Ozmosi | KT-621 Drug Profile
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KT-621

Alternative Names: KT-621, KT621, KT 621
Clinical Status: Active
Latest Update: 2026-05-18
Latest Update Note: Clinical Trial Update

Product Description

KT-621 (STAT6): STAT6 is an essential transcription factor specific to the IL-4/IL-13 signaling pathway and the central driver of Type 2 inflammation in allergic diseases. STAT6 is a genetically validated target and the pathway has been clinically validated by approved IL-4/IL-13-targeting biologics, including dupilumab. In preclinical studies, KT-621, Kymera's first-in-class oral STAT6 degrader, demonstrated full inhibition of the IL-4/IL-13 pathway in all relevant human cell contexts with picomolar potency that was superior to dupilumab, and equivalent or superior efficacy to dupilumab in multiple preclinical efficacy studies. In addition, at low oral doses, KT-621 demonstrated near full in vivo STAT6 degradation and was well-tolerated in multiple preclinical toxicity studies. KT-621, a once daily oral small molecule degrader with a preclinical biologics-like efficacy profile, has the potential to have broad activity across multiple diseases, including atopic dermatitis, asthma, chronic obstructive pulmonary disorder, eosinophilic esophagitis and chronic rhinosinusitis with nasal polyps, among others. The Company expects to initiate a Phase 1 clinical trial in the second half of 2024 and report the Phase 1 results in 2025. (Sourced from: https://investors.kymeratx.com/news-releases/news-release-details/rd-day-highlights-kymeras-immunology-strategy-and-emerging)

Mechanisms of Action: STAT6 Inhibitor

Novel Mechanism: Yes

Modality: Small Molecule

Route of Administration: Oral

FDA Designation: Fast Track - Dermatitis, Atopic *

Approval Status: Not Approved

Approved Countries: None

Approved Indications: None

Company: Kymera Therapeutics
Company Location: Eastern America
Company Founding Year: 2015
Additional Commercial Interests: None

Clinical Description

Map of Global Clinical Trials for KT-621

Countries in Clinic: Australia, Canada, Czech Republic, Germany, Japan, Poland, Serbia, Slovakia, South Korea, Spain, United Kingdom, United States

Active Clinical Trial Count: 7

Recent & Upcoming Milestones

  • Clinical Outcomes Expected - Kymera Therapeutics announced they will present P2 Dermatitis, Atopic results in 3Q27 for KT-621
  • Clinical Outcomes Expected - Kymera Therapeutics announced they will present P2 Asthma results in YE27 for KT-621
  • Clinical Outcomes Reported - Kymera Therapeutics presented P1 Dermatitis, Atopic|Asthma results on 2026-05-16 for KT-621

Highest Development Phases

Phase 2: Asthma|Dermatitis, Atopic|Pulmonary Eosinophilia

Phase 1: Healthy Volunteers

Trial ID

Trial

Phase

Trial Status

Disease

Primary Completion Date

Probability of Success

Latest Trial Update Date

Data Updated

NCT07217015

BROADEN2

P2

Recruiting

Dermatitis, Atopic

2027-06-01

12%

2026-04-24

NCT07323654

BREADTH

P2

Recruiting

Pulmonary Eosinophilia|Asthma

2027-12-01

12%

2026-05-19

jRCT2031250674

jRCT2031250674

P2

Not yet recruiting

Dermatitis, Atopic

2027-06-30

NCT06945458

BroADen

P1

Completed

Dermatitis, Atopic

2025-11-10

50%

2026-01-27

Primary Endpoints

2025-522370-36-00

KT621-AD-201

P2

Not yet recruiting

Dermatitis, Atopic

2028-06-30

12%

2025-523180-38-00

KT621-AS-202

P2

Not yet recruiting

Asthma

2027-12-31

NCT06673667

KT621-HV-101

P1

Completed

Healthy Volunteers

2025-04-23

88%

2025-10-03

Patient Enrollment|Primary Completion Date|Primary Endpoints|Study Completion Date|Treatments|Trial Status