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KT-621

Phase 2

Atopic Dermatitis | Small molecule | Immunology |Kymera Therapeutics, Inc.|Last Updated: May 18, 2026

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
RandomizedDouble-BlindPLACEBO_CONTROLLEDBiomarker
Total Trials2
Total Enrollment222
FDA Designations
No designations recorded
Clinical Trials (2)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT07217015A Study of KT-621 Administered Orally to Participants With Moderate to Severe Atopic DermatitisPHASE2 RECRUITING 200 — — Nov 24, 2025Jun 1, 2028May 18, 202667 United States, Australia +6
NCT06945458Safety, PK, PD, and Clinical Activity of Orally Administered KT-621 in Adult Patients With Atopic Dermatitis (AD)PHASE1 COMPLETED 22 — — Apr 17, 2025Nov 10, 2025Jan 26, 202612 United States
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Study Endpoints
Primary Endpoints
Change from baseline in Eczema Area and Severity Index (EASI) score
From baseline through Week 16
Incidence of adverse events (AEs)
From enrollment through the safety follow-up visit on Day 43
Incidence of treatment-emergent potentially clinically-significant abnormalities in electrocardiogram (ECG) results, vital signs, or laboratory test results from the serum chemistry, hematology (with differential), chemistry, or coagulation panels.
From enrollment through the safety follow-up visit on Day 43
Secondary Endpoints
Incidence of treatment-emergent adverse events (TEAEs)
From baseline through Week 16, and from Week 16 through Week 68
Incidence of treatment-emergent serious adverse events (SAEs)
From baseline through Week 16, and from Week 16 through Week 68
Percentage change from baseline in body surface area (BSA) affected by AD
From baseline to Week 16 and to Week 68
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Study Design & Arms
AllocationRANDOMIZED
MaskingTRIPLE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
Group 1: KT-621 Dose 1EXPERIMENTAL -
Group 2: KT-621 Dose 2EXPERIMENTAL -
Group 3: KT-621 Dose 3EXPERIMENTAL -
Group 4: PlaceboPLACEBO_COMPARATOR -
KT-621EXPERIMENTALEach participant receives daily oral doses of KT-621 throughout the 28-day treatment period.
Interventions
NameTypeDescription
KT-621DRUGOral drug
PlaceboOTHEROral placebo matched to KT-621
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Eligibility Criteria
Age Range12 Years — 75 Years
SexALL
Healthy VolunteersNo
Study Sites67

Inclusion Criteria: * Must be 12 to 75 years of age, inclusive, at the time of signing the IAF (informed assent form) and/or ICF (informed consent form). * Must have chronic AD that has been present for at least 3 years (for participants ≥ 18 years of age) or 1 year (for participants \< 18 years of...

Countries:United StatesAustraliaCanadaCzechiaGermanyJapanPolandSouth Korea
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Competitive Landscape -Atopic Dermatitis 82 trials
CompanyTickerTrialsLead PhaseDrugs
Eli Lilly and CompanyLLY6PHASE3Baricitinib, corticosteroid, Lebrikizumab, Corticosteroid
AbbVie, Inc.ABBV10PHASE3Upadacitinib, corticosteroids, Dupilumab, Upadacitinib Dose, Dupilumab Dose
Pfizer Inc.PFE12PHASE3Abrocitinib, PF-08049820, PF-07275315, PF-07264660, Midazolam
Sanofi SA Sponsored ADRSNY13PHASE3Amlitelimab, corticosteroids, tacrolimus or pimecrolimus, calcineurin inhibitors, Dupilumab SAR231893
Regeneron Pharmaceuticals, Inc.REGN4PHASE3Dupilumab, REGN20423, dupilumab
Incyte CorporationINCY3PHASE3Ruxolitinib, Vehicle, TCS
Amgen Inc.AMGN1PHASE3Rocatinlimab
Organon & Co.OGN1PHASE3Tapinarof , 1%, Vehicle
Novartis AG Sponsored ADRNVS2PHASE2GIA632, GHZ339
Apogee Therapeutics, Inc.APGE3PHASE2APG777, APG990, Dupilumab
Johnson & JohnsonJNJ1PHASE2JNJ-95597528
Kymera Therapeutics, Inc.KYMR1PHASE2KT-621
Nektar TherapeuticsNKTR1PHASE2Rezpegaldesleukin
Corvus Pharmaceuticals, Inc.CRVS1PHASE2Soquelitinib
Celldex Therapeutics, Inc.CLDX1PHASE2Barzolvolimab
Evommune, Inc.EVMN1PHASE2EVO756
Aclaris Therapeutics, Inc.ACRS1PHASE2ATI-045
Q32 Bio IncQTTB1PHASE2ADX-914
Turn Therapeutics Inc.TTRX1PHASE2GX-03
Arcutis Biotherapeutics IncARQT1PHASE1ARQ-234
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Recent Changes (Last 90 Days)
LOWMay 26, 2026NCT07217015primaryCompletionDate: changed
LOWMay 24, 2026NCT07217015studyFirstPostDate: changed