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FG-4592 · 9 trials · 10 indications
Hemoglobin response to FG-4592 is defined as an increase in mean Hb of ≥1.0 grams (g)/deciliter (dL) from baseline within any 8-week period during the study without transfusion.
| Arm | Type | Description |
|---|---|---|
| FG-4592 | EXPERIMENTAL | Intervention is investigational treatment FG-4592 |
| EPO | ACTIVE_COMPARATOR | Intervention is subject's current dose of Li Xue Bao (epoetin alfa) |
| Placebo | PLACEBO_COMPARATOR | Double blinded placebo control |
| Phase 2 Part: FG-4592 | EXPERIMENTAL | Fixed starting doses (different doses for lower body weight \& higher body weight) of FG-4592 administered orally 3 times a week (TIW) for up to 26 weeks; dose adjustments to Hb levels are allowed during the study. |
| Phase 3 Part: FG-4592 | EXPERIMENTAL | Fixed starting doses (different doses for lower body weight \& higher body weight) of FG-4592 administered orally TIW for up to 26 weeks; dose adjustments to Hb levels are allowed during the study. |
| Phase 3 Part: Placebo | PLACEBO_COMPARATOR | Placebo (matching to FG-4592) administered orally TIW for up to 26 weeks. |
| Epoetin alfa | ACTIVE_COMPARATOR | Standard of care |
| 1: FG-4592 in subjects with moderate hepatic impairment | EXPERIMENTAL | - |
| 2: FG-4592 in healthy subjects | EXPERIMENTAL | - |
| 1: young male subjects | EXPERIMENTAL | 3x single dose of FG-4592 and a placebo |
| 2: young female subjects | EXPERIMENTAL | 3x single dose of FG-4592 and a placebo |
| 3: elderly male subjects | EXPERIMENTAL | 3x single dose of FG-4592 and a placebo |
| 4: elderly female subjects | EXPERIMENTAL | 3x single dose of FG-4592 and a placebo |
| warfarin and FG-4592 | EXPERIMENTAL | Single dose of warfarin and Multiple doses of FG-4592 in combination with a single dose of warfarin |
| Name | Type | Description |
|---|---|---|
| FG-4592 | DRUG | - |
| Epoetin Alfa | DRUG | - |
| Placebo | DRUG | - |
| Warfarin | DRUG | Oral |
Inclusion Criteria: 1. Ages 18 to 75 years 2. Subject has voluntarily signed and dated an informed consent form (ICF), approved by an Ethics Committee (EC), after the nature of the study has been explained and the subject has had the opportunity to ask questions; a separate ICF is needed for subjec...
FG-4592 is an investigational small molecule being developed for anemia, including anemia in end stage renal disease and anemia in chronic kidney disease. It has been studied in healthy adult subjects for pharmacokinetic purposes. The drug is in Phase 3 development by Kyntra Bio, Inc. and is not yet approved.
FG-4592 is a small molecule therapeutic being developed for anemia. Its specific molecular target has not been disclosed in the available clinical trial information. The drug is being studied for its effects on anemia in chronic kidney disease and end stage renal disease.
FG-4592 is being developed by Kyntra Bio, Inc., a biopharmaceutical company. The company's stock ticker is KYNB. The drug is currently in Phase 3 clinical development for anemia indications.
FG-4592 is in Phase 3 clinical development for anemia. It is an investigational drug and has not been approved by regulatory authorities. The clinical program includes completed Phase 1 and Phase 2 trials, with the drug advancing to later-stage development.
FG-4592 has completed three clinical trials. NCT01376063 studied drug interactions in healthy adults, NCT01599507 evaluated the drug in chronic kidney disease patients in China, NCT02161224 assessed liver function effects, and NCT02161796 examined dose proportionality in healthy subjects. All trials are completed.
FG-4592 is also known as roxadustat, an investigational oral medication for anemia. It is being developed by Kyntra Bio, Inc. under the ticker KYNB. The drug has completed Phase 1 and Phase 2 trials and is currently in Phase 3 development.