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Pharmacokinetic comparability study of Risperidone (LYN-005)

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Trial Profile

Pharmacokinetic comparability study of Risperidone (LYN-005)

Status: Planning
Phase of Trial: Phase I

Latest Information Update: 21 Jul 2021

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At a glance

  • Drugs Risperidone (Primary)
  • Indications Schizophrenia
  • Focus Pharmacokinetics; Registrational

Most Recent Events

  • 21 Jul 2021 New trial record
  • 19 Jul 2021 According to a Lyndra Therapeutics media release, the company announced the positive outcome of an end-of-phase 2 (EOP2) meeting with the U.S. Food and Drug Administration (FDA) and expect to initiate this pivotal program in early 2022.
  • 19 Jul 2021 According to a Lyndra Therapeutics media release, the company and the FDA aligned on key elements like a 90-person pharmacokinetic (PK) comparability study that bridges to the previously established safety and efficacy of risperidone and a double-blind safety study of 6 months duration to characterize the safety profile of the Lyndra dosage form. Both studies will evaluate LYN-005 at weekly doses ranging from 2 to 6 mg risperidone daily.

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