Daily oral artesunate for people with pulmonary arterial hypertension — safety and tolerability
Official title: Phase I Study: A Dose-Escalation Study Evaluating the Safety and Tolerability of Artesunate in Patients With Pulmonary Arterial Hypertension
Run by Stanford University · NCT06872112 · Data updated 2026-11-12
Over 20 weeks, adults with pulmonary arterial hypertension will try daily oral artesunate to see if it is safe and tolerable.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years to 60 Years |
| Sex | All |
| Enrollment | 15 (estimated) |
| Sponsor | Stanford University Academic / other |
| Locations | 1 site (Stanford, California) |
| Status | Recruiting |
| Started | April 1, 2026 |
| Main results expected | January 1, 2029 |
| Study ends | January 1, 2029 |
| Registry record updated | April 23, 2026 |
| Trial ID | NCT06872112 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults 18–75 years old with pulmonary arterial hypertension WHO functional class I–III who remain symptomatic despite maximally tolerated treatment with two or more PAH drug classes are ideal candidates.
✕Probably not a fit
Patients with serious concurrent illnesses, those outside the 18–75 age range, or those with WHO class IV disease or contraindications to artesunate are unlikely to benefit from participation.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This is a single-center, open-label Phase 1 dose-escalation trial testing daily oral artesunate in adults with pulmonary arterial hypertension over 20 weeks. Participants are adults aged 18 to 75 with WHO functional class I–III disease despite maximally tolerated background therapy. The study will escalate doses to characterize safety, tolerability, and adverse event profiles while monitoring clinical status and laboratory parameters. Results will inform dosing and feasibility for future efficacy studies.
Why it matters
Potential benefit: If safe and tolerated, artesunate could offer a new oral treatment option to complement existing PAH therapies.
How similar studies have gone: This is a novel repurposing of artesunate for PAH with limited prior clinical data in this condition.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria * Each participant must meet the following criteria to be enrolled in this study: * Adults aged 18 to 75 years. * WHO functional class I, II/III despite treatment with maximally tolerated doses of 2 or more treatment modalities including PDE5 inhibitors, guanylate cyclase stimulators, endothelin receptor antagonists, and prostanoids when appropriate. Exclusion Criteria * Participants who meet any of the following criteria will be excluded from the study. * Participants with serious concomitant morbidity per investigator assessment.
Where it's running
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Stanford University
Stanford, California, United States Recruiting
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.