Drugs / Imlifidase
Imlifidase
also known as
IdeS · HMED-IdeS · Idefirix · Ides recombinant · Imlifidasa · Imunoglobulin G Degrading Enzyme of Streptococcus pyogenous
Regulatory milestones approvals, filings & regulatory actions · 3 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Filed | US (FDA) | — | kidney transplantation | 2025-12-19 | “today announced the submission of a Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) for imlifidase.” hansabiopharma.com ↗ |
| Approved · conditional | EU (EMA) | Idefirix | — | 2020-08-25 | europa.eu ↗ |
| Filed | EU (EMA) | IDEFIRIX | kidney transplantation | 2019-02-28 | “The Marketing Authorization Application for imlifidase in kidney transplantation was accepted for review by the European Medicines Agency on Feb. 28, 2019.” hansabiopharma.com ↗ “The Marketing Authorization Application for imlifidase in kidney transplant was accepted for review by the European Medicines Agency on Feb. 28, 2019” hansabiopharma.com ↗ “Hansa has submitted a Marketing Authorisation Application (MAA) to the European Medicines Agency (EMA) for IDEFIRIX™ (INN: imlifidase)” hansabiopharma.com ↗ “The European Medicines Agency (EMA) accepted Hansa’s Marketing Authorization Application (MAA) for review of IDEFIRIX (imlifidase).” hansabiopharma.com ↗ “Hansa has submitted a Marketing Authorisation Application to the European Medicines Agency (EMA) for IDEFIRIX™ (INN: imlifidase)” hansabiopharma.com ↗ “On Feb. 28, 2019 our MAA for imlifidase in kidney transplantation was accepted for review by the European Medicines Agency, EMA.” hansabiopharma.com ↗ “the MAA for imlifidase in kidney transplantation in Europe, which was accepted for review by EMA on Feb 28, 2019.” hansabiopharma.com ↗ |
Trials 18
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 12 trials | ||||||
| Phase 1 | NCT06241950 | Jan 2024 → Oct 2025 | Duchenne muscular dystrophy | Sarepta Therapeutics, Inc. | Terminated | No outcome recorded Stop: Business |
| Phase 1 | NCT01802697 | Feb → Dec 2013 | — | Hansa Biopharma AB | Completed | No outcome recorded |
| Phase 1/21 trial | ||||||
| Phase 1/2 | NCT02426684 | Jun 2015 → Nov 2017 | kidney disorder | Cedars-Sinai Medical Center | Completed | No outcome recorded |
| Phase 211 trials · 1 met primary | ||||||
| Phase 2 | NCT06518005 | Nov 2024 → Sep 2026 overdue | Crigler-Najjar syndrome | Genethon | Recruiting | No outcome recorded |
| Phase 2 | NCT06461546 | Oct 2024 → Dec 2026 | — | Fundacion Clinic per a la Recerca Biomédica | Withdrawn | No outcome recorded |
| Phase 2 | NCT05753930 | Jun 2023 → Feb 2027 expected | — | Hansa Biopharma AB | Recruiting | No outcome recorded |
| Phase 2 | NCT05049850 | Dec 2022 → Feb 2024 | — | Hansa Biopharma AB | Terminated | No outcome recorded |
| Phase 2 | NCT03943589 | Nov 2019 → Feb 2024 | Guillain-Barre syndrome | Hansa Biopharma AB | Completed | No outcome recorded |
| Phase 2 | NCT03897205 | Apr 2019 → May 2022 | transplant rejection | Hansa Biopharma AB | Completed | Met primary |
| Phase 2 | NCT03157037 | Jun 2017 → Jul 2020 | anti-glomerular basement membrane disease | Mårten Segelmark | Completed | No outcome recorded |
| Phase 2 | NCT02854059 | Sep 2016 → Jan 2017 | thrombotic thrombocytopenic purpura | Hansa Biopharma AB | Terminated | No outcome recorded |
| Phase 2 | NCT02790437 | Jun 2016 → Dec 2017 | chronic renal failure syndrome | Hansa Biopharma AB | Completed | No outcome recorded |
| Phase 2 | NCT02475551 | Jun 2015 → Oct 2016 | end stage renal failure | Hansa Biopharma AB | Completed | No outcome recorded |
| Phase 2 | NCT02224820 | Jun 2014 → Feb 2015 | chronic kidney disease | Hansa Biopharma AB | Completed | No outcome recorded |
| Phase 34 trials · 1 met primary · 1 missed | ||||||
| Phase 3 | NCT05937750 | Jul 2023 → Apr 2030 expected | — | Hansa Biopharma AB | Active not recruiting | No outcome recorded |
| Phase 3 | NCT05679401 | Dec 2022 → Jun 2025 | anti-glomerular basement membrane disease | Hansa Biopharma AB | Terminated | Missed primary |
| Phase 3 | NCT05369975 | Apr 2022 → Apr 2026 | — | Hansa Biopharma AB | Completed | Met primary |
| Phase 3 | NCT04935177 | Oct 2021 → Jun 2025 | — | Hansa Biopharma AB | Completed | No outcome recorded |
News releases announcing trial results or a regulatory action · 46
| Date | Issuer | Release |
|---|---|---|
| 2026-05-27 | Hansa Biopharma AB | Results Hansa Biopharma reports positive efficacy and safety results from Idefirix[®] European post authorization study in kidney transplantation hansabiopharma.com ↗
The one ‑ year graft failure ‑ free survival observed in this highly sensitized patient population confirms the clinical benefit of Idefirix and demonstrates expected efficacy outcomes supported by a safety profile consistent with prior clinical experience. |
| 2026-05-04 | Genethon | Results Genethon to Present Efficacy Data from 3 Major Clinical Trials of Its Gene Therapy Products at the 2026 American Society of Gene & Cell Therapy Annual Meeting May 11-15 in Boston, MA genethon.com ↗
Data presented from the first patient treated with GNT-018-IDES trial demonstrates the feasibility of imlifidase as pretreatment in gene therapy for patients with Crigler–Najjar syndrome who are immune to AAV vectors. |
| 2026-03-04 | Hansa Biopharma AB | Regulatory PDUFA Action Date for Hansa Biopharma’s Imlifidase BLA Set for December 19, 2026 hansabiopharma.com ↗
With the PDUFA date now set, we are one step closer to potentially offering imlifidase as a transformative therapy option for patients who today have very limited access to a life ‑ changing kidney transplant. |
| 2026-02-18 | Hansa Biopharma AB | Regulatory Hansa Biopharma’s Biologics License Application (BLA) for imlifidase accepted by the FDA hansabiopharma.com ↗
today announced that its Biologics License Application (BLA) for imlifidase has been accepted by the U.S. Food and Drug Administration (FDA). |
| 2025-12-19 | Hansa Biopharma AB | Regulatory Hansa Biopharma Submits BLA to FDA for Imlifidase in desensitization for Kidney Transplantation hansabiopharma.com ↗
Hansa Biopharma AB, (“Hansa” or “the Company”), (Nasdaq Stockholm: HNSA), today announced the submission of a Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) for imlifidase. |
| 2025-12-16 | Hansa Biopharma AB | Results Hansa provides update on Pivotal Phase 3 trial in anti-glomerular basement membrane (anti-GBM) disease hansabiopharma.com ↗
Despite the deep and rapid reduction of anti-GBM antibodies following imlifidase treatment, it did not result in a statistically significant outcome in this setting. |
| 2025-10-10 | Hansa Biopharma AB | Results Data from GNT-018-IDES trial supports feasibility of imlifidase as pretreatment in gene therapy treatment for patients with Crigler–Najjar syndrome who are immune to AAV hansabiopharma.com ↗
This encouraging result, achieved in a clinical trial, is a significant advance in the treatment of patients with immunity to AAVs who were previously ineligible for clinical trials and existing gene therapy treatments. |
| 2025-10-10 | Genethon | Results Data from GNT-018-IDES trial supports feasibility of imlifidase as pretreatment in gene therapy treatment for patients with Crigler–Najjar syndrome who are immune to AAV genethon.com ↗
This encouraging result, achieved in a clinical trial, is a significant advance in the treatment of patients with immunity to AAVs who were previously ineligible for clinical trials and existing gene therapy treatments. |
| 2025-09-24 | Hansa Biopharma AB | Results Imlifidase successfully meets primary endpoint in pivotal US Phase 3 ConfIdeS trial in kidney transplantation hansabiopharma.com ↗
The trial was well conducted, with patient retention in excess of 90%, and met the primary endpoint of kidney function at 12 months as measured by mean estimated Glomerular Filtration Rate (eGFR) with a p-value of <0.0001. |
| 2025-08-01 | Hansa Biopharma AB | Results Hansa Biopharma announces supportive data from treatment with imlifidase prior to the administration of gene therapy for Duchenne muscular dystrophy hansabiopharma.com ↗
After one dose of imlifidase, three patients experienced a rapid reduction of IgG antibodies, to levels ≥95% less than baseline. |
| 2025-06-30 | Hansa Biopharma AB | Results Hansa Biopharma presents positive outcomes of five-year follow-up study of imlifidase in kidney transplantation at ESOT Congress 2025 in London hansabiopharma.com ↗
The extended pooled analysis, including data from the 17-HMedIdeS-14 study, showed sustained positive outcomes out to five years of highly sensitized patients who received an imlifidase-enabled kidney transplant. |
| 2024-12-17 | Hansa Biopharma AB | Results Hansa Biopharma announces positive full results from 15-HMedIdeS-09 Phase 2 study and comparative analysis of imlifidase in patients with Guillain-Barré Syndrome hansabiopharma.com ↗
Hansa Biopharma, “Hansa” (Nasdaq Stockholm: HNSA), today announced positive full results from the 15-HMedIdeS-09 single arm Phase 2 study of imlifidase, a first in class IgG cleaving enzyme, in Guillain-Barré Syndrome (GBS) and an indirect treatment comparison of the 15-HMedIdeS-09 study data to the International Guillain-Barré Syndrome Outcome Study (IGOS), a worldwide prospective study by the Inflammatory Neuropathy Consortium on prognosis and biomarkers of GBS. |
| 2023-12-14 | Hansa Biopharma AB | Results Imlifidase met primary endpoint in 16-HMedIdes-12 phase 2 trial in patients with AMR following kidney transplantation hansabiopharma.com ↗
Patients treated with imlifidase demonstrated a statistically significant reduction of DSAs by 94.4% compared to a 35.6% (p-value: <0.001) reduction in patients who received standard of care (plasma exchange, or PE). |
| 2023-12-07 | Hansa Biopharma AB | Results Imlifidase demonstrated positive safety, tolerability, and early efficacy outcomes in 15-HMedIdeS-09 phase 2 trial in Guillain-Barré Syndrome (GBS) hansabiopharma.com ↗
Hansa Biopharma, “Hansa” (Nasdaq Stockholm: HNSA), today announced positive high-level data from the 15-HMedIdeS-09 phase 2 trial that demonstrated imlifidase was safe and well tolerated when administered prior to standard of care, including rapid improvement in disease-related efficacy measures. |
| 2023-10-17 | Hansa Biopharma AB | Results Imlifidase demonstrated 90% patient survival and 82% graft survival at five years in extended pooled analysis with data from 17-HMedIdeS-14 study hansabiopharma.com ↗
After 5 years, the patient survival rate was 90% (three deaths occurring between six months and one year, and no deaths occurring between one and five years) and graft survival (death censored) was 82%, in line with outcomes seen at 3-years post-transplant. |
| 2023-07-11 | Hansa Biopharma AB | Regulatory Idefirix (imlifidase) receives provisional approval in Australia as desensitization treatment in highly sensitized patients prior to kidney transplantation hansabiopharma.com ↗
Hansa applauds the TGA for being the first regulatory body to approve the use of Idefirix in transplants from both living and deceased donors, thus ensuring comprehensive access for highly sensitized patients in Australia to this important therapy. |
| 2022-12-08 | Hansa Biopharma AB | Regulatory Hansa Biopharma announces positive reimbursement decision in Italy for Idefirix® (imlifidase) as desensitization treatment for highly sensitized patients in kidney transplantation hansabiopharma.com ↗
The positive decision by AIFA provides highly sensitized patients in Italy with an important opportunity to access a potentially lifesaving kidney transplant |
| 2022-11-28 | Hansa Biopharma AB | Results Hansa Biopharma announces positive topline data from the imlifidase phase 2 study in antibody mediated rejection (AMR) episodes post kidney transplantation hansabiopharma.com ↗
The topline data associated with the primary endpoint shows that imlifidase has significantly superior efficacy compared to plasma exchange in reducing DSAs during the five days following the start of treatment. |
| 2022-09-12 | Hansa Biopharma AB | Regulatory The Scottish Medicines Consortium (SMC) recommends use of Hansa Biopharma’s Idefirix® (imlifidase) as desensitization treatment for highly sensitized kidney transplant patients hansabiopharma.com ↗
Hansa Biopharma, “Hansa” (Nasdaq Stockholm: HNSA), a pioneer in enzyme technology for rare immunological conditions, today announce the recommendation by the Scottish Medicines Consortium (SMC) for its first-in-class treatment Idefirix ® in the desensitization of highly sensitized adult patients prior to kidney transplant from a deceased donor. |
| 2022-08-22 | Hansa Biopharma AB | Regulatory Hansa Biopharma and Medison Pharma announce positive reimbursement decision in Poland for Idefirix® in highly sensitized kidney transplant patients hansabiopharma.com ↗
Based on the decision to grant reimbursement, Idefirix ® will be fully financed and available to patients who qualify for a newly established drug program run by multiple transplant centres in Poland from September 1 st 2022. |
| 2022-05-13 | Hansa Biopharma AB | Regulatory Hansa Biopharma announces temporary marketing authorization in Switzerland for Idefirix® (imlifidase) in kidney transplantation hansabiopharma.com ↗
today announces that the Swiss Agency for Therapeutic Products (Swissmedic) has granted temporary marketing authorization for Idefirix ® in adult patients with a positive crossmatch against an available organ from a diseased donor. |
| 2022-04-21 | Hansa Biopharma AB | Regulatory Hansa Biopharma interim report January – March 2022 hansabiopharma.com ↗
Hansa and Medison Pharma announced that a marketing authorization in Israel for Idefirix ® has been granted for desensitization treatment of highly sensitized kidney transplant patients. |
| 2022-04-20 | Hansa Biopharma AB | Regulatory Hansa Biopharma granted added benefit ASMR 3 by French Transparency Commission for Idefirix® (imlifidase) as desensitization treatment for highly sensitized kidney transplant patients hansabiopharma.com ↗
today announces that its treatment Idefirix ® has been granted an ASMR 3 rating by the Transparency Commission (TC) of the French National Authority for Health (HAS) as part of the ongoing pricing and reimbursement process. |
| 2022-04-19 | Hansa Biopharma AB | Regulatory Hansa Biopharma announces U.S. FDA acceptance of Investigational New Drug (IND) application for Phase 3 study of imlifidase in anti-GBM disease hansabiopharma.com ↗ |
| 2022-03-28 | Hansa Biopharma AB | Regulatory Hansa Biopharma and Medison Pharma announce marketing authorization in Israel for Idefirix® (imlifidase) for desensitization treatment of highly sensitized kidney transplant patients hansabiopharma.com ↗
Israel is the first market outside of Europe to grant regulatory approval for Idefirix ® |
| 2022-03-08 | Hansa Biopharma AB | Results Key data demonstrating the potential of Hansa Biopharma’s imlifidase to significantly alter course of anti-GBM disease published in JASN hansabiopharma.com ↗
At six months 67% of the included patients had functioning kidneys versus 18% in a historical control cohort. |
| 2022-02-25 | Hansa Biopharma AB | Regulatory Hansa Biopharma announces positive early access decision by French Haute Autorité de Santé to use Idefirix® (imlifidase) as desensitization treatment for highly sensitized kidney transplant patients hansabiopharma.com ↗ |
| 2021-07-09 | Hansa Biopharma AB | Results Hansa Biopharma announces long term follow-up data demonstrating 3-year graft survival of 84% after imlifidase treatment and transplantation hansabiopharma.com ↗
Three-year overall allograft survival was 84% in crossmatch positive patients treated with imlifidase. |
| 2020-09-24 | Hansa Biopharma AB | Results Hansa Biopharm announces positive high-level data from investigator-initiated phase 2 trial with imlifidase to treat anti-GBM disease hansabiopharma.com ↗
The first high-level data read out has been completed and the encouraging results indicate that imlifidase treatment may lead to increased renal survival in patients with anti-GBM antibody disease due to rapid clearance of IgG antibodies. |
| 2020-06-25 | Hansa Biopharma AB | Regulatory Hansa Biopharma receives positive CHMP opinion for Idefirix[TM] (imlifidase) for kidney transplant in EU hansabiopharma.com ↗ |
| 2020-05-20 | Hansa Biopharma AB | Results Hansa Biopharma announces upcoming presentations including a late breaking poster presentation at the 2020 American Transplant Congress hansabiopharma.com ↗
The data demonstrate patient and graft survival rates of 90% after treatment. |
| 2020-03-06 | Hansa Biopharma AB | Results Hansa Biopharma announces long term follow-up data that demonstrates 2-year graft survival of 89% after imlifdase treatment and transplantation hansabiopharma.com ↗
2-year death censored graft survival was 24 out of 27 patients (89%), and overall graft survival was 24 of 30 patients (80%). |
| 2019-12-13 | Hansa Biopharma AB | Regulatory Hansa Biopharma has agreed with the FDA on a regulatory path forward for imlifidase in kidney transplantation of highly sensitized patients in the U.S. hansabiopharma.com ↗
Upon agreement with the FDA, following submission of a final study protocol, the Company will conduct a randomized, controlled clinical study in a limited group of highly sensitized kidney patients using a surrogate endpoint. |
| 2019-09-18 | Hansa Biopharma AB | Results Hansa Biopharma: Positive results presented at ESOT; imlifidase enabled transplantation in 46 sensitized patients hansabiopharma.com ↗
Following imlifidase treatment, the DSA levels rapidly decreased and all crossmatches were converted to negative, thus enabling transplantation of all patients. |
| 2019-08-30 | Hansa Biopharma AB | Results Hansa Biopharma: New imlifidase data presented at ESOT, Copenhagen hansabiopharma.com ↗
The results show that imlifidase treatment rapidly and prior to transplantation inactivated donor specific antibodies (DSAs) and converted positive crossmatches to negative. |
| 2019-06-07 | Hansa Biopharma AB | Results Plenary Presentation at the 2019 American Transplant Congress Demonstrates Significant Reduction in Time on the Waitlist for Patients Treated with Imlifidase Compared to Matched Controls hansabiopharma.com ↗
In his presentation, Dr. Huang reported a statistically significant reduction in time on the waitlist for transplantation among imlifidase treated patients compared to similarly sensitized matched controls. |
| 2019-05-02 | Hansa Biopharma AB | Results Hansa Biopharma Announces Upcoming Presentations at the 2019 American Transplant Congress hansabiopharma.com ↗
Results show excellent graft survival out to three years. |
| 2019-04-15 | Hansa Biopharma AB | Regulatory Hansa Biopharma Receives Ethics and Regulatory Clearance to Start Phase 2 Study of Imlifidase in Guillain Barré Syndrome hansabiopharma.com ↗ |
| 2019-03-26 | Hansa Biopharma AB | Regulatory Hansa Biopharma Receives Ethics and Regulatory Clearance to Start Phase 2 Study of imlifidase in Acute Antibody Mediated Rejection in Kidney Transplantation hansabiopharma.com ↗ |
| 2018-10-26 | Hansa Biopharma AB | Results Presentation at ASN Kidney Week 2018 Highlights Stable Renal Function at up to 24 Months Following Transplantation Enabled by Imlifidase hansabiopharma.com ↗
The presentation described results from the U.S. investigator initiated Phase 2 study demonstrating continued stable renal function over time in long term follow up, up to 24 months after transplantation enabled by imlifidase. |
| 2018-10-24 | Hansa Biopharma AB | Regulatory Hansa Medical Receives Positive Opinion for Orphan Drug Designation in the EU for Imlifidase for Anti-GBM Disease hansabiopharma.com ↗ |
| 2018-10-17 | Hansa Biopharma AB | Regulatory Hansa Medical Receives FDA Fast Track Designation for Imlifidase for Transplantation hansabiopharma.com ↗
“This Fast Track Designation is validation of imlifidase’s potential to address the significant unmet medical need for highly sensitized patients, a patient population for which transplantation is extremely difficult or impossible,” said Søren Tulstrup, President and Chief Executive Officer of Hansa. |
| 2018-09-27 | Hansa Biopharma AB | Results Hansa Medical Reports Positive Final Top Line Results from Two Phase 2 Studies of Imlifidase for Kidney Transplantation hansabiopharma.com ↗
Imlifidase enabled kidney transplantation for all 35 highly sensitized patients. |
| 2018-07-09 | Hansa Biopharma AB | Regulatory Hansa Medical lead candidate imlifidase (IdeS) granted orphan drug designation by the FDA for anti-GBM antibody disease hansabiopharma.com ↗
We are very pleased to receive orphan designation for imlifidase in the US for the treatment of anti-GBM. |
| 2018-06-06 | Hansa Biopharma AB | Results Presentation at the 2018 American Transplant Congress highlights the long-term risk-benefit profile of imlifidase (IdeS) in kidney transplantation hansabiopharma.com ↗
In addition, Professor Jordan highlighted that that the two-year follow-up data demonstrate good patient and graft survival without increased infection risk and that no serious adverse events related to imlifidase have been reported in his study. |
| 2018-05-30 | Hansa Biopharma AB | Results Long-term follow up data from investigator-initiated Phase II study with imlifidase (IdeS) to be presented at 2018 American Transplant Congress (ATC) hansabiopharma.com ↗
The long-term follow up results from the study, demonstrate that patients desensitized with imlifidase (IdeS) and transplanted with HLA-incompatible kidney show good renal function and minimal evidence of antibody mediated rejection (AMR) at a mean 18.76 months post kidney transplantation. |
All press releases naming this drug 86 releases
Evidence & citations 10 cited values
Every value below carries the sentence it was read from. 23 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Imlifidase | “Safety, immunogenicity, pharmacokinetics, and efficacy of degradation of anti-HLA antibodies by IdeS (imlifidase) in chronic kidney disease patients.” PMID 29561066 ↗ Apr 2018 |
| Known as | HMED-IdeS | ChEMBL registry synonym — accepted as the source's own label CHEMBL4297981 ↗ |
| Known as | Idefirix | ChEMBL registry synonym — accepted as the source's own label CHEMBL4297981 ↗ |
| Known as | IdeS | ClinicalTrials.gov intervention name — accepted as the source's own label NCT02426684 ↗ |
| Known as | Ides recombinant | ChEMBL registry synonym — accepted as the source's own label CHEMBL4297981 ↗ |
| Known as | Imlifidasa | ChEMBL registry synonym — accepted as the source's own label CHEMBL4297981 ↗ |
| Known as | Imunoglobulin G Degrading Enzyme of Streptococcus pyogenous | “GOOD-IDES-01 (treating GOODpasture's disease with Imunoglobulin G Degrading Enzyme of Streptococcus pyogenous) (ClinicalTrials.gov identifier: NCT03157037) trial , where imlifidase” PMID 37385828 ↗ Dec 2023 |
| Action | Inhibit | “The IgG-degrading enzyme derived from Streptococcus pyogenes (IdeS), an endopeptidase, cleaves human IgG into F(ab')2 and Fc fragments inhibiting complement-dependent...” PMID 28767349 ↗ Aug 2017 |
| Modality | Protein / enzyme biologic | “the IgG cleaving enzyme Immunoglobuli G degrading enzyme of streptococcus pyogenes (IdeS)” NCT01802697 ↗ |
| Route | Intravenous | “Twenty healthy subjects were given intravenous single ascending doses of IdeS.” PMID 26177518 ↗ Jul 2015 |