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

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

Status

Recruiting

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT06872112

Acronym

(STOP-PAH)

Enrollment

Registered

2025-03-12

Start date

2026-04-01

Completion date

2029-01-01

Last updated

2026-04-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pulmonary Arterial Hypertension (PAH)

Keywords

Pulmonary Arterial Hypertension, Artesunate, PAH

Brief summary

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.

Interventions

DRUGArtesunate

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

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 60 Years

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame
Number of Participants with treatment-related Adverse Events (AEs) and Serious Adverse Events (SAEs)	16 weeks

Countries

United States

Contacts

STUDY_DIRECTORRoham Zamanian, MD

Stanford University

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Apr 24, 2026