BMS-986165

ApprovedSmall molecule

Bristol-Myers Squibb

BMS-986165 is one of 230 small molecule programs targeting Systemic Lupus Erythematosus. It is currently in Approved.

Indications

Total Trials

Active Trials

229

Competitors

Pipeline

Status by Indication[3][1]

Indication

Systemic Lupus ErythematosusActive, not recruiting

Kidney DiseaseActive, not recruiting

Prostate CancerActive, not recruiting

PsoriasisActive, not recruiting

Ulcerative ColitisActive, not recruiting

Psoriatic ArthritisActive, not recruiting

Lupus NephritisActive, not recruiting

Cutaneous Lupus ErythematosusActive, not recruiting

Systemic Lupus ErythematosusPhase 2

Active, not recruiting

Kidney DiseasePhase 1

Active, not recruiting

Prostate CancerPhase 2

Active, not recruiting

PsoriasisPhase 3

Active, not recruiting

Ulcerative ColitisPhase 2

Active, not recruiting

Psoriatic ArthritisPhase 2

Active, not recruiting

Lupus NephritisPhase 2

Active, not recruiting

Cutaneous Lupus ErythematosusApproved

Active, not recruiting

Competition

Competitive Landscape

1399 competitors in Prostate Cancer

#DrugCompanyPhaseTrials

BMS-986165

Bristol-Myers Squibb

Approved

1 2

Novantrone

Pfizer

Preclinical

5 3

Mekinist

Novartis

Preclinical

3 4

Trexall

Alnylam Pharmaceuticals

Preclinical

—5

Jatenzo

GGrupo Espanol de Tumores Neuroendocrinos

Preclinical

2 6

Viagra

VViatris Specialty LLC

Preclinical

1 7

Duragesic

CCephalon

Preclinical

1 8

Ranexa

MMenarini International Operations Luxembourg SA

Preclinical

1 9

Osmitrol

BB. Braun Medical Inc.

Preclinical

—10

Ifex

BBaxter Healthcare Corporation

Preclinical

—

Ranked by pipeline maturity and clinical activity. Current drug highlighted in teal.

Timeline

Expected Milestones

Q3 2026

Phase 3Active, not recruiting

Psoriasis

NCT04036435

Q4 2026

Post-ApprovalRecruiting

Cutaneous Lupus Erythematosus

NCT06875960

Q3 2027

Phase 3Not yet recruiting

Psoriasis

NCT07326813

Q1 2030

Phase 2Recruiting

Prostate Cancer

NCT07335796

Clinical

Trials by Indication[1]

Psoriasis8 trials

Safety Study of BMS-986165 in Healthy Subjects and to Treat Psoriasis

Completed· Bristol-Myers Squibb logo

Bristol-Myers Squibb·Phase 1·NCT02534636·140 enrolled

Effectiveness and Safety of BMS-986165 Compared to Placebo and Active Comparator in Participants With Psoriasis

Completed· Bristol-Myers Squibb logo

Bristol-Myers Squibb·Phase 3·NCT03624127·666 enrolled

Long-Term Study That Measures the Safety and Efficacy of Deucravacitinib (BMS-986165) in Participants With Psoriasis

Active, not recruiting· Bristol-Myers Squibb logo

Bristol-Myers Squibb·Phase 3·NCT04036435·1,466 enrolled

Show 5 more trials

Study to Evaluate Effectiveness and Safety in Subjects With Moderate to Severe Psoriasis

Completed· Bristol-Myers Squibb logo

Bristol-Myers Squibb·Phase 2·NCT02931838·268 enrolled

An Investigational Study to Evaluate Experimental Medication BMS-986165 in Japanese Participants With Moderate-to-Severe Psoriasis

Completed· Bristol-Myers Squibb logo

Bristol-Myers Squibb·Phase 3·NCT03924427·74 enrolled

An Investigational Study to Evaluate Experimental Medication BMS-986165 Compared to Placebo in Participants With Plaque Psoriasis (POETYK-PSO-3) in Mainland China, Taiwan, and South Korea

Completed· Bristol-Myers Squibb logo

Bristol-Myers Squibb·Phase 3·NCT04167462·220 enrolled

An Investigational Study to Evaluate Experimental Medication BMS-986165 Compared to Placebo and a Currently Available Treatment in Participants With Moderate-to-Severe Plaque Psoriasis

Completed· Bristol-Myers Squibb logo

Bristol-Myers Squibb·Phase 3·NCT03611751·1,020 enrolled

A Clinical Study to Evaluate the Efficacy and Safety of D-2570 in the Treatment of Moderate to Severe Plaque Psoriasis.

Not yet recruiting·IInventisBio Co., Ltd·Phase 3·NCT07326813·477 enrolled

Experimental5 trials

Assessment of Gut Absorption of Experimental Medication BMS-986165 in Healthy Males

Completed· Bristol-Myers Squibb logo

Bristol-Myers Squibb·Phase 1·NCT03873415·9 enrolled

An Investigational Study of Cyclosporine on Experimental Medication BMS-986165 in Healthy Male Participants

Completed· Bristol-Myers Squibb logo

Bristol-Myers Squibb·Phase 1·NCT03419910·54 enrolled

An Investigational Study of Experimental Medication BMS-986165 in Healthy Participants to Study Electrocardiogram Effects

Completed· Bristol-Myers Squibb logo

Bristol-Myers Squibb·Phase 1·NCT03541564·84 enrolled

Show 2 more trials

An Investigational Study to Evaluate Experimental Medication BMS-986165 Given as a Tablet and Solution in Healthy Male Participants

Completed· Bristol-Myers Squibb logo

Bristol-Myers Squibb·Phase 1·NCT03739788·8 enrolled

An Investigational Study of Experimental Medication BMS-986165 in Healthy Participants

Completed· Bristol-Myers Squibb logo

Bristol-Myers Squibb·Phase 1·NCT03660436·131 enrolled

Systemic Lupus Erythematosus2 trials

An Investigational Study to Evaluate BMS-986165 in Participants With Systemic Lupus Erythematosus

Completed· Bristol-Myers Squibb logo

Bristol-Myers Squibb·Phase 2·NCT03252587·363 enrolled

Long-Term Safety and Efficacy Study of Deucravacitinib in Participants With Systemic Lupus Erythematosus

Completed· Bristol-Myers Squibb logo

Bristol-Myers Squibb·Phase 2·NCT03920267·261 enrolled

Drug2 trials

A Study to Investigate the Effects of Cytochrome P450 1A2 Induction by Ritonavir on BMS-986165 Drug Levels and Effects in Healthy Participants

Completed· Bristol-Myers Squibb logo

Bristol-Myers Squibb·Phase 1·NCT04055506·16 enrolled

An Investigational Study to Determine the Drug Level Profile of BMS-986165 in Healthy Male Volunteers Following Transporter Inhibition.

Completed· Bristol-Myers Squibb logo

Bristol-Myers Squibb·Phase 1·NCT04086719·16 enrolled

ART2 trials

A Taste Assessment of BMS-986165 in Healthy Participants

Completed· Bristol-Myers Squibb logo

Bristol-Myers Squibb·Phase 1·NCT03751228·9 enrolled

The Effects Diflunisal on the Levels of BMS-986165 in Healthy Participants

Completed· Bristol-Myers Squibb logo

Bristol-Myers Squibb·Phase 1·NCT04113668·48 enrolled

21 more indications

Ulcerative Colitis2 trials

Safety and Efficacy of Deucravacitinib in Participants With Moderate to Severe Ulcerative Colitis

Completed· Bristol-Myers Squibb logo

Bristol-Myers Squibb·Phase 2·NCT03934216·131 enrolled

A Study of the Safety, Efficacy, and Biomarker Response of BMS-986165 in Participants With Moderate to Severe Ulcerative Colitis

Completed· Bristol-Myers Squibb logo

Bristol-Myers Squibb·Phase 2·NCT04613518·38 enrolled

Psoriatic Arthritis1 trial

Efficacy and Safety of BMS-986165 Compared With Placebo in Participants With Active Psoriatic Arthritis (PsA)

Completed· Bristol-Myers Squibb logo

Bristol-Myers Squibb·Phase 2·NCT03881059·203 enrolled

Adult1 trial

A Study to Compare the Taste and Levels in Blood Plasma of BMS-986165 When Taken as Different Formulations by Healthy Adult Participants

Completed· Bristol-Myers Squibb logo

Bristol-Myers Squibb·Phase 1·NCT04305899·40 enrolled

Kidney Disease1 trial

A Study to Assess the Safety of Experimental Medication BMS986165 in Participants With Normal Kidney Function and Participants With Mild to End-Stage Kidney Disease.

Completed· Bristol-Myers Squibb logo

Bristol-Myers Squibb·Phase 1·NCT03890770·44 enrolled

Cutaneous Lupus Erythematosus1 trial

A Study to Continue the Administration of Deucravacitinib in Participants With Systemic Lupus Erythematosus (SLE) or Discoid and/or Subacute Cutaneous Lupus Erythematosus (DLE/SCLE) Who Have Completed Study IM011074 or Study IM011132

Recruiting· Bristol-Myers Squibb logo

Bristol-Myers Squibb·Phase 4·NCT06875960·35 enrolled

Systemic1 trial

Study to Characterize the Effects of Cytochrome p450 1A2 Inhibition on Systemic Exposure to BMS-986165

Completed· Bristol-Myers Squibb logo

Bristol-Myers Squibb·Phase 1·NCT03930602·16 enrolled

Double-blind1 trial

Single and Multiple Dose Pharmacokinetics of BMS-986165 in a Randomized, Double-Blind, Placebo-Controlled Study in Healthy Chinese Subjects

Completed· Bristol-Myers Squibb logo

Bristol-Myers Squibb·Phase 1·NCT03956953·135 enrolled

Prostate Cancer1 trial

A Study of BMS986365 in Combination With Degarelix in People With Prostate Cancer

Recruiting·MMemorial Sloan Kettering Cancer Center·Phase 2·NCT07335796·30 enrolled

Methotrexate1 trial

A Study to Investigate BMS-986165 and Methotrexate in Healthy Male Patients

Completed· Bristol-Myers Squibb logo

Bristol-Myers Squibb·Phase 1·NCT03402087·30 enrolled

Metabolism1 trial

Pharmacokinetics and Metabolism of [14C]BMS-986165 in Healthy Male Participants

Completed· Bristol-Myers Squibb logo

Bristol-Myers Squibb·Phase 1·NCT03004768·6 enrolled

Lupus Nephritis1 trial

An Investigational Study to Evaluate the Safety and Effectiveness of BMS-986165 With Background Treatment in Participants With Lupus Nephritis

Terminated· Bristol-Myers Squibb logo

Bristol-Myers Squibb·Phase 2·NCT03943147·16 enrolled

Treatment1 trial

A Study Comparing the Effects of Famotidine Pretreatment and of Food on the Relative Bioavailability of BMS-986165 in Healthy Volunteers

Completed· Bristol-Myers Squibb logo

Bristol-Myers Squibb·Phase 1·NCT04209699·18 enrolled

Metformin1 trial

Effect of BMS-986165 on the Blood Levels of Metformin

Completed· Bristol-Myers Squibb logo

Bristol-Myers Squibb·Phase 1·NCT04671953·36 enrolled

Moderate to Severe Crohn's Disease1 trial

An Investigational Study of Experimental Medication BMS-986165 in Participants With Moderate to Severe Crohn's Disease

Terminated· Bristol-Myers Squibb logo

Bristol-Myers Squibb·Phase 2·NCT03599622·239 enrolled

Female1 trial

The Effect of BMS-986165 Combined With an Oral Contraceptive (Ethinyl Estradiol/Norethindrone) in Healthy Female Patients

Completed· Bristol-Myers Squibb logo

Bristol-Myers Squibb·Phase 1·NCT03262727·49 enrolled

Tics1 trial

Pharmacokinetics (Drug Levels in Blood) of BMS-986165 When Taken as Various Solid Tablet Prototypes by Healthy Participants

Completed· Bristol-Myers Squibb logo

Bristol-Myers Squibb·Phase 1·NCT04249284·18 enrolled

Statin1 trial

Effect of BMS-986165 on the Pharmacokinetics of Rosuvastatin

Completed· Bristol-Myers Squibb logo

Bristol-Myers Squibb·Phase 1·NCT03044873·20 enrolled

Function1 trial

An Investigational Study of BMS-986165 in Participants With Normal Liver Function and Participants With Mild to Severe Liver Damage

Completed· Bristol-Myers Squibb logo

Bristol-Myers Squibb·Phase 1·NCT03890809·32 enrolled

Gastric Acid1 trial

A Study to Investigate the Effects of Gastric Acid Suppression by Rabeprazole and BMS-986165 on How Fast and Complete The Drug is Absorbed Into the Body of Healthy Participants

Completed· Bristol-Myers Squibb logo

Bristol-Myers Squibb·Phase 1·NCT03979248·21 enrolled

Gastric1 trial

A Study to Evaluate BMS-986165 Tablet Formulation Relative to BMS-986165 Capsule Formulation and the Effect of a High-Fat/ High-Calorie Meal and Increased Gastric pH on the BMS-986165 Tablet Formulation

Completed· Bristol-Myers Squibb logo

Bristol-Myers Squibb·Phase 1·NCT03254784·49 enrolled

Unspecified1 trial

A Study to Determine the Pharmacokinetic Profile of BMS-986165 Tablets

Completed· Bristol-Myers Squibb logo

Bristol-Myers Squibb·Phase 1·NCT04065932·33 enrolled

Sources

References

[1]
ClinicalTrials.gov — 41 trial records for BMS-986165. U.S. National Library of Medicine, National Institutes of Health.
[2]
ChEMBL — BMS-986165 compound record. European Bioinformatics Institute (EMBL-EBI).
[3]
Open Targets Platform — Drug–disease associations for BMS-986165. EMBL-EBI & Wellcome Sanger Institute.
[4]
SEC EDGAR — Bristol-Myers Squibb company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Modality: Small molecule[2]
Highest Phase: Approved[1]
Company: Bristol-Myers Squibb

BMS-986165

Status by Indication[3][1]

Competitive Landscape

Expected Milestones

Q3 2026

Q4 2026

Q3 2027

Q1 2030

Trials by Indication[1]

Psoriasis8 trials

Experimental5 trials

Systemic Lupus Erythematosus2 trials

Drug2 trials

ART2 trials

Ulcerative Colitis2 trials

Psoriatic Arthritis1 trial

Adult1 trial

Kidney Disease1 trial

Cutaneous Lupus Erythematosus1 trial

Systemic1 trial

Double-blind1 trial

Prostate Cancer1 trial

Methotrexate1 trial

Metabolism1 trial

Lupus Nephritis1 trial

Treatment1 trial

Metformin1 trial

Moderate to Severe Crohn's Disease1 trial

Female1 trial

Tics1 trial

Statin1 trial

Function1 trial

Gastric Acid1 trial

Gastric1 trial

Unspecified1 trial

References

Drug Info

Quick Facts

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