Daily oral artesunate for people with pulmonary arterial hypertension — safety and tolerability
Phase I Study: A Dose-Escalation Study Evaluating the Safety and Tolerability of Artesunate in Patients With Pulmonary Arterial Hypertension
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 |
| Enrollment | 15 (estimated) |
| Ages | 18 Years to 60 Years |
| Sex | All |
| Sponsor | Stanford University Academic / other |
| Locations | 1 site (Stanford, California) |
| Trial ID | NCT06872112 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
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.
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 performed: This is a novel repurposing of artesunate for PAH with limited prior clinical data in this condition.
Eligibility criteria
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 this trial is running
Stanford, California
- Stanford University — Stanford, California, United States (Recruiting)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.