BP1.4979 / Bioprojet - LARVOL DELTA

Pilot Study on BP1.4979 Effect on Binge Eating Disorders (clinicaltrials.gov) - P2 | N=67 | Completed | Sponsor: Bioprojet | Active, not recruiting ➔ Completed

Trial completion • Binge Eating Disorder • CNS Disorders

Proof of Concept Study on BP1.4979 Effect on Primary Premature Ejaculation (clinicaltrials.gov) - P2 | N=60 | Recruiting | Sponsor: Bioprojet | Not yet recruiting ➔ Recruiting

Enrollment open • Sexual Disorders

Proof of Concept Study on BP1.4979 Effect on Essential Tremor (clinicaltrials.gov) - P2 | N=50 | Not yet recruiting | Sponsor: Bioprojet

New P2 trial • Essential Tremor • Movement Disorders

Pilot Study on BP1.4979 Effect on Binge Eating Disorders (clinicaltrials.gov) - P2 | N=66 | Active, not recruiting | Sponsor: Bioprojet | Recruiting ➔ Active, not recruiting | Trial completion date: Mar 2025 ➔ Sep 2025 | Trial primary completion date: Mar 2025 ➔ Sep 2025

Enrollment closed • Trial completion date • Trial primary completion date • Binge Eating Disorder • CNS Disorders

Proof of Concept Study on BP1.4979 Effect on Primary Premature Ejaculation (clinicaltrials.gov) - P2 | N=60 | Not yet recruiting | Sponsor: Bioprojet

New P2 trial • Sexual Disorders

Pilot Study on BP1.4979 Effect on Binge Eating Disorders (clinicaltrials.gov) - P2 | N=66 | Recruiting | Sponsor: Bioprojet | Trial completion date: Dec 2023 ➔ Mar 2025 | Trial primary completion date: Dec 2023 ➔ Mar 2025

Trial completion date • Trial primary completion date • Binge Eating Disorder • CNS Disorders

Pilot Study on BP1.4979 Effect on Binge Eating Disorders (clinicaltrials.gov) - P2 | N=66 | Recruiting | Sponsor: Bioprojet | Trial completion date: Mar 2023 ➔ Dec 2023 | Trial primary completion date: Mar 2023 ➔ Dec 2023

Trial completion date • Trial primary completion date • Binge Eating Disorder • CNS Disorders

Pilot Study on BP1.4979 Effect on Binge Eating Disorders (clinicaltrials.gov) - P2 | N=66 | Recruiting | Sponsor: Bioprojet | Not yet recruiting ➔ Recruiting | Trial completion date: Nov 2022 ➔ Mar 2023 | Initiation date: Dec 2021 ➔ Mar 2022 | Trial primary completion date: Nov 2022 ➔ Mar 2023

Enrollment open • Trial completion date • Trial initiation date • Trial primary completion date • Binge Eating Disorder • CNS Disorders

Pilot Study on BP1.4979 Effect on Binge Eating Disorders (clinicaltrials.gov) - P2; N=66; Not yet recruiting; Sponsor: Bioprojet

Clinical • New P2 trial • Binge Eating Disorder • CNS Disorders

P13-04: Clinical Trial Assessing the Efficacy and Safety of BP1.4979 in Restless Legs Syndrome (clinicaltrials.gov) - P2; N=29; Terminated; Sponsor: Bioprojet; N=91 ➔ 29; Recruiting ➔ Terminated; Study facing recruitment difficulties related to stringent eligibility criteria

Clinical • Enrollment change • Trial termination • Movement Disorders • Restless Legs Syndrome • Sleep Disorder

Occupancy of dopamine D and D receptors by a novel D3 partial agonist BP1.4979: a [C]-(+)-PHNO PET study in humans. (PubMed, Neuropsychopharmacology) - "Serum levels of BP1.4979 were higher than its active metabolite, BP1.6239, while no notable increases in the inactive metabolite, BP1.6197, were found. These findings indicate the range of doses that can be used to occupy selectively the DRD over the DRD with BP1.4979 and speak to the use of in vivo imaging approaches in dose finding studies."

Journal

P13-04: Clinical Trial Assessing the Efficacy and Safety of BP1.4979 in Restless Legs Syndrome (clinicaltrials.gov) - P2; N=91; Recruiting; Sponsor: Bioprojet; Trial completion date: Mar 2019 ➔ Mar 2020; Trial primary completion date: Mar 2019 ➔ Mar 2020

Clinical • Trial completion date • Trial primary completion date