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Hansa Biopharma AB (SE:HNSA)
:HNSA
Delandistrogene Moxeparvovec, Imlifidase
Duchenne Muscular Dystrophy
Phase I
Enrolling By Invitation
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)
Jan 26, 2024
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Imlifidase Administered In The 20-Hmedides-19 (Paes) Study, Best Available Treatment Administered In The 20-Hmedides-19 (Paes) Study
Long Term Efficacy And Safety
Phase III
Recruiting
A Long-term Follow-up Trial of Patients Previously Treated With Imlifidase Prior to Kidney Transplantation and a Non-comparative Transplanted Patient Group
Jun 13, 2023
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Imlifidase
Kidney Transplantation In Highly Sensitized Patients
Phase II
Recruiting
Imlifidase Prior to Kidney Transplant in Highly Sensitised Children
Feb 23, 2023
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Imlifidase, Plasma Exchange (Plex), Cyclophosphamide (Cyc), Glucocorticoids
Anti-Glomerular Basement Membrane Disease, Anti-Glomerular Basement Membrane Antibody Disease, Goodpasture Syndrome, Good Pasture Syndrome
Phase III
Active Not Recruiting
A Study With Imlifidase in Anti-GBM Disease
Dec 15, 2022
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Imlifidase, Normal Transplantation Routine
Kidney Transplantation In Highly Sensitized Patients
Phase III
Active Not Recruiting
Efficacy and Safety in Imlifidase Desensitized Kidney Tx Patients, Including Two Non-Comparative Reference Cohorts
May 06, 2022
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Imlifidase
Kidney Transplantation In Highly Sensitized Patients
Phase II
Terminated
A Study to Investigate DSA Rebound in Patients Treated With Imlifidase Prior to Transplantation
Sep 09, 2021
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Imlifidase, Eculizumab, IVIg, Plex, Anti-Cd20 Antibodies, Remain On Wait List
Kidney Transplantation In Highly Sensitized Patients
Phase III
Completed
Renal Function in Highly Sensitized Patients 1 Year After Desensitization With Imlifidase Prior to DD Kidney Tx
Jun 14, 2021
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Imlifidase
Guillain-Barré Syndrome (Gbs)
Phase II
Completed
A Study of Imlifidase in Patients With Guillain-Barré Syndrome
Apr 30, 2019
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FAQ
What are the FDA phases for drug approval?
The FDA approval process for new drugs is divided into several phases:
a. Preclinical testing
b. Phase 1 – Safety and dosage
c. Phase 2 – Effectiveness and side effects
d. Phase 3 – Confirmation of effectiveness, monitoring of adverse reactions, and comparison with existing treatments
e. Phase 4 – Post-marketing studies to track long-term safety and effectiveness
a. Preclinical testing
b. Phase 1 – Safety and dosage
c. Phase 2 – Effectiveness and side effects
d. Phase 3 – Confirmation of effectiveness, monitoring of adverse reactions, and comparison with existing treatments
e. Phase 4 – Post-marketing studies to track long-term safety and effectiveness
What is a clinical trial?
A clinical trial is a carefully designed study in which researchers test a drug, treatment, or medical device in people to evaluate its safety, effectiveness, and potential side effects. These trials are essential for determining whether a new treatment should be approved for widespread use.
What drugs does Hansa Biopharma AB (HNSA) have in its pipeline
HNSA is currently developing the following drugs: Delandistrogene Moxeparvovec, Imlifidase, Imlifidase Administered In The 20-Hmedides-19 (Paes) Study, Best Available Treatment Administered In The 20-Hmedides-19 (Paes) Study, Imlifidase. These drug candidates are in various stages of clinical development as the company works toward FDA approval.