Approval Probability
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Damoctocog · 1 trial · 1 indication
Area under the concentration time profile curve.
| Arm | Type | Description |
|---|---|---|
| BAY94-9027 and Elocta | EXPERIMENTAL | Subjects received two treatments: 60 IU/kg BAY94-9027 in the first period, followed by 60 IU/kg Elocta in the second period, with a washout period before each treatment |
| Elocta and BAY94-9027 | EXPERIMENTAL | Subjects received two treatments: 60 IU/kg Elocta in the first period, followed by 60 IU/kg BAY94-9027 in the second period, with a washout period before each treatment |
| Name | Type | Description |
|---|---|---|
| Damoctocog (Jivi, BAY94-9027) | DRUG | 60 international units (IU)/kg, given as a 10 minute injection, 1 dose |
| Elocta | DRUG | 60 IU/kg, given as a 10 minute injection, 1 dose |
Inclusion Criteria: * Males, age 18 to 65 years. * Subjects with Severe Hemophilia A with a documented plasma FVIII level of \< 1% * ≥ 150 exposure days with FVIII concentrate(s) as supported by medical records Exclusion Criteria: * Evidence of current or past inhibitor antibody: * History of any...
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 |
Damoctocog is being developed for the treatment of Hemophilia A, a bleeding disorder caused by a deficiency in clotting factor VIII. It is an investigational therapy studied in adult male patients with Hemophilia A. The clinical program has evaluated its use in this specific bleeding disorder.
Damoctocog targets F8, also known as clotting factor VIII. It is classified as an exogenous protein, meaning it is an externally administered form of the factor VIII protein. By targeting F8, Damoctocog aims to address the underlying factor deficiency in Hemophilia A.
Damoctocog is being developed by Bayer AG, a multinational pharmaceutical and life sciences company. Bayer AG trades on the OTC market under the ticker BAYRY. The company is responsible for the clinical development of this investigational therapy for Hemophilia A.
Damoctocog is in Phase 1 clinical development. It is an investigational therapy and has not been approved by the FDA for any indication. The Phase 1 program has been conducted to evaluate the drug in patients with Hemophilia A.
Damoctocog has been studied in one completed Phase 1 clinical trial, NCT03364998, titled BAY94-9027 PK Study Comparing to Another Long Acting Product. This trial enrolled 18 adult male participants with Hemophilia A in Bulgaria. It was a controlled, randomized study without double-blinding.
Yes, Damoctocog is also known as Jivi and by the developmental code BAY94-9027. These names refer to the same investigational therapy for Hemophilia A. Jivi is the brand name, while Damoctocog is the international nonproprietary name.