Table 1.
Current status of in-human silica studies.
| Study | Design/Route | Application and Mechanism | Reported adverse events/major findings |
|---|---|---|---|
| Core-Shell silica (Zanoni et al., 2021) (6 nm) | Non-randomized (Phase I/IIa) | Imaging of Sentinel Lymph Nodes using silica shells with fluorescent dye, coated with poly(ethylene glycol) (PEG) and integrin-targeting, cyclic arginine-glycine–aspartic acid–tyrosine peptides (cRGDY) | Route: Intradermal |
| “Cornell-dots” | No adverse events observed | ||
| Core-Shell silica (Phillips et al., 2014) (<10 nm) | Microdosing | Imaging of melanoma using silica shell with fluorescent dye, coated with PEG and cRGDY with 124Iodine | Route: Intravenous |
| “Cornell-dots” | No toxic or adverse events related to the nanoparticles observed | ||
| Silica-gold-iron nanoparticles (Kharlamov et al., 2015) (90–150 nm) | Multi-center, observational, open-label, three arms | Atherosclerotic plaque reduction using plasmonic photothermal therapy | Route: Intraarterial/ intraarterial implant |
| No target lesion major cardiac adverse events | |||
| Gold-silica nanoshells (Rastinehad et al., 2019) (150 nm) | NR | Ablation of prostate tumors using photothermal ablative therapy | Route: Intravenous |
| “Auroshell” | No serious adverse events during the procedure and at 90 d | ||
| Mesoporous silica-lipid nanoparticles (Meola et al., 2021) (19 & 50 nm) | Randomized, cross-over, double-blinded (Phase I/II) | Enhanced delivery of simvastatin (SIM) using mesoporous silica | Route: Oral |
| No serious adverse events reported during the study | |||
| Mesoporous rod shaped silica (Baek et al., 2022) (300 × 1300 nm) | Open-label, single-arm, multicenter | Improvement of blood sugar control using silica to sequester gastrointestinal enzymes | Route: Oral |
| “SiPore15” | No severe adverse events after 12 weeks. Most adverse events were mild and were gastrointestinal in origin | ||
| Mesoporous silica (Bukara et al., 2016) (500 nm (Jammaer et al., 2009)) | Open-label, randomized, two-way cross-over | Enhanced delivery of fenofibrate using mesoporous silica compared to micronized fenofibrate | Route: Oral |
| No serious adverse events reported and no relevant differences in clinical laboratory tests between the subjects in the treatment and the reference groups | |||
| Porous silica-lipid nanoparticles (Tan et al., 2014) (15.20 μm with 3–20 nm pores) | Randomized, double-blinded, one-period single oral dose (Phase I) | Enhanced delivery of ibuprofen using silica to improve solubility compared to commercial tablet | Route: Oral |
| Negligible acute side effects related to the administration of both the investigational and reference formulations. | |||
| Colloidal silica (Tieroshyn et al., 2020) (Size NR) | Randomized, double-blind, placebo-controlled, 4-center (Phase II) | Silica as an anti-diarrheal agent compared to placebo | Route: Oral |
| “Carbowhite” | Carbowhite was well tolerated and no adverse effects were reported | ||
| Silica Shells (van Zuuren et al., 2021) (Size NR) | Multi-centered randomized, double blind, vehicle controlled parallel group (Phase II) – Recently FDA Approved (Randles-Friedman, Iwaniuk) | Prolonged release of benzoyl peroxide using silica shells | Route: Topical |
| 52-week long-term safety study, side effects mostly mild | |||
| Silicic acid anhydride (Zschocke et al., 2008) (Size NR) | Randomized, open‐label, comparator‐controlled | Comparison of silica vs Topical acyclovir for the treatment of recurrent herpes labialis | Route: Topical |
| No serious adverse events |