What clinical evidence exists specifically evaluating adverse events tied to commercial 'Gelatide' supplement formulations?
Executive summary
No reporting in the documents provided contains clinical trial data or safety analyses that explicitly evaluate adverse events tied to a commercial supplement called "Gelatide"; the sources instead include safety datasets for broadly related substances (gelatin, GLP‑1 receptor agonists, urolithin A) and regulatory surveillance tools that would be used to detect product‑specific signals (DrugBank, FAERS, FDA guidance) [1] [2] [3]. Absent direct evidence on Gelatide, the closest usable context is how regulators and published trials have handled adverse events for commercial bioactive products and prescription peptides — a framework that highlights what would be needed to credibly assess Gelatide’s safety.
1. No direct clinical evidence for “Gelatide” found in the supplied reporting
A systematic read of the supplied items turns up no trial reports, FAERS signals, company filings, or peer‑reviewed analyses that name Gelatide or present adverse event (AE) data tied to a Gelatide product; therefore there is no documented clinical evidence in these sources to quantify harms or SAE rates for a commercial Gelatide formulation (reporting limitation acknowledged per available sources). The available databases and surveillance reports cited — DrugBank for structured adverse effect data (broadly for drugs) and the FDA’s FAERS summaries — demonstrate where one would expect to find product‑specific safety signals, but they do not, in these extracts, contain a Gelatide entry [1] [2].
2. What comparable evidence looks like: prescription peptide/agonist trials and their adverse event reporting
Late‑stage pharmaceutical trials supplied here illustrate the standard clinical approach to documenting AEs and discontinuations: registrational Phase 3 programs report rates of common adverse events, discontinuations due to AEs, and perform meta‑analyses when class‑wide concerns emerge — for example, Lilly’s retatrutide trials and related coverage list GI side effects and discontinuation rates that ranged into double digits in treated groups versus low single‑digits for placebo (nausea, diarrhea, constipation; discontinuation 8.8–18% in subgroups versus ~4–5% placebo) [4] [5] [6]. Regulatory meta‑analysis work by the FDA on GLP‑1 receptor agonists likewise shows the agency aggregates 91 placebo‑controlled trials to evaluate psychiatric and other risks, concluding no increased risk for suicidal ideation/behavior across trials in that analysis — an example of rigorous, cross‑trial safety assessment [7]. These examples are useful comparators for the type and quality of evidence required to evaluate a marketed bioactive product’s safety profile.
3. Non‑drug supplements in the record show mixed reporting and limited SAE signals
Reporting on non‑prescription bioactives in the supplied set is sparse but illustrative: summaries about urolithin A (Mitopure) describe trials with “strong safety and tolerability” and “no serious adverse events reported” in specific small trials, demonstrating that some supplements do publish safety data but often from limited sample sizes and short durations [8]. Conversely, larger randomized drug trials like SELECT for semaglutide report prespecified AE tables and secondary analyses (including kidney endpoints and AE stratification by baseline eGFR), showing that higher‑quality safety signal detection requires large, long trials and detailed subgroup analyses [9] [10].
4. What’s missing and where to look next to evaluate Gelatide specifically
Because none of the provided documents present Gelatide‑tagged clinical trial entries, the next evidence steps that the sources imply would be: search FAERS/other pharmacovigilance databases for product names or ingredients (FDA FAERS summaries exist to surface potential signals) and query trial registries and peer‑reviewed literature for Gelatide or its active ingredient (the ClinicalTrials.gov system and DrugBank are referenced as standard repositories) [2] [11] [1]. Also relevant: manufacturers’ regulatory filings and Phase 3‑style safety appendices exemplified by the retatrutide disclosures and FDA review processes, which show what rigorous safety documentation looks like when available [5] [3].
5. Caveats, competing narratives and potential agendas
Manufacturers and marketers of supplements often publicize favorable tolerability from small trials while postmarketing surveillance (FAERS) and larger randomized trials can reveal rarer or class‑specific harms; pharmaceutical examples here show how favorable efficacy headlines can coexist with substantial discontinuation rates and significant surveillance activity by regulators [6] [7]. Given the absence of Gelatide‑specific data in the supplied reporting, any claim about Gelatide’s safety or risk profile would be unsubstantiated by these sources until product‑named clinical data, FAERS reports, or regulatory filings are located (reporting limitation reiterated).