Study to Evaluate the Pharmacokinetics (PK) and Safety/Tolerability of Long-Acting Oral LYN-005

Phase 3 Completed 83 enrolled Lyndra Inc.

Non-randomizedParallel-groupOpen-labelTreatment

Summary

Lyndra Therapeutics, Inc. is developing LYN-005, a long-acting oral (LAO) capsule (LYNX™ dosage form) of risperidone. This pivotal study (LYN-005-C-301) will evaluate the PK as well as safety and tolerability of multiple administrations of the LYN-005 formulation at two dose levels.

Timeline

Start: 2023-04-13
Primary completion: 2023-11-03
Completion: 2023-12-01

Publications

Citrome L, Nagaraj N, Traverso G, Dumas T, Scranton R. Long-acting oral weekly risperidone (LYN-005) for schizophrenia in the USA (STARLYNG-1): a multicentre, open-label, non-randomised phase 3 trial. Lancet Psychiatry. 2025 Jul;12(7):504-512. doi: 10.1016/S2215-0366(25)00135-X.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Risperidone	Other / unclassified	1 mg	Oral
Subject	Risperidone	Other / unclassified	3 mg	Oral
Subject	Risperidone	Other / unclassified	15 mg	Oral
Subject	Risperidone	Other / unclassified	45 mg	Oral

Study to Evaluate the Pharmacokinetics (PK) and Safety/Tolerability of Long-Acting Oral LYN-005

Summary

Timeline

Publications

Drugs

Indications