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Oral Iron + Erythropoietin
Oral Iron + Erythropoietin is a Iron supplement + Erythropoiesis-stimulating agent (ESA) Small molecule drug developed by American Regent, Inc.. It is currently in Phase 3 development for Anemia of chronic kidney disease, Chemotherapy-induced anemia, Iron deficiency anemia. Also known as: Ferrous sulfate.
This combination therapy replaces iron stores to support hemoglobin synthesis while erythropoietin stimulates red blood cell production to treat anemia.
This combination therapy replaces iron stores to support hemoglobin synthesis while erythropoietin stimulates red blood cell production to treat anemia. Used for Anemia of chronic kidney disease, Chemotherapy-induced anemia, Iron deficiency anemia.
At a glance
| Generic name | Oral Iron + Erythropoietin |
|---|---|
| Also known as | Ferrous sulfate |
| Sponsor | American Regent, Inc. |
| Drug class | Iron supplement + Erythropoiesis-stimulating agent (ESA) |
| Target | Iron (Fe2+/Fe3+) and erythropoietin receptor (EPOR) |
| Modality | Small molecule |
| Therapeutic area | Hematology |
| Phase | Phase 3 |
Mechanism of action
Oral iron provides the essential mineral substrate required for hemoglobin and myoglobin synthesis, addressing iron deficiency. Erythropoietin is a hormone that stimulates erythropoiesis in the bone marrow, increasing red blood cell production. Together, they address both the iron substrate limitation and the erythropoietic drive needed to correct anemia, particularly in patients with chronic kidney disease or chemotherapy-induced anemia.
Approved indications
- Anemia of chronic kidney disease
- Chemotherapy-induced anemia
- Iron deficiency anemia
Common side effects
- Hypertension
- Headache
- Gastrointestinal disturbance (from oral iron)
- Thrombotic events
- Pure red cell aplasia (rare, ESA-related)
Key clinical trials
- Patient Blood Management in Cardiac Surgery (NA)
- Darbe Plus IV Iron to Decrease Transfusions While Maintaining Iron Sufficiency in Preterm Infants (PHASE2)
- Hypoxia-inducible Factor Prolyl Hydroxylase Inhibitors on Sarcopenia in Hemodialysis Patients (PHASE4)
- Roxadustat's Effect on Heart, Nutrition, and Inflammation in Hemodialysis Patients (PHASE1, PHASE2)
- Roxadustat for Bone and Neuropsychiatric Aspects in Hemodialysis Patients (PHASE1, PHASE2)
- Comparison of Oral Iron With IV Iron in Patients With Anemia of Chronic Renal Failure Not on Dialysis (PHASE3)
- Effect of Ultra-short-term Treatment of Patients With Iron Deficiency or Anemia Undergoing Adolescent Scoliosis Correction (NA)
- Effect of the Combined Programme on Perioperative Anaemia（CPPA） (NA)
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- Oral Iron + Erythropoietin CI brief — competitive landscape report
- Oral Iron + Erythropoietin updates RSS · CI watch RSS
- American Regent, Inc. portfolio CI
Frequently asked questions about Oral Iron + Erythropoietin
What is Oral Iron + Erythropoietin?
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Related
- Drug class: All Iron supplement + Erythropoiesis-stimulating agent (ESA) drugs
- Target: All drugs targeting Iron (Fe2+/Fe3+) and erythropoietin receptor (EPOR)
- Manufacturer: American Regent, Inc. — full pipeline
- Therapeutic area: All drugs in Hematology
- Indication: Drugs for Anemia of chronic kidney disease
- Indication: Drugs for Chemotherapy-induced anemia
- Indication: Drugs for Iron deficiency anemia
- Also known as: Ferrous sulfate
- Compare: Oral Iron + Erythropoietin vs similar drugs
- Pricing: Oral Iron + Erythropoietin cost, discount & access