irafamdastat (BMS-986368) / BMS - LARVOL DELTA

A Study to Assess the Relative Bioavailability of Irafamdastat (BMS-986368) and to Assess the Food Effect on the Pharmacokinetics of Irafamdastat in Healthy Adult Participants (clinicaltrials.gov) - P1 | N=24 | Not yet recruiting | Sponsor: Celgene

New P1 trial

Results from 2 phase 1 studies evaluating the dual FAAH/MAGL inhibitor irafamdastat in healthy adults (including Japanese and elderly) (CTAD 2026) - No abstract available

Clinical • P1 data

A Pilot Study to Evaluate the Efficacy, Safety and Tolerability of BMS-986368, a FAAH/MAGL Inhibitor, in Participants With Post-Stroke Spasticity (The STIPS Study) (clinicaltrials.gov) - P2 | N=42 | Recruiting | Sponsor: Alberto Esquenazi | Not yet recruiting ➔ Recruiting

Enrollment open • Cardiovascular • Movement Disorders

A Pilot Study to Evaluate the Efficacy, Safety and Tolerability of BMS-986368, a FAAH/MAGL Inhibitor, in Participants With Post-Stroke Spasticity (The STIPS Study) (clinicaltrials.gov) - P2 | N=42 | Not yet recruiting | Sponsor: Alberto Esquenazi

New P2 trial • Cardiovascular • Movement Disorders

A Study to Evaluate the Blood Levels, Safety, and Tolerability of BMS-986368 in Healthy Chinese Participants (clinicaltrials.gov) - P1 | N=16 | Not yet recruiting | Sponsor: Celgene

New P1 trial

A Comprehensive Preclinical Characterization Of BMS‑986368, A First-in-class, Oral, Dual Inhibitor Of FAAH/MAGL (AAIC 2026) - No abstract available

Preclinical

IM045-1018: Study to Evaluate the Efficacy, Safety and Tolerability of BMS-986368, a FAAH/MAGL Inhibitor, in Participants with Multiple Sclerosis Spasticity (clinicaltrialsregister.eu) - P1/2 | N=100 | Recruiting | Sponsor: Celgene Corp.

New P1/2 trial • CNS Disorders • Movement Disorders • Multiple Sclerosis

A Comprehensive Preclinical Characterization of BMS‑986368, a First-in-Class, Oral, Dual Inhibitor of Fatty Acid Amide Hydrolase and Monoacylglycerol Lipase (ACTRIMS Forum 2026) - P2 | "The antiseizure and antiepileptogenic activity of BMS-986368 at 2-30 mg/kg was determined using electroconvulsive shock (ECS) threshold and maximal ECS tests, pentylenetetrazole seizure models, and amygdala electrical kindling models. BMS-986368 is a first-in-class, orally bioavailable, centrally penetrant dual FAAH/MAGL inhibitor with a moderate half-life that was efficacious in rodent seizure and epileptogenic models and well tolerated in CMs for 9 months. BMS-986368 is under phase 2 investigation for the treatment of MS spasticity (BALANCE-MSS-1; NCT06782490) and other neurologic hyperexcitability disorders."

Preclinical • CNS Disorders • Epilepsy • Inflammation • 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 | Trial completion date: Sep 2027 ➔ Jan 2028 | Trial primary completion date: Jul 2027 ➔ Nov 2027

Trial completion date • Trial primary completion date • 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 | Trial completion date: Jan 2027 ➔ Jun 2027 | Trial primary completion date: Nov 2026 ➔ May 2027

Trial completion date • Trial primary completion date • CNS Disorders • Movement Disorders • Multiple Sclerosis

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