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pirfenidone

Generic: PIRFENIDONE·Brand: ESBRIET, PIRFENIDONE

pirfenidone: 9 clinical trials tracked.

pirfenidone evidence translation

What we can confirm

9 tracked trials

No verified listed company relationship

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 · 1 study sponsors
Clinical Trial Registry Records (9)

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

NCT07755813Registry updated 2026-08-10·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)

NCT07284602Registry updated 2026-07-17·Phase 3
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)

NCT07082842Registry updated 2026-04-21·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

NCT07015398Registry updated 2025-10-10·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

Evaluation of Pirfenidone as a Therapy in Patients With Predicted Moderate to Severe Acute Pancreatitis

NCT05350371Registry updated 2026-09-23·Phase 1/Phase 2
Completed

Primary endpoint: Development of Anticipated or Un-anticipated Adverse Events (Class 3 or 4)

InterventionalRandomizedquadruple1 enrolledStarted 2023-08Completion 2026-022 sites · United StatesUniversity of Alabama at Birmingham

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)

NCT05321420Registry updated 2025-10-16·Phase 2
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

NCT07456800Registry updated 2026-03-06·Phase 1
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

NCT05060822Registry updated 2026-04-21·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

NCT07588646Registry updated 2026-05-15·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.