Open-label Extension Study of Seralutinib in Adult Subjects with PAH

An Open-label Extension Study Evaluating the Long-term Safety and Efficacy of Seralutinib Orally Inhaled for the Treatment of Pulmonary Arterial Hypertension (PAH)

Status

Recruiting

Phases

Phase 3

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCT2051240238

Enrollment

Registered

2025-01-08

Start date

2025-02-01

Completion date

Unknown

Last updated

2026-06-29

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

Conditions

Pulmonary Arterial Hypertension Pulmonary Arterial Hypertension, PHA, 6MWT

Interventions

Subjects will receive IP BID, inhaled orally with a dry powder inhaler (DPI), for up to 156 weeks or until market approval in an applicable country or region (whichever occurs first), or until the stu

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Subjects must have completed a qualifying last visit in a prior seralutinib PAH study on investigational product (IP) in accordance with the protocol. *Please contact us for more details.

Exclusion criteria

Exclusion criteria: *Please contact us for more details.

Design outcomes

Primary

Measure	Time frame
Incidence of treatment-emergent adverse events	—

Secondary

Measure	Time frame
- Changes in distance achieved on the six-minute walk test (6MWT) - Changes in NT-proBNP	—

Countries

etc., France, Germany, Japan, UK, USA

Contacts

Public ContactNaoko Matsushima

Japan Clinical Research Operations K.K.

naoko.matsushima@jcro.jp+81-3-6205-4165

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026