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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 |
Top 8 of 9 competitors
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| Novo Nordisk A/S Sponsored ADR Class B | NVO | 15 | PHASE3 | Concizumab, Mim8, Denecimig, NNC0442-0344 A, turoctocog alfa pegol |
| Sanofi SA Sponsored ADR | SNY | 5 | PHASE3 | Fitusiran, efanesoctocog alfa |
| Pfizer Inc. | PFE | 8 | PHASE3 | Fidanacogene elaparvovec, Marstacimab |
| BioMarin Pharmaceutical Inc. | BMRN | 2 | PHASE3 | Valoctocogene roxaparvovec |
| Hoffmann-La Roche | RHHBY | 8 | PHASE3 | Emicizumab, NXT007, SPK-8011QQ, SPK-8011, SPK-8016 |
| Regeneron Pharmaceuticals, Inc. | REGN | 2 | PHASE1 | REGV131, LNP1265 |
| Takeda Pharmaceutical Co. Ltd. Sponsored ADR | TAK | 2 | PHASE1 | AskBio009 |
| Bayer | BAYRY | 6 | - | Damoctocog-alfa-pegol |
Coagulation Factor IX variant is an investigational biologic being developed by Gyre Therapeutics, Inc. for Hemophilia B, a bleeding disorder. It is a next-generation recombinant Factor IX variant designed as an exogenous protein therapy. It has completed a Phase 2 clinical trial in adult subjects with Hemophilia B.
Coagulation Factor IX variant is being developed for the treatment of Hemophilia B, a hereditary bleeding disorder caused by deficient or defective clotting Factor IX. The clinical program has studied it in adult subjects with Hemophilia B. It is an investigational therapy and has not been approved for commercial use.
Coagulation Factor IX variant targets F8, also known as coagulation Factor VIII, and is classified as an exogenous protein therapy. It is a next-generation recombinant Factor IX variant. By supplying a modified clotting factor, it is intended to support the coagulation cascade in patients with Hemophilia B.
Coagulation Factor IX variant is being developed by Gyre Therapeutics, Inc., which trades under the ticker GYRE. The company is the sponsor of the clinical program evaluating this next-generation recombinant Factor IX variant in adult subjects with Hemophilia B.
Coagulation Factor IX variant is in Phase 2 development. It is an investigational therapy and has not been approved by the FDA. One Phase 2 trial has been completed, and no trials are currently active. The program enrolled six participants in that completed study.
Coagulation Factor IX variant has been evaluated in one completed Phase 2 trial, NCT03995784, titled Study of Next-Generation Recombinant Factor IX Variant in Adult Subjects With Hemophilia B. The trial enrolled six participants and was an uncontrolled study without randomization or double blinding. No trials are currently active.