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Coagulation Factor IX variant · 1 trial · 1 indication
| Name | Type | Description |
|---|---|---|
| Coagulation Factor IX variant | BIOLOGICAL | Single intravenous injection of CB2679d/Dalcinonacog alfa |
Coagulation Factor IX variant is an investigational therapy being studied for the treatment of hemophilia B, a genetic bleeding disorder caused by a deficiency of clotting factor IX. It is currently in Phase 2 clinical development and has not been approved by regulatory authorities.
Coagulation Factor IX variant is being developed by Gyre Therapeutics, Inc., a biopharmaceutical company traded on the stock exchange under the ticker symbol GYRE. The company is conducting clinical trials to evaluate the safety and efficacy of this investigational therapy for hemophilia B.
Coagulation Factor IX variant is currently in Phase 2 clinical development. It is an investigational drug and has not been approved by the FDA or any other regulatory agency. The drug is still being studied in clinical trials to assess its safety and effectiveness in patients with hemophilia B.
Coagulation Factor IX variant has been studied in one clinical trial registered as NCT03995784, titled 'Study of Next-Generation Recombinant Factor IX Variant in Adult Subjects With Hemophilia B.' This Phase 2 trial was completed and enrolled 6 participants with hemophilia B. The trial was uncontrolled and not randomized or double-blinded.
Coagulation Factor IX variant is classified as a monoclonal antibody modality, though it is designed to function as a recombinant factor IX variant for hemophilia B treatment. The drug is being developed to address the clotting factor deficiency in patients with hemophilia B.