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TX45

Phase 2

Hypertension, Pulmonary | Small molecule | Cardiovascular |Tectonic Therapeutic, Inc. Common Stock|Last Updated: Sep 8, 2026

Target and mechanism

ModalitySmall molecule

Also known as TX000045- Dose A, TX000045

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLED
Total Trials1
Total Enrollment25

FDA Designations

No designations recorded

Clinical trial landscape

TX45 · 2 trials · 4 indications

Phase 2 2
NCT06616974A Study of TX000045 in Patients With Pulmonary Hypertension Secondary to Heart Failure With Preserved Ejection Fraction (the APEX Study)Pulmonary Hypertension
RECRUITING180 Analytics
NCT07473700Study of TX000045 in Participants With Pulmonary Hypertension Due to Interstitial Lung DiseaseHypertension, Pulmonary
RECRUITING25 Analytics
PHASE2RECRUITING
A Study of TX000045 in Patients With Pulmonary Hypertension Secondary to Heart Failure With Preserved Ejection Fraction (the APEX Study)
Pulmonary Hypertension
NCT06616974180
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PHASE2RECRUITING
Study of TX000045 in Participants With Pulmonary Hypertension Due to Interstitial Lung Disease
Hypertension, Pulmonary
NCT0747370025
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Study Endpoints

Primary Endpoints

Mean Change from Baseline in PVR up to 16 Weeks
Baseline up to 16 weeks
Number of Participants with Adverse Events (AEs), Adverse Events of Special Interest (AESIs) and Serious Adverse Events (SAEs)
Baseline up to 21 weeks
Number of Participants with Clinically Significant Changes from Baseline in Safety Laboratory Assessments, 12-Lead Electrocardiogram (ECG) Assessments and Vital Sign Assessments
Baseline up to 21 weeks

Secondary Endpoints

Mean Change from Baseline in Mean Pulmonary Arterial Pressure (mPAP) up to 21 Weeks
Baseline up to 21 weeks
Mean Change from Baseline in Hemodynamic Parameter: Pulmonary Capillary Wedge Pressure (PCWP)
Baseline up to 21 weeks
Mean Change from Baseline in Hemodynamic Parameter: Cardiac Output (CO)
Baseline up to 21 weeks
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Study Design & Arms

Treatment Arms

ArmTypeDescription
TX000045 300 mgEXPERIMENTALParticipants will receive subcutaneous (SC) injection of TX000045 at a dose of 300 milligrams (mg) every 4 weeks (Q4W) from Week 1 up to Week 13.

Interventions

NameTypeDescription
TX000045- Dose ADRUGThe participants will receive a subcutaneous injection of Dose A of TX000045 every 2 weeks for 24 weeks.
TX000045- Dose BDRUGThe participants will receive subcutaneous injection of Dose B of TX000045 every 4 weeks for 24 weeks where they will alternate between TX000045 and placebo every 2 weeks.
PlaceboDRUGThe participants will receive a subcutaneous injection of placebo every 2 weeks for 24 weeks.
TX000045DRUGSubcutaneous Injection.
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Eligibility Criteria

Age Range18 Years to 80 Years
SexALL

Inclusion Criteria: * Confirmed diagnosis of ILD based on imaging: chest computed tomography (CT) performed within the past 12 months with fibrotic lung disease (greater than or equal to (\>=) 10 percent (%) lung parenchyma with fibrosis) consistent with idiopathic interstitial pneumonia, ILD in as...

Countries:United StatesPolandRomaniaSerbiaSouth KoreaSpain
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Recent Changes (Last 90 Days)

LOWSep 8, 2026NCT07473700startDate: changed
LOWSep 8, 2026NCT07473700startDate: changed