Imlifidase

Phase 2Protein / enzyme

HHansa Biopharma AB

Imlifidase is one of 70 small molecule programs targeting Kidney Transplant. It is currently in Phase 2.

Indications

Total Trials

Active Trials

Competitors

Pipeline

Status by Indication[3][1]

Indication

Kidney TransplantActive, not recruiting

Crigler-Najjar SyndromeActive, not recruiting

Duchenne Muscular DystrophyActive, not recruiting

Kidney TransplantPreclinical

Active, not recruiting

Crigler-Najjar SyndromePhase 2

Active, not recruiting

Duchenne Muscular DystrophyPhase 1

Active, not recruiting

Competition

Competitive Landscape

476 competitors in Kidney Transplant

#DrugCompanyPhaseTrials

Simulect

Novartis

Preclinical

15 2

Medrol

Pfizer

Preclinical

12 3

Imlifidase

HHansa Biopharma AB

Phase 2

3 4

Zemplar

AbbVie

Preclinical

2 5

Cysteine Hydrochloride

Novartis

Preclinical

1 6

Jardiance

Boehringer Ingelheim

Preclinical

3 7

Nydrazid

KKaruna Therapeutics, Inc., a Bristol Myers Squibb company

Preclinical

2 8

Osmitrol

BB. Braun Medical Inc.

Preclinical

1 9

Glucophage

EMD Serono

Preclinical

1 10

Acupan

YYonsei University

Preclinical

Ranked by pipeline maturity and clinical activity. Current drug highlighted in teal.

Timeline

Expected Milestones

Q3 2030

Phase 2Recruiting

Crigler-Najjar Syndrome

NCT06518005

Q3 2031

Phase 2Recruiting

Kidney Transplant

NCT05753930

Clinical

Trials by Indication[1]

Kidney Transplant3 trials

Imlifidase Prior to Kidney Transplant in Highly Sensitised Children

Recruiting·HHansa Biopharma AB·Phase 2·NCT05753930·10 enrolled

An Efficacy and Safety Study of Imlifidase in Treatment of Antibody-Mediated Rejection in Kidney Transplant Patients

Completed·HHansa Biopharma AB·Phase 2·NCT03897205·30 enrolled

A Follow up Study of Patients Treated With Imlifidase Prior to Kidney Transplantation

Completed·HHansa Biopharma AB··NCT03611621·31 enrolled

Efficacy and Safety2 trials

Efficacy and Safety in Imlifidase Desensitized Kidney Tx Patients, Including Two Non-Comparative Reference Cohorts

Active, not recruiting·HHansa Biopharma AB·Phase 3·NCT05369975·225 enrolled

Open-Label Phase II Study to Evaluate the Efficacy and Safety of IdeS in Anti-GBM Disease

Completed·MMårten Segelmark·Phase 2·NCT03157037·15 enrolled

AIN1 trial

A Study of Imlifidase in Patients With Guillain-Barré Syndrome

Completed·HHansa Biopharma AB·Phase 2·NCT03943589·30 enrolled

Renal Transplantation1 trial

Imlifidase in Living Donor Renal Transplantation Highly Sensitized Recipients

Withdrawn·FFundacion Clinic per a la Recerca Biomédica·Phase 2·NCT06461546

Desensitization1 trial

Renal Function in Highly Sensitized Patients 1 Year After Desensitization With Imlifidase Prior to DD Kidney Tx

Completed·HHansa Biopharma AB·Phase 3·NCT04935177·64 enrolled

5 more indications

Long-term Follow-up1 trial

An Long-term Follow-up Trial of Kidney Tx Patients Treated With Imlifidase or PE After an AMR

Terminated·HHansa Biopharma AB··NCT04711850·18 enrolled

Duchenne Muscular Dystrophy1 trial

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· Sarepta Therapeutics logo

Sarepta Therapeutics·Phase 1·NCT06241950·5 enrolled

GBM1 trial

A Study With Imlifidase in Anti-GBM Disease

Terminated·HHansa Biopharma AB·Phase 3·NCT05679401·50 enrolled

Transplantation1 trial

A Study to Investigate DSA Rebound in Patients Treated With Imlifidase Prior to Transplantation

Terminated·HHansa Biopharma AB·Phase 2·NCT05049850·3 enrolled

Crigler-Najjar syndrome1 trial

Efficacy and Safety of GNT0003 Following Imlifidase Pre-treatment in Severe Crigler-Najjar Syndrome

Recruiting·GGenethon·Phase 2·NCT06518005·3 enrolled

Sources

References

[1]
ClinicalTrials.gov — 13 trial records for Imlifidase. U.S. National Library of Medicine, National Institutes of Health.
[2]
ChEMBL — Imlifidase compound record. European Bioinformatics Institute (EMBL-EBI).
[3]
Open Targets Platform — Drug–disease associations for Imlifidase. EMBL-EBI & Wellcome Sanger Institute.
[4]
SEC EDGAR — Hansa Biopharma AB company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Modality: Protein / enzyme[2]
Highest Phase: Phase 2[1]
Company: HHansa Biopharma AB

Imlifidase

Status by Indication[3][1]

Competitive Landscape

Expected Milestones

Q3 2030

Q3 2031

Trials by Indication[1]

Kidney Transplant3 trials

Efficacy and Safety2 trials

AIN1 trial

Renal Transplantation1 trial

Desensitization1 trial

Long-term Follow-up1 trial

Duchenne Muscular Dystrophy1 trial

GBM1 trial

Transplantation1 trial

Crigler-Najjar syndrome1 trial

References

Drug Info

Quick Facts

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