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A blood disorder characterized by low hemoglobin levels in premature neonates that usually spontaneously resolves within 3-6 months post birth. A combination of factors including the transition from the liver to the bone marrow for erythropoiesis in a neonate, blood loss experienced during delivery, the shortened life span of fetal blood cells, and an acclimation to a relatively hyperoxic environment outside the womb can predispose a neonate to this condition.
No approved treatments are currently available for anemia of prematurity. An additional 1 compound holds orphan drug designation.
While no drugs are FDA-approved specifically for anemia of prematurity, some of the following designated compounds may be used off-label in clinical practice. Treatment decisions should be made in consultation with a specialist familiar with this condition.
The following drugs have received orphan drug designation from the FDA for anemia of prematurity. Orphan designation reflects regulatory interest and does not indicate approval for treatment.
Brand Name | Generic Name | Sponsor |
|---|
2 clinical trials registered. Interventions under study include other interventions. Pipeline includes 2 NA. Research is primarily sponsored by academic and government institutions.
22 publications have been identified in PubMed for anemia of prematurity. Research spans Clinical Trial Publication (50%), Review / Meta-Analysis (14%), and Case Report / Case Series (14%).
Research Type | Count | % of Total |
|---|---|---|
Clinical study results | 11 | 50% |
Data assembled from 4 of 12 sources · Last updated Sep 20, 2026, 12:28 PM UTC
Designated
Exclusivity End |
|---|
Designation Status |
|---|
Epoetin alpha | Epoetin alpha | Janssen Research & Development, LLC | 1988 | — | Withdrawn |
2 trials found
Research summaries |
3 |
14% |
Patient case studies | 3 | 14% |
Disease patterns and progression | 3 | 14% |
Laboratory research | 2 | 9% |
Di Chiara M (2026). [PMID: 42123981](https://pubmed.ncbi.nlm.nih.gov/42123981/). *Nutrients*. [Epidemiology / Natural History]
Çolak N (2026). [PMID: 41749523](https://pubmed.ncbi.nlm.nih.gov/41749523/). *Children (Basel, Switzerland)*. [Clinical Trial Publication]
Li F (2026). [PMID: 41971369](https://pubmed.ncbi.nlm.nih.gov/41971369/). *Front Nutr*. [Epidemiology / Natural History]
Reibel-Georgi NJ (2025). [PMID: 39277077](https://pubmed.ncbi.nlm.nih.gov/39277077/). *The Journal of pediatrics*. [Clinical Trial Publication]
Farag MM (2025). [PMID: 40380201](https://pubmed.ncbi.nlm.nih.gov/40380201/). *Italian journal of pediatrics*. [Clinical Trial Publication]
Maxwell JR (2025). [PMID: 41392547](https://pubmed.ncbi.nlm.nih.gov/41392547/). *Bioanalysis*. [Basic Science / Preclinical]
Haribalakrishna A (2025). [PMID: 40485549](https://pubmed.ncbi.nlm.nih.gov/40485549/). *Journal of pediatric gastroenterology and nutrition*. [Case Report / Case Series]
McCotter LM (2025). [PMID: 41093764](https://pubmed.ncbi.nlm.nih.gov/41093764/). *Neonatal network : NN*. [Clinical Trial Publication]
He Z (2025). [PMID: 39708564](https://pubmed.ncbi.nlm.nih.gov/39708564/). *Computer methods and programs in biomedicine*. [Epidemiology / Natural History]
Unknown (2025). [PMID: 39825646](https://pubmed.ncbi.nlm.nih.gov/39825646/). *Zhongguo dang dai er ke za zhi = Chinese journal of contemporary pediatrics*. [Clinical Trial Publication]