Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
HX575 · 1 trial · 1 indication
Proportion of patients with a change in hemoglobin levels more than 2 g/dL under treatment with HX575, estimated between weeks 5-12.
| Arm | Type | Description |
|---|---|---|
| HX575 epoetin alfa Hexal AG | EXPERIMENTAL | HX575 (erythropoietin alfa of the Sponsor Hexal AG). Eligible patients to be randomized in ratio 2:1 and to be subcutaneously treated (solution for injection (s.c.)) for 12 weeks with HX575 in pre-filled syringes. The maximum weekly dose of HX575 was 300 IU/kg body weight to maintain hemoglobin levels in the therapeutic range. Application of the drug required at least once per week and allowed maximum three times per week. |
| ERYPO® Janssen-Cilag | ACTIVE_COMPARATOR | ERYPO® Janssen-Cilag, Germany. Eligible patients were treated subcutaneously (solution for injection (s.c.)) with ERYPO® (Janssen-Cilag, Germany) in pre-filled syringes for 12 weeks.The maximum weekly dose of HX575 was 300 IU/kg body weight to maintain hemoglobin levels in the therapeutic range. Application of the drug required at least once per week and allowed maximum three times per week. |
| Name | Type | Description |
|---|---|---|
| HX575, solution for injection (s.c.) | DRUG | 1000, 2000, 4000, 8000 and 10.000 IU of rh erythropoiethin |
| ERYPO®, Janssen-Cilag, solution for injection (s.c.) | DRUG | 1000, 2000, 4000, 8000 and 10.000 IU of epoetin alfa |
Inclusion Criteria: * Patients with a confirmed diagnosis of solid tumors * Patients who receive cyclic palliative chemotherapy with a cycle duration of 1 -4 weeks (for at least 12 weeks) during the study * Patients with chemotherapy associated anemia (hemoglobin \< 10.0 g/dl at screening) * Life e...
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| Bristol-Myers Squibb Company | BMY | 2 | PHASE3 | Luspatercept |
| Takeda Pharmaceutical Co. Ltd. Sponsored ADR | TAK | 2 | PHASE3 | Elritercept |
| Disc Medicine, Inc. | IRON | 2 | PHASE2 | DISC-0974 |
| Akebia Therapeutics, Inc. | AKBA | 2 | PHASE3 | Vadadustat |
| Ascentage Pharma Group International Unsponsored ADR | AAPG | 1 | PHASE1 | APG-5918 |
| Bayer | BAYRY | 1 | - | Molidustat |
HX575 is being developed for the treatment of anemia, specifically chemotherapy associated anemia in cancer patients. It is a solution for injection administered subcutaneously. The clinical program has focused on patients with anemia related to cancer chemotherapy, a hematology indication.
HX575 is being developed by Novartis AG, which trades under the ticker NVS. The company is the sponsor of the clinical program evaluating HX575 in anemia. Novartis is a multinational pharmaceutical company headquartered in Switzerland.
HX575 is in Phase 3 clinical development. The Phase 3 trial for HX575 has been completed. No active trials are currently listed for HX575. The drug remains investigational and has not been approved by the FDA for any indication.
HX575 has been studied in one Phase 3 clinical trial, NCT00711958, titled Study to Assess the Efficacy and Safety of HX575 in the Treatment of Chemotherapy Associated Anemia in Cancer Patients. The trial enrolled 114 patients, was randomized, double blind, and active controlled, and was conducted in Germany and Romania.
Yes, HX575 is also known as HX575 solution for injection (s.c.). The s.c. designation refers to subcutaneous administration. Both names refer to the same investigational drug candidate being developed by Novartis for anemia.