Studied in registered human trials with published pharmacokinetic data, but not approved. Dosing outside a trial protocol has no established safety margin.
No pharmacokinetic data (absorption, half-life, Tmax) located in any allowed-host source.
A cited human study (PMID 22708467) describes oral Sigumir within a multi-component protocol in 62 elderly TMJ-disease patients, but the abstract gives no microgram/mg dose, schedule, or duration.
All identified allowed-host literature is from one Russian lineage (Khavinson/Ryzhak, published in Advances in Gerontology). The only direct clinical citation is a small (n=62), apparently open-label case series in TMJ disease; two reviews mention Sigumir only in passing with no data. No RCT, no independent (non-Khavinson) replication, no Western literature found.
No dedicated human safety, toxicology, or adverse-event data found in any allowed-host source. No dose-ranging or long-term safety studies located. Absence of reported harm in these small, unblinded studies reflects lack of rigorous evaluation, not a demonstrated safety profile.
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