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Drugs and Medicinal Substances

Donislecel

Alimentary Tract and Metabolism Agents

Donislecel, sold under the brand name Lantidra, is a cellular therapy used to treat type 1 diabetes. It consists of allogeneic pancreatic islet cells taken from deceased donors and infused into a patient's hepatic portal vein in a single procedure, where the transplanted beta cells can secrete insulin and help regulate blood sugar. It is indicated for adults with type 1 diabetes who experience repeated severe episodes of low blood sugar despite intensive disease management and who are unable to reach their target blood sugar control. In clinical trials involving thirty participants, twenty-one achieved independence from insulin injections for at least one year, with some remaining insulin-free for more than five years. The United States Food and Drug Administration approved donislecel in June 2023, the first cellular therapy approved to treat type 1 diabetes. It is developed by CellTrans, Inc.

Facts
Classification
Approval Status
Approved 1
ATC ClassSourced to the subject's own account
A: Alimentary Tract and Metabolism 2
Route of Administration
Intravenous 3
First Approved / Isolated Year
2023 4
Sources
1. Donislecel (Wikipedia)
Lead section, approval-status statement
Quote, Lead section, approval-status statement
Donislecel was approved for medical use in the United States in June 2023.
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2. Anatomical Therapeutic Chemical Classification System (Wikipedia)
WikipediaFirst-level anatomical group codes, Code A
Quote, First-level anatomical group codes, Code A
Alimentary tract and metabolism
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3. Donislecel (Wikipedia)
WikipediaInfobox drug, routes_of_administration
Quote, Infobox drug, routes_of_administration
Islet cell transplantation via intravenous infusion
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4. Drugs.com: Lantidra (donislecel-jujn) FDA Approval History
FDA Approval History
Quote, FDA Approval History
Lantidra (donislecel-jujn) was first approved by the FDA on June 28, 2023
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