BMS-986368 / BMS - LARVOL DELTA

Design of a Phase 2, Randomized, Double-blind, Placebo-controlled Trial of BMS-986368, a Fatty Acid Amide Hydrolase/monoacylglycerol Lipase Inhibitor, for Spasticity Treatment in Multiple Sclerosis (ACRM 2025) - "• Educate on the unique mechanism of action of BMS-986368, a dual fatty acid amide hydrolase/monoacylglycerol lipase inhibitor. • Discuss the current treatment gap in patients with multiple sclerosis spasticity."

Clinical • P2 data • CNS Disorders • Movement Disorders • Multiple Sclerosis

Study to Evaluate the Efficacy, Safety, and Tolerability of BMS-986368, for the Treatment of Agitation in Participants With Alzheimer's Disease (clinicaltrials.gov) - P2 | N=120 | Recruiting | Sponsor: Celgene | Not yet recruiting ➔ Recruiting

Enrollment open • Alzheimer's Disease • CNS Disorders

MSS: A Study to Evaluate the Efficacy, Safety and Tolerability of BMS-986368 in Participants With Multiple Sclerosis Spasticity (clinicaltrials.gov) - P2 | N=200 | Recruiting | Sponsor: Celgene | Not yet recruiting ➔ Recruiting

Enrollment open • CNS Disorders • Movement Disorders • Multiple Sclerosis

Study Design of BALANCE-AAD-1, a Phase 2, Randomized, Double-Blind, Placebo-Controlled Trial of the FAAH/MAGL Inhibitor BMS-986368 for Treatment of Agitation in Patients with Alzheimer Disease (ASCP 2025) - "Brexpiprazole is the only treatment approved for AD-related agitation, highlighting the need for alternative treatment options with improved side effect profiles. The endocannabinoid pathway is a promising target for treatment of agitation in patients with AD. Pending efficacy and safety results, BMS-986368 could provide a novel and important new treatment option for AD-associated agitation"

Clinical • Late-breaking abstract • P2 data • Alzheimer's Disease • CNS Disorders • Psychiatry

Study to Evaluate the Efficacy, Safety, and Tolerability of BMS-986368, for the Treatment of Agitation in Participants With Alzheimer's Disease (clinicaltrials.gov) - P2 | N=120 | Not yet recruiting | Sponsor: Celgene | Trial completion date: May 2027 ➔ Sep 2027 | Trial primary completion date: Mar 2027 ➔ Jul 2027

Trial completion date • Trial primary completion date • Alzheimer's Disease • CNS Disorders

Study to Evaluate the Efficacy, Safety, and Tolerability of BMS-986368, for the Treatment of Agitation in Participants With Alzheimer's Disease (clinicaltrials.gov) - P2 | N=120 | Not yet recruiting | Sponsor: Celgene

New P2 trial • Alzheimer's Disease • CNS Disorders

MSS: A Study to Evaluate the Efficacy, Safety and Tolerability of BMS-986368 in Participants With Multiple Sclerosis Spasticity (clinicaltrials.gov) - P2 | N=200 | Not yet recruiting | Sponsor: Celgene

New P2 trial • CNS Disorders • Movement Disorders • Multiple Sclerosis

A Study to Evaluate the Safety, Tolerability, and Drug Levels of Orally Administered BMS-986368 in Healthy Participants, Healthy Elderly Participants, and Healthy Participants of Japanese Ethnicity (clinicaltrials.gov) - P1 | N=56 | Completed | Sponsor: Celgene | Recruiting ➔ Completed

Trial completion

IM045-1002: A Study to Assess the Effects of Itraconazole, Food, and pH on the Drug Levels of BMS-986368 in Healthy Participants (clinicaltrials.gov) - P1 | N=32 | Completed | Sponsor: Celgene | Recruiting ➔ Completed

Trial completion

A Study to Evaluate the Safety, Tolerability, and Drug Levels of Orally Administered BMS-986368 in Healthy Participants, Healthy Elderly Participants, and Healthy Participants of Japanese Ethnicity (clinicaltrials.gov) - P1 | N=64 | Recruiting | Sponsor: Celgene | Not yet recruiting ➔ Recruiting

Enrollment open

A Study to Evaluate the Safety, Tolerability, and Drug Levels of Orally Administered BMS-986368 in Healthy Participants, Healthy Elderly Participants, and Healthy Participants of Japanese Ethnicity (clinicaltrials.gov) - P1 | N=64 | Not yet recruiting | Sponsor: Celgene

New P1 trial

A Study to Evaluate the Absorption, Metabolism, and Excretion of Orally Administered [14C]-BMS-986368 in Healthy Male Participants (clinicaltrials.gov) - P1 | N=8 | Completed | Sponsor: Celgene | Recruiting ➔ Completed

Trial completion

A Study to Evaluate the Absorption, Metabolism, and Excretion of Orally Administered [14C]-BMS-986368 in Healthy Male Participants (clinicaltrials.gov) - P1 | N=8 | Recruiting | Sponsor: Celgene | Not yet recruiting ➔ Recruiting

Enrollment open

Positron Emission Tomography (PET) Imaging Study to Evaluate Enzyme Availability in the Central Nervous System Before and After CC-97489 Administration in Healthy Participants (clinicaltrials.gov) - P1 | N=32 | Completed | Sponsor: Celgene | Recruiting ➔ Completed

Trial completion

A Study to Evaluate the Absorption, Metabolism, and Excretion of Orally Administered [14C]-BMS-986368 in Healthy Male Participants (clinicaltrials.gov) - P1 | N=8 | Not yet recruiting | Sponsor: Celgene

New P1 trial

Positron Emission Tomography (PET) Imaging Study to Evaluate Enzyme Availability in the Central Nervous System Before and After CC-97489 Administration in Healthy Participants (clinicaltrials.gov) - P1 | N=38 | Recruiting | Sponsor: Celgene | Trial completion date: Oct 2023 ➔ Jan 2024 | Trial primary completion date: Oct 2023 ➔ Jan 2024

Trial completion date • Trial primary completion date

Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of CC-97489 in Healthy Adult Participants (clinicaltrials.gov) - P1 | N=84 | Terminated | Sponsor: Celgene | Recruiting ➔ Terminated; Business objectives changed.

Trial termination

Positron Emission Tomography (PET) Imaging Study to Evaluate Enzyme Availability in the Central Nervous System Before and After CC-97489 Administration in Healthy Participants (clinicaltrials.gov) - P1 | N=38 | Recruiting | Sponsor: Celgene | Trial completion date: Mar 2023 ➔ Oct 2023 | Trial primary completion date: Mar 2023 ➔ Oct 2023

Trial completion date • Trial primary completion date

Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of CC-97489 in Healthy Adult Participants (clinicaltrials.gov) - P1 | N=100 | Recruiting | Sponsor: Celgene | Trial completion date: Dec 2022 ➔ Oct 2023 | Trial primary completion date: Dec 2022 ➔ Oct 2023

Trial completion date • Trial primary completion date

Positron Emission Tomography (PET) Imaging Study to Evaluate Enzyme Availability in the Central Nervous System Before and After CC-97489 Administration in Healthy Participants (clinicaltrials.gov) - P1 | N=32 | Recruiting | Sponsor: Celgene | Trial completion date: Nov 2022 ➔ Mar 2023 | Trial primary completion date: Nov 2022 ➔ Mar 2023

Trial completion date • Trial primary completion date

Positron Emission Tomography (PET) Imaging Study to Evaluate Enzyme Availability in the Central Nervous System Before and After CC-97489 Administration in Healthy Participants (clinicaltrials.gov) - P1; N=32; Recruiting; Sponsor: Celgene; Not yet recruiting ➔ Recruiting

Clinical • Enrollment open

Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of CC-97489 in Healthy Adult Participants (clinicaltrials.gov) - P1; N=100; Recruiting; Sponsor: Celgene

Clinical • New P1 trial

Positron Emission Tomography (PET) Imaging Study to Evaluate Enzyme Availability in the Central Nervous System Before and After CC-97489 Administration in Healthy Participants (clinicaltrials.gov) - P1; N=32; Not yet recruiting; Sponsor: Celgene

Clinical • New P1 trial