NCT06176118Not yet recruitingPhase 2
Clinical Trial of 2-HOBA in Pulmonary Arterial Hypertension
Source: ClinicalTrials.gov · Last updated 17 Jun 2026
Brief summary (registry, in English)
Based on existing literature and clinical trials, 2- hydroxbenzylamine (2-HOBA) has clear impact on mechanisms that much of the international field of pulmonary hypertension (PH) research agrees are central to disease progression. The investigator's preliminary data and Phase I studies demonstrate not only a clear positive impact on reducing pulmonary vascular resistances in Group I and II PH, and both cytokine and molecular biomarkers of disease, but also indicated the potential for a substantial positive effect on heart function under load stress. In this Phase II project, investigators will test the safety and efficacy of 2-HOBA in PH patients, improving the function of the right ventricle under stress in a large animal model, and effectiveness in the context of standard-of-care in mouse models and large animals, to establish the remaining data needed to proceed to commercialization.
- Status (registry)
- Not yet recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 12 (estimated)
- First submitted
- 30 Nov 2023
- Start date
- 1 Sept 2026
- Primary completion date
- Dec 2027
- Lead sponsor
- Vanderbilt University Medical Center
- NCT number
- NCT06176118
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 12
- From 1 Sept 2026 to the primary completion date, Dec 2027
- No sites listed in no country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Drug and toxin associated PAH patients with active drug use
- Prior diagnosis of cirrhosis
Other illness
- Prohibited from normal activity due to wheelchair bound status, bed bound status, reliance on a cane/walker, activity-limiting angina, activity-limiting osteoarthritis, or other condition that limits activity
- Diagnosis of PAH etiology other than idiopathic, heritable, simple congenital heart defect, or associated with drugs or toxins
- Malignancy
Lab values
- eGFR by MDRD \<60mL/min
Other
- Sensitivity to 2-HOBA
- Sensitivity to aspirin or salicylates
- Aspirin-related rhinitis or wheezing
- Pregnancy
- Non-english speaking
Who the study is looking for
- Adults aged 18 or older
- Diagnosed with idiopathic, heritable, simple congenital heart defect, or drug- or toxin-associated pulmonary arterial hypertension (PAH) according to World Health Organization consensus recommendations.
- Stable PAH-specific medication regimen for three months prior to enrollment. Subjects with only a single diuretic adjustment in the prior three months will be included. Adjustments in IV prostacyclin for side effect management are allowed.
- FEV1\> or = 60% predicted and no more than mild abnormalities on lung imaging
- WHO Functional Class II-IV
- Ambulatory
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
This page is information, not medical advice. Discuss any trial with your doctor.