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KT-621

Phase 2

Asthma (Diagnosis) | Small molecule | Respiratory |Kymera Therapeutics, Inc.|Last Updated: Aug 17, 2026

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 Trials1
Total Enrollment264

FDA Designations

FAST_TRACK

Clinical trial landscape

KT-621 · 5 trials · 4 indications

Phase 2 3Phase 1 2
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)
NCT07677059264
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PHASE2RECRUITING
A Study of KT-621 Administered Orally to Adult Participants With Moderate to Severe Eosinophilic Asthma
Eosinophilic Asthma
NCT07323654264
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PHASE2ACTIVE NOT_RECRUITING
A Study of KT-621 Administered Orally to Participants With Moderate to Severe Atopic Dermatitis
Atopic Dermatitis
NCT07217015200
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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
Incidence of adverse events
From enrollment through the safety follow-up visit on either Day 14 (SAD) or Day 38 (MAD)
Treatment-emergent potentially clinically-significant abnormalities in safety laboratory parameters: hematology
From enrollment through the safety follow-up visit on either Day 14 (SAD) or Day 38 (MAD)

Hemoglobin, Hematocrit, Erythrocytes, Mean corpuscular volume, Platelets, Leukocytes, Eosinophils, Basophils Neutrophils Lymphocytes Monocytes

Treatment-emergent potentially clinically significant abnormalities in safety laboratory parameters: serum chemistry
From enrollment through the safety follow-up visit on either Day 14 (SAD) or Day 38 (MAD)

Glucose, Blood urea nitrogen, Creatinine, Sodium, Potassium, Calcium, Chloride, Magnesium, Bicarbonate, Phosphate, Bilirubin, total and direct, Alkaline phosphatase, Aspartate transaminase (=SGOT), Alanine transaminase (=SGPT), Gamma glutamyl transferase, Total protein, Albumin, Creatine kinase, HbA1c, Lactate dehydrogenase (LDH)

Treatment-emergent potentially clinically significant abnormalities in safety laboratory parameters: coagulation
From enrollment through the safety follow-up visit on either Day 14 (SAD) or Day 38 (MAD)

Activated partial thromboplastin time, Prothrombin time, International Normalized Ratio, Fibrinogen

Treatment-emergent potentially clinically significant abnormalities in electrocardiogram values: QTcF (milliseconds)
From enrollment through the safety follow-up visit on either Day 14 (SAD) or Day 38 (MAD)
Treatment-emergent potentially clinically significant abnormalities in vital signs: heart rate (beats per minute)
From enrollment through the safety follow-up visit on either Day 14 (SAD) or Day 38 (MAD)
Treatment-emergent potentially clinically significant abnormalities in vital signs: blood pressure (mmHg)
From enrollment through the safety follow-up visit on either Day 14 (SAD) or Day 38 (MAD)
Treatment-emergent potentially clinically significant abnormalities in vital signs: respiratory rate (breaths per minute)
From enrollment through the safety follow-up visit on either Day 14 (SAD) or Day 38 (MAD)
Treatment-emergent potentially clinically significant abnormalities in vital signs: temperature (degrees Celsius)
From enrollment through the safety follow-up visit on either Day 14 (SAD) or Day 38 (MAD)

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 -
PlaceboPLACEBO_COMPARATOREach participant receives either a single oral dose (SAD) or multiple oral doses (MAD) of matched placebo.

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 Sites1

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 StatesArgentinaGermanyPolandRomaniaSerbiaSlovakiaSouth KoreaSpainUnited KingdomAustraliaCanadaCzechiaJapan
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Recent Changes (Last 90 Days)

LOWAug 17, 2026NCT07323654lastUpdatePostDate: changed
LOWAug 17, 2026NCT07323654lastUpdatePostDate: changed
LOWJun 30, 2026NCT07677059NEW_TRIAL: changed
MEDIUMJun 30, 2026NCT07217015Status: RECRUITING → ACTIVE_NOT_RECRUITING
LOWJun 30, 2026NCT07677059NEW_TRIAL: changed
MEDIUMJun 30, 2026NCT07217015Status: RECRUITING → ACTIVE_NOT_RECRUITING
LOWJun 30, 2026NCT07677059NEW_TRIAL: changed
MEDIUMJun 30, 2026NCT07217015Status: RECRUITING → ACTIVE_NOT_RECRUITING
LOWJun 29, 2026NCT07323654lastUpdatePostDate: changed
LOWJun 29, 2026NCT07323654lastUpdatePostDate: changed

Frequently asked questions about KT-621

What is KT-621 used for?

KT-621 is an investigational oral small molecule being developed for atopic dermatitis and eosinophilic asthma. It is also being studied in healthy participants to assess safety and pharmacology. The drug is in Phase 2 clinical development for these conditions.

What does KT-621 target?

KT-621 targets STAT6, a protein involved in immune signaling. By inhibiting STAT6, the drug aims to modulate pathways relevant to allergic and inflammatory conditions such as atopic dermatitis and asthma.

Who makes KT-621?

KT-621 is being developed by Kymera Therapeutics, Inc., a biopharmaceutical company listed on NASDAQ under the ticker KYMR. The company is conducting clinical trials of KT-621 in multiple countries.

What phase is KT-621 in?

KT-621 is in Phase 2 clinical development. It has completed Phase 1 trials in healthy participants and patients with atopic dermatitis. Current Phase 2 trials are evaluating the drug in moderate to severe atopic dermatitis and eosinophilic asthma.

What clinical trials is KT-621 in?

KT-621 has completed Phase 1 trials NCT06673667 in healthy participants and NCT06945458 in atopic dermatitis patients. Active Phase 2 trials include NCT07217015 for moderate to severe atopic dermatitis and NCT07323654 for moderate to severe eosinophilic asthma.

Is KT-621 FDA approved?

KT-621 is not FDA approved. It is an investigational drug currently in Phase 2 clinical trials. The FDA has granted fast track designation for KT-621, which is intended to expedite development and review of therapies for serious conditions.