August 2025 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 that are 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 PPF
MIST
- 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)
- Learn more about this study
- Learn more about this drug
Seeking participants with ILD
PHINDER
- Study ID: NCT05776225
- Intervention: Observational
- Sponsor: United Therapeutics a Public Benefit Corporation
- Study Contact: United Therapeutics Global Medical Information (919.485.8350; clinicaltrials@unither.com)
- Learn more about this study
When Donna began to gasp for air while walking up the stairs and exercising, her inner voice reasoned that it was due to laziness, weight gain, or aging. Donna did not suspect that the root cause was a serious health condition. After some time, Donna's doctor diagnosed her with asthma and referred her to a pulmonologist and rheumatologist. Her new care team diagnosed her with ILD and PF, caused by scleroderma, an autoimmune disease.
Receiving this diagnosis, Donna feared for the future and worried about how her children would get through life without her. Thankfully, she found a behavioral health therapist who was able to help her deal with the emotional side of living with ILD. The experience showed Donna the healing power of talking. As a PFF Ambassador, Donna practices the healing power of talking by sharing her story, educating others on ILD, and encouraging patients to do the same like joining a support group. Donna also took steps to shape her future and the futures of her fellow PF community members by supporting research progress. For several years, she participated in a clinical trial, sharing her unique experience to help guide the development of potential new treatments. Today, she speaks on the impact on the clinical trials have had on her personal journey.
For assistance on how to share and talk about your diagnosis with family and friends, check out the PFF Friends and Family Card.
Phase 2a idiopathic pulmonary fibrosis (IPF) study's positive results
In June 2025, Insilico Medicine announced the positive results of its phase 2a study based in China, GENESIS-IPF. Insilico Medicine used artificial intelligence (AI) to help create rentosertib, and this study showed that people living with IPF who took the drug had better lung function compared to those who were on placebo. GENESIS-IPF also demonstrated the safety and tolerability of rentosertib, meeting the study's primary endpoint.
A primary endpoint is the measurement that researchers use to determine if a medication or other intervention works as intended. Insilico Medicine is currently conduction a phase 2 study in the US, and you can learn more here.
This is one of the first times an AI-designed drug has shown promising results for the potential treatment of IPF. Scientists are excited because this could mean faster, smarter ways to make new medicines in the future.
Taladegib (ENV-101) receives orphan drug approval
Orphan drug designation is a pathway the US Food and Drug Administration (FDA) has to support the development and evaluation of new treatments for rare diseases. The FDA has authority to grant orphan drug designation to a drug or biological product to prevent, diagnose, or treat a rare disease or condition such as IPF.
In July 2025, the FDA granted Endeavor BioMedicines' investigational therapy, taladegib, orphan drug designation. Endeavor is currently studying the therapy in its phase 2b WHISTLE-PF for patients living with IPF.
In the U.S., a rare disease is considered a condition which affects fewer than 200,000 people across the country. The orphan drug designation illustrates there is still a significant unmet need for patients living with IPF. You can read more about this update here.
The world's largest conference on PF is coming to Chicago this fall
As the PFF celebrates a milestone 25 years of funding groundbreaking research, uniting patients and professionals, and lighting the path toward a cure, it also prepares for its eighth highly anticipated PFF Summit conference. Set to take place in Chicago from November 13 to 15, the Summit underscores the Foundation's enduring legacy and future ambitions.
At the PFF Summit, you'll dive into the latest updates on research with activities such as the scientific poster presentations and sessions like "Research in the pipeline: What might the next 25 years hold?" In addition, the popular Clinical Trial Innovation Series makes a return to the Summit. In this two-part series, groundbreaking research takes the stage as trial sponsors report on the latest findings in clinical trials.
Our PFF Medical Team members have exciting research to share
Important advancements in PF and ILD research were presented at this year's American Thoracic Society (ATS) conference in San Francisco. The meeting featured developments across clinical trials and updated guidance on early detection and evaluation. In a video recap, three members of the PFF medical team share their perspectives on research driving the field forward.
- Dr. Kevin Flaherty discussed new data on nerandomilast in treating IPF and PPF.
- Dr. Joyce Lee reviews the latest ATS Clinical Statement on Interstitial Lung Abnormalities
- Dr. Amy Hajari Case introduces innovative research from PFF Scholars and Care Center Network staff-many of these projects supported by the PFF Registry.
These updates underscore the power of collaboration in advancing care and deepening our understanding of PF and ILD.
If you have any questions or comments about this newsletter, please email partnerships@