Drugs / bexotegrast
Trials 6
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 2 | NCT06097260 | Nov 2023 → Apr 2025 | idiopathic pulmonary fibrosis | Pliant Therapeutics, Inc. | Terminated | No outcome recorded |
| Phase 2 | NCT05621252 | Jul 2022 → Dec 2023 | idiopathic pulmonary fibrosis | Pliant Therapeutics, Inc. | Completed | Met primary |
| Phase 2 | NCT04565249 | Oct 2020 → Jun 2021 | COVID-19, acute respiratory distress syndrome | Pliant Therapeutics, Inc. | Terminated | No outcome recorded |
| Phase 2 | NCT04480840 | Jul 2020 → Feb 2024 | primary sclerosing cholangitis | Pliant Therapeutics, Inc. | Completed | Met primary |
| Phase 2 | NCT04396756 | Mar 2020 → Feb 2023 | idiopathic pulmonary fibrosis | Pliant Therapeutics, Inc. | Completed | Met primary |
| Phase 2 | NCT04072315 | Feb 2020 → Jun 2022 | idiopathic pulmonary fibrosis | Pliant Therapeutics, Inc. | Completed | No outcome recorded |
News releases announcing trial results or a regulatory action · 40
| Date | Issuer | Release |
|---|---|---|
| 2025-08-07 | Pliant Therapeutics, Inc. | Results Pliant Therapeutics Provides Corporate Update and Reports Second Quarter 2025 Financial Results pliantrx.com ↗
Following an analysis of the full safety and efficacy data from the BEACON-IPF Phase 2b/3 clinical trial, the Company has discontinued development of bexotegrast in idiopathic pulmonary fibrosis (IPF). |
| 2025-06-27 | Pliant Therapeutics, Inc. | Results Pliant Therapeutics Provides Update on BEACON-IPF pliantrx.com ↗
Results showed that at doses of 160 mg and 320 mg, bexotegrast demonstrated an unfavorable risk-benefit profile. |
| 2025-05-21 | Pliant Therapeutics, Inc. | Results Pliant Therapeutics Presents Clinical and Preclinical Data at the American Thoracic Society International Conference pliantrx.com ↗
Results showed that bexotegrast, a dual inhibitor of αVβ6/αVβ1 integrins, reduced expression of genes related to TGF-β signaling and fibrogenesis in alveolar type 1 (AT1) cells and multiple fibroblast subpopulations. |
| 2025-03-03 | Pliant Therapeutics, Inc. | Results Pliant Therapeutics Provides Update on BEACON-IPF, a Phase 2b/3 Trial in Patients with Idiopathic Pulmonary Fibrosis pliantrx.com ↗
Pliant Therapeutics, Inc. (Nasdaq: PLRX) today announced that following a prespecified data review and recommendation by the trial’s independent Data Safety Monitoring Board (DSMB), as well as a secondary review and recommendation by an outside expert panel, Pliant has discontinued the BEACON-IPF Phase 2b trial evaluating bexotegrast in patients with idiopathic pulmonary fibrosis (IPF). |
| 2025-03-03 | Pliant Therapeutics, Inc. | Results Pliant Therapeutics Provides Corporate Update and Reports Fourth Quarter 2024 Financial Results pliantrx.com ↗
Following a prespecified data review and recommendation by the trial’s independent DSMB, as well as a secondary review and recommendation by an outside expert panel, Pliant has discontinued the BEACON-IPF Phase 2b trial. |
| 2024-11-18 | Pliant Therapeutics, Inc. | Results Pliant Therapeutics Presents Data from its Bexotegrast Program at The Liver Meeting® 2024 pliantrx.com ↗
Bexotegrast, an oral inhibitor of αvβ6 and αvβ1 integrins, was shown to improve markers and symptoms of cholestasis and stabilized markers of liver fibrosis in participants with primary sclerosing cholangitis: Week 24 results from the Phase 2 INTEGRIS-PSC trial |
| 2024-09-10 | Pliant Therapeutics, Inc. | Results Pliant Therapeutics Presents Data from its Bexotegrast Program at the European Respiratory Society International Congress 2024 pliantrx.com ↗
Following 12 weeks of treatment, bexotegrast demonstrated a reduction in type 1 collagen in contrast to an increase on placebo, supporting bexotegrast’s antifibrotic effects and suggesting favorable lung remodeling. |
| 2024-07-15 | Pliant Therapeutics, Inc. | Results Pliant Therapeutics Announces Positive Long-Term Data from the INTEGRIS-PSC Phase 2a Trial Demonstrating Bexotegrast was Well Tolerated at 320 mg with Continued Antifibrotic and Anti-Cholestatic Activity Displayed Across Multiple Measures pliantrx.com ↗
Pliant Therapeutics, Inc. (Nasdaq: PLRX) today announced positive 24-week data from the 320 mg cohort of INTEGRIS-PSC, a multinational, randomized, double-blind, placebo-controlled Phase 2a clinical trial of bexotegrast in patients with primary sclerosing cholangitis (PSC) and suspected moderate to severe liver fibrosis. |
| 2024-06-06 | Pliant Therapeutics, Inc. | Results Pliant Therapeutics Presents Data from its Bexotegrast Program at the European Association for the Study of the Liver (EASL) International Liver Congress™ pliantrx.com ↗
Results showed that bexotegrast was well tolerated across all dose cohorts over 12 weeks of treatment. |
| 2024-05-21 | Pliant Therapeutics, Inc. | Results Pliant Therapeutics Presents Data from its Bexotegrast Program at the American Thoracic Society International Conference pliantrx.com ↗
Across 11 Phase 1 and 4 Phase 2 trials, bexotegrast was well tolerated, most treatment-emergent adverse events being mild to moderate with trial participants experiencing low drug discontinuation rates. |
| 2024-05-14 | Pliant Therapeutics, Inc. | Results Pliant Therapeutics Announces Positive Topline Data from a Phase 2a Collagen PET Imaging Clinical Trial of Bexotegrast in Patients with Idiopathic Pulmonary Fibrosis pliantrx.com ↗
Bexotegrast-treated patients showed reduced total lung collagen post treatment as measured by positron emission tomography (PET) imaging, compared to increased total lung collagen in the placebo group, suggesting potential reversal of fibrosis. |
| 2024-03-12 | Pliant Therapeutics, Inc. | Regulatory Pliant Therapeutics Announces Accelerated Bexotegrast Development Plan for the Treatment of Idiopathic Pulmonary Fibrosis pliantrx.com ↗
The adaptive design implementation, based on acceptance by the European Union (EU) and other global health authorities, will significantly shorten bexotegrast’s late-stage development compared to a traditional Phase 3 trial. |
| 2024-02-04 | Pliant Therapeutics, Inc. | Results Pliant Therapeutics Announces Positive Safety and Exploratory Efficacy Data from the INTEGRIS-PSC Phase 2a Trial of Bexotegrast 320 mg in Patients with Primary Sclerosing Cholangitis and Suspected Liver Fibrosis pliantrx.com ↗
Pliant Therapeutics, Inc. (Nasdaq: PLRX) today announced 12-week interim data from the 320 mg dose group of INTEGRIS-PSC, a multinational, randomized, double-blind, placebo-controlled Phase 2a clinical trial of bexotegrast in patients with primary sclerosing cholangitis (PSC) and suspected moderate to severe liver fibrosis. |
| 2023-11-13 | Pliant Therapeutics, Inc. | Results Pliant Therapeutics Presentations at The Liver Meeting® 2023 Highlight Bexotegrast, an Inhibitor of αvß6 and αvß1 Integrins, in Primary Sclerosing Cholangitis pliantrx.com ↗
A highlight of the conference was the late-breaker presentation of our recent positive interim data from the INTEGRIS-PSC trial, demonstrating the potential of bexotegrast in the unmet area of need of patients with PSC. |
| 2023-11-09 | Pliant Therapeutics, Inc. | Results Pliant Therapeutics Provides Corporate Update and Reports Third Quarter 2023 Financial Results pliantrx.com ↗
The third quarter was highlighted by positive interim data from the INTEGRIS-PSC trial of bexotegrast demonstrating a favorable safety profile and encouraging antifibrotic activity in PSC. |
| 2023-09-26 | Pliant Therapeutics, Inc. | Results Pliant Therapeutics Announces Positive Safety and Exploratory Efficacy Data from Phase 2a INTEGRIS-PSC Clinical Trial of Bexotegrast in Patients with Primary Sclerosing Cholangitis and Suspected Liver Fibrosis pliantrx.com ↗
Pliant Therapeutics, Inc. (Nasdaq: PLRX), today announced positive data from INTEGRIS-PSC, a Phase 2a clinical trial of bexotegrast in patients with primary sclerosing cholangitis (PSC) and suspected moderate to severe liver fibrosis. |
| 2023-09-11 | Pliant Therapeutics, Inc. | Results Pliant Therapeutics Announces Presentations at the European Respiratory Society International Congress 2023 pliantrx.com ↗
Results showed that bexotegrast at 320 mg was well tolerated for up to 40 weeks of treatment with no discontinuations due to treatment-emergent adverse events occurring from Week 12 to Week 40. |
| 2023-06-23 | Pliant Therapeutics, Inc. | Results Pliant Therapeutics Presents Data from its Bexotegrast Program at the European Association for the Study of the Liver (EASL) International Liver Congress™ pliantrx.com ↗
The study design and baseline demographics from the 85 participants randomized into the 40, 80 and 160 mg dose cohorts or placebo was presented from the ongoing INTEGRIS-PSC Phase 2a study. |
| 2023-05-24 | Pliant Therapeutics, Inc. | Results Pliant Therapeutics Presents Data from its Bexotegrast Program at the American Thoracic Society International Conference pliantrx.com ↗
Results showed that bexotegrast was well tolerated across all four dose groups with bexotegrast-treated participants experiencing a reduction in forced vital capacity (FVC) decline over 12 weeks versus placebo, on and off background therapy. |
| 2023-04-30 | Pliant Therapeutics, Inc. | Results Pliant Therapeutics Announces Positive Long-Term Data from the INTEGRIS-IPF Phase 2a Trial Demonstrating Bexotegrast was Well Tolerated at 320 mg with Durable Improvement Shown in FVC and Across Multiple Measures pliantrx.com ↗
Pliant Therapeutics, Inc. (Nasdaq: PLRX) today announced 24-week data from the 320 mg dose group of INTEGRIS-IPF, a multinational, randomized, dose-ranging, double-blind, placebo-controlled Phase 2a clinical trial of bexotegrast (PLN-74809) in patients with idiopathic pulmonary fibrosis (IPF). |
| 2023-03-13 | Pliant Therapeutics, Inc. | Results Pliant Therapeutics Announces Positive DSMB Safety Review and Initiation of Enrollment of Phase 2a Trial of Bexotegrast (PLN-74809) at 320 mg Dose in Primary Sclerosing Cholangitis pliantrx.com ↗
Recent independent Data Safety Monitoring Board (DSMB) review recommended the INTEGRIS-PSC Phase 2a trial continue without modification and proceed to evaluate 320 mg dose |
| 2023-03-09 | Pliant Therapeutics, Inc. | Results Pliant Therapeutics Provides Corporate Update and Reports Fourth Quarter 2022 Financial Results pliantrx.com ↗
2023 has already been productive with the release of additional positive data from the INTEGRIS-IPF 320 mg cohort, where bexotegrast displayed a continued favorable safety profile and outperformed all lower dose cohorts on exploratory efficacy endpoints. |
| 2023-01-22 | Pliant Therapeutics, Inc. | Results Pliant Therapeutics Announces Positive Data from the INTEGRIS-IPF Phase 2a Trial Demonstrating Bexotegrast 320 mg was Well Tolerated and Achieved Statistically Significant FVC Increase in Patients with Idiopathic Pulmonary Fibrosis pliantrx.com ↗ |
| 2022-12-15 | Pliant Therapeutics, Inc. | Regulatory Pliant Therapeutics Receives Orphan Designation from the European Medicines Agency for Bexotegrast (PLN-74809) for the Treatment of Idiopathic Pulmonary Fibrosis pliantrx.com ↗
Pliant Therapeutics (NASDAQ: PLRX) announced today that its lead drug candidate, bexotegrast (PLN-74809), an oral, once daily, dual-selective αvß6/αvß1 integrin inhibitor, has received Orphan Drug Designation from the European Medicines Agency (EMA) for the potential treatment of idiopathic pulmonary fibrosis (IPF). |
| 2022-09-01 | Pliant Therapeutics, Inc. | Results Pliant Therapeutics Announces Positive DSMB Safety Review of INTEGRIS-IPF Phase 2a Trial of PLN-74809 at 320 mg Dose in Idiopathic Pulmonary Fibrosis pliantrx.com ↗
Pliant Therapeutics, Inc. (Nasdaq: PLRX), a clinical stage biopharmaceutical company focused on discovering and developing novel therapies for the treatment of fibrosis, today announced a positive safety review of the ongoing INTEGRIS-IPF Phase 2a trial of PLN-74809 at 320 mg once-daily dose in patients with idiopathic pulmonary fibrosis (IPF) from a regularly scheduled meeting of its independent Data Safety Monitoring Board (DSMB). |
| 2022-07-21 | Pliant Therapeutics, Inc. | Regulatory Pliant Therapeutics Receives FDA Fast Track Designation for PLN-74809 for the Treatment of Primary Sclerosing Cholangitis pliantrx.com ↗
Pliant Therapeutics (NASDAQ: PLRX) announced today that PLN-74809, its oral, dual-selective α v ß 6 / α v ß 1 integrin inhibitor, has received Fast Track designation from the U.S. Food and Drug Administration (FDA) for the potential treatment of primary sclerosing cholangitis (PSC). |
| 2022-07-10 | Pliant Therapeutics, Inc. | Results Pliant Therapeutics Announces Positive Safety and Efficacy Data from Phase 2a INTEGRIS-IPF Clinical Trial of PLN-74809 in Patients with Idiopathic Pulmonary Fibrosis pliantrx.com ↗
Pliant Therapeutics, Inc. (Nasdaq: PLRX), today announced positive data from INTEGRIS-IPF, a multinational, randomized, double-blind, placebo-controlled Phase 2a clinical trial of PLN-74809 in patients with idiopathic pulmonary fibrosis (IPF). |
| 2022-06-24 | Pliant Therapeutics, Inc. | Results Pliant Therapeutics Announces Presentations at the International Liver Congress™ 2022 Highlighting Preclinical and Clinical Data in Support of the INTEGRIS-PSC Phase 2a Clinical Trial pliantrx.com ↗
Preliminary safety data from the INTEGRIS-PSC study continue to show a favorable tolerability profile for PLN-74809. |
| 2022-05-18 | Pliant Therapeutics, Inc. | Results Pliant Therapeutics Announces Presentations at 2022 American Thoracic Society International Conference pliantrx.com ↗
The most frequently reported adverse events were headache and constipation, and no drug-related severe adverse events were reported. |
| 2022-05-03 | Pliant Therapeutics, Inc. | Regulatory Pliant Therapeutics Receives FDA Fast Track Designation for PLN-74809 for the Treatment of Idiopathic Pulmonary Fibrosis pliantrx.com ↗
Pliant Therapeutics (NASDAQ: PLRX) announced today that PLN-74809, its oral, dual-selective α v ß 6 /α v ß 1 integrin inhibitor, has received Fast Track designation from the U.S. Food and Drug Administration (FDA) for the potential treatment of idiopathic pulmonary fibrosis (IPF). |
| 2022-02-28 | Pliant Therapeutics, Inc. | Results Pliant Therapeutics Announces Positive Data from Expanded Phase 1b BAL Trial of PLN-74809 Demonstrated Suppression of TGF-β Signaling in Healthy Volunteers pliantrx.com ↗
Results showed that PLN-74809 inhibited TGF-β activation on Day 7 by up to 92% and 76% at 6- and 24-hours, respectively, following dosing. |
| 2022-02-24 | Pliant Therapeutics, Inc. | Results Pliant Therapeutics Announces Positive DSMB Safety Review and Commencement of Enrollment of Phase 2a Trial of PLN-74809 at 320 mg Dose in Idiopathic Pulmonary Fibrosis pliantrx.com ↗
Pliant Therapeutics, Inc. (Nasdaq: PLRX), a clinical stage biopharmaceutical company focused on discovering and developing novel therapies for the treatment of fibrosis, today announced that, following a positive independent Data Safety Monitoring Board (DSMB) safety review, enrollment has commenced in a Phase 2a trial of PLN-74809 at 320 mg dosed once daily for at least six months in patients with idiopathic pulmonary fibrosis (IPF). |
| 2022-01-11 | Pliant Therapeutics, Inc. | Regulatory Pliant Therapeutics Highlights Recent Developments for Lead Program PLN-74809 and Expected 2022 Milestones pliantrx.com ↗
FDA has authorized evaluation of long-term treatment with PLN-74809 at doses up to 320 mg in IPF |
| 2021-09-07 | Pliant Therapeutics, Inc. | Results Pliant Therapeutics Reports Positive Interim Results from Phase 2a PET Imaging Clinical Trial in Patients with Idiopathic Pulmonary Fibrosis pliantrx.com ↗
Pliant Therapeutics, Inc. (Nasdaq: PLRX), a clinical stage biotechnology company focused on discovering and developing novel therapeutics for the treatment of fibrosis, today announced positive interim results from a Phase 2a positron emission tomography (PET) imaging-based clinical trial of PLN-74809, an oral small molecule dual selective inhibitor of α v β 6 /α v β 1 , in patients with idiopathic pulmonary fibrosis (IPF). |
| 2021-03-16 | Pliant Therapeutics, Inc. | Results Pliant Therapeutics Announces Successful Completion of PLN-1474 Phase 1 Study and Development Transition to Global Pharmaceutical Partner pliantrx.com ↗ |
| 2020-09-24 | Pliant Therapeutics, Inc. | Results Pliant Therapeutics Presents Data at American Thoracic Society 2020 Virtual Sessions pliantrx.com ↗
Presentation: PLN-74809, A Dual αVβ6/αVβ1, Oral, Selective Integrin Inhibitor, Is Well Tolerated and Reduces Lung TGF-β Activity in Healthy Volunteers |
| 2019-06-27 | Pliant Therapeutics, Inc. | Results Pliant Therapeutics Reports Positive Results of Phase 1b Clinical Study Supporting Advancement of PLN-74809 for Treatment of Idiopathic Pulmonary Fibrosis pliantrx.com ↗
PLN-74809 was shown to inhibit TGF-β activation by up to 70% in alveolar macrophages collected from healthy volunteers, in a dose- and exposure-dependent manner. |
| 2019-04-09 | Pliant Therapeutics, Inc. | Results Pliant Therapeutics Reports Positive Results of Phase 1 Clinical Study Support Advancement of PLN-74809 for Idiopathic Pulmonary Fibrosis pliantrx.com ↗
The small molecule inhibitor of the α V β 6 and α V β 1 integrins was shown to be safe and well tolerated in healthy volunteers, and the results support further development in patients with idiopathic pulmonary fibrosis (IPF), a chronic and progressive fibrotic lung disease with few treatment options. |
| 2018-11-20 | Pliant Therapeutics, Inc. | Regulatory Pliant Therapeutics Receives FDA Orphan Drug Designation for Lead Program PLN-74809 in Primary Sclerosing Cholangitis pliantrx.com ↗ |
| 2018-08-06 | Pliant Therapeutics, Inc. | Regulatory Pliant Therapeutics Receives FDA Orphan Drug Designation for Lead Program PLN-74809 in Idiopathic Pulmonary Fibrosis pliantrx.com ↗
today announced that the U.S. Food and Drug Administration (FDA) has granted orphan drug designation for the company’s anti-fibrotic lead compound, PLN-74809, for the treatment of idiopathic pulmonary fibrosis (IPF). |
All press releases naming this drug 46 releases
Evidence & citations 5 cited values
Every value below carries the sentence it was read from. 9 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Bexotegrast | “The aim of this study was to investigate the safety and exploratory pharmacodynamics of bexotegrast (PLN-74809), an oral, once-daily inhibitor of αvβ6 and αvβ1 integrins, in...” PMID 41016442 ↗ Sep 20254“Bexotegrast (PLN-74809) is an oral, once-daily, dual-selective inhibitor of αvβ6 and αvβ1 integrins under late-stage evaluation for treatment of IPF.” PMID 40153543 ↗ Jul 2025 “Bexotegrast (PLN-74809) is an oral, once-daily, dual-selective inhibitor of αvβ6 and αvβ1 integrins under investigation for the treatment of IPF.” PMID 39499805 ↗ Mar 2025 “Randomized, Double-blind Study of Efficacy and Safety of Bexotegrast (PLN-74809) for Idiopathic Pulmonary Fibrosis” NCT06097260 ↗ “Bexotegrast (PLN-74809) is an oral, once-daily, investigational drug in development for the treatment of IPF.” PMID 38843105 ↗ Aug 2024 |
| Known as | PLN-74809 | “The aim of this study was to investigate the safety and exploratory pharmacodynamics of bexotegrast (PLN-74809), an oral, once-daily inhibitor of αvβ6 and αvβ1 integrins, in...” PMID 41016442 ↗ Sep 20255“Bexotegrast (PLN-74809) is an oral, once-daily, dual-selective inhibitor of αvβ6 and αvβ1 integrins under investigation for the treatment of IPF.” PMID 39499805 ↗ Mar 2025 “Randomized, Double-blind Study of Efficacy and Safety of Bexotegrast (PLN-74809) for Idiopathic Pulmonary Fibrosis” NCT06097260 ↗ |
| Action | Inhibit | “dual-selective inhibitor of αvβ6 and αvβ1 integrins” PMID 39499805 ↗ Mar 2025 |
| Modality | Small molecule | — CHEMBL5095257 ↗ |
| Route | Oral | “an oral, once-daily” PMID 39499805 ↗ Mar 2025 |