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
PLN-101095, BEACON-IPF, and Bexotegrast. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend.
Select a button below to view the list of FDA events for that drug.
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:
- August 18, 2026
- Indication:
- Inhibitor of αvβ8 and αvβ1 integrins in development for the treatment of solid tumors
Announcement
Pliant Therapeutics, Inc. announced the receipt of Fast Track designation from the U.S. Food and Drug Administration (FDA) for PLN-101095, an oral, small molecule, dual selective inhibitor of αvβ8 and αvβ1 integrins, in combination with pembrolizumab for the potential the treatment of solid tumors that are resistant to immune checkpoint inhibitors (ICIs).
Read Announcement- Drug:
- PLN-101095
- Announced Date:
- April 30, 2026
- Indication:
- Inhibitor of αvβ8 and αvβ1 integrins in development for the treatment of solid tumors
Announcement
Pliant Therapeutics announced the dosing of the first participant in the FORTIFY Phase 1b open-label indication expansion clinical trial of PLN-101095 in combination with pembrolizumab, in patients with immune checkpoint inhibitor (ICI)-refractory advanced or metastatic solid tumors. PLN-101095 is an oral, small molecule, dual selective inhibitor of the integrins αvβ8 and αvβ1.
AI Summary
Pliant Therapeutics announced dosing of the first participant in the FORTIFY Phase 1b open-label indication expansion trial of PLN-101095 combined with pembrolizumab in patients with immune checkpoint inhibitor–refractory advanced or metastatic solid tumors. The trial will test the safety and early signs of benefit of the combo in solid tumor cohorts that have stopped responding to prior checkpoint therapy. This is an initial clinical step to see if adding PLN-101095 can help overcome resistance to PD‑1 blockade.
PLN-101095 is an oral small molecule that selectively inhibits the integrins αvβ8 and αvβ1. These integrins are linked to immune suppression in the tumor microenvironment, so blocking them may boost immune attack when paired with pembrolizumab. Bernard Coulie, Pliant’s CEO, said the dosing milestone and expansion are supported by the drug’s mechanism and that the company looks forward to exploring the candidate’s full potential.
Read Announcement- Drug:
- PLN-101095
- Announced Date:
- April 18, 2026
- Indication:
- Inhibitor of αvβ8 and αvβ1 integrins in development for the treatment of solid tumors
Announcement
Pliant Therapeutics, Inc announced the presentation of updated data from its Phase 1 trial of PLN-101095, in combination with pembrolizumab, in patients with immune checkpoint inhibitor (ICI)-refractory advanced or metastatic solid tumors.
AI Summary
Pliant Therapeutics announced updated Phase 1 data for PLN-101095 given with pembrolizumab in patients with ICI‑refractory advanced or metastatic solid tumors, presented orally at AACR’s Clinical Trials Mini Symposium. Confirmed responses deepened, with an average maximum tumor reduction of 89% from baseline and a median time on treatment of 19 months. The drug was generally well tolerated, with only two discontinuations. Rash was the most common treatment‑related adverse event, all Grade 1–2 and mostly occurring within two days of the first pembrolizumab dose. One Grade 3 TRAE was reported.
Pharmacokinetic data showed dose‑ordered exposure at Day 14; doses ≥1,000 mg twice daily achieved sustained IC90 coverage and all participants at ≥1,000 mg BID maintained IC75 coverage over 24 hours, supporting consistent target engagement. Pliant has started a Phase 1b open‑label expansion enrolling three cohorts (NSCLC, high tumor mutational burden tumors, and clear cell renal cell carcinoma). Patients receive 14 days of 1,000 mg BID PLN‑101095 monotherapy before adding pembrolizumab. Enrollment is underway and interim data are expected in 2027.
Read Announcement- Drug:
- PLN-101095
- Announced Date:
- March 18, 2026
- Indication:
- Inhibitor of αvβ8 and αvβ1 integrins in development for the treatment of solid tumors
Announcement
Pliant Therapeutics, Inc. announced the presentation of data from the Phase 1 trial of PLN-101095 at the upcoming American Association for Cancer Research (AACR) Annual Meeting taking place in San Diego, California from April 17-22, 2026.
AI Summary
Pliant Therapeutics announced it will present data from the Phase 1 trial of PLN-101095 at the American Association for Cancer Research (AACR) Annual Meeting in San Diego, April 17–22, 2026. The abstract was selected for an oral presentation in the Clinical Trials Mini Symposium. The talk, led by Timothy A. Yap, M.D., Ph.D., (University of Texas MD Anderson Cancer Center), is scheduled for April 18 at 10:21–10:31 a.m. Pacific Time in Ballroom 6A of the San Diego Convention Center (Session CTMS01: Updates in Anticancer Immunotherapies).
The study is a first-in-human Phase 1 trial of PLN-101095, a first-in-class dual αvβ8/αvβ1 integrin inhibitor, given alone and combined with pembrolizumab in patients with advanced solid tumors that are refractory to immune checkpoint inhibitors. The presentation will share early safety and activity data and marks a clinical step for Pliant’s approach to overcoming resistance to immunotherapy.
Read Announcement- Drug:
- PLN-101095
- Announced Date:
- December 4, 2025
- Indication:
- Inhibitor of αvβ8 and αvβ1 integrins in development for the treatment of solid tumors
Announcement
Pliant Therapeutics, Inc. announced interim data from its Phase 1 dose escalation clinical trial evaluating PLN-101095, in combination with pembrolizumab, in patients with immune checkpoint inhibitor (ICI)-refractory advanced or metastatic solid tumors.
AI Summary
Pliant Therapeutics reported interim Phase 1 dose‑escalation data for PLN‑101095 given with pembrolizumab in patients with immune checkpoint inhibitor (ICI)‑refractory advanced or metastatic solid tumors. In the three highest dose cohorts, 4 of 10 secondary ICI‑refractory patients responded: one confirmed complete response and three partial responses (two confirmed). Responses were seen in cholangiocarcinoma, melanoma, head and neck squamous cell carcinoma, and non‑small cell lung cancer. Median time on treatment for these patients was 15 months, and 60% of secondary refractory patients had stable disease or tumor reduction.
Responding patients showed large increases in plasma interferon‑gamma (4–13×) after a 14‑day run‑in with PLN‑101095; non‑responders did not. The drug was generally well tolerated with few discontinuations (n=2) and demonstrated dose‑dependent pharmacokinetics. Pliant plans to accelerate development with a Phase 1b expansion in 2026 and reports a cash position to support operations through 2028.
Read Announcement- 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.
Read Announcement
BEACON-IPF FDA Regulatory 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).
Read Announcement
Bexotegrast FDA Regulatory 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
