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b , As in a , Quantification of PMA-induced NETs in WT and XKR8-deficient dHL-60 cells with inhibitors HC067047 (1 M), Pyr3 (5 M), SKF96365 (20 M), 9-phenanthrol (30 M), JNJ-28583113 (10 M), Carvacrol (100 g/mL) ( n = 8)

doi:10.1093/rheumatology/keab518 12

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Several factors explain the lack of approval: insufficient clinical trials (no completed Phase 3 trials for most indications), safety concerns (FDA has identified specific adverse events), commercial considerations (patent status affects development investment), regulatory pathway (approval requires specific, rigorous documentation), and competition (Tesamorelin already approved for related indication)

A total of 12 events were reported in five participants (35.7%) in the normal hepatic function group, three events in three participants (42.9%) in the mild hepatic impairment group and one event in one participant (14.3%) in the moderate hepatic impairment group