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Healios KK (4593) Drug Pipeline
| Drug Name | Condition | Stage | Status | Study Name | Trial Start Date | Article |
|---|---|---|---|---|---|---|
| Multistem | Trauma, Adult Stem Cells | Phase II | Recruiting | MultiStem® for Treatment of Trauma Induced Multiple Organ Failure/Systemic Inflammatory Response Syndrome | Aug 26, 2020 | ― |
| Multistem | Ards | phase2AndPhase3 | Unknown | MultiStem Administration for COVID-19 Induced ARDS (MACoVIA) | Apr 27, 2020 | ― |
| Hlcm051 | Respiratory Distress Syndrome, Adult | Phase II | Completed | Efficacy and Safety Study of HLCM051(MultiStem®) for Pneumonic Acute Respiratory Distress Syndrome | Jan 08, 2019 | ― |
| Multistem | Ischemic Stroke | Phase III | Unknown | MultiStem® Administration for Stroke Treatment and Enhanced Recovery Study | May 23, 2018 | ― |
| Hlcm051 | Stroke, Acute | phase2AndPhase3 | Completed | Treatment Evaluation of Acute Stroke for Using in Regenerative Cell Elements | Nov 07, 2016 | ― |
| Multistem | Acute Respiratory Distress Syndrome | phase1AndPhase2 | Completed | A Phase 1/2 Study to Assess MultiStem® Therapy in Acute Respiratory Distress Syndrome | Nov 18, 2015 | ― |
| Sham, Ami Multistem Cells | Heart Attack, Nstemi | Phase II | Terminated | A Phase 2 Trial of AMI MultiStem® Therapy in Subjects With Non-ST Elevation Acute Myocardial Infarction | Oct 24, 2014 | ― |
| Multistem | Ischemic Stroke | Phase II | Completed | Study to Examine the Effects of MultiStem in Ischemic Stroke | Sep 15, 2011 | ― |
| Multistem Low Dose, Multistem High Dose | Colitis, Ulcerative | Phase II | Completed | A Study To Investigate The Safety And Possible Clinical Benefit Of Multistem(r) In Patients With Moderate To Severe Ulcerative Colitis | Nov 10, 2010 | ― |
| Drug Name | Stage | Condition | Status | Study Name | Trial Start Date | Article |
|---|---|---|---|---|---|---|
| Multistem | Phase II | Trauma, Adult Stem Cells | Recruiting | MultiStem® for Treatment of Trauma Induced Multiple Organ Failure/Systemic Inflammatory Response Syndrome | Aug 26, 2020 | ― |
| Multistem | phase2AndPhase3 | Ards | Unknown | MultiStem Administration for COVID-19 Induced ARDS (MACoVIA) | Apr 27, 2020 | ― |
| Hlcm051 | Phase II | Respiratory Distress Syndrome, Adult | Completed | Efficacy and Safety Study of HLCM051(MultiStem®) for Pneumonic Acute Respiratory Distress Syndrome | Jan 08, 2019 | ― |
| Multistem | Phase III | Ischemic Stroke | Unknown | MultiStem® Administration for Stroke Treatment and Enhanced Recovery Study | May 23, 2018 | ― |
| Hlcm051 | phase2AndPhase3 | Stroke, Acute | Completed | Treatment Evaluation of Acute Stroke for Using in Regenerative Cell Elements | Nov 07, 2016 | ― |
| Multistem | phase1AndPhase2 | Acute Respiratory Distress Syndrome | Completed | A Phase 1/2 Study to Assess MultiStem® Therapy in Acute Respiratory Distress Syndrome | Nov 18, 2015 | ― |
| Sham, Ami Multistem Cells | Phase II | Heart Attack, Nstemi | Terminated | A Phase 2 Trial of AMI MultiStem® Therapy in Subjects With Non-ST Elevation Acute Myocardial Infarction | Oct 24, 2014 | ― |
| Multistem | Phase II | Ischemic Stroke | Completed | Study to Examine the Effects of MultiStem in Ischemic Stroke | Sep 15, 2011 | ― |
| Multistem Low Dose, Multistem High Dose | Phase II | Colitis, Ulcerative | Completed | A Study To Investigate The Safety And Possible Clinical Benefit Of Multistem(r) In Patients With Moderate To Severe Ulcerative Colitis | Nov 10, 2010 | ― |
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 Healios KK (JP:4593) have in its pipeline
Healios KK JP:4593 is currently developing the following drugs: Multistem, Hlcm051, Sham, Ami Multistem Cells, Multistem Low Dose, Multistem High Dose. These drug candidates are in various stages of clinical development as the company works toward FDA approval.