7 Pulmonology Headlines You Missed in September 2025

September 2025 brought a mix of advances and setbacks in pulmonology, with new clinical trial readouts and regulatory updates highlighting the evolving landscape of respiratory care. Landmark data in idiopathic pulmonary fibrosis, sarcoidosis, and emphysema underscored both the promise of novel therapies and the ongoing challenges of treating progressive lung disease. At the same time, large-scale studies shed light on the intergenerational effects of smoke exposure, reinforcing the long-term importance of preventive measures in public health.

Meanwhile, asthma care saw encouraging progress with an investigational oral therapy showing meaningful improvements in lung function and the FDA broadening access to an anti-inflammatory rescue option. Alongside these developments, new smoking cessation data further supported cytisinicline as a safe and effective tool, particularly for patients with COPD.

Check out this September 2025 pulmonology month in review for a recap of HCPLive’s coverage of the top news and research from the past few weeks:

1. Treprostinil Inhalation Significantly Improves FVC in People With Idiopathic Pulmonary FIbrosis

The phase 3 TETON-2 trial of nebulized treprostinil in idiopathic pulmonary fibrosis (IPF) met its primary endpoint, showing a significant improvement in absolute forced vital capacity (FVC) compared with placebo, with a mean difference of 95.6 mL at 52 weeks. Benefits were consistent across subgroups, including those on background antifibrotic therapy, and extended to most secondary outcomes such as quality of life, diffusion capacity, and time to first clinical worsening event. The therapy was well-tolerated with no new safety signals, and United Therapeutics plans to use data from TETON-2 and the ongoing TETON-1 study to support a supplemental FDA application for IPF.

2. Efzofitimod Fails to Meet Primary End Point in Phase 3 Pulmonary Sarcoidosis Trial

The phase 3 EFZO-FIT trial of efzofitimod in pulmonary sarcoidosis did not meet its primary endpoint of significantly reducing daily oral corticosteroid (OCS) use at 48 weeks, though patients on the higher dose achieved modestly greater steroid tapering than placebo. Despite the miss, efzofitimod was linked to clinically meaningful improvements in quality of life, with higher KSQ-Lung scores and more patients achieving complete steroid withdrawal compared with placebo. The therapy was well-tolerated, and aTyr Pharma plans to discuss the findings with the FDA to determine a regulatory path forward.

3. Passive Smoke Exposure in Prepubescent Males Affects Lung Function in Children, Grandchildren

A longitudinal study from the Tasmanian Longitudinal Health Study found that paternal passive smoke exposure before puberty was linked to impaired lung function trajectories in children and grandchildren across adulthood. Offspring of exposed fathers had higher odds of below-average FEV1 and early low–rapid decline FEV1/FVC, with risks amplified when children were also exposed to passive smoke. Mediation analysis suggested that active paternal smoking, offspring smoking, and childhood passive smoke exposure each partially contributed to these intergenerational effects.

4. Emphysema During Lung Cancer Screening Predicts All-Cause Mortality up to 25 Years Later

A 25-year prospective study of more than 9,000 adults in a lung cancer screening cohort found that baseline emphysema detected on low-dose chest CT strongly predicted all-cause, COPD, and cardiovascular mortality. Nearly 80% of participants with emphysema had no prior diagnosis, underscoring the hidden burden of disease in asymptomatic adults. Mortality risk increased with emphysema severity, with the strongest associations observed for COPD-related deaths.

5. Dexpramipexole Oral Add-On for Asthma Significantly Improves Lung Function Over Placebo

A phase 3 trial has shown that dexpramipexole, an investigational oral therapy, significantly improved lung function in patients with eosinophilic asthma when added to standard treatment. Results from the EXHALE-4 study demonstrated that the 150 mg twice-daily dose achieved statistically significant improvements in pre-bronchodilator FEV1 compared with placebo, with benefits observed as early as Week 4. The therapy also reduced blood eosinophil counts and was well tolerated, with a safety profile consistent with earlier studies.

6. Cytisinicline Demonstrates Value as Smoking Cessation Tool in People With or Without COPD

A post-hoc analysis of the phase 3 ORCA-2 and ORCA-3 trials found that cytisinicline significantly increased smoking abstinence rates compared with placebo in both COPD and non-COPD subgroups. In participants with COPD, quit rates reached 17.3%–19.1% with cytisinicline versus 2.1% with placebo, while non-COPD participants achieved 19.3%–32.6% compared to 5.5%–8.6% with placebo. The therapy was well tolerated, with insomnia and headache as the most common adverse events, supporting its potential as a safe and effective smoking cessation option.

7. FDA Expands Albuterol/Budesonide Label to Adults With Mild Asthma

On October 1, 2025, AstraZeneca announced FDA approval of a supplemental new drug application for albuterol/budesonide (Airsupra), expanding its indication to include adults with mild asthma. Based on results from the phase 3b BATURA trial, the therapy reduced the risk of severe exacerbations by nearly half compared with albuterol and lowered annual systemic steroid use, while maintaining a favorable safety profile. The update builds on prior evidence from the MANDALA and DENALI trials, further supporting Airsupra as the first anti-inflammatory rescue option across asthma severities.