Omeros (3O8) Drug Pipeline
| Drug Name | Condition | Stage | Status | Study Name | Trial Start Date | Article |
|---|---|---|---|---|---|---|
| Oms906 Study Drug | Paroxysmal Nocturnal Hemoglobinuria | Phase II | Recruiting | Long-Term Safety, Tolerability and Efficacy of OMS906 in Paroxysmal Nocturnal Hemoglobinuria | Feb 17, 2024 | ― |
| Oms906 Study Drug | C3 Glomerulopathy, Idiopathic Immune Complex-Mediated Glomerulonephritis | Phase II | Recruiting | Safety and Efficacy Study of OMS906 in Patients With C3G and ICGN | Jan 04, 2024 | ― |
| Ravulizumab, Oms906 Study Drug - 3 Mg/Kg, Oms906 Study Drug - 5 Mg/Kg | Paroxysmal Nocturnal Hemoglobinuria | Phase II | Active Not Recruiting | Safety and Efficacy of OMS906 in Paroxysmal Nocturnal Hemoglobinuria Patients With a Sub-optimal Response to Ravulizumab | Jul 11, 2023 | ― |
| Oms906 Study Drug | Paroxysmal Nocturnal Hemoglobinuria | Phase I | Unknown | Study of the Safety and Efficacy of OMS906 in Patients With Paroxysmal Nocturnal Hemoglobinuria | May 04, 2023 | ― |
| Biological: Narsoplimab | Thrombotic Microangiopathies, Hematopoietic Stem Cell Transplantation | Phase II | Recruiting | Efficacy and Safety Study of Narsoplimab in Pediatric Patients With High-Risk Hematopoietic Stem Cell Transplant TMA | Apr 06, 2023 | ― |
| Oms721, Vehicle (D5w Or Saline) | Iga Nephropathy | Phase III | Terminated | Study of the Safety and Efficacy of OMS721 in Patients With Immunoglobulin A (IgA) Nephropathy | Jun 21, 2018 | ― |
| Oms721 | Atypical Hemolytic Uremic Syndrome, Thrombotic Microangiopathies | Phase III | Recruiting | Safety and Efficacy Study of OMS721 in Patients With Atypical Hemolytic Uremic Syndrome | Apr 17, 2017 | ― |
| Oms721 (Narsoplimab) | Lupus Nephritis, Igan, Mn, C3 Glomerulopathy | Phase II | Unknown | Safety Study of IgAN, LN, MN, & C3 Glomerulopathy Including Dense Deposit Disease Treated With OMS721 | Feb 10, 2016 | ― |
| Oms721 | Thrombotic Microangiopathies | Phase II | Completed | Safety and Efficacy Study of OMS721 in Patients With Thrombotic Microangiopathies | Aug 18, 2014 | ― |
| Phenylephrine Hcl, Oms302 | Unilateral Cataract Extraction, Congenital Cataract | Phase III | Completed | A Randomized Study in Children Ages Birth Through Three Years Undergoing Unilateral Cataract Extraction With or Without Lens Replacement | May 01, 2014 | ― |
| Drug Name | Stage | Condition | Status | Study Name | Trial Start Date | Article |
|---|---|---|---|---|---|---|
| Oms906 Study Drug | Phase II | Paroxysmal Nocturnal Hemoglobinuria | Recruiting | Long-Term Safety, Tolerability and Efficacy of OMS906 in Paroxysmal Nocturnal Hemoglobinuria | Feb 17, 2024 | ― |
| Oms906 Study Drug | Phase II | C3 Glomerulopathy, Idiopathic Immune Complex-Mediated Glomerulonephritis | Recruiting | Safety and Efficacy Study of OMS906 in Patients With C3G and ICGN | Jan 04, 2024 | ― |
| Ravulizumab, Oms906 Study Drug - 3 Mg/Kg, Oms906 Study Drug - 5 Mg/Kg | Phase II | Paroxysmal Nocturnal Hemoglobinuria | Active Not Recruiting | Safety and Efficacy of OMS906 in Paroxysmal Nocturnal Hemoglobinuria Patients With a Sub-optimal Response to Ravulizumab | Jul 11, 2023 | ― |
| Oms906 Study Drug | Phase I | Paroxysmal Nocturnal Hemoglobinuria | Unknown | Study of the Safety and Efficacy of OMS906 in Patients With Paroxysmal Nocturnal Hemoglobinuria | May 04, 2023 | ― |
| Biological: Narsoplimab | Phase II | Thrombotic Microangiopathies, Hematopoietic Stem Cell Transplantation | Recruiting | Efficacy and Safety Study of Narsoplimab in Pediatric Patients With High-Risk Hematopoietic Stem Cell Transplant TMA | Apr 06, 2023 | ― |
| Oms721, Vehicle (D5w Or Saline) | Phase III | Iga Nephropathy | Terminated | Study of the Safety and Efficacy of OMS721 in Patients With Immunoglobulin A (IgA) Nephropathy | Jun 21, 2018 | ― |
| Oms721 | Phase III | Atypical Hemolytic Uremic Syndrome, Thrombotic Microangiopathies | Recruiting | Safety and Efficacy Study of OMS721 in Patients With Atypical Hemolytic Uremic Syndrome | Apr 17, 2017 | ― |
| Oms721 (Narsoplimab) | Phase II | Lupus Nephritis, Igan, Mn, C3 Glomerulopathy | Unknown | Safety Study of IgAN, LN, MN, & C3 Glomerulopathy Including Dense Deposit Disease Treated With OMS721 | Feb 10, 2016 | ― |
| Oms721 | Phase II | Thrombotic Microangiopathies | Completed | Safety and Efficacy Study of OMS721 in Patients With Thrombotic Microangiopathies | Aug 18, 2014 | ― |
| Phenylephrine Hcl, Oms302 | Phase III | Unilateral Cataract Extraction, Congenital Cataract | Completed | A Randomized Study in Children Ages Birth Through Three Years Undergoing Unilateral Cataract Extraction With or Without Lens Replacement | May 01, 2014 | ― |
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 Omeros Corporation (DE:3O8) have in its pipeline
Omeros DE:3O8 is currently developing the following drugs: Oms906 Study Drug, Ravulizumab, Oms906 Study Drug - 3 Mg/Kg, Oms906 Study Drug - 5 Mg/Kg, Biological: Narsoplimab, Oms721, Vehicle (D5w Or Saline), Oms721, Oms721 (Narsoplimab), Phenylephrine Hcl, Oms302, Part 1 Oms302, Part 2 Oms302, Oms643762, Oms302, Vehicle, Oms103hp-S. These drug candidates are in various stages of clinical development as the company works toward FDA approval.
