PLN-74809

Overview

PLN-74809 is a small-molecule that dually inhibits both αβ and αβ to treat both idiopathic pulmonary fibrosis (IPF) and primary sclerosing cholangitis (PSC). The compound was granted orphan drug designation by the US FDA in August 2018 for treatment of IPF, and Pliant Therapeutics recently raised $100 million in Series C financing to support further clinical development of this compound. Phase 2a studies are currently evaluating PLN-74809 safety and efficacy for participants with IPF (NCT04396756)across 10 participating countries, and for participants with PSC (NCT04480840). In addition, the compound is also currently in Phase 2a trials (NCT04565249) for the treatment of COVID-19 related acute respiratory distress syndrome.

Indication

Through dual inhibition of integrins αβ and αβ, PLN-74809 reduces subsequent activation of TGF-β1, which is actively involved in the growth of fibrotic tissue in lung and bile ducts. Further studies showed that PLN-74809 inhibited collagen gene expression in PSC and IPF patient tissue.

Associated Conditions

No associated conditions information available.

Clinical Trials

Title	Posted	Study ID	Phase	Status	Sponsor
Randomized, Double-blind Study of Efficacy and Safety of Bexotegrast (PLN-74809) for Idiopathic Pulmonary Fibrosis	2023/10/24	NCT06097260	Phase 2	Active, not recruiting	Pliant Therapeutics, Inc.
Imaging Evaluation of PLN-74809 in Participants With IPF (PLN-74809)	2022/11/18	NCT05621252	Phase 2	Completed	Pliant Therapeutics, Inc.
Evaluation of the Safety, Tolerability, and Pharmacokinetics of PLN-74809 in Participants With Acute Respiratory Distress Syndrome (ARDS) Associated With at Least Severe COVID-19	2020/09/25	NCT04565249	Phase 2	Terminated	Pliant Therapeutics, Inc.
Phase 2a Evaluation of Safety, Tolerability, and Pharmacokinetics of PLN-74809 in Patients With Primary Sclerosing Cholangitis (PSC)	2020/07/21	NCT04480840	Phase 2	Completed	Pliant Therapeutics, Inc.
Evaluation of Efficacy and Safety of PLN-74809 in Patients With Idiopathic Pulmonary Fibrosis	2020/05/21	NCT04396756	Phase 2	Completed	Pliant Therapeutics, Inc.
Phase 2a Evaluation of PLN-74809 on αvβ6 Receptor Occupancy Using PET Imaging in Participants With IPF/	2019/08/28	NCT04072315	Phase 2	Completed	Pliant Therapeutics, Inc.

FDA Drug Approvals

Approved Product	Manufacturer	NDC Code	Route	Strength	Effective Date
No FDA approvals found for this drug.

EMA Drug Approvals

Approved Product	Authorization Holder	Status	Issued Date
No EMA approvals found for this drug.

HSA Drug Approvals

Approved Product	Manufacturer	Approval Number	Dosage Form	Strength	Approval Date
No HSA approvals found for this drug.

NMPA Drug Approvals

Approved Product	Company	Approval Number	Drug Type	Dosage Form	Approval Date
No NMPA approvals found for this drug.

PPB Drug Approvals

Approved Product	Registration No.	Company	Licence No.	Strength	Registration Date
No PPB approvals found for this drug.

TGA Drug Approvals

Approved Product	ARTG ID	Sponsor	Registration Type	Status	Registration Date
No TGA approvals found for this drug.

AI-Powered Research

Premium Access