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Afimetoran

Phase 2

Systemic Lupus Erythematosus | Small molecule | Immunology |Bristol-Myers Squibb Company|Trials Updated: Jul 30, 2026

Afimetoran development status

Highest phase Phase 2
Registered trials 11 across 1 sponsor since Aug 2018

Afimetoran target and mechanism

Molecular targetTLR7, TLR8
Target classInhibitor
ModalitySmall molecule

Also known as BMS-986256

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLEDDMC
Total Trials2
Total Enrollment261

FDA Designations

No designations recorded

Afimetoran clinical trials

Afimetoran · 2 trials · 2 indications

Phase 2 1Phase 1 1
NCT04895696A Study Evaluating the Efficacy and Safety of Afimetoran Compared With Placebo in Participants With Active Systemic Lupus Erythematosus (SLE)Systemic Lupus Erythematosus
ACTIVE NOT_RECRUITING248 Analytics
PHASE2ACTIVE NOT_RECRUITING
A Study Evaluating the Efficacy and Safety of Afimetoran Compared With Placebo in Participants With Active Systemic Lupus Erythematosus (SLE)
Systemic Lupus ErythematosusUnlock trial analytics

Study Endpoints

Primary Endpoints

Proportion of participants that achieve an SLE (Systemic Lupus Erythematosus) Responder Index (4) (SRI(4)) response at Week 48
Up to 48 Weeks
Incidence of Serious Adverse Events (SAEs)
Up to 24 weeks
Incidence of Adverse Events (AEs)
Up to 20 weeks
Number of laboratory test abnormalities: Hematology
Up to 20 weeks
Number of laboratory test abnormalities: Urinalysis
Up to 20 weeks
Number of laboratory test abnormalities: Clinical Chemistry
Up to 20 weeks
Incidence of clinically significant changes in physical examination findings
Up to 20 weeks
Incidence of clinically significant changes in vital signs: Body temperature
Up to 20 weeks
Incidence of clinically significant changes in vital signs: Respiratory rate
Up to 20 weeks
Incidence of clinically significant changes in vital signs: Blood pressure
Up to 20 weeks
Incidence of clinically significant changes in vital signs: Heart rate
Up to 20 weeks
Incidence of clinically significant changes in Electrocardiogram (ECG) parameters
Up to 20 weeks

Secondary Endpoints

Proportion of participants that achieve a British Isles Lupus Assessment Group (BILAG)-based Combine Lupus Assessment (BICLA) response at Week 24 and Week 48
Up to 48 Weeks
Proportion of participants who achieve an SRI(4) response at Week 24
Up to 24 Weeks
Proportion of participants who achieve a Lupus Low Disease Activity State (LLDAS) response at Week 24 and Week 48
Up to 48 Weeks
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Study Design & Arms

AllocationRANDOMIZED
MaskingQUADRUPLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Afimetoran: Dose 1EXPERIMENTAL -
Afimetoran: Dose 2EXPERIMENTAL -
Afimetoran: Dose 3EXPERIMENTAL -
PlaceboPLACEBO_COMPARATOR -
BMS-986256EXPERIMENTAL -

Interventions

NameTypeDescription
AfimetoranDRUGSpecified dose on specified days
PlaceboOTHERSpecified dose on specified days
BMS-986256DRUGSpecified Dose on Specified Days
BMS-986256 PlaceboOTHERSpecified Dose on Specified Days
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Eligibility Criteria

Age Range18 Years to 70 Years
SexALL
Healthy VolunteersNo
Study Sites147

Inclusion Criteria: * Diagnosed ≥ 12 weeks before the screening visit and qualify as having SLE according to the SLE International Collaborating Clinics (SLICC) Classification Criteria at the screening visit * Test positive, as determined by the central laboratory, for at least one of the following...

Countries:United StatesArgentinaAustraliaBrazilChileChinaColombiaFranceGermanyIndiaIrelandJapanMexicoPolandPuerto RicoRomaniaSpainTaiwanUnited Kingdom
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Recent Changes (Last 90 Days)

LOWJul 30, 2026NCT04895696Enrollment: 268 → 248
LOWJul 30, 2026NCT04895696Enrollment: 268 → 248

Frequently asked questions about Afimetoran

What is Afimetoran used for?

Afimetoran is being studied for the treatment of active systemic lupus erythematosus (SLE), an autoimmune disease. It is an investigational oral small molecule and has not been approved for any indication. Bristol-Myers Squibb is evaluating it in adults with active SLE in a Phase 2 clinical trial.

What does Afimetoran target?

Afimetoran targets TLR7 and TLR8, two toll-like receptors involved in immune signaling. It acts as an inhibitor of these receptors. By blocking TLR7 and TLR8, the drug is designed to dampen the inflammatory immune responses that drive systemic lupus erythematosus. This mechanism is being tested in a Phase 2 study.

Who is developing Afimetoran?

Afimetoran is being developed by Bristol-Myers Squibb Company, which trades under the ticker BMY. The company is running a Phase 2 clinical trial of the drug in patients with active systemic lupus erythematosus. No other developer or partnership for afimetoran is disclosed in the available information.

What phase is Afimetoran in?

Afimetoran is in Phase 2 clinical development. It is investigational and has not been approved by the FDA or any other regulatory agency. The ongoing Phase 2 trial is evaluating its efficacy and safety compared with placebo in participants with active systemic lupus erythematosus.

What clinical trials is Afimetoran in?

Afimetoran is being studied in one clinical trial, NCT04895696, titled a study evaluating the efficacy and safety of afimetoran compared with placebo in participants with active systemic lupus erythematosus. The Phase 2 trial has enrolled 248 participants, is randomized, double-blind, and placebo-controlled, and is currently active but not recruiting.

Is Afimetoran the same as other lupus drugs?

Afimetoran is a distinct investigational small molecule developed by Bristol-Myers Squibb. It is not the same as any approved lupus therapy. It is identified by the ChEMBL ID CHEMBL4650329 and is being studied specifically as a TLR7 and TLR8 inhibitor for active systemic lupus erythematosus.