This section highlights FDA-related milestones and regulatory updates for drugs developed by Pliant Therapeutics (PLRX).
Over the past two years, Pliant Therapeutics has reported clinical trial outcomes, regulatory submissions, approvals, and other FDA events for drugs and therapies such as
BEACON-IPF, Bexotegrast, PLN-101095, and PLN-74809. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend.
BEACON-IPF - FDA Regulatory Timeline and Events
BEACON-IPF is a drug developed by Pliant Therapeutics for the following indication: In Patients with Idiopathic Pulmonary Fibrosis.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- BEACON-IPF
- Announced Date:
- March 3, 2025
- Indication:
- In Patients with Idiopathic Pulmonary Fibrosis
Announcement
Pliant Therapeutics, Inc. 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).
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Bexotegrast - FDA Regulatory Timeline and Events
Bexotegrast is a drug developed by Pliant Therapeutics for the following indication: Primary Sclerosing Cholangitis and Suspected Liver Fibrosis.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- Bexotegrast
- Announced Date:
- February 7, 2025
- Indication:
- Primary Sclerosing Cholangitis and Suspected Liver Fibrosis
Announcement
Pliant Therapeutics, Inc announced that following a prespecified data review and recommendations by the trial's independent Data Safety Monitoring Board (DSMB), the Company has voluntarily paused enrollment and dosing in the ongoing BEACON-IPF Phase 2b trial of bexotegrast in patients with idiopathic pulmonary fibrosis (IPF).
AI Summary
Pliant Therapeutics, Inc. announced that it has voluntarily paused enrollment and dosing in its ongoing BEACON-IPF Phase 2b trial for bexotegrast, following a prespecified review and recommendations from the independent Data Safety Monitoring Board (DSMB). The pause is being implemented so the company can take a closer look at the DSMB’s concerns and better understand the data that led to this decision.
Patients already enrolled in the trial will continue to receive monitoring and care while the study remains blinded to protect its integrity. Investigators have been informed of the update, and the company is in the process of notifying global regulatory authorities as it carefully reviews the trial data.
Read Announcement- Drug:
- Bexotegrast
- Announced Date:
- September 10, 2024
- Indication:
- Primary Sclerosing Cholangitis and Suspected Liver Fibrosis
Announcement
Pliant Therapeutics, Inc. announced its presentations at the European Respiratory Society (ERS) International Congress 2024 taking place in Vienna, Austria September 7 - 11, 2024.
AI Summary
Pliant Therapeutics, Inc. announced it will present its latest data at the European Respiratory Society (ERS) International Congress 2024 in Vienna, Austria, from September 7–11, 2024. The presentations will include clinical data from a type 1 collagen PET imaging study that evaluated the drug bexotegrast in patients with idiopathic pulmonary fibrosis (IPF). Researchers shared that after 12 weeks of treatment, bexotegrast reduced type 1 collagen deposits in contrast to an increase observed in a placebo group, suggesting the drug’s beneficial effects on lung remodeling. Additionally, attendees will see an integrated safety summary from the INTEGRIS clinical programs and supportive nonclinical findings from the bexotegrast development program. These data contribute to the ongoing BEACON-IPF trial and reinforce the potential of bexotegrast as a promising treatment option for fibrotic lung diseases.
Read Announcement- Drug:
- Bexotegrast
- Announced Date:
- July 15, 2024
- Indication:
- Primary Sclerosing Cholangitis and Suspected Liver Fibrosis
Announcement
Pliant Therapeutics, Inc 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.
AI Summary
Pliant Therapeutics, Inc. announced positive 24-week data from the 320 mg cohort of the INTEGRIS-PSC Phase 2a trial in patients with primary sclerosing cholangitis (PSC) and suspected moderate to severe liver fibrosis. In this multinational, randomized, double-blind, placebo-controlled study, bexotegrast was well tolerated for up to 40 weeks with no treatment-related severe or serious adverse events.
The trial demonstrated that patients receiving 320 mg of bexotegrast showed improvements in liver stiffness measured by transient elastography, and there were statistically significant reductions in alkaline phosphatase (ALP) levels compared to placebo. MRI imaging further indicated enhanced hepatocyte function and improved bile flow from Weeks 12 to 24. These findings suggest potential stabilization of liver fibrosis. Additionally, recent FDA feedback provided clear guidance on the next steps for the PSC development program, supporting future dose-ranging trials.
Read Announcement- Drug:
- Bexotegrast
- Announced Date:
- June 6, 2024
- Indication:
- Primary Sclerosing Cholangitis and Suspected Liver Fibrosis
Announcement
Pliant Therapeutics, Inc announced two poster presentations, including a late-breaker, were presented at the European Association for the Study of the Liver (EASL) International Liver Congress™ being held June 5-8, 2024.
AI Summary
Pliant Therapeutics, a late-stage biotechnology company, announced that it presented two poster presentations at the European Association for the Study of the Liver (EASL) International Liver Congress™ held from June 5-8, 2024. One of these was a late-breaker presentation where Dr. Michael Trauner shared interim results from the Phase 2a INTEGRIS-PSC trial. The study focused on the safety and efficacy of bexotegrast in treating primary sclerosing cholangitis. Results showed that the drug was well tolerated and helped control markers related to liver fibrosis. Additionally, another poster presented by Dr. Johanna Schaub revealed insights from gene expression analysis in human liver tissue, highlighting bexotegrast’s unique mechanism in reducing TGF-β signaling in fibrogenic cells. These findings add promising data to Pliant Therapeutics’ ongoing efforts to develop novel treatments for fibrotic liver diseases.
Read Announcement- Drug:
- Bexotegrast
- Announced Date:
- May 14, 2024
- Indication:
- Primary Sclerosing Cholangitis and Suspected Liver Fibrosis
Announcement
Pliant Therapeutics, Inc. announced topline data from a 12-week, randomized, double-blind, placebo-controlled trial of bexotegrast (PLN-74809) conducted at Massachusetts General Hospital evaluating change in total collagen levels in the lungs of patients with idiopathic pulmonary fibrosis (IPF).
AI Summary
Pliant Therapeutics, Inc. has shared positive topline results from a 12-week trial of its drug bexotegrast (PLN-74809) in patients with idiopathic pulmonary fibrosis (IPF). The study, carried out at Massachusetts General Hospital, was a randomized, double-blind, placebo-controlled trial aimed at assessing changes in total collagen levels in the lungs—a key factor in the development of lung scarring. Researchers focused on whether the reduction of collagen could help slow disease progression or improve lung function. These initial results offer promising insights into bexotegrast’s potential as a treatment option for IPF, a condition that currently has limited therapies available. The data underscores the need for further research to fully understand the drug’s safety and effectiveness, and it may pave the way for future studies to better address the challenges faced by patients with IPF.
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PLN-101095 - FDA Regulatory Timeline and Events
PLN-101095 is a drug developed by Pliant Therapeutics for the following indication: Inhibitor of αvβ8 and αvβ1 integrins in development for the treatment of solid tumors.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- PLN-101095
- Announced Date:
- March 17, 2025
- Indication:
- Inhibitor of αvβ8 and αvβ1 integrins in development for the treatment of solid tumors
Announcement
Pliant Therapeutics, Inc announced data from the first three of five potential cohorts of its ongoing Phase 1 dose escalation clinical trial evaluating PLN-101095, an integrin αvβ8 and αvβ1 inhibitor, in combination with pembrolizumab, in patients with immune checkpoint inhibitor (ICI) -refractory advanced or metastatic solid tumors.
AI Summary
Pliant Therapeutics, Inc. announced encouraging early data from the first three cohorts of an ongoing Phase 1 dose escalation trial. The study is testing PLN-101095—an inhibitor that targets integrins αvβ8 and αvβ1—in combination with pembrolizumab in patients whose advanced or metastatic solid tumors did not respond to previous immune checkpoint inhibitor treatments. In cohort three, where patients received 1000 mg twice daily, three out of six patients (50%) showed confirmed partial responses, indicating notable antitumor activity. Overall, PLN-101095 was well tolerated at all tested doses. Patients initially received PLN-101095 alone for 14 days before adding pembrolizumab to their regimen. These early results support further evaluation, as researchers continue to enroll more patients and explore higher dosing regimens in additional study cohorts.
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PLN-74809 - FDA Regulatory Timeline and Events
PLN-74809 is a drug developed by Pliant Therapeutics for the following indication: Idiopathic Pulmonary Fibrosis (IPF).
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- PLN-74809
- Announced Date:
- May 21, 2024
- Indication:
- Idiopathic Pulmonary Fibrosis (IPF)
Announcement
Pliant Therapeutics, Inc announced that the Company presented clinical data and preclinical data of bexotegrast (PLN-74809) this week as part of the American Thoracic Society (ATS) 2024 International Conference, held from May 17-22, 2024.
AI Summary
Pliant Therapeutics recently presented both clinical and preclinical data on its lead candidate, bexotegrast (PLN-74809), at the American Thoracic Society (ATS) 2024 International Conference from May 17-22, 2024. The company showcased comprehensive clinical safety and imaging findings, alongside preclinical data that support the ongoing development of bexotegrast in fibrotic disease treatment. Researchers highlighted the drug’s dual inhibition of the αvβ6 and αvβ1 integrins, which helps reduce TGF-β signaling—a key factor in fibrosis progression. The data presented not only affirm the tolerability and promising safety profile of bexotegrast but also provide robust support for its efficacy as observed in fibrotic human lung models. These insights back up the progress of the BEACON-IPF trial, underlining the potential of bexotegrast as a novel treatment option for conditions like idiopathic pulmonary fibrosis.
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