Hansa Biopharma AB(DE:24H)
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DE:24H
Hansa Biopharma AB stock drug pipeline
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Hansa Biopharma AB (24H) Drug Pipeline
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| Drug Name | Condition | Stage | Status | Study Name | Trial Start Date | Article |
|---|---|---|---|---|---|---|
| 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 | ― |
| 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 | ― |
| Imlifidase | Kidney Transplantation In Highly Sensitized Patients | Phase II | Recruiting | Imlifidase Prior to Kidney Transplant in Highly Sensitised Children | Feb 23, 2023 | ― |
| 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 | ― |
| 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 | ― |
| 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 | ― |
| 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 | ― |
| Imlifidase | Guillain-Barré Syndrome (Gbs) | Phase II | Completed | A Study of Imlifidase in Patients With Guillain-Barré Syndrome | Apr 30, 2019 | ― |
| Drug Name | Stage | Condition | Status | Study Name | Trial Start Date | Article |
|---|---|---|---|---|---|---|
| Delandistrogene Moxeparvovec, Imlifidase | Phase I | Duchenne Muscular Dystrophy | 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 | ― |
| Imlifidase Administered In The 20-Hmedides-19 (Paes) Study, Best Available Treatment Administered In The 20-Hmedides-19 (Paes) Study | Phase III | Long Term Efficacy And Safety | 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 | ― |
| Imlifidase | Phase II | Kidney Transplantation In Highly Sensitized Patients | Recruiting | Imlifidase Prior to Kidney Transplant in Highly Sensitised Children | Feb 23, 2023 | ― |
| Imlifidase, Plasma Exchange (Plex), Cyclophosphamide (Cyc), Glucocorticoids | Phase III | Anti-Glomerular Basement Membrane Disease, Anti-Glomerular Basement Membrane Antibody Disease, Goodpasture Syndrome, Good Pasture Syndrome | Active Not Recruiting | A Study With Imlifidase in Anti-GBM Disease | Dec 15, 2022 | ― |
| Imlifidase, Normal Transplantation Routine | Phase III | Kidney Transplantation In Highly Sensitized Patients | Active Not Recruiting | Efficacy and Safety in Imlifidase Desensitized Kidney Tx Patients, Including Two Non-Comparative Reference Cohorts | May 06, 2022 | ― |
| Imlifidase | Phase II | Kidney Transplantation In Highly Sensitized Patients | Terminated | A Study to Investigate DSA Rebound in Patients Treated With Imlifidase Prior to Transplantation | Sep 09, 2021 | ― |
| Imlifidase, Eculizumab, IVIg, Plex, Anti-Cd20 Antibodies, Remain On Wait List | Phase III | Kidney Transplantation In Highly Sensitized Patients | Completed | Renal Function in Highly Sensitized Patients 1 Year After Desensitization With Imlifidase Prior to DD Kidney Tx | Jun 14, 2021 | ― |
| Imlifidase | Phase II | Guillain-Barré Syndrome (Gbs) | Completed | A Study of Imlifidase in Patients With Guillain-Barré Syndrome | Apr 30, 2019 | ― |
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
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 (DE:24H) have in its pipeline
Hansa Biopharma AB DE:24H 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, Imlifidase, Plasma Exchange (Plex), Cyclophosphamide (Cyc), Glucocorticoids, Imlifidase, Normal Transplantation Routine, Imlifidase, Eculizumab, IVIg, Plex, Anti-Cd20 Antibodies, Remain On Wait List. These drug candidates are in various stages of clinical development as the company works toward FDA approval.
