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
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 |
