BMS-986166
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- LARVOL DELTA
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August 27, 2025
Targeting Intracellular Pathways in Atopic Dermatitis with Small Molecule Therapeutics.
(PubMed, Curr Issues Mol Biol)
- "Although biologic agents such as dupilumab, tralokinumab, and lebrikizumab have revolutionized AD management, their high costs, injectable administration, and limited global accessibility highlight the need for alternative options...This review provides a comprehensive analysis of key agents including Janus kinase (JAK) inhibitors (upadacitinib, abrocitinib, baricitinib, ruxolitinib, delgocitinib), phosphodiesterase 4 (PDE4) inhibitors (crisaborole, difamilast, roflumilast, apremilast), as well as STAT6 degraders (KT621, NX3911), aryl hydrocarbon receptor modulators, histamine H4 receptor antagonists (adriforant, izuforant), and sphingosine-1-phosphate receptor modulators (etrasimod, BMS-986166). We summarize their mechanisms of action, pharmacological profiles, and pivotal clinical trial data, emphasizing their potential to address unmet therapeutic needs. Finally, we discuss safety concerns, long-term tolerability, and future directions for integrating small molecule..."
Journal • Review • Atopic Dermatitis • Dermatitis • Dermatology • Immunology • Inflammation • STAT6
June 24, 2023
Synthetic methodology development driven by the needs of medicinal chemistry efforts: Examples from the identification of S1P1 receptor modulators and RORγt inverse agonists
(ACS-Fall 2023)
- "For this program, the development of various synthetic approaches expedited the identification of two clinical compounds, BMS-986104 and BMS-986166.In addition, I will discuss the discovery of a photochemical decarboxylative annulation methodology developed for the retinoic acid-related orphan receptor gamma t (RORγt) inverse agonist program. This decarboxylative intramolecular arene alkylation works even with electronically poor arenes where Friedel-Craft reaction usually fails and proved enabling for the synthesis of a highly electron-deficient arene core."
S1PR1
March 22, 2023
A Study to Evaluate the Drug Levels of BMS-986166 in Healthy Male Participants
(clinicaltrials.gov)
- P1 | N=7 | Completed | Sponsor: Bristol-Myers Squibb | Not yet recruiting ➔ Completed
Trial completion
February 24, 2023
A Study of BMS-986166 or Branebrutinib for the Treatment of Participants With Atopic Dermatitis
(clinicaltrials.gov)
- P2 | N=17 | Completed | Sponsor: Bristol-Myers Squibb | Active, not recruiting ➔ Completed | Trial completion date: Jan 2024 ➔ Aug 2022
Trial completion • Trial completion date • Atopic Dermatitis • Dermatitis • Dermatology • Immunology
September 29, 2022
A Study of BMS-986166 or Branebrutinib for the Treatment of Participants With Atopic Dermatitis
(clinicaltrials.gov)
- P2 | N=17 | Active, not recruiting | Sponsor: Bristol-Myers Squibb | Recruiting ➔ Active, not recruiting | N=150 ➔ 17 | Trial primary completion date: Nov 2023 ➔ Aug 2022
Enrollment change • Enrollment closed • Trial primary completion date • Atopic Dermatitis • Dermatitis • Dermatology • Immunology
August 29, 2022
A Study of BMS-986166 or Branebrutinib for the Treatment of Participants With Atopic Dermatitis
(clinicaltrials.gov)
- P2 | N=150 | Recruiting | Sponsor: Bristol-Myers Squibb | Trial completion date: Feb 2023 ➔ Jan 2024 | Trial primary completion date: Jan 2023 ➔ Nov 2023
Trial completion date • Trial primary completion date • Atopic Dermatitis • Dermatitis • Dermatology • Immunology
June 08, 2022
A Study to Evaluate the Drug Levels of BMS-986166 in Healthy Male Participants
(clinicaltrials.gov)
- P1 | N=8 | Not yet recruiting | Sponsor: Bristol-Myers Squibb
New P1 trial
May 13, 2022
A Study to Assess the Effect of Itraconazole, Phenytoin and Gemfibrozil on the Drug Levels of BMS-986166 in Healthy Participants
(clinicaltrials.gov)
- P1 | N=15 | Completed | Sponsor: Bristol-Myers Squibb | Active, not recruiting ➔ Completed | N=72 ➔ 15
Enrollment change • Trial completion
April 13, 2022
A Study to Assess the Effect of Itraconazole, Phenytoin and Gemfibrozil on the Drug Levels of BMS-986166 in Healthy Participants
(clinicaltrials.gov)
- P1 | N=72 | Active, not recruiting | Sponsor: Bristol-Myers Squibb | Recruiting ➔ Active, not recruiting | Trial completion date: Jan 2022 ➔ Apr 2022 | Trial primary completion date: Jan 2022 ➔ Apr 2022
Enrollment closed • Trial completion date • Trial primary completion date
March 18, 2022
A Study to Characterize the Drug Levels of an Oral Contraceptive With and Without BMS-986166 in Healthy Female Participants of Childbearing Potential
(clinicaltrials.gov)
- P1 | N=25 | Completed | Sponsor: Bristol-Myers Squibb | Recruiting ➔ Completed
Trial completion
March 09, 2022
A Study to Evaluate the Safety, Tolerability, Drug Levels, and Drug Effects of BMS-986166 in Healthy Japanese Participants
(clinicaltrials.gov)
- P1 | N=23 | Completed | Sponsor: Bristol-Myers Squibb | Not yet recruiting ➔ Completed | Trial completion date: Nov 2021 ➔ Feb 2022 | Trial primary completion date: Nov 2021 ➔ Feb 2022
Trial completion • Trial completion date • Trial primary completion date
September 24, 2021
[VIRTUAL] BMS-986166, a novel S1PR1,4,5 modulator, is highly efficacious in a mouse model of atopic dermatitis
(EADV 2021)
- No abstract available
Preclinical • Atopic Dermatitis • Dermatitis • Dermatology • Immunology
August 20, 2021
A Study of BMS-986166 or Branebrutinib for the Treatment of Participants With Atopic Dermatitis
(clinicaltrials.gov)
- P2; N=150; Recruiting; Sponsor: Bristol-Myers Squibb
Clinical • New P2 trial • Atopic Dermatitis • Dermatitis • Dermatology • Immunology
August 18, 2021
A Study to Characterize the Pharmacokinetics of an Oral Contraceptive With and Without BMS-986166 in Healthy Female Participants of Childbearing Potential
(clinicaltrials.gov)
- P1; N=24; Recruiting; Sponsor: Bristol-Myers Squibb; Not yet recruiting ➔ Recruiting
Enrollment open
August 13, 2021
A Study to Assess the Effect of Itraconazole, Phenytoin, and Gemfibrozil on the Drug Levels of BMS-986166 in Healthy Participants
(clinicaltrials.gov)
- P1; N=60; Recruiting; Sponsor: Bristol-Myers Squibb; Not yet recruiting ➔ Recruiting
Enrollment open
July 16, 2021
A Study to Evaluate the Safety, Tolerability, Drug Levels, and Drug Effects of BMS-986166 in Healthy Japanese Participants
(clinicaltrials.gov)
- P1; N=20; Not yet recruiting; Sponsor: Bristol-Myers Squibb
Clinical • New P1 trial
July 09, 2021
Effect of Itraconazole, Phenytoin, and Gemfibrozil on the Pharmacokinetics of BMS-986166
(clinicaltrials.gov)
- P1; N=60; Not yet recruiting; Sponsor: Bristol-Myers Squibb
Clinical • New P1 trial
June 22, 2021
A Study to Characterize the Pharmacokinetics of an Oral Contraceptive With and Without BMS-986166 in Healthy Female Participants of Childbearing Potential
(clinicaltrials.gov)
- P1; N=24; Not yet recruiting; Sponsor: Bristol-Myers Squibb
Clinical • New P1 trial
October 26, 2020
Population Pharmacokinetic Analysis of BMS-986166, a Novel Selective Sphingosine-1-Phosphate-1 Receptor Modulator, and Exposure-Response Assessment of Lymphocyte Counts and Heart Rate in Healthy Participants.
(PubMed, Clin Pharmacol Drug Dev)
- "Predicted decreases in nDDHR and nALC were 9 bpm and 20% following placebo, with maximum decreases of 10 bpm in nDDHR due to drug effect, and approximately 80% in nALC due to drug and placebo. A 0.5-mg/day dose regimen achieves the target 65% reduction in nALC associated with a 2-bpm decrease in nDDHR over placebo."
Clinical • Journal • PK/PD data • Immunology
April 21, 2020
The safety and pharmacokinetics of a novel, selective S1P1R modulator in healthy participants.
(PubMed, Expert Opin Investig Drugs)
- P1 | "Between Day 0 and 35, median nadir lymphocyte reductions were 53.7%, 75.9% and 81.9% with 0.25-, 0.75- and 1.5-mg BMS-986166 doses. ALC recovery began 14, 14-21 and 7 days after last dose of 0.25, 0.75 and 1.5 mg. BMS-986166 was generally well tolerated in this population and warrants further investigation.Trial registration: ClinicalTrials.gov: NCT02790125, NCT03038711."
Clinical • Journal • PK/PD data
February 21, 2019
Identification and Preclinical Pharmacology of ((1R,3S)-1-amino-3-((S)-6-(2-methoxyphenethyl)-5,6,7,8-tetrahydronaphthalen-2-yl)cyclopentyl)methanol (BMS-986166): A Differentiated Sphingosine-1-Phosphate (S1P1) Receptor Modulator Advanced into Clinical Trials.
(PubMed, J Med Chem)
- "In comparison to fingolimod (1), a full agonist of S1P currently marketed for the treatment of relapse remitting multiple sclerosis (RRMS), 2 offers several potential advantages having demonstrated improved safety multiples in preclinical evaluations against undesired pulmonary and cardiovascular effects. The pharmacokinetic/pharmacodynamic (PK/PD) relationship as well as pulmonary and cardiovascular safety assessments will be discussed. Furthermore, efficacy of 14a in multiple preclinical models of autoimmune disease are presented."
Journal
February 13, 2020
Aryl ether and thioether-derived bicyclic S1P1 partial agonists: Optimization of the PK, PD and safety profiles through sidechain modifications
(ACS-Sp 2020)
- "Our efforts towards the identification of partial agonists of S1P1 with differentiated safety profiles led to the discovery and clinical development of BMS-986104 (1) and BMS-986166 (2). In this presentation, the effects of analogs 3–6 on the levels of lymphocyte reduction in the rat (the desired pharmacology) along with pulmonary and cardiovascular-related effects (undesired pharmacology) will be detailed. The projected safety profiles of select compounds were found to be superior to that of FTY720 and comparable to what was observed for 1 and 2, with notable reductions in t1/2."
Clinical
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