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KT-621

Phase 2

Asthma (Diagnosis) | Small molecule | Respiratory |Kymera Therapeutics, Inc.|Trials Updated: Oct 7, 2026

KT-621 development status

Highest phase Phase 2
Registered trials 6 across 1 sponsor since Nov 2024

KT-621 target and mechanism

Molecular targetSTAT6
Target classProtein
ModalitySmall molecule

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLEDDMC
Total Trials4
Total Enrollment750

FDA Designations

FAST_TRACK

KT-621 clinical trials

KT-621 · 4 trials · 3 indications

Phase 2 3Phase 1 1
NCT07677059A Long-term Study of KT-621 Administered Orally to Participants With Asthma Previously Enrolled in a KT-621 Asthma StudyAsthma (Diagnosis)
RECRUITING264 Analytics
NCT07323654A Study of KT-621 Administered Orally to Adult Participants With Moderate to Severe Eosinophilic AsthmaEosinophilic Asthma
RECRUITING264 Analytics
NCT07217015A Study of KT-621 Administered Orally to Participants With Moderate to Severe Atopic DermatitisAtopic Dermatitis
ACTIVE NOT_RECRUITING200 Analytics
PHASE2RECRUITING
A Long-term Study of KT-621 Administered Orally to Participants With Asthma Previously Enrolled in a KT-621 Asthma Study
Asthma (Diagnosis)Unlock trial analytics
PHASE2RECRUITING
A Study of KT-621 Administered Orally to Adult Participants With Moderate to Severe Eosinophilic Asthma
Eosinophilic AsthmaUnlock trial analytics
PHASE2ACTIVE NOT_RECRUITING
A Study of KT-621 Administered Orally to Participants With Moderate to Severe Atopic Dermatitis
Atopic DermatitisUnlock trial analytics

Study Endpoints

Primary Endpoints

Incidence of treatment-emergent adverse events (TEAEs)
From baseline through Week 52
Incidence of treatment-emergent serious adverse events (SAEs)
From baseline through Week 52
Change from baseline in pre-bronchodilator FEV1
From baseline to Week 12
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

Change from baseline in pre-bronchodilator FEV1
From baseline (as assessed in the parent study) to Week 52
Change from baseline in post-bronchodilator FEV1
From baseline (as assessed in the parent study) to Week 52
Change from baseline in Asthma Control Questionnaire 5-question version (ACQ-5) score
From baseline (as assessed in the parent study) to Week 52
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Study Design & Arms

AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
KT-621EXPERIMENTAL -
Group 1: KT-621 Dose 1EXPERIMENTAL -
Group 2: KT-621 Dose 2EXPERIMENTAL -
Group 3: KT-621 Dose 3EXPERIMENTAL -
Group 4: PlaceboPLACEBO_COMPARATOR -

Interventions

NameTypeDescription
KT-621DRUGOral drug
PlaceboOTHEROral placebo matched to KT-621
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites7

Inclusion Criteria: * Must have completed all visits of the parent study, per its protocol, up to the end of treatment (EoT) visit. * Must be willing and able to comply with scheduled visits, treatment plan, laboratory tests, other study-related procedures, and questionnaires, including completing ...

Countries:United StatesGermanyPolandSerbiaArgentinaAustriaBelgiumItalyRomaniaSlovakiaSouth KoreaSpainUnited KingdomAustraliaCanadaCzechiaJapan
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Recent Changes (Last 90 Days)

LOWOct 7, 2026NCT07677059startDate: changed
LOWOct 7, 2026NCT07677059startDate: changed
LOWOct 6, 2026NCT07323654lastUpdatePostDate: changed
LOWOct 6, 2026NCT07217015lastUpdatePostDate: changed
LOWOct 6, 2026NCT07323654lastUpdatePostDate: changed
LOWOct 6, 2026NCT07217015lastUpdatePostDate: changed
LOWAug 17, 2026NCT07323654lastUpdatePostDate: changed
LOWAug 17, 2026NCT07323654lastUpdatePostDate: changed

Frequently asked questions about KT-621

What is KT-621?

KT-621 is an oral small molecule drug developed by Kymera Therapeutics, Inc. (ticker KYMR) that targets STAT6. It is being studied in Phase 2 clinical trials for asthma, including eosinophilic asthma, and for atopic dermatitis. KT-621 has received FDA Fast Track designation.

What is KT-621 used for?

KT-621 is being developed to treat respiratory and inflammatory conditions, specifically asthma (diagnosis), eosinophilic asthma, and atopic dermatitis. It is an investigational therapy and has not been approved for any indication. Clinical studies are enrolling adults with asthma and adults and adolescents with atopic dermatitis.

What does KT-621 target?

KT-621 targets STAT6, a protein involved in inflammatory signaling. By binding STAT6, the oral small molecule is designed to modulate the pathway that drives type 2 inflammation associated with conditions such as asthma and atopic dermatitis. STAT6 is the molecular target of KT-621.

Who makes KT-621?

KT-621 is developed by Kymera Therapeutics, Inc., which trades under the ticker KYMR. Kymera is the sponsor of the clinical trials evaluating KT-621 in asthma and atopic dermatitis.

What phase is KT-621 in?

KT-621 is in Phase 2 clinical development. It is investigational and has not been approved by the FDA. The Phase 2 program includes studies in asthma and atopic dermatitis, and KT-621 has been granted FDA Fast Track designation.

What clinical trials is KT-621 in?

KT-621 is being evaluated in several trials. NCT07677059 is a Phase 2 long-term study in asthma. NCT07323654 is a Phase 2 study in moderate to severe eosinophilic asthma. NCT07217015 is a Phase 2 study in moderate to severe atopic dermatitis. NCT06945458 was a completed Phase 1 study in atopic dermatitis.