Galcanezumab is a humanized immunoglobulin G (IgG) monoclonal antibody (mAb) 
indicated for the prevention of migraine that binds to calcitonin gene-related 
peptide. A population pharmacokinetic (PK) analysis was performed to 
characterize galcanezumab PK using data pooled from 7 clinical studies. Clinical 
studies included healthy individuals and patients with episodic or chronic 
migraine who were administered between 5 and 300 mg galcanezumab. The PK data 
were analyzed using nonlinear mixed-effects modeling. Galcanezumab 
concentration-time data were described with a 1-compartment model with 
first-order absorption following subcutaneous administration and linear 
elimination. At the median body weight of 74 kg, the estimated population 
apparent clearance (CL/F) was 0.00785 L/h (34% IIV), the apparent volume of 
distribution was 7.33 L (34% IIV), and half-life was 27 days. Patient body 
weight was found to have a modest effect of CL/F, with median galcanezumab 
concentrations being lower in the heaviest patients compared to the lightest 
patients, but this outcome was determined not to be clinically relevant in the 
context of model-estimated random variability. Dosing adjusted for body weight 
is not warranted in adults. Age, sex, race/ethnicity, immunogenicity, 
renal/hepatic markers, and injection-site location did not affect galcanezumab 
PK. In conclusion, galcanezumab exhibits PK parameters typical for an IgG mAb 
administered subcutaneously. The population PK model developed in this study 
demonstrates that galcanezumab exhibits linear PK that was not influenced in a 
clinically relevant manner by the patient factors evaluated.