Idiopathic Pulmonary Fibrosis Clinical Trials and Studies: EMA, PDMA, FDA Approvals, Mechanism of Action, ROA, NDA, IND, and Companies by DelveInsight

DelveInsight's, "Idiopathic Pulmonary Fibrosis Pipeline Insight" report provides comprehensive insights about 80+ companies and 100+ pipeline drugs in Idiopathic Pulmonary Fibrosis pipeline landscape. It covers the Idiopathic Pulmonary Fibrosis pipeline drug profiles, including clinical and nonclinical stage products. It also covers the Idiopathic Pulmonary Fibrosis therapeutics assessment by product type, stage, route of administration, and molecule type. It further highlights the inactive Idiopathic Pulmonary Fibrosis pipeline products in this space.

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Key Takeaways from the Idiopathic Pulmonary Fibrosis Pipeline Report

* In January 2025:- PureTech:- This study is a randomized, double-blind, being conducted at centers globally to evaluate the safety and efficacy of LYT-100 compared to pirfenidone or placebo in 240 treatment naive adult patients with IPF greater than or equal to 40 years in age. Patients will be randomized in a ratio of 1:1:1:1 to receive treatment of LYT-100, pirfenidone, or placebo to be taken daily for up to 183 days (26 week treatment period) with the primary outcome of Rate of decline in Forced Vital Capacity (FVC; in mL) over 26 weeks. Secondary endpoints, including spirometry, inflammatory biomarkers, and patient-reported outcomes will also be evaluated.
* In January 2025:- Tvardi Therapeutics, Incorporated:- The primary objective of this study is to evaluate the safety and tolerability of oral daily administration of TTI-101 over a 12-week treatment duration in participants with idiopathic pulmonary fibrosis (IPF).
* In February 2025:- Pliant Therapeutics Inc.:- This is a randomized, double-blind, dose-ranging, placebo-controlled study to evaluate the efficacy and safety of 2 doses of bexotegrast (PLN-74809) [160 and 320 mg] taken for 52 weeks by participants with IPF taking and not taking background therapy (ie, nintedanib or pirfenidone). The study will consist of an up to 35-day Screening Period, a 52-week Treatment Period, and a 14 day Safety Follow-up Period. Of note, participants who are not taking background therapy at study entry will be allowed to initiate it at any time during the study.
* In January 2025:- Boehringer Ingelheim:- This study is open to adults 40 years or older with idiopathic pulmonary fibrosis (IPF). People can join the study if they are not on any treatment for IPF are on stable treatment for at least 3 months before starting the study. The purpose of this study is to find out whether a medicine called BI 1819479 helps people with IPF. 3 different doses of BI 1819479 are tested in this study.
* DelveInsight's Idiopathic Pulmonary Fibrosis pipeline report depicts a robust space with 80+ active players working to develop 100+ pipeline therapies for Idiopathic Pulmonary Fibrosis treatment.
* The leading Idiopathic Pulmonary Fibrosis Companies such as FibroGen, United Therapeutics, Bellerophon Therapeutics, MediciNova, Novartis, Endeavor BioMedicines, Pliant Therapeutics, Nitto Denko, Kadmon Pharmaceuticals, Calliditas Therapeutics, Avalyn Pharmaceuticals, PureTech Health, Taiho Pharmaceutical, Bristol-Myers Squibb, Galecto Biotech AB, CSL Behring, Celgene Pharmaceutical, Vicore Pharma, Boehringer Ingelheim, Guangdong Raynovent, Sunshine Lake Pharma Co, Suzhou Zelgen Biopharmaceuticals, Algernon Pharmaceuticals, Horizon Therapeutics, Daewoong Pharmaceutical, Metagone Biotech, AstraZeneca, Lung Therapeutics, Bridge Biotherapeutics, Kinarus AG, Insmed, Reviva Pharmaceuticals, Annapurna Bio, Guangdong Hengrui Pharmaceutical Co., Ltd., Ark Biosciences, Ocean Biomedical and others.
* Promising Idiopathic Pulmonary Fibrosis Therapies such as Pirfenidone, Deupirfenidone, SC1011, TTI-101, Pamrevlumab, PLN-74809, GSK3915393, and others.

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Idiopathic Pulmonary Fibrosis Emerging Drugs Profile

* Pamrevlumab: FibroGen

Pamrevlumab is a proprietary therapeutic antibody developed by FibroGen to inhibit the activity of connective tissue growth factor (CTGF), a common factor in chronic fibrotic and proliferative disorders characterized by persistent and excessive scarring that can lead to organ dysfunction and failure. Pamrevlumab represents a potential treatment for a broad array of fibrotic and proliferative disorders that affect organ systems throughout the body. Currently, the drug is in the Phase III stage of its development for the treatment of Idiopathic Pulmonary Fibrosis.

* Tipelukast: MediciNova

MN-001 (tipelukast) is a novel, orally bioavailable small molecule compound which exerts its effects through several mechanisms to produce its anti-fibrotic and anti-inflammatory activity in preclinical models, including leukotriene (LT) receptor antagonism, inhibition of phosphodiesterases (PDE) (mainly 3 and 4), and inhibition of 5-lipoxygenase (5-LO). The 5-LO/LT pathway has been postulated as a pathogenic factor in fibrosis development and MN-001's inhibitory effect on 5-LO and the 5-LO/LT pathway is considered to be a novel approach to treat fibrosis. MN-001 has been shown to down-regulate expression of genes that promote fibrosis including LOXL2, Collagen Type 1 and TIMP-1. MN-001 has also been shown to down-regulate expression of genes that promote inflammation including CCR2 and MCP-1. In addition, histopathological data shows that MN-001 reduces fibrosis in multiple animal models. The US Food and Drug Administration (FDA) has granted orphan-drug designation to MN-001 (tipelukast) for treatment of idiopathic pulmonary fibrosis (IPF). Currently, the drug is in the Phase II stage of its development for the treatment of IPF.

* PLN-74809: Pliant Therapeutics

PLN-74809 is an oral small-molecule dual-selective inhibitor of v6 and v1 integrins for the treatment of IPF. While present at very low levels in healthy tissues, these integrins are upregulated in the lungs of IPF patients where they activate TGF-, a key driver of the fibrotic process. Blocking these integrins is designed to stop TGF- activation, potentially halting the growth of scar tissue. PLN-74809 has received Fast Track Designation and Orphan Drug Designation from the US Food and Drug Administration (FDA) in IPF and Orphan Drug Designation from the European Medicines Agency (EMA) in IPF. The company has completed enrollment in the Phase 2a clinical trial of PLN-74809 in patients with idiopathic pulmonary fibrosis (IPF) and announced positive data from the trial.

* HZN-825: Horizon Pharmaceuticals

HZN-825 is an oral selective LPAR1 antagonist that has shown early signs of clinical impact in systemic sclerosis. LPAR1 signaling has been implicated in fibrosis and inflammation, and preclinical and clinical evidence support the antifibrotic potential of LPAR1 antagonism across multiple organ systems, including both lung and skin. Currently, the drug is in the Phase II stage of its development for the treatment of Idiopathic Pulmonary Fibrosis.

* Brilaroxazine: Reviva Pharmaceuticals

Brilaroxazine, a novel serotonin-dopamine modulator with multifaceted activities has the potential to treat idiopathic pulmonary fibrosis (IPF). Serotonin (5-HT) signaling plays a key role, via 5-HT2A/2B/7 receptors, in the vasoactive effect on pulmonary arteries and lung myofibroblast actions. Brilaroxazine displays a high affinity and functional activity for the 5-HT2A/2B/7 receptors and moderate affinity for the serotonin transporter. Brilaroxazine's effects on vascular fibrosis (5-HT2B receptor), proliferation (5-H2A/2B receptor), relaxation (5-HT2A receptor), inflammation (5-HT7 receptor), and pro-inflammatory cytokines have created interest in the potential to treat IPF. Brilaroxazine was evaluated in a bleomycin (BLM)-induced rat model of IPF receiving either brilaroxazine 15 mg twice daily for 21 days starting at day 1 (BT) or at day 10 (BI) and demonstrated efficacy with significant improvements in key endpoints in the bleomycin (BLM)-induced rat model of IPF. Currently, the drug is in the Phase I stage of its development for the treatment of IPF.

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Idiopathic Pulmonary Fibrosis Companies

FibroGen, United Therapeutics, Bellerophon Therapeutics, MediciNova, Novartis, Endeavor BioMedicines, Pliant Therapeutics, Nitto Denko, Kadmon Pharmaceuticals, Calliditas Therapeutics, Avalyn Pharmaceuticals, PureTech Health, Taiho Pharmaceutical, Bristol-Myers Squibb, Galecto Biotech AB, CSL Behring, Celgene Pharmaceutical, Vicore Pharma, Boehringer Ingelheim, Guangdong Raynovent, Sunshine Lake Pharma Co, Suzhou Zelgen Biopharmaceuticals, Algernon Pharmaceuticals, Horizon Therapeutics, Daewoong Pharmaceutical, Metagone Biotech, AstraZeneca, Lung Therapeutics, Bridge Biotherapeutics, Kinarus AG, Insmed, Reviva Pharmaceuticals, Annapurna Bio, Guangdong Hengrui Pharmaceutical Co., Ltd., Ark Biosciences, Ocean Biomedical and others.

Idiopathic Pulmonary Fibrosis pipeline report provides the therapeutic assessment of the pipeline drugs by the Route of Administration. Products have been categorized under various ROAs such as

* Oral
* Parenteral
* Intravitreal
* Subretinal
* Topical

Idiopathic Pulmonary Fibrosis Products have been categorized under various Molecule types such as

* Monoclonal Antibody
* Peptides
* Polymer
* Small molecule
* Gene therapy

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Scope of the Idiopathic Pulmonary Fibrosis Pipeline Report

* Coverage- Global
* Idiopathic Pulmonary Fibrosis Companies- FibroGen, United Therapeutics, Bellerophon Therapeutics, MediciNova, Novartis, Endeavor BioMedicines, Pliant Therapeutics, Nitto Denko, Kadmon Pharmaceuticals, Calliditas Therapeutics, Avalyn Pharmaceuticals, PureTech Health, Taiho Pharmaceutical, Bristol-Myers Squibb, Galecto Biotech AB, CSL Behring, Celgene Pharmaceutical, Vicore Pharma, Boehringer Ingelheim, Guangdong Raynovent, Sunshine Lake Pharma Co, Suzhou Zelgen Biopharmaceuticals, Algernon Pharmaceuticals, Horizon Therapeutics, Daewoong Pharmaceutical, Metagone Biotech, AstraZeneca, Lung Therapeutics, Bridge Biotherapeutics, Kinarus AG, Insmed, Reviva Pharmaceuticals, Annapurna Bio, Guangdong Hengrui Pharmaceutical Co., Ltd., Ark Biosciences, Ocean Biomedical and others.
* Idiopathic Pulmonary Fibrosis Therapies- Pirfenidone, Deupirfenidone, SC1011, TTI-101, Pamrevlumab, PLN-74809, GSK3915393, and others.
* Idiopathic Pulmonary Fibrosis Therapeutic Assessment by Product Type: Mono, Combination, Mono/Combination
* Idiopathic Pulmonary Fibrosis Therapeutic Assessment by Clinical Stages: Discovery, Pre-clinical, Phase I, Phase II, Phase III

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Table of Content

* Introduction
* Executive Summary
* Idiopathic Pulmonary Fibrosis: Overview
* Pipeline Therapeutics
* Therapeutic Assessment
* Idiopathic Pulmonary Fibrosis- DelveInsight's Analytical Perspective
* Late Stage Products (Phase III)
* Pamrevlumab: FibroGen
* Drug profiles in the detailed report.....
* Mid Stage Products (Phase II)
* Tipelukast: MediciNova
* Drug profiles in the detailed report.....
* Early Stage Products (Phase I)
* Brilaroxazine: Reviva Pharmaceuticals
* Drug profiles in the detailed report.....
* Preclinical and Discovery Stage Products
* Drug name: Company name
* Drug profiles in the detailed report.....
* Inactive Products
* Idiopathic Pulmonary Fibrosis Key Companies
* Idiopathic Pulmonary Fibrosis Key Products
* Idiopathic Pulmonary Fibrosis- Unmet Needs
* Idiopathic Pulmonary Fibrosis- Market Drivers and Barriers
* Idiopathic Pulmonary Fibrosis- Future Perspectives and Conclusion
* Idiopathic Pulmonary Fibrosis Analyst Views
* Idiopathic Pulmonary Fibrosis Key Companies
* Appendix

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