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TX45

Phase 2

Pulmonary Hypertension | Small molecule | Cardiovascular |Tectonic Therapeutic, Inc. Common Stock|Trials Updated: Oct 27, 2026

TX45 target and mechanism

ModalitySmall molecule

Also known as TX000045

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLED
Total Trials2
Total Enrollment205

FDA Designations

No designations recorded

TX45 clinical trials

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 HypertensionUnlock trial analytics
PHASE2RECRUITING
Study of TX000045 in Participants With Pulmonary Hypertension Due to Interstitial Lung Disease
Hypertension, PulmonaryUnlock trial analytics

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)

LOWOct 27, 2026NCT07473700startDate: changed
LOWOct 27, 2026NCT07473700startDate: changed
LOWSep 8, 2026NCT07473700startDate: changed
LOWSep 8, 2026NCT07473700startDate: changed

Frequently asked questions about TX45

What is TX45?

TX45 is an investigational small molecule drug being developed by Tectonic Therapeutic, Inc. (ticker TECX) for pulmonary hypertension. It is in Phase 2 clinical development. TX45 is also known as TX000045 and TX000045-Dose A. It has not been approved by the FDA and remains under clinical study.

What is TX45 used for in pulmonary hypertension?

TX45 is being studied for pulmonary hypertension, including pulmonary hypertension due to interstitial lung disease and pulmonary hypertension secondary to heart failure with preserved ejection fraction. Both are forms of pulmonary hypertension in which elevated blood pressure in the lung arteries complicates underlying heart or lung disease.

Who makes TX45?

TX45 is being developed by Tectonic Therapeutic, Inc., which trades under the ticker TECX. Tectonic Therapeutic is the sponsor of the clinical program studying TX45 in pulmonary hypertension.

What phase is TX45 in?

TX45 is in Phase 2 clinical development. It is investigational and has not been approved by the FDA. Two Phase 2 trials have been registered, one currently recruiting and one completed, with a combined planned enrollment of 205 participants.

What clinical trials is TX45 in?

TX45 is being studied in two Phase 2 trials. NCT07473700 is recruiting 25 participants with pulmonary hypertension due to interstitial lung disease across the United States, Poland, Romania, Serbia, South Korea, and Spain. NCT06616974, the APEX study, is recruiting 180 participants with pulmonary hypertension secondary to heart failure with preserved ejection fraction.

Is TX45 the same as TX000045?

Yes. TX45 is the same drug as TX000045 and TX000045-Dose A. These are alternative names for the same investigational small molecule developed by Tectonic Therapeutic for pulmonary hypertension, so search results under any of these names refer to the same Phase 2 program.