ArticleCPT: pharmacometrics & systems pharmacology2026
Population PK-PD Modeling of Danicopan Add-On Therapy in Participants With Paroxysmal Nocturnal Hemoglobinuria Treated With Ravulizumab or Eculizumab.
Article in CPT: pharmacometrics & systems pharmacology, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.
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Abstract
Danicopan is a first-in-class orally administered complement factor D inhibitor, approved as an add-on therapy to ravulizumab or eculizumab for the treatment of clinically significant extravascular hemolysis in patients with paroxysmal nocturnal hemoglobinuria (PNH). Population pharmacokinetics (PK) and pharmacodynamics (PK-PD) modeling was used to characterize danicopan PK and to evaluate the relationship between steady-state exposure and alternative pathway (AP) activity using data from healthy participants and patients with PNH treated with ravulizumab or eculizumab to support the danicopan dose regimens. Danicopan PK was described using a two-compartment model with linear elimination, with absorption characterized by a zero-order release followed by first-order absorption. Body weight, sex, renal impairment, formulation, and food status were identified as significant covariates affecting danicopan PK. Food status affected the absorption of danicopan but had a minimal effect on relative bioavailability. An inhibitory E
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