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New inhaled drug shows promise for Long-Term control of rare lung disease

NCT ID NCT06274801

Disease control Sponsor: Gossamer Bio USA, Inc. Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jul 30, 2026 · Updated 2 times

Summary

This study looks at the long-term safety of an inhaled medication called seralutinib for people with pulmonary arterial hypertension (PAH), a serious condition where high blood pressure damages the arteries in the lungs. About 316 participants who finished a previous seralutinib trial will continue taking the drug via an inhaler. Researchers will track side effects and measure changes in walking distance and heart stress markers over time.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
seralutinib (inhaled powder)
What this could lead to
If successful, this could confirm seralutinib as a safe long-term treatment option for pulmonary arterial hypertension, potentially improving exercise capacity and heart function.
What could go wrong
This is an open-label extension with no placebo group, so results may be less reliable. Side effects are still being monitored, and the drug may not work for everyone.
Why investors are watching

Gossamer Bio, a very small publicly traded company, is running a Phase 3 open-label extension study of its inhaled drug seralutinib for pulmonary arterial hypertension (PAH), a serious lung condition. This trial tests long-term safety and effectiveness in 330 patients who already completed an earlier seralutinib study. For a micro-cap company, this readout is a major checkpoint because the drug is likely its main product, and the outcome will shape its future.

If it works: If the trial shows seralutinib is safe and works well over the long term, Gossamer Bio could move closer to seeking regulatory approval and eventually selling the drug. That success would give the company a viable product and a clearer path to revenue.

If it fails: If the trial shows safety problems or poor long-term results, Gossamer Bio could face a major setback, since it depends heavily on this drug. Clinical trials often fail, and a negative outcome could hurt the company's prospects significantly.

AI-written from the trial record. Speculative, and not investment advice.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 330 people

The number the study aims to enrol. It can still change while the study runs.

Started

Sep 2024

Expected to finish

Dec 2026

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 75 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. Subjects must have completed a qualifying last visit in a prior seralutinib PAH study on investigational product (IP) and in accordance with the protocol. 2. Evidence of an informed consent document, signed and dated by the subject, indicating that the subject has been informed of all pertinent aspects of the study prior to initiation of any subject-mandated procedures. 3. Willingness and ability to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures 4. Women of childbearing potential (WOCBP) must have a negative urine or serum pregnancy test at enrollment visit before first administration of Investigational Product (IP) in this study. 5. WOCBP who are not abstinent and intend to be sexually active with a non-sterilized male partner must be willing to use a highly effective method of contraception from consent through 30 days following the last administration of IP. 6. Male subjects: Non-sterilized male subjects who are not abstinent and intend to be sexually active with a female partner of childbearing potential must use a male condom from consent through 90 days after the last dose of IP. Exclusion Criteria: 1. Severe acute or chronic medical or laboratory abnormality that may increase the risk associated with study participation or seralutinib administration, unless associated with an ongoing AE and discussed with the Sponsor's medical monitor (MM) (or designee). 2. Have any other condition or reason that, in the opinion of the Investigator, would prohibit the subject from participating in the study.

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Conditions

The condition(s) this trial relates to.

pulmonary arterial hypertension

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Pulmonary arterial hypertension

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The study's own enquiry address

    This study publishes an address for enquiries. See it below .

  2. The places running it

    100 sites in 28 countries. The list below names each one and where it is.

  3. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  4. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Study contacts

  • Contact

    Email: •••••@•••••

Locations

  • "Evangelismos" General Hospital of Athens, 1st Department of Clinical Care and Pulmonary Hypertension Clinic

    RECRUITING

    Athens, Greece

  • "Niculae Stancioiu" Emergency Heart Institute for Cardiovascular Diseases, Cardiology 1 Department

    RECRUITING

    Cluj-Napoca, Romania

  • A.O.U. Policlinico Umberto I

    RECRUITING

    Roma, Italy

  • AHEPA University General Hospital of Thessaloniki, 1st Cardiology Clinic

    RECRUITING

    Thessaloniki, Greece

  • ATTIKON University Hospital, 2nd Critical Care Department

    RECRUITING

    Athens, Greece

  • Aarhus Universiteshospital

    RECRUITING

    Aarhus, Denmark

  • Amsterdam UMC, location VU mc

    COMPLETED

    Amsterdam, Netherlands

  • Asan Medical Center

    RECRUITING

    Seoul, South Korea

  • Azienda Ospedaliera Dei Colli - Ospedale Monaldi

    RECRUITING

    Naples, Italy

  • CHI St. Luke's Health Baylor College of Medicine Medical Center

    RECRUITING

    Houston, Texas, 77030, United States

  • CHU Bicetre, Service de Pneumologie et Reanimation Respiratorie

    RECRUITING

    Le Kremlin-Bicêtre, France

  • CHU de Nice - Hopital Pasteur

    COMPLETED

    Nice, France

  • CHU de Poitiers

    RECRUITING

    Poitiers, France

  • Cardiologia Palermo

    RECRUITING

    Buenos Aires, Argentina

  • Centre Hospitalier REgional Universitaire de Lille Hopital Cardiologique - Institut Coeur Poumon Service de Cardiologie

    RECRUITING

    Lille, France

  • Centro de Investigacion Clinica UC-CICUC

    RECRUITING

    Santiago, Chile

  • Complexo de Prevencao, Diagnostico, Terapia e Reabilitacao Respiratoria - Hospital Dia di Pulmao

    RECRUITING

    Blumenau, Brazil

  • Department of Veterans Affairs Greater Los Angeles Healthcare System

    RECRUITING

    Los Angeles, California, 90073, United States

  • Enroll SpA

    RECRUITING

    Santiago, Chile

  • Erasmus MC

    WITHDRAWN

    Rotterdam, Netherlands

  • Europejskie Centrum Zdrowia Otwock Sp.zo.o. Szpital im. Fryderyka Chopina Oddzial Kardiologiczny

    RECRUITING

    Otwock, Poland

  • Fondazione IRCCS Policlinico San Matteo

    RECRUITING

    Pavia, Italy

  • Freeman Hospital

    RECRUITING

    Newcastle, United Kingdom

  • Fundacion Abood Shaio

    RECRUITING

    Bogotá, Colombia

  • Fundacion Neumologica Colombiana

    RECRUITING

    Bogotá, Colombia

  • Golden Jubilee National Hospital

    RECRUITING

    Clydebank, United Kingdom

  • Hammersmith Hospital

    COMPLETED

    London, United Kingdom

  • Hopital Erasme

    WITHDRAWN

    Anderlecht, Belgium

  • Hospital Clinic I Provincial

    RECRUITING

    Barcelona, Spain

  • Hospital Provincial Dr. Jose Maria Cullen

    RECRUITING

    Santa Fe, Argentina

  • Hospital Universitario 12 De Octubre

    RECRUITING

    Madrid, Spain

  • Hospital Universitario Marques de Valdecilla

    RECRUITING

    Santander, Spain

  • Hospital Universitario Virgen del Rocio

    COMPLETED

    Seville, Spain

  • Hospital Universitario de Toledo

    COMPLETED

    Toledo, Spain

  • Hospital of Lithuanian University of Health Sciences Kauno klinikos

    RECRUITING

    Kaunas, Lithuania

  • Houston Methodist Outpatient Center

    COMPLETED

    Houston, Texas, 77030, United States

  • INTEGRIS Cardiovascular Physicians

    ACTIVE_NOT_RECRUITING

    Oklahoma City, Oklahoma, 73112, United States

  • IRCCS Azienda Ospedaliero Universitaria Di Bologna - Policlinico S. Orsola-Malpighi - UOC Cardiologia

    RECRUITING

    Bologna, Italy

  • Inova Fairfax Medical Campus

    RECRUITING

    Falls Church, Virginia, 22042, United States

  • Institut klinicke a experimentalni mediciny Klinika kardiologie Ambulance plicni hypertenze

    RECRUITING

    Prague, Czechia

  • Instituto Medico Rio Cuarto

    RECRUITING

    Río Cuarto, Argentina

  • Instituto Nacional de Cardiologia Ignacio Chavez

    RECRUITING

    Mexico City, Mexico

  • Instituto das Pequenas Missionarias de Maria Imaculada - Hospital Madre Teresa

    RECRUITING

    Belo Horizonte, Brazil

  • Instituto de Cardiologia de Corrientes Juana Francisca Cabral

    RECRUITING

    Corrientes, Argentina

  • Instituto do Coracao do Hospital das Clinicas da Faculdade de medicina da Universidade de Sao Paulo

    RECRUITING

    São Paulo, Brazil

  • Institutul De Urgenta Pentru Boli Cardiovasculare Prof. Dr. C. C. Iliescu Cardiology 2

    RECRUITING

    Bucharest, Romania

  • Instuto de Investigacion Clinicas Quilmes

    RECRUITING

    Quilmes, Argentina

  • Intermountain Medical Center

    RECRUITING

    Murray, Utah, 84107, United States

  • Irmandade da Santa Casa de Misericórdia de Porto Alegre

    RECRUITING

    Porto Alegre, Brazil

  • Keio University Hospital

    RECRUITING

    Shinjuku-Ku, Japan

  • King Fahad Medical City

    COMPLETED

    Riyadh, Saudi Arabia

  • King Faisal Specialist Hospital and Research Center

    COMPLETED

    Riyadh, Saudi Arabia

  • Klinikum Würzburg Mitte gGmbH Medizinische Klinik mit Schwerpunkt Pneumologie und Beatmungsmedizin

    RECRUITING

    Würzburg, Germany

  • Klinikum der LMU Medizinische Klinik und Poliklinik V

    RECRUITING

    Munich, Germany

  • Krakowski Szpital Specjalistyczny Im. Sw. Jana Pawla II, Oddzial Kliniczny Chorob Serca i Naczyn z Pododdzialem Intensywnego Nadzoru Kardiologicznego

    RECRUITING

    Krakow, Poland

  • Krankenhaus Neuwittelsbach

    RECRUITING

    München, Germany

  • Kyorin University Hospital

    RECRUITING

    Mitaka, Japan

  • Kyushu University Hospital

    RECRUITING

    Fukuoka, Japan

  • Lady Davis Carmel Medical Center

    RECRUITING

    Haifa, Israel

  • London Health Sciences Centre - Victoria Hospital

    RECRUITING

    London, Canada

  • Mater Misericordiae University Hospital

    RECRUITING

    Dublin, Ireland

  • Mayo Clinic Jacksonville

    RECRUITING

    Jacksonville, Florida, 32224, United States

  • Medical University of South Carolina - Nexus Research Center

    RECRUITING

    Charleston, South Carolina, 29425, United States

  • NHO Okayama Medical Center

    RECRUITING

    Okayama, Japan

  • NYU Langone Health

    RECRUITING

    New York, New York, 10016, United States

  • Nagoya University Hospital

    RECRUITING

    Nagoya, Japan

  • National Cerebral and Cardiovascular Center

    RECRUITING

    Suita, Japan

  • National Heart Centre Singapore

    RECRUITING

    Singapore, Singapore

  • National University Heart Centre

    WITHDRAWN

    Singapore, Singapore

  • Northside Hospital - Atlanta

    RECRUITING

    Atlanta, Georgia, 30342, United States

  • Norton Pulmonary Specialists

    RECRUITING

    Louisville, Kentucky, 40202, United States

  • Nucleo de Gestao de Pesquisa/Hospital Sao Paulo - SPDM/UNIFESP

    ACTIVE_NOT_RECRUITING

    São Paulo, Brazil

  • Onassis Cardiac Surgery Center, Non-Invasive Cardiology Department

    COMPLETED

    Kallithea, Greece

  • Pauls Stradins Clinical University Hospital

    RECRUITING

    Riga, Latvia

  • Peter Lougheed Center

    RECRUITING

    Calgary, Canada

  • Piedmont Physicians Pulmonary & Sleep Medicine of Buckhead

    RECRUITING

    Atlanta, Georgia, 30309, United States

  • Pulmonary Associates of Richmond, Inc.

    RECRUITING

    Richmond, Virginia, 23230, United States

  • Pulmonary Hypertension Research Queensland

    RECRUITING

    Auchenflower, Australia

  • Royal Free Hospital, Clinical Research Facility

    RECRUITING

    London, United Kingdom

  • Royal Hallamshire Hospital

    RECRUITING

    Sheffield, United Kingdom

  • Royal Hobart Hospital

    RECRUITING

    Hobart, Australia

  • Royal Papworth Hospital NHS Foundation Trust

    RECRUITING

    Cambridge, United Kingdom

  • Samsung Medical Center

    RECRUITING

    Seoul, South Korea

  • Seoul National University Hospital

    RECRUITING

    Seoul, South Korea

  • Severance Hospital, Yonsei University Health System

    WITHDRAWN

    Seoul, South Korea

  • St Vincent's Hospital (Melbourne)

    RECRUITING

    Fitzroy, Australia

  • Stanford Healthcare

    RECRUITING

    Stanford, California, 94305, United States

  • Temple Heart and Vascular Institute (Outpatient Clinic)

    RECRUITING

    Philadelphia, Pennsylvania, 19140, United States

  • The Emory Clinic

    RECRUITING

    Atlanta, Georgia, 30322, United States

  • The Hospital of the University of Pennsylvania

    RECRUITING

    Philadelphia, Pennsylvania, 19104, United States

  • Thoraxklinik Heidelberg gGmbH am Universitätsklinikum Heidelberg Zentrum für pulmonale Hypertonie

    RECRUITING

    Heidelberg, Germany

  • UC Davis Health Medical Center

    RECRUITING

    Sacramento, California, 95817, United States

  • UI Health Hospital

    RECRUITING

    Chicago, Illinois, 60612, United States

  • UNC Hospitals

    COMPLETED

    Chapel Hill, North Carolina, 27514, United States

  • UPMC Presbyterian Hospital

    RECRUITING

    Pittsburgh, Pennsylvania, 15213, United States

  • UT Southwestern Medical Center

    RECRUITING

    Dallas, Texas, 75390, United States

  • Uniao Brasileira de Educacao e Assistencia Hospital Sao Lucas da PUCRS

    RECRUITING

    Porto Alegre, Brazil

  • Unidad de Investigacion Clinica en Medicina, S.C.

    RECRUITING

    Monterrey, Mexico

  • Unidade Local de Saude de Santa Maria, E.P.E. Hospital Pulido Valente

    RECRUITING

    Lisbon, Portugal

  • Unidade Local de Saude de Santo Antonio, E.P.E. Hospital de Santo Antonio

    RECRUITING

    Porto, Portugal

  • Universitatsklinikum Giessen und Marburg GmbH Zentrum fur lnnere Medizin, Med. Klinik und Poliklinik II Studienambulanz fur Pulmonale Hypertonie

    RECRUITING

    Giessen, Germany

  • University Clinical Centre of Serbia, Cardiology Clinic

    RECRUITING

    Belgrade, Serbia

  • University Health Network, Toronto General Hospital

    COMPLETED

    Toronto, Canada

  • University Hospitals of Leuven (Campus Gasthuisberg)

    RECRUITING

    Leuven, Belgium

  • University of Cincinnati Medical Center

    RECRUITING

    Cincinnati, Ohio, 45219, United States

  • University of Florida Health

    RECRUITING

    Gainesville, Florida, 32610, United States

  • University of Kansas Medical Center

    RECRUITING

    Kansas City, Kansas, 66160, United States

  • University of Michigan

    RECRUITING

    Ann Arbor, Michigan, 48109, United States

  • University of Nebraska Medical Center

    RECRUITING

    Omaha, Nebraska, 68198, United States

  • University of New Mexico Health Sciences Center

    COMPLETED

    Albuquerque, New Mexico, 87131, United States

  • University of Ottawa Heart Institute

    ACTIVE_NOT_RECRUITING

    Ottawa, Canada

  • University of Rochester Medical Center

    RECRUITING

    Rochester, New York, 14642, United States

  • University of Texas Health Science Center at San Antonio

    RECRUITING

    San Antonio, Texas, 78229, United States

  • University of Tokyo Hospital

    RECRUITING

    Bunkyō City, Japan

  • University of Utah Hospital

    RECRUITING

    Salt Lake City, Utah, 84132, United States

  • Universitätsklinikum Dresden, Medizinische Klinik I / Pneumologisches Studiensekretariat

    WITHDRAWN

    Dresden, Germany

  • Valley Advanced Lung Diseases Institute

    RECRUITING

    Fresno, California, 93720, United States

  • Všeobecná fakultní nemocnice v Praze ll. interní klinika kardiologie a angiologie VFN a 1.LF UK Centrum pro plicní hvpertenzi

    RECRUITING

    Prague, Czechia

  • Washington University School of Medicine

    RECRUITING

    St Louis, Missouri, 63110, United States

  • Zentrum fur Pulmonale Hypertonie, Klinik Ill fur lnnere Medizin (Kardiologie, Pneumologie, lnternistische lntensivmedizin), Herzzentrum der Universitat zu Koln

    RECRUITING

    Cologne, Germany

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