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 · 1 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Approved · conditional | EU (EMA) | Idefirix | — | 2020-08-25 | europa.eu ↗ |
Trials 18 · a red edge is where a trial was stopped
| 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 |
| 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 | ||||||
| Phase 2 | NCT06518005 | Nov 2024 → Sep 2026 expected | 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| Phase 2 | NCT06461546 | Oct 2024 → Dec 2026 | — | Fundacion Clinic per a la Recerca Biomédica | Withdrawn | No outcome recorded |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 | No outcome recorded |
| 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 | ||||||
| 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 | No outcome recorded |
| Phase 3 | NCT05369975 | Apr 2022 → Apr 2026 | — | Hansa Biopharma AB | Completed | No outcome recorded |
| Phase 3 | NCT04935177 | Oct 2021 → Jun 2025 | — | Hansa Biopharma AB | Completed | No outcome recorded |
Press releases naming this drug 1 release
| Date | Issuer | Release |
|---|---|---|
| 2020-07-02 | Sarepta Therapeutics, Inc. | Sarepta Therapeutics Signs Agreement with Hansa Biopharma for Imlifidase sarepta.com ↗ |
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 NCT01802697 ↗ |
| 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 |