Evicenter
P&T meetings

Imlifidase

Kidney transplantation in highly sensitized patients

Manufacturer
Hansa Biopharma
Regulatory submission
BLA submitted December 2025
Last updated
85 sources

Product information and disease descriptionProduct descriptionProduct informationPharmacology

Pharmacodynamics

5 evidence topics · 6 sources

Pharmacodynamics and immunogenicity: NCT02224820

“<1% plasma IgG remaining within 48 hours” (opens the source at this quote in a new tab)

“Anti-IdeS antibodies developed 1 week after treatment, peaking at 2 weeks.” (opens the source at this quote in a new tab)

Phase 1 study in healthy subjects: NCT01802697

“Twenty healthy subjects were given intravenous single ascending doses of IdeS.” (opens the source at this quote in a new tab)

“IgG reached nadir 6-24 hours after dosing and then slowly recovered.” (opens the source at this quote in a new tab)

Imlifidase-generated single-cleaved IgG

“ScIgG has a significantly reduced capacity to mediate Fc-dependent effector functions.” (opens the source at this quote in a new tab)

F(ab′)2 fragments and complement activation: in vitro study

“F(ab′)2 fragments generated from anti-HLA antibodies after imlifidase cleavage had a biological impact on intact IgG binding, leading to reduced complement activation.” (opens the source at this quote in a new tab)

Anti-IdeS antibodies in healthy humans

“clinically significant levels of IdeS-neutralizing activity were found in only ~1% of the individuals tested.” (opens the source at this quote in a new tab)