A Study Evaluating the Safety and Tolerability of Artesunate in Patients With Pulmonary Arterial Hypertension

This is a 20-week, Phase 1, single-center, open-label, dose-escalation study evaluating the safety and tolerability of daily oral artesunate in patients with PAH.

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Key information

Conditions

Pulmonary Arterial Hypertension (PAH) Hypertension, Pulmonary Lung Diseases Pulmonary Arterial Hypertension Respiratory Tract Diseases

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Stanford University

Stanford, California, 94305, United States

Location status: Recruiting

Location contact

Roham Zamanian, MD

CONTACT

[email protected]

(650) 725-7061

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Artesunate

Drug

Participants will receive artesunate capsules. Participants will receive artesunate capsules TID in a dose escalation manner (60 mg, 120 mg, 180 mg total daily).

Primary outcomes

Number of Participants with treatment-related Adverse Events (AEs) and Serious Adverse Events (SAEs)

Time frame: 16 weeks

Sponsors and collaborators

Lead sponsor

Joseph C. Wu

Other

Registry information

Official study title

Phase I Study: A Dose-Escalation Study Evaluating the Safety and Tolerability of Artesunate in Patients With Pulmonary Arterial Hypertension

Acronym: (STOP-PAH)

Important dates

Study start: 2026
Primary completion: 2029
Study completion: 2029
First posted: Mar 12, 2025
Registry last updated: Apr 23, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Recruiting