risperidone CR (DLP-114) / Delpor - LARVOL DELTA

Can an Implantable Device Deliver a Year of Maintenance Risperidone? Results from a Phase 1 PK/Safety Study Evaluating 6- and 12-Month Versions of the DLP-114 Device in Schizophrenia (ASCP 2024) - P1/2 | "After device insertion, 24 of 28 subjects (86%) completed the study. Reasons for early discontinuation were: 1) lost to follow-up (n=2); signs of impending relapse (n=1); and request for early removal of DLP-114 (n=1). Device placement and removal procedures were well tolerated."

Clinical • P1 data • CNS Disorders • Insomnia • Pain • Psychiatry • Schizophrenia • Sleep Disorder

Safety, Tolerability, and Pharmacokinetics of Switching From Oral Risperidone to Risperidone Implant (clinicaltrials.gov) - P1/2 | N=28 | Completed | Sponsor: Delpor, Inc. | Active, not recruiting ➔ Completed

Trial completion • CNS Disorders • Psychiatry • Schizophrenia

Safety, Tolerability, and Pharmacokinetics of Switching From Oral Risperidone to Risperidone Implant (clinicaltrials.gov) - P1/2 | N=30 | Active, not recruiting | Sponsor: Delpor, Inc. | Trial completion date: Jul 2022 ➔ Mar 2023 | Trial primary completion date: Apr 2022 ➔ Dec 2022

Trial completion date • Trial primary completion date • CNS Disorders • Psychiatry • Schizophrenia

Safety, Tolerability, and Pharmacokinetics of Switching From Oral Risperidone to Risperidone Implant (clinicaltrials.gov) - P1/2 | N=30 | Active, not recruiting | Sponsor: Delpor, Inc. | Recruiting ➔ Active, not recruiting

Enrollment closed • CNS Disorders • Psychiatry • Schizophrenia

Delpor Announces First Patient Dosed in Phase 1b/2a Clinical Trial of Once-Yearly Risperidone Implant (Businesswire) - "Delpor, Inc. (Delpor)...today announced that it has initiated and dosed the first patient in a phase 1b/2a clinical trial of DLP-114, a long-acting formulation of the antipsychotic risperidone for schizophrenia maintenance therapy. This is an open-label study in stable schizophrenia patients to evaluate the safety, tolerability, and pharmacokinetics of switching from oral risperidone to a once-yearly or twice-yearly risperidone implant (DLP-114)."

Trial status • CNS Disorders • Schizophrenia

Safety, Tolerability, and Pharmacokinetics of Switching From Oral Risperidone to Risperidone Implant (clinicaltrials.gov) - P1/2; N=30; Recruiting; Sponsor: Delpor, Inc.; Not yet recruiting ➔ Recruiting

Enrollment open • CNS Disorders • Psychiatry • Schizophrenia

Safety, Tolerability, and Pharmacokinetics of Switching From Oral Risperidone to Risperidone Implant (clinicaltrials.gov) - P1/2; N=30; Not yet recruiting; Sponsor: Delpor, Inc.; Trial completion date: Dec 2021 ➔ Jun 2022; Initiation date: Sep 2020 ➔ Feb 2021; Trial primary completion date: Nov 2021 ➔ Mar 2022

Clinical • Trial completion date • Trial initiation date • Trial primary completion date • CNS Disorders • Psychiatry • Schizophrenia

DLP-114: Safety, Tolerability, and Pharmacokinetics of Switching From Oral Risperidone to Risperidone Implant (clinicaltrials.gov) - P1/2; N=30; Not yet recruiting; Sponsor: Delpor, Inc.

Clinical • New P1/2 trial • CNS Disorders • Schizophrenia