LV-101 FDA Approval Status
Last updated by Judith Stewart, BPharm on July 27, 2021.
FDA Approved: No
Brand name: LV-101
Generic name: carbetocin
Dosage form: Intranasal
Company: Levo Therapeutics, Inc.
Treatment for: Prader-Willi Syndrome
LV-101 (carbetocin intranasal) is an oxytocin analog in development as a treatment for hyperphagia and behavioral distress associated with Prader-Willi syndrome (PWS).
- Prader-Willi syndrome is a rare, genetically determined neurodevelopmental disorder characterized by mild to moderate levels of intellectual disability, compulsivity, growth hormone deficiency, life-threatening hyperphagia, and anxiety.
- Oxytocin deficiency is thought to be a contributory factor in PWS, and carbetocin works as a selective oxytocin-receptor agonist.
- Carbetocin was designed to have an improved receptor binding profile compared to oxytocin, with greater affinity for the oxytocin receptor and lower affinity for related vasopressin receptors.
- LV-101 (carbetocin intranasal) is intended to be administered to patients with PWS three times each day before meals.
- LV-101 has been granted orphan drug and Fast Track designations from the U.S. Food and Drug Administration (FDA).
Development timeline for LV-101
Further information
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