Omidubicel, marketed as Omisirge, is a blood-derived cell therapy made from allogeneic stem cells taken from donor umbilical cord blood, processed and cultured with nicotinamide, a form of vitamin B3, to expand and preserve the donor cells. It is used in patients twelve years and older with blood cancers to accelerate neutrophil recovery and reduce infection risk following stem cell transplantation, and in patients six years and older with severe aplastic anemia after reduced intensity conditioning. The therapy is given intravenously and works by restoring the infection-fighting white blood cells of the immune system after transplant. It received United States Food and Drug Administration approval in April 2023 with priority review, breakthrough therapy and orphan drug designations, and a further approval in December 2025 extended its use to severe aplastic anemia.
Facts
Classification
Approval Status ATC ClassSourced to the subject's own accountL: Antineoplastic and Immunomodulating Agents 2 Route of Administration First Approved / Isolated Year Sources
1. Omidubicel (Wikipedia)
Lead section, approval-status statementQuote, Lead section, approval-status statement
Omidubicel was approved for medical use in the United States in April 2023.
2. Anatomical Therapeutic Chemical Classification System (Wikipedia)
WikipediaFirst-level anatomical group codes, Code LQuote, First-level anatomical group codes, Code L
Antineoplastic and immunomodulating agents
3. Wikidata: Omidubicel
WikidataWikidata P636 (route-of-administration: intravenous)Quote, Wikidata P636 (route-of-administration: intravenous)
Route of administration: intravenous infusion and defusion
4. Drugs.com: Omisirge (omidubicel-onlv) FDA Approval History
FDA Approval HistoryQuote, FDA Approval History
Omisirge (omidubicel-onlv) received FDA approval on April 17, 2023
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