Imlifidase is an enzyme-based immunosuppressive medicine marketed as Idefirix for desensitization before kidney transplantation in highly sensitized adults. It acts by breaking down IgG antibodies to reduce the risk of graft rejection. The medicine holds conditional marketing authorization in the European Union since August 2020.
The FDA accepted Hansa Biopharma’s BLA for imlifidase and set a PDUFA action date of Dec. 19, 2026. The filing is backed by Phase 3 ConfIdeS data showing statistically significant efficacy.
The FDA has accepted Hansa Biopharma's Biologics License Application for imlifidase, a desensitization treatment for highly sensitized adult kidney transplant patients with positive crossmatch against deceased donors, with a PDUFA date of December 19, 2026.
Hansa Biopharma announced on February 18, 2026 that the FDA has accepted its Biologics License Application for imlifidase, supported by positive Phase 3 ConfIdeS trial results in highly sensitized kidney transplant patients.
| NCT ID | Title | Status | Phase |
|---|---|---|---|
| NCT06518005 |
Efficacy and Safety of GNT0003 Following Imlifidase Pre-treatment in Severe Crigler-Najjar Syndrome |
RECRUITING | PHASE2 |
| NCT06461546 |
Imlifidase in Living Donor Renal Transplantation Highly Sensitized Recipients |
WITHDRAWN | PHASE2 |
| NCT06241950 |
A Gene Transfer Therapy Study to Evaluate the Safety and Efficacy of Delandistrogene Moxeparvovec (SRP-9001) Following Imlifidase Infusion in Participants With Duchenne Muscular Dystrophy (DMD) Determined to Have Pre-existing Antibodies to Recombinant Adeno-Associated Virus Serotype (rAAVrh74) |
TERMINATED | PHASE1 |
| NCT05753930 |
Imlifidase Prior to Kidney Transplant in Highly Sensitised Children |
RECRUITING | PHASE2 |
| NCT05679401 |
A Study With Imlifidase in Anti-GBM Disease |
TERMINATED | PHASE3 |
| NCT05369975 |
Efficacy and Safety in Imlifidase Desensitized Kidney Tx Patients, Including Two Non-Comparative Reference Cohorts |
COMPLETED | PHASE3 |
| NCT05049850 |
A Study to Investigate DSA Rebound in Patients Treated With Imlifidase Prior to Transplantation |
TERMINATED | PHASE2 |
| NCT04935177 |
Renal Function in Highly Sensitized Patients 1 Year After Desensitization With Imlifidase Prior to DD Kidney Tx |
COMPLETED | PHASE3 |
| NCT04711850 |
An Long-term Follow-up Trial of Kidney Tx Patients Treated With Imlifidase or PE After an AMR |
TERMINATED | |
| NCT03943589 |
A Study of Imlifidase in Patients With Guillain-Barré Syndrome |
COMPLETED | PHASE2 |
