Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Ravulizumab · 1 trial · 1 indication
Cohort A
Cohort B Not requiring a red blood cell (RBC) transfusion per the protocol
Cohort B LDH ≤1.5 × ULN at each visit
| Arm | Type | Description |
|---|---|---|
| Cohort A | EXPERIMENTAL | Randomized 1:1 |
| Cohort B | EXPERIMENTAL | Randomized 1:1 |
| Name | Type | Description |
|---|---|---|
| Ravulizumab | DRUG | Administered Intravenous (IV) per the protocol |
| Pozelimab | DRUG | Administered IV and subcutaneous (SC) per the protocol |
| Cemdisiran | DRUG | Administered SC per the protocol |
| Eculizumab | DRUG | Administered IV per the protocol |
Key Inclusion Criteria: 1. Diagnosis of PNH confirmed by high-sensitivity flow cytometry testing with PNH granulocytes or monocytes as described in the protocol 2. Active disease, as defined by the presence of 1 or more PNH-related signs or symptoms as described in the protocol 3. LDH level ≥2 × UL...
Ravulizumab is used for Paroxysmal Nocturnal Hemoglobinuria (PNH), a rare blood disorder. It is being studied in adult patients with PNH who have not recently received or have not received complement inhibitor treatment. The drug is currently in Phase 3 clinical development for this indication.
Ravulizumab is being developed by Regeneron Pharmaceuticals, Inc., a biopharmaceutical company traded on the NASDAQ under the ticker symbol REGN. The company is conducting clinical trials to evaluate the drug's safety and efficacy in patients with Paroxysmal Nocturnal Hemoglobinuria.
Ravulizumab is in Phase 3 clinical development. It is being evaluated in an active, not recruiting Phase 3 study for Paroxysmal Nocturnal Hemoglobinuria. The drug is investigational and has not been approved by regulatory authorities based on the available information.
Ravulizumab is being studied in a Phase 3 clinical trial with the identifier NCT05133531. This trial is evaluating the safety and efficacy of the drug in adult patients with Paroxysmal Nocturnal Hemoglobinuria who have not recently received or have not received complement inhibitor treatment. The trial is active but not recruiting.
Ravulizumab is a monoclonal antibody, as indicated by its target class of -mab. It is being studied for its effects in Paroxysmal Nocturnal Hemoglobinuria, a condition involving complement system dysregulation. The specific molecular target of Ravulizumab has not been disclosed in the available information.
Ravulizumab is not the same as Pozelimab or Cemdisiran. The Phase 3 clinical trial NCT05133531 is evaluating a combination therapy of Pozelimab plus Cemdisiran in patients with Paroxysmal Nocturnal Hemoglobinuria. Ravulizumab is a separate drug being developed by Regeneron Pharmaceuticals for the same condition.