedicated safety evaluation to the largest SiPore® trial.
Across the current human evidence base, reported adverse events have primarily been mild and transient gastrointestinal symptoms.
- First-in-ManDedicated human safety study
- STARProof-of-concept clinical study
- SHINELarge randomized clinical trial
- Real-World EvidenceContinued observation of tolerability in everyday use
LARGE RANDOMIZED CLINICAL TRIAL
SHINE
SHINE is the largest SiPore® clinical trial conducted to date. Safety and tolerability were assessed throughout the study, and SiPore® was generally well tolerated in the studied population.
- Participants
- N = 318
- Design
- Randomized • Double-blind • Placebo-controlled
Baek J, et al. 2026. eClinicalMedicine 97:104042.
Read the paperFirst-in-ManN = 20 • Male participants • Oral mesoporous silicaDEDICATED HUMAN SAFETY STUDY
- Key findings
- An early human study specifically evaluated safety and tolerability at oral intakes up to 9 g/day. The study reported that oral mesoporous silica was safe and well tolerated in the studied male participants.
- Publication / source
- Hagman E, et al. 2020. “Oral intake of mesoporous silica is safe and well tolerated in male humans.” PLOS ONE.
- Read the paper
- View publication
STARN = 43 • Prediabetes or newly diagnosed type 2 diabetesPROOF-OF-CONCEPT CLINICAL STUDY
- Key findings
- STAR extended clinical evaluation into individuals with impaired glucose metabolism. Oral consumption of SiPore® was reported as safe and well tolerated in the study population.
- Publication / source
- Baek J, et al. 2022. Nanomedicine.
- Read the paper
- View publication
TOLERABILITY
What “generally well tolerated” means.
What was reported? “Generally well tolerated” does not mean that no adverse events can occur. Across the human research program, reported tolerability findings have primarily involved gastrointestinal symptoms that were mild and transient.
REPORTED SEVERITYPrimarily mildThe current evidence base describes most reported adverse events as mild rather than serious.
MOST RELEVANT CATEGORYGastrointestinalGI symptoms are the most relevant tolerability events reported across the current evidence base.
COURSEGenerally transientReported gastrointestinal events were generally temporary rather than persistent.
EVIDENCE APPROACHContinue to monitorSafety and tolerability remain part of the clinical and real-world evidence program as the evidence base expands.
SAFETY MONITORING
More than adverse-event reporting.
Clinical safety evaluation considers more than whether participants report symptoms. Across the SiPore® clinical program, safety assessments have included clinical observations and laboratory measures designed to identify potential systemic effects.
CLINICAL SAFETYAdverse events & vital signsClinical observations used to identify tolerability issues and changes in general health status.
LABORATORY SAFETYBlood & organ functionHematology and relevant liver and renal markers have been included in safety monitoring.
NUTRITIONAL STATUSVitamins & mineralsSelected vitamin and mineral markers have been monitored in clinical research.
Does SiPore® interfere with vitamins and minerals?
What has clinical monitoring shown?
Because SiPore® acts during digestion, it is reasonable to ask whether it also affects micronutrient status. Internal clinical evidence supplied for this page reports no significant changes in measured vitamin or mineral levels across the evaluated clinical studies, including monitoring of vitamin D and selected vitamin and mineral markers.
PRODUCT-SPECIFIC USE
Medication timing and suitability belong with the finished product.
Taking a SiPore®-powered product? Directions, medication timing, contraindications and suitability can differ by finished product and regulatory classification. Always follow the instructions provided with the specific product.
EVIDENCE IN ONE VIEW
Safety has been evaluated at multiple stages of the program.
- MECHANISM RESEARCHSupports a gut-local, non-systemic mode of action.
- FIRST-IN-MANDedicated human safety and tolerability evaluation.
- STAR + SHINESafety and tolerability evaluated alongside clinical outcomes.
- REAL-WORLD EVIDENCEContinued observation of tolerability in everyday use.
The U.S. real-world evidence study also reported good tolerability and high adherence in everyday use.
OUR APPROACH TO SAFETY
Safety claims should be as precise as the science behind them.
SiPore.com does not use absolute safety language.
Instead, we present: where SiPore® works, how it has been studied, what was observed, and the limits of the available evidence. That means using “generally well tolerated” when describing the overall evidence base and providing study-specific detail where appropriate.
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Gut-local by design. Evaluated in people.
SiPore® works locally in the gastrointestinal tract and does not enter the bloodstream. Across human clinical research, it has been generally well tolerated.