January 2026 clinical trial highlights
Clinical trial participants are essential in the quest for new treatments and a cure for pulmonary fibrosis (PF).
Each month, we'll highlight a few of the many trials enrolling volunteers. To view more available trials for various forms of interstitial lung disease (ILD), please visit the 🔍 PFF Clinical Trial Finder.
Seeking participants with ILD and IPF
129Xe MRI Cardiopulmonary
- Study ID: NCT06038630
- Trial Phase: Phase 2
- Intervention: 129Xe gas exchange MRI
- Sponsor: Bastiaan Driehuys, Duke University
- Study Contact: Bastiaan Driehuys, PhD (919.684.7786; bastiaan.driehuys@duke.edu)
Seeking participants with IPF
INS018_055 Administered Orally to Subjects With IPF
- Study ID: NCT05975983
- Trial Phase: Phase 2
- Intervention: Oral drug
- Sponsor: InSilico Medicine Hong Kong Limited
- Study Contact: Monique Duncan (+86.1881.755.4306; Insilico-Clinicaltrial@
insilico.ai )
Seeking participants with IPF
Ifetroban in IPF
- Study ID: NCT05571059
- Trial Phase: Phase 2
- Intervention: Oral drug
- Sponsor: Cumberland Pharmaceuticals
- Study Contact: Ingrid Anderson, PhD, CCRP (615.627.4121, ianderson@cumberlandpharma.com
)
Seeking participants with progressive pulmonary fibrosis (PPF)
Inhaled AP01 in Participants With PPF
- Study ID: NCT06329401
- Trial Phase: Phase 2
- Intervention: Inhaled drug
- Sponsor: Avalyn Pharma Inc.
- Study Contact: Craig S. Conoscenti, MD (206.707.0304; cconoscenti@avalynpharma.com); Daniele Tompkins (973.983.3700 Ext. 205; dtompkins@devprobiopharma.com)
Putting a face to the science: living with Sjögren’s syndrome and PF
When Carolyn couldn’t walk ten feet without gasping for breath, she knew something was wrong. As simple tasks became challenging, she took a leave of absence from her teaching career. After her dentist noticed her teeth were losing enamel and her mouth was unusually dry, Carolyn was diagnosed with Sjögren’s syndrome, an incurable autoimmune disorder that attacks moisture-producing glands. This disorder affected her lungs, leading to PF. The next decade consisted of uncertainty, but was filled with hope as Carolyn participated in clinical trials and discovered her new normal. Her journey culminated in a lung transplant and although the road to recovery was not easy, today, she is doing well. Carolyn continues to educate people about PF and ILD. To learn more about lung transplantation, watch the PFF Disease Education Webinar “Lung Transplant: How to prepare.”
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First IPF biomarker clears initial FDA step toward qualification
In December 2025, PFF announced in a press release that the PROLIFIC Risk Score has been accepted into the U.S. Food and Drug Administration (FDA) Center for Drug Evaluation and Research (CDER) Biomarker Qualification Program.
This score is the first and only IPF biomarker to be accepted into the program. The FDA’s acceptance of our Letter of Intent (LOI) is an important step in the process and signals the potential of this tool to support more efficient clinical trials and accelerate the development of new treatments for IPF.
The PROLIFIC Risk Score is a prognostic measure based on a panel of serum proteins reflecting lung cell injury, scarring, and inflammation. It was developed using data from the PFF Patient Registry and various clinical trial datasets to predict outcomes such as transplant-free survival and lung function.
Register for the PFF Clinical Trial Innovation Webinar | February 2026
Join the PFF and industry representatives for the PFF Clinical Trial Innovation (CTI) Webinar Series on Wednesday, February 11, 2026. You will learn about the development of innovative therapies and advancements in PF and ILD research.
The webinar will feature the following clinical trials: |
Participation in the CTI Webinar Series and references to specific commercial entities (companies) or products do not reflect endorsement by the PFF. The PFF does not endorse or promote any products or services participants discuss in the CTI Webinar Series, and participants cannot suggest otherwise. Please note that any information contained in this presentation is for informational and educational purposes only. It is not intended to be a substitute for professional medical advice. Always consult your personal physician or health care provider to determine if a clinical trial is right for you. |
FDA Rare Disease Day 2026
The FDA will host a virtual public meeting for Rare Disease Day on Monday, February 23, 2026. This year’s theme is “Moving Forward. Looking Ahead. An Event for Patients."
The meeting aims to explore collaborative ways to engage with patient communities to accelerate the development of medical products for rare diseases. The goal is to ensure the patient voice remains central to medical product development and regulation.
Panel topics will include patient-focused FDA initiatives, patient engagement opportunities, addressing challenges and opportunities with AI technology, and utilizing real-world data and evidence at the FDA.
For more information regarding meeting registration, please review the FDA Registration Form.
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