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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

DateArticle
Jul  6, 2021FDA Grants Priority Review for Levo Therapeutics’ New Drug Application for LV-101 (Intranasal Carbetocin) for the Treatment of Prader-Willi Syndrome
Aug  6, 2020Levo Therapeutics Announces Top-line Results from Phase 3 CARE-PWS Study of LV-101 (Intranasal Carbetocin) for the Treatment of Prader-Willi Syndrome
Nov 18, 2019Levo Therapeutics Receives Fast Track Designation from FDA for Intranasal Carbetocin for the Treatment of Prader-Willi Syndrome
Dec 12, 2018Levo Therapeutics Announces Initiation of the CARE-PWS Phase 3 Study of Intranasal Carbetocin for the Treatment of Prader-Willi Syndrome
Jun 21, 2018Levo Therapeutics Announces Publication of Phase 2 Study Results and Planned Phase 3 Study of Intranasal Carbetocin for the Treatment of Prader-Willi Syndrome
Oct 27, 2016Levo Therapeutics to License Exclusive Rights to Ferring Pharmaceuticals' Orphan-Designated Drug, Carbetocin, for the Treatment of Prader-Willi Syndrome

Further information

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