Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as Procrit
Epoetin Alpha · 2 trials · 2 indications
The count of the number of packed red blood cell transfusions an infant receives during the entire course of their initial hospital stay.
First-order absorption rate constant (Ka) estimated using a population pharmacokinetic model. The estimate was derived from plasma erythropoietin concentration data collected at multiple time points following dosing throughout the 28-day study period.
Bioavailability estimated using a population pharmacokinetic target-mediated drug disposition (TMDD) model. Bioavailability represents the fraction of the administered dose reaching the systemic circulation and is reported as a unitless proportion ranging from 0 to 1. The estimate was derived from plasma erythropoietin concentration data collected at multiple time points following dosing throughout the 28-day study period.
Central volume of distribution (Vc) estimated using a population pharmacokinetic target-mediated drug disposition (TMDD) model. The estimate was derived from plasma erythropoietin concentration data collected at multiple time points following dosing throughout the 28-day study period.
Peripheral volume of distribution (Vp) estimated using a population pharmacokinetic target-mediated drug disposition (TMDD) model. The estimate was derived from plasma erythropoietin concentration data collected at multiple time points following dosing throughout the 28-day study period.
| Arm | Type | Description |
|---|---|---|
| Epoetin Alpha study 1 | EXPERIMENTAL | Epoetin Alpha Tthe number of separate doses (per kg) to be given over 4 weeks by day of age will not exceed 10. These will be administered as follows: day of life (DOL) 2 (1200 U), DOL 4 (600 U), DOL 5 (600 U), DOL 6 (600U), DOL 7 (600 U), DOL 9 (600 U), DOL 14 (600 U), DOL 15 (600 U), DOL 16 (1200 U), and DOL 28 (600 U). The greatest dose in any 1 wk period is 3600 U. Infant study 1 Drug Intervention: all infants will be treated with Epoetin Alpha during the first four weeks of life to provide data for determining: 1) the PK/PD model determined optimized Epoetin Alpha dosing schedule; and 2) clinical and laboratory covariates predictive of which infants are good and poor Epoetin Alpha responder. |
| Name | Type | Description |
|---|---|---|
| Epoetin Alpha | DRUG | Infant study 1: VLBW infant study subjects (weighing 1.0 to 1.5 kg at birth) who are otherwise receiving standard clinical care will be treated with Epoetin Alpha according to a dosing algorithm. |
| PROCRIT (Epoetin alfa) | DRUG | - |
Inclusion Criteria: 1. Post-menstrual age at birth less than 37 wk; 2. birth weight of 1,001 to 1,500 g; 3. postnatal age \<48 h; 4. respiratory distress requiring ventilation; 5. signed consent by parent or guardian. Exclusion Criteria: 1. Anticipated survival \<72 h; 2. Hemolytic anemia due to ...
Epoetin Alpha is being studied for the treatment of neonatal anemia, a condition in which newborns have low red blood cell counts. It is an investigational therapy in this setting and is being developed by Johnson & Johnson. The research focuses on optimized erythropoietin treatment for affected infants.
Epoetin Alpha targets EPOR, the erythropoietin receptor, and acts as an agonist at that receptor. By binding and activating EPOR, it stimulates signaling associated with red blood cell production. This receptor agonist activity is the basis for its study in neonatal anemia.
Epoetin Alpha is developed by Johnson & Johnson, which trades under the ticker JNJ. The company is the sponsor associated with the clinical development of this asset in neonatal anemia.
Epoetin Alpha is in Phase 2 development for neonatal anemia. It is an investigational therapy and is not described as approved for this indication. The Phase 2 program has completed its listed trial, and no active trials are currently recorded.
Epoetin Alpha has been studied in the Phase 2 trial NCT02075970, titled Optimized Erythropoietin (EPO) Treatment. That trial enrolled 33 participants with neonatal anemia in the United States and is completed. It was an uncontrolled study without randomization or double blinding.
Yes, Epoetin Alpha is described as a small molecule and is classified as an agonist of the erythropoietin receptor, EPOR. It falls within the hematology therapeutic area and is being evaluated for neonatal anemia under development by Johnson & Johnson.