Studied in registered human trials with published pharmacokinetic data, but not approved. Dosing outside a trial protocol has no established safety margin.
FLAG: A half-life of 159-195 h (~7 days) is widely cited but I could NOT trace it to an allowed primary source, it originates in the Lancet phase 1b paper (non-permitted host) and is absent from the PubMed abstract of the phase 2 trial. Reported null rather than repeat an unverifiable figure. Long-acting design (C20 diacid acylation) supports once-weekly dosing.
Phase 2 monotherapy dose-finding: 0.3, 0.6, 1.2, 2.4, 4.5 mg once weekly SC. Investigational.
Published phase 1b/phase 2 trials; no regulatory label. Half-life not traceable to an allowed primary source.
Investigational; no boxed warning. Trial adverse events predominantly gastrointestinal, mostly mild-moderate. Not for clinical dosing decisions.