Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
EPREX · 1 trial · 1 indication
Mean absolute change in haemoglobin level from baseline to 6 months after treatment with EPIAO/EPREX in parallel groups (g/dl).
Mean absolute change in weekly epoetin dosage per kg body weight from baseline to 6 months after treatment with EPIAO/EPREX in parallel groups (IU/kg/week).
| Arm | Type | Description |
|---|---|---|
| Reference group | ACTIVE_COMPARATOR | Generic name: recombinant human erythropoetin injection which is indicated for the treatment of anaemia caused by chronic renal disease. Dosage form:Injection Strength: 2000IU, 3000IU, 4000IU Frequency and Dosage: Intravenously injection 1-3 times a week for a period of 52 weeks. |
| Experimental group | EXPERIMENTAL | Generic name: recombinant human erythropoetin injection which is indicated for the treatment of anaemia caused by chronic renal disease. Dosage form: Injection Strength: 2000IU, 3000IU, 4000IU Frequency and Dosage: Intravenously injection 1-3 times a week for a period of 52 weeks. |
| Name | Type | Description |
|---|---|---|
| EPREX® | DRUG | Recombinant human erythropoietin falls under the pharmacological class of haematopoietic / anti anaemic agents. It has been developed for the treatment of anaemia in subjects with chronic kidney disease. Erythropoietin, also known as EPO, is a glycoprotein hormone that controls erythropoiesis, or RBC production. It is a cytokine (protein signalling molecule) for erythrocyte precursors in the bone marrow. Human EPO has a molecular weight of 34,000. |
| EPIAO® | DRUG | Recombinant human erythropoietin falls under the pharmacological class of haematopoietic / anti anaemic agents. It has been developed for the treatment of anaemia in subjects with chronic kidney disease. Erythropoietin, also known as EPO, is a glycoprotein hormone that controls erythropoiesis, or RBC production. It is a cytokine (protein signalling molecule) for erythrocyte precursors in the bone marrow. Human EPO has a molecular weight of 34,000. |
Inclusion Criteria: * Male and female subjects between the age of 18 to 75 years * Subjects with end stage renal disease (CKD stage 5) on hemodialysis and on epoetin treatment for at least 3 months prior to screening * Subjects with haemoglobin between 10 g/dl to 12 g/dl * Subjects who are on clini...
EPREX is a small molecule being developed for the treatment of Renal Anemia, a condition of low red blood cell counts associated with chronic kidney disease. It is currently in Phase 3 clinical development as an investigational therapy for this indication.
EPREX is a small molecule, but its specific molecular target has not been disclosed. The drug is being studied for its effects on Renal Anemia, a condition characterized by insufficient erythropoietin production and subsequent anemia.
EPREX is being developed by Sunshine Biopharma Inc., a biopharmaceutical company traded on the NASDAQ under the ticker symbol SBFM. The company is conducting clinical trials to evaluate the drug's safety and efficacy in patients with Renal Anemia.
EPREX is in Phase 3 clinical development. It has completed one Phase 3 trial, which was a randomized, double-blind, active-controlled study. The drug is investigational and has not yet been approved by regulatory authorities.
EPREX has been studied in one completed Phase 3 clinical trial, identified as NCT02947438. This trial, titled 'Biosimilar Erythropoietin in Anaemia Treatment (Maintenance Phase Study),' enrolled 207 participants with Renal Anemia across Russia and Thailand.
EPREX is being studied as a potential biosimilar to erythropoietin, as indicated by the clinical trial title. However, the drug is a small molecule and is still in clinical development, so it is not yet established as a marketed biosimilar product.