Recent Updates
Recently added Catalysts

Afimetoran

Phase 2

Systemic Lupus Erythematosus | Small molecule | Immunology |Bristol-Myers Squibb Company|Last Updated: May 14, 2026

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
Premium
Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
Premium
Trial Design
RandomizedDouble-BlindPLACEBO_CONTROLLEDDMCBiomarker
Total Trials1
Total Enrollment268
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT04895696A Study Evaluating the Efficacy and Safety of Afimetoran Compared With Placebo in Participants With Active Systemic Lupus Erythematosus (SLE)PHASE2 ACTIVE NOT_RECRUITING 268Oct 11, 2021Apr 22, 2029May 14, 2026147 United States, Argentina +17
Unlock Drug Trial Details
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
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
Unlock Study Endpoints
Study Design & Arms
AllocationRANDOMIZED
MaskingQUADRUPLE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
Afimetoran: Dose 1EXPERIMENTAL -
Afimetoran: Dose 2EXPERIMENTAL -
Afimetoran: Dose 3EXPERIMENTAL -
PlaceboPLACEBO_COMPARATOR -
Interventions
NameTypeDescription
AfimetoranDRUGSpecified dose on specified days
PlaceboOTHERSpecified dose on specified days
Unlock Study Design Details
Eligibility Criteria
Age Range18 Years — 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
Unlock Eligibility Criteria
Recent Changes (Last 90 Days)
LOWMay 26, 2026NCT04895696primaryCompletionDate: changed
LOWMay 24, 2026NCT04895696studyFirstPostDate: changed