Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as OMS721 (narsoplimab)
narsoplimab · 1 trial · 2 indications
Percentage of patients alive at 100 days following the diagnosis of high-risk HSCT-TMA
| Arm | Type | Description |
|---|---|---|
| Narsoplimab single arm-treatment | EXPERIMENTAL | Narsoplimab 4 mg/kg |
| Name | Type | Description |
|---|---|---|
| Biological: narsoplimab | DRUG | Treatment with narsoplimab 4 mg/kg will be administered |
Inclusion Criteria: 1. Age at least 28 days and less than 18 years prior to informed consent (Visit 0). 2. Have informed consent from at least one parent or legal guardian as required by local law and regulation. Patient informed consent will be required if the patient has reached the local legal a...
Narsoplimab is an investigational monoclonal antibody being developed by Omeros Corporation for thrombotic microangiopathies, a group of conditions involving blood vessel damage and clotting in small vessels. It is currently in Phase 2 clinical development and has not been approved by the FDA.
Narsoplimab is being studied for the treatment of thrombotic microangiopathies, including high-risk cases occurring after hematopoietic stem cell transplant. The ongoing Phase 2 trial is evaluating its efficacy and safety in pediatric patients who develop this complication following transplant.
Narsoplimab targets MASP2, also known as mannan-binding lectin serine protease 2. It acts as an inhibitor of this enzyme, which is part of the lectin pathway of complement activation. By targeting MASP2, narsoplimab is designed to interfere with complement-mediated processes involved in thrombotic microangiopathies.
Narsoplimab is being developed by Omeros Corporation, a biopharmaceutical company traded on the Nasdaq under the ticker symbol OMER. Omeros is the sponsor of the ongoing clinical trial for the drug.
Narsoplimab is in Phase 2 clinical development. It is an investigational therapy and has not been approved by the FDA for any indication. The current Phase 2 trial is actively recruiting participants.
Narsoplimab is being evaluated in a Phase 2 trial, NCT05855083, titled "Efficacy and Safety Study of Narsoplimab in Pediatric Patients With High-Risk Hematopoietic Stem Cell Transplant TMA." The trial is recruiting and plans to enroll 18 participants across the United States, Germany, Israel, Netherlands, and Spain.
Yes, narsoplimab is also referred to as Biological: narsoplimab. This alternative name is used in some clinical trial listings and regulatory documents. Both names refer to the same investigational monoclonal antibody developed by Omeros Corporation.