KNX100 / Kinoxis Therapeutics - LARVOL DELTA

Study to Examine the Safety, Tolerability and Pharmacokinetics of ascending doses of KNX100 in healthy volunteers. (ANZCTR) - P1 | N=12 | Completed | Sponsor: Kinoxis Therapeutics Pty Ltd | Recruiting ➔ Completed

Trial completion

From Bench to Bedside: The Development of A Novel Clinical-Stage Therapeutic, KNX100, for the Treatment of Opioid Use Disorder (CPDD 2025) - "KNX100 outperformed lofexidine in reducing withdrawal related negative affective symptoms and withdrawal-induced aversion in a conditioned place aversion model. Given strong preclinical evidence, Kinoxis is advancing KNX100 into a placebo-controlled, randomized, crossover, in-patient Proof of Concept study in ~45 patients with moderate-to-severe OUD. The study will evaluate KNX100’s effect on cue-induced craving and reactivity in non-treatment-seeking patients. The primary outcome is craving reduction, with secondary outcomes assessing cue reactivity, withdrawal, safety, and tolerability."

Clinical • Addiction (Opioid and Alcohol) • Substance Abuse • DRD2

Study to Examine the Safety, Tolerability and Pharmacokinetics of ascending doses of KNX100 in healthy volunteers. (ANZCTR) - P1 | N=12 | Recruiting | Sponsor: Kinoxis Therapeutics Pty Ltd | Not yet recruiting ➔ Recruiting | Initiation date: Mar 2025

Enrollment open • Trial initiation date

Study to Examine the Safety, Tolerability and Pharmacokinetics of ascending doses of KNX100 in healthy volunteers. (ANZCTR) - P1 | N=12 | Not yet recruiting | Sponsor: Kinoxis Therapeutics Pty Ltd

New P1 trial

Study to Examine the Safety, Tolerability, and Efficacy of KNX100 in the Treatment of Subjects with Agitation Associated with Dementia (ANZCTR) - P2 | N=60 | Recruiting | Sponsor: Kinoxis Therapeutics Pty Ltd | Not yet recruiting ➔ Recruiting | Initiation date: Aug 2024

Enrollment open • Trial initiation date • Alzheimer's Disease • CNS Disorders • Dementia

Study to Examine the Safety, Tolerability, and Efficacy of KNX100 in the Treatment of Subjects with Agitation Associated with Dementia (ANZCTR) - P2 | N=60 | Not yet recruiting | Sponsor: Kinoxis Therapeutics Pty Ltd

New P2 trial • Alzheimer's Disease • CNS Disorders • Dementia

KTX101: A Phase 1 Study Investigating the Safety, Tolerability and Pharmacokinetics of KNX100 in Healthy Volunteers (clinicaltrials.gov) - P1 | N=64 | Completed | Sponsor: Kinoxis Therapeutics Pty Ltd | Recruiting ➔ Completed | Trial completion date: Dec 2023 ➔ Sep 2023

Trial completion • Trial completion date • Substance Abuse

KTX101: A Phase 1 Study Investigating the Safety, Tolerability and Pharmacokinetics of KNX100 in Healthy Volunteers (clinicaltrials.gov) - P1 | N=64 | Recruiting | Sponsor: Kinoxis Therapeutics Pty Ltd | N=40 ➔ 64 | Trial completion date: Sep 2023 ➔ Dec 2023 | Trial primary completion date: Nov 2022 ➔ Sep 2023

Enrollment change • Trial completion date • Trial primary completion date • Substance Abuse

KTX101: A Phase 1 Study Investigating the Safety, Tolerability and Pharmacokinetics of KNX100 in Healthy Volunteers (clinicaltrials.gov) - P1 | N=40 | Recruiting | Sponsor: Kinoxis Therapeutics Pty Ltd | Not yet recruiting ➔ Recruiting

Enrollment open • Substance Abuse

KTX101: A Phase 1 Study Investigating the Safety, Tolerability and Pharmacokinetics of KNX100 in Healthy Volunteers (clinicaltrials.gov) - P1; N=40; Not yet recruiting; Sponsor: Kinoxis Therapeutics Pty Ltd; N=64 ➔ 40; Trial completion date: Sep 2022 ➔ Sep 2023; Initiation date: Sep 2021 ➔ Feb 2022; Trial primary completion date: Jun 2022 ➔ Nov 2022

Enrollment change • Trial completion date • Trial initiation date • Trial primary completion date • Substance Abuse

KTX101: A Phase 1, Two Part Study Investigating the Safety, Tolerability and Pharmacokinetics of KNX100 in Healthy Volunteers (clinicaltrials.gov) - P1; N=64; Not yet recruiting; Sponsor: Kinoxis Therapeutics Pty Ltd

Clinical • New P1 trial • Substance Abuse