BMS-986196
/ BMS
- LARVOL DELTA
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August 16, 2025
Discovery of BMS-986196: A brain-penetrant, covalent inhibitor providing rapid inactivation of Bruton's Tyrosine Kinase (BTK)
(ACS-Fall 2025)
- "This presentation will outline the evolution of our strategy to identify a brain-penetrant, covalent inhibitor of BTK that has the intrinsic potency, selectivity, and pharmacokinetic properties necessary to provide a rapid rate of inactivation systemically and in the CNS to treat patients with MS. With in vivo efficacy, a desirable tolerability profile, and pre-clinical target engagement in the brain confirmed by PET imaging, BMS-986196 advanced into clinical studies."
CNS Disorders • Inflammation • Multiple Sclerosis • BTK
April 25, 2025
A Study to Evaluate the Safety, Tolerability, Kinetics, Biodistribution and Repeatability of 11C-BMS-986196 After Intravenous (IV) Administration in Healthy Participants and After Repeat IV Administration in Participants With Multiple Sclerosis
(clinicaltrials.gov)
- P1 | N=10 | Terminated | Sponsor: Bristol-Myers Squibb | Completed ➔ Terminated; Business objectives have changed
Trial termination • CNS Disorders • Multiple Sclerosis
March 27, 2024
A Study to Evaluate the Safety, Tolerability, Kinetics, Biodistribution and Repeatability of 11C-BMS-986196 After Intravenous (IV) Administration in Healthy Participants and After Repeat IV Administration in Participants With Multiple Sclerosis
(clinicaltrials.gov)
- P1 | N=10 | Completed | Sponsor: Bristol-Myers Squibb | Recruiting ➔ Completed | Trial completion date: Aug 2024 ➔ Dec 2023 | Trial primary completion date: Aug 2024 ➔ Dec 2023
Trial completion • Trial completion date • Trial primary completion date • CNS Disorders • Multiple Sclerosis
February 19, 2024
A Study to Evaluate the Safety, Tolerability, Kinetics, Biodistribution and Repeatability of 11C-BMS-986196 After Intravenous (IV) Administration in Healthy Participants and After Repeat IV Administration in Participants With Multiple Sclerosis
(clinicaltrials.gov)
- P1 | N=14 | Recruiting | Sponsor: Bristol-Myers Squibb | Trial completion date: Jul 2023 ➔ Aug 2024 | Trial primary completion date: Jul 2023 ➔ Aug 2024
Trial completion date • Trial primary completion date • CNS Disorders • Multiple Sclerosis
November 13, 2023
A Study to Evaluate the Drug Levels, Physical and Chemical Changes, and Removal of BMS-986196 in Healthy Male Participants
(clinicaltrials.gov)
- P1 | N=8 | Completed | Sponsor: Bristol-Myers Squibb | Recruiting ➔ Completed
Trial completion
July 22, 2023
A Phase 1 Study of the Safety, Pharmacokinetics and Pharmacodynamics of BMS-986196, an Oral CNS-penetrant BTK Inhibitor, in Healthy Adults
(MSMilan 2023)
- "BMS-986196 was safe and tolerated at all dose levels in this study. Taken together, the safety, pharmacokinetic and BTK occupancy results support future clinical studies of BMS-986196."
Clinical • P1 data • PK/PD data • CNS Disorders • Multiple Sclerosis
September 26, 2023
A Study to Evaluate the Drug-drug Interaction Potential of BMS-986196 in Healthy Participants
(clinicaltrials.gov)
- P1 | N=18 | Completed | Sponsor: Bristol-Myers Squibb | Recruiting ➔ Completed
Trial completion
September 25, 2023
A Study to Evaluate the Drug-drug Interaction of BMS-986196 With Oral Contraceptives in Healthy Female Participants
(clinicaltrials.gov)
- P1 | N=15 | Completed | Sponsor: Bristol-Myers Squibb | Recruiting ➔ Completed
Trial completion
September 15, 2023
A Study to Evaluate the Drug Levels, Physical and Chemical Changes, and Removal of BMS-986196 in Healthy Male Participants
(clinicaltrials.gov)
- P1 | N=8 | Recruiting | Sponsor: Bristol-Myers Squibb | Not yet recruiting ➔ Recruiting
Enrollment open
September 13, 2023
A Study to Evaluate the Effect of Food on the Drug Levels of BMS-986196 in Healthy Adult Participants
(clinicaltrials.gov)
- P1 | N=28 | Not yet recruiting | Sponsor: Bristol-Myers Squibb
New P1 trial
September 21, 2023
A Study to Evaluate the Effect of Food on the Drug Levels of BMS-986196 in Healthy Adult Participants
(clinicaltrials.gov)
- P1 | N=0 | Withdrawn | Sponsor: Bristol-Myers Squibb | Not yet recruiting ➔ Withdrawn
Trial withdrawal
August 08, 2023
A Study to Evaluate the Drug Levels, Physical and Chemical Changes, and Removal of BMS-986196 in Healthy Male Participants
(clinicaltrials.gov)
- P1 | N=8 | Not yet recruiting | Sponsor: Bristol-Myers Squibb
New P1 trial
July 27, 2023
A Study to Evaluate the Drug-drug Interaction of BMS-986196 With Oral Contraceptives in Healthy Female Participants
(clinicaltrials.gov)
- P1 | N=15 | Recruiting | Sponsor: Bristol-Myers Squibb | Not yet recruiting ➔ Recruiting
Enrollment open
July 20, 2023
A Study to Evaluate the Drug-drug Interaction Potential of BMS-986196 in Healthy Participants
(clinicaltrials.gov)
- P1 | N=18 | Recruiting | Sponsor: Bristol-Myers Squibb | Not yet recruiting ➔ Recruiting
Enrollment open
June 06, 2023
A Study to Evaluate the Drug-drug Interaction of BMS-986196 With Oral Contraceptives in Healthy Female Participants
(clinicaltrials.gov)
- P1 | N=15 | Not yet recruiting | Sponsor: Bristol-Myers Squibb
New P1 trial
May 10, 2023
A Study to Evaluate the Drug-drug Interaction Potential of BMS-986196 in Healthy Participants
(clinicaltrials.gov)
- P1 | N=18 | Not yet recruiting | Sponsor: Bristol-Myers Squibb
New P1 trial
April 12, 2023
A Study to Evaluate the Safety, Tolerability, Kinetics, Biodistribution and Repeatability of 11C-BMS-986196 After Intravenous (IV) Administration in Healthy Participants and After Repeat IV Administration in Participants With Multiple Sclerosis
(clinicaltrials.gov)
- P1 | N=14 | Recruiting | Sponsor: Bristol-Myers Squibb | Trial completion date: Mar 2023 ➔ Jul 2023 | Trial primary completion date: Mar 2023 ➔ Jul 2023
Trial completion date • Trial primary completion date • CNS Disorders • Multiple Sclerosis
February 10, 2023
A Study to Evaluate the Safety, Tolerability, Kinetics, Biodistribution and Repeatability of 11C-BMS-986196 After Intravenous (IV) Administration in Healthy Participants and After Repeat IV Administration in Participants With Multiple Sclerosis
(clinicaltrials.gov)
- P1 | N=14 | Recruiting | Sponsor: Bristol-Myers Squibb | Trial completion date: Jul 2022 ➔ Mar 2023 | Trial primary completion date: Jul 2022 ➔ Mar 2023
Trial completion date • Trial primary completion date • CNS Disorders • Multiple Sclerosis
January 12, 2023
A Study to Determine the Safety, Drug Levels and Drug Effects of BMS-986196 and Food and Formulation Effects on Relative Absorption Healthy Participants
(clinicaltrials.gov)
- P1 | N=102 | Completed | Sponsor: Bristol-Myers Squibb | Recruiting ➔ Completed
Trial completion
May 31, 2022
A Study to Evaluate the Safety, Tolerability, Kinetics, Biodistribution and Repeatability of 11C-BMS-986196 After Intravenous (IV) Administration in Healthy Participants and After Repeat IV Administration in Participants With Multiple Sclerosis
(clinicaltrials.gov)
- P1 | N=14 | Recruiting | Sponsor: Bristol-Myers Squibb | Not yet recruiting ➔ Recruiting | Trial completion date: Mar 2022 ➔ Jul 2022 | Trial primary completion date: Mar 2022 ➔ Jul 2022
Enrollment open • Trial completion date • Trial primary completion date • CNS Disorders • Multiple Sclerosis
January 27, 2022
A Study to Determine the Safety, Drug Levels and Drug Effects of BMS-986196 and Food and Formulation Effects on Relative Absorption Healthy Participants
(clinicaltrials.gov)
- P1 | N=102 | Recruiting | Sponsor: Bristol-Myers Squibb | Not yet recruiting ➔ Recruiting
Enrollment open
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