Posted by VYKOURA is a newly approved medication (marketing start date: 02/03/2026) containing leucovorin calcium, a prescription injectable drug used in hospital and clinical settings to support cancer therapy and reduce the toxic effects of certain chemotherapy drugs. Although its origins date back decades (initial U.S. approval in 1952), this medication remains critically relevant today — especially in oncology and metabolic rescue protocols, now marketed also in a reformulated version (after 74 years) supported by the solubilizing potency of betadex sulfobutylether sodium (SBECD).
Leucovorin is an active form of folate (vitamin B9) and acts as a folate analog. In the body, it helps “rescue” normal cells from the harmful effects of folate–antagonizing chemotherapy agents such as methotrexate, which can otherwise damage healthy tissue. Through its folate activity, leucovorin supports DNA synthesis and cellular repair in normal cells.
VYKOURA is given via intravenous (IV) or intramuscular (IM) injection. To the best of our knowledge, this formulation is the 22nd marketed product containing SBECD. The registrant – Avyxa Holdings, LLC. has another SBECD containing product: DOCIVYX (docetaxel) injection.
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2026/220406s000lbl.pdf