Patient Identification And Enrollment ConstraintsChallenges in identifying eligible patients could constrain trial enrollment and slow commercial uptake, increasing execution risk for both development programs and the marketed franchise.
Regulatory Approval UncertaintyLikelihood that regulators will require a confirmatory late-stage study introduces approval timing uncertainty and extends development risk for pruritus indications.
Tolerability RiskA somewhat higher rate of diarrhea with volixibat compared with a competitor creates a tolerability concern that could reduce patient persistence and limit prescribing despite most events being mild to moderate.