GRI Bio discusses positive Phase 2a IPF data for GRI-0621
GRI Bio discussed positive Phase 2a idiopathic pulmonary fibrosis data for GRI-0621, highlighting biomarker results indicating improvements in fibrosis and lung repair.
Idiopathic pulmonary fibrosis is a chronic progressive fibrosing interstitial lung disease of unknown cause characterized by worsening dyspnea, cough, and declining lung function. It primarily affects older adults and has a poor prognosis despite available antifibrotic therapies. Diagnosis typically requires multidisciplinary evaluation and exclusion of secondary causes.
GRI Bio discussed positive Phase 2a idiopathic pulmonary fibrosis data for GRI-0621, highlighting biomarker results indicating improvements in fibrosis and lung repair.
The FDA has granted orphan drug designation to Nuformix PLC's tranilast lysate candidate for treating idiopathic pulmonary fibrosis. The designation provides regulatory incentives including potential market exclusivity in the US. Nuformix is a London-based developer focused on fibrosis and oncology treatments.
Deupirfenidone, a deuterated form of pirfenidone, is set to be tested in a phase 3 trial this year after successful phase 2b results. The FDA and European Commission have granted orphan drug designation to support its late-stage development.
Bristol Myers Squibb's growth portfolio increased 17% in 2025, partially offsetting a 15% decline in legacy products facing generic competition. The company's stock gained 11.4% in the past month on strong fourth-quarter results.
Insmed reported total revenues of $606.4 million for 2025, with ARIKAYCE growing 19% annually. The FDA granted orphan drug designation to treprostinil palmitil for pulmonary arterial hypertension treatment in January 2026.
PureTech Health announced that deupirfenidone has received Orphan Drug Designation from both the U.S. FDA and European Commission for idiopathic pulmonary fibrosis, with a Phase 3 trial planned for the first half of 2026.
PureTech Health's deupirfenidone has received Orphan Drug Designation from both the U.S. FDA and European Commission for treating idiopathic pulmonary fibrosis, a rare and fatal lung disease. Phase 2b trial results showed superior efficacy compared to existing therapies.
AbbVie reported progress on two clinical studies: a Phase 2a trial of ABBV-142 for idiopathic pulmonary fibrosis now recruiting patients, and completion of a JUVÉDERM VOLITE study for facial skin quality improvement.
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Artificial intelligence emerged as the dominant topic in clinical research during 2025, with applications spanning operational efficiency, drug discovery, and patient recruitment, though no AI-discovered drug has yet achieved FDA marketing approval.
| NCT ID | Title | Status | Phase |
|---|---|---|---|
| NCT07600021 |
A Phase II Study to Evaluate the Efficacy and Safety of SYH2059 Tablets in Adult Patients With Idiopathic Pulmonary Fibrosis |
NOT_YET_RECRUITING | PHASE2 |
| NCT07588646 |
Study To Investigate The Potential DDI Between HEC585 And Pirfenidone/Nintedanib In Healthy Subjects |
COMPLETED | PHASE1 |
| NCT07520110 |
Metformin to Attenuate Progressive Respiratory Decline in Idiopathic Pulmonary Fibrosis |
NOT_YET_RECRUITING | PHASE3 |
| NCT07516951 |
A Study to Find an Efficacious and Safe Dose of CHF10067 (Zampilimab) in Participants With Idiopathic Pulmonary Fibrosis |
NOT_YET_RECRUITING | PHASE2 |
| NCT07454291 |
A Study to Evaluate Pharmacokinetics and Drug-drug Interactions of ENV-101 (Taladegib) in Healthy Participants |
RECRUITING | PHASE1 |
| NCT07407543 |
A Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of SRN001 in Healthy Korean and Caucasian Adult Males |
RECRUITING | PHASE1 |
| NCT07404423 |
OPEN-IPF: Observational Prediction modEl for cliNical Outcomes in Idiopathic Pulmonary Fibrosis |
NOT_YET_RECRUITING | |
| NCT07312305 |
Small Airways Disease Functional Assessment in Idiopathic Pulmonary Fibrosis (SWIFT-IPF) |
RECRUITING | |
| NCT07299695 |
Intravenous Immunoglobulin for the Treatment of Acute Exacerbations of Idiopathic Pulmonary Fibrosis |
RECRUITING | PHASE3 |
| NCT07284459 |
Study to Evaluate the Efficacy, Safety, and Tolerability of PIPE 791 in Subjects With Idiopathic Pulmonary Fibrosis |
RECRUITING | PHASE2 |