NCT06475781 (WINDWARD) is a Phase 2 clinical trial of Mirivadelgat in Group 3 Pulmonary Hypertension, sponsored by Foresee Pharmaceuticals Co., Ltd..

Who is sponsoring NCT06475781?

NCT06475781 is sponsored by Foresee Pharmaceuticals Co., Ltd..

What drugs are being tested in NCT06475781?

Interventions in NCT06475781: Mirivadelgat, placebo.

What condition does NCT06475781 study?

NCT06475781 studies Group 3 Pulmonary Hypertension.

Is NCT06475781 still recruiting?

NCT06475781 is currently recruiting now. Last updated 2 October 2025.

Last reviewed 2025-10-02 · How we verify

NCT06475781: WINDWARD

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

A Multinational Phase 2, Randomized, Double-Blinded, Placebo-Controlled, Multiple-Dose Study to Evaluate the Safety and Efficacy of Mirivadelgat, an Aldehyde Dehydrogenase 2 Activator, in Patients With Pulmonary Hypertension Associated With Interstitial Lung Disease (PH-ILD)

Recruiting now Phase 2 Last updated 2 October 2025

What this trial tests

Phase 2 trial testing Mirivadelgat in Group 3 Pulmonary Hypertension in 126 participants. Currently enrolling.

Timeline

1 March 2025

Primary endpoint
1 June 2028

1 August 2028

Quick facts

Lead sponsor	Foresee Pharmaceuticals Co., Ltd.
Phase	Phase 2
Status	Recruiting now
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	quadruple
Primary purpose	treatment
Enrollment	126
Start date	1 March 2025
Primary completion	1 June 2028
Estimated completion	1 August 2028
Sites	9 locations across Taiwan

Drugs / interventions tested

Mirivadelgat — full drug profile →
placebo

Conditions studied

Group 3 Pulmonary Hypertension — all drugs for Group 3 Pulmonary Hypertension →

Sponsor

Foresee Pharmaceuticals Co., Ltd. — full company profile →

Who can join

Adults 18 to 85, any sex, with Group 3 Pulmonary Hypertension. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

Pulmonary Vascular Resistance (PVR)
Time frame: 12 weeks
The mean change from baseline to Week 12 in PVR assessed by right heart catheterization (RHC) for mirivadelgat vs. placebo.

Sponsor's own description

The goal of this clinical trial is to see if mirivadelgat will work in patients with Pulmonary Hypertension Associated with Interstitial Lung Disease (PH-ILD). It will also learn about the safety of mirivadelgat. The main question it aims to answer is if mirivadelgat will improve pulmonary vascular resistance (PVR). Pulmonary vascular resistance is a way to measure blood flow in the lungs. Researchers will compare mirivadelgat to a placebo (a look-alike capsule that contains no drug) to see if mirivadelgat works to improve the symptoms of PH-ILD. The symptoms of PH-ILD that are being looked at are exercise tolerance, heart function, and general well-being. Participants will: Take mirivadelgat or a placebo once a day for 12 weeks Visit the clinic once every 4 weeks for checkups and tests Receive phone calls every one or two weeks to check on how things are going

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

Shifting Paradigms in the Management of Pulmonary Hypertension.
Pradhan A, Tyagi R, Sharma P, Bajpai J, et al · · 2024 · cited 8× · PMID 39872419 · DOI 10.15420/ecr.2024.11
Review of the Diagnosis and Management of Pulmonary Hypertension Associated with Interstitial Lung Disease (ILD-PH).
Kattih Z, Kim HC, Aryal S, Nathan SD. · · 2025 · cited 2× · PMID 40142837 · DOI 10.3390/jcm14062029

Verify or expand the search:

Other Foresee Pharmaceuticals Co., Ltd. trials

Trials by the same sponsor.

NCT07191535 — Effect of Linvemastat in Patients With Partially Controlled Asthma (syMMPonia) · Phase 2 · not yet recruiting
NCT06795178 — Efficacy, Safety, and Pharmacokinetics of FP-014, 11.25 mg in Patients With Advanced Prostate Cancer · Phase 3 · withdrawn
NCT06795191 — Efficacy, Safety, and Pharmacokinetics of FP-014, 22.5 mg in Patients With Advanced Prostate Cancer · Phase 3 · withdrawn
NCT06334211 — Safety, Tolerability, and Pharmacokinetics, of Single and Multiple Ascending Doses of FP-020 in Healthy Adult Volunteers · Phase 1 · completed
NCT04750278 — A Phase 2/3 Study to Evaluate FP-025 in Patients With Severe to Critical COVID 19 · Phase 2, PHASE3 · terminated

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT06475781 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Foresee Pharmaceuticals Co., Ltd.
Last refreshed: 2 October 2025

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT06475781.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing