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pirfenidone

Generic: PIRFENIDONE·Brand: ESBRIET, PIRFENIDONE

pirfenidone: 8 clinical trials tracked.

pirfenidone evidence translation

What we can confirm

8 tracked trials

No verified listed developer

What it means

AI will separate confirmed drug evidence from unknown company context.

What to watch

Watch trial status, endpoints, and the next source-backed update.
BioSniper AIPage evidence connected

Prepared research question

What is verified about pirfenidone, and what remains unknown?

Run cited research

Traceable citations · Unknowns marked

See linked entities and source evidence3 indications · 2 study sponsors
Clinical Trials (8)

Evaluation of Pirfenidone as a Novel Therapeutic Strategy Against Chronic Pancreatitis.

NCT07755813·Phase 2
Not yet recruiting

Primary endpoint: Number of Participants With at Least One Grade 3 or Grade 4 Adverse Event as Assessed by CTCAE Version 5.0

InterventionalRandomizedtriple60 targetStarted 2026-08Completion 2030-08Vikas Dudeja

A Randomized, Double-Blind, Head-to-Head Phase 3 Trial to Evaluate the Efficacy and Safety of LYT-100 (Deupirfenidone) Compared to Pirfenidone at 52 Weeks in Adults With Idiopathic Pulmonary Fibrosis (SURPASS-IPF)

NCT07284602·Phase 3·PRTC
Recruiting

Primary endpoint: Absolute change in forced vital capacity (FVC) measured in mL

InterventionalRandomizedquadruple1,100 targetStarted 2026-06Completion 2029-079 sites · United StatesPureTech

A Multicenter, Parallel, Randomized, Placebo (Double-blind) and Pirfenidone (Open-label) Controlled Phase III Clinical Trial Evaluating the Efficacy and Safety of HEC585 Tablets in Patients With Idiopathic Pulmonary Fibrosis (IPF)

NCT07082842·Phase 3
Recruiting

Primary endpoint: Change in FVC from baseline at 52 weeks (mL)

InterventionalRandomizedquadruple472 targetStarted 2025-10Completion 2032-021 site · ChinaSunshine Lake Pharma Co., Ltd.

A Phase 1, Two-Part, Open-Label Drug-Drug Interaction Study to Evaluate the Steady State Pharmacokinetics and Safety Following Co-Administration of Nalbuphine Extended-Release Tablets (NAL ER), and Pirfenidone or Nintedanib in Healthy Adult Subjects

NCT07015398·Phase 1·TRVI
Completed

Primary endpoint: Maximum Plasma Concentration (Cmax) of NAL ER, Pirfenidone, and Nintedanib

Interventionalopen132 enrolledStarted 2025-06Completion 2025-091 site · United StatesTrevi Therapeutics

A Randomized Double-blind, Four-Arm Active and Placebo-controlled Dose-Finding Trial to Evaluate the Efficacy, Tolerability, Safety and Dose Response of LYT-100 in Patients With Idiopathic Pulmonary Fibrosis (IPF)

NCT05321420·Phase 2·PRTC
Active, not recruiting

Primary endpoint: Rate of decline in Forced Vital Capacity over 26 weeks (Part A)

InterventionalRandomizedquadruple240 targetStarted 2022-07Completion 2025-1250 sites · Argentina, Chile, Colombia, Georgia…PureTech

A Phase 1, Double-Blind, Randomized, Crossover Study in Older Healthy Subjects to Compare the Safety, Tolerability, and Pharmacokinetics of Lyt-100 (Deupirfenidone) to Pirfenidone

NCT07456800·Phase 1·PRTC
Completed

Primary endpoint: Part 1: Cmax of BID deupirfenidone versus TID pirfenidone

InterventionalRandomizedquadruple116 enrolledStarted 2021-07Completion 2022-013 sites · United StatesPureTech

A Phase II, Multi-center, Randomized, Placebo-controlled (Double-blind Design), Active Comparator-controlled (Open-label Design), Parallel-group, Dose-finding Study, to Evaluate the Efficacy and Safety of HEC585 Tablets in Patients With IPF

NCT05060822·Phase 2
Active, not recruiting

Primary endpoint: Change from Baseline to Week 24 in %FVC compared with placebo

InterventionalRandomizedquadruple270 targetStarted 2021-06Completion 2026-121 site · ChinaSunshine Lake Pharma Co., Ltd.

A Single-center, Open-label Study Designed to Assess the Drug-drug Interaction of HEC585 And Pirfenidone/Nintedanib In Healthy Subjects

NCT07588646·Phase 1
Completed

Primary endpoint: Area under the curve from 0 to 24 hours [AUC (0~24)]

Interventionalopen33 enrolledStarted 2021-06Completion 2021-111 site · ChinaSunshine Lake Pharma Co., Ltd.