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Deupirfenidone

Phase 3

Idiopathic Pulmonary Fibrosis | Small Molecules | Respiratory |PureTech Health plc|Trials Updated: Oct 23, 2026

Deupirfenidone development status

Highest phase Phase 3
Registered trials 5 across 1 sponsor since Jan 2020

Deupirfenidone target and mechanism

ModalitySmall Molecules

Also known as LYT-100 BCRL, LYT-100

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLEDDMC
Total Trials2
Total Enrollment1,340

FDA Designations

No designations recorded

Deupirfenidone clinical trials

Deupirfenidone · 2 trials · 2 indications

Phase 3 1Phase 2 1
NCT07284602Trial to Evaluate the Efficacy and Safety of LYT-100 (Deupirfenidone) Compared to Pirfenidone in Adults With Idiopathic Pulmonary Fibrosis (IPF)Idiopathic Pulmonary Fibrosis (IPF)
RECRUITING1,100 Analytics
PHASE3RECRUITING
Trial to Evaluate the Efficacy and Safety of LYT-100 (Deupirfenidone) Compared to Pirfenidone in Adults With Idiopathic Pulmonary Fibrosis (IPF)
Idiopathic Pulmonary Fibrosis (IPF)Unlock trial analytics

Study Endpoints

Primary Endpoints

Absolute change in forced vital capacity (FVC) measured in mL
Baseline to Week 52

Evaluate the efficacy of deupirfenidone compared with pirfenidone on reduction in lung function decline in participants with IPF

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

Rate of decline in Forced Vital Capacity (FVC; in mL)

Secondary Endpoints

Absolute change in FVC percent predicted (FVCpp)
Baseline to Week 52
Forced Vital Capacity (FVC) percent predicted change (Part A)
Baseline to Week 26
Time to hospitalization or mortality (Part A)
26 weeks
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Study Design & Arms

AllocationRANDOMIZED
MaskingQUADRUPLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
ActiveEXPERIMENTALdeupirfenidone 825 mg TID
Active ComparatorACTIVE_COMPARATORpirfenidone 801 mg TID
PlaceboPLACEBO_COMPARATORPlacebo oral administration
pirfenidone 801 mg TIDACTIVE_COMPARATORpirfenidone 801 mg TID oral administration
LYT-100 550 mg TIDEXPERIMENTALLYT-100 (Deupirfenidone) 550 mg TID oral administration
LYT-100 825 mg TIDEXPERIMENTALLYT-100 (Deupirfenidone) 825 mg TID oral administration

Interventions

NameTypeDescription
DeupirfenidoneDRUGsize AA Swedish orange capsule
Pirfenidone (PFD)DRUGsize AA Swedish orange capsule
PlaceboDRUGplacebo
PirfenidoneDRUGpirfenidone 801 mg TID
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Eligibility Criteria

Age Range40 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites18

Inclusion Criteria: * Is ≥40 years of age at the time of informed consent. * Meets the diagnostic criteria of IPF American Thoracic Society (ATS)/European Respiratory Society (ERS)/Japanese Respiratory Society (JRS)/Latin American Thoracic Society (ALAT) 2022 guidelines. * Has a maximum time from i...

Countries:United StatesCanadaArgentinaChileColombiaGeorgiaGreeceIndiaMalaysiaMexicoPhilippinesRomaniaSouth AfricaSouth KoreaThailand
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Recent Changes (Last 90 Days)

MEDIUMOct 30, 2026NCT07284602Status: NOT_YET_RECRUITING → RECRUITING
MEDIUMOct 30, 2026NCT05321420primaryCompletionDate: changed
MEDIUMOct 30, 2026NCT07284602Status: NOT_YET_RECRUITING → RECRUITING
MEDIUMOct 30, 2026NCT05321420primaryCompletionDate: changed
MEDIUMOct 30, 2026NCT07284602Status: NOT_YET_RECRUITING → RECRUITING
MEDIUMOct 30, 2026NCT05321420primaryCompletionDate: changed

Frequently asked questions about Deupirfenidone

What is deupirfenidone used for?

Deupirfenidone is being developed for the treatment of idiopathic pulmonary fibrosis (IPF), a chronic lung disease. It is an investigational small molecule studied in adults aged 40 years and older with IPF. It has not been established as an approved therapy and remains in clinical development.

Who is developing deupirfenidone?

Deupirfenidone is being developed by PureTech Health plc, which trades under the ticker PRTCY. The company is advancing the small molecule through clinical development in idiopathic pulmonary fibrosis, with a Phase 3 trial currently recruiting and a Phase 2 trial ongoing.

What phase is deupirfenidone in?

Deupirfenidone is in Phase 3 development for idiopathic pulmonary fibrosis. Two clinical trials are active: a Phase 3 study comparing it to pirfenidone and a Phase 2 study. It is investigational and has not been approved by the FDA for any indication.

What clinical trials is deupirfenidone in?

Deupirfenidone is being studied in two trials. NCT07284602 is a recruiting Phase 3 trial comparing LYT-100 (deupirfenidone) to pirfenidone in adults with IPF in the United States and Canada, enrolling 1,100 participants. NCT05321420 is a Phase 2 trial in IPF with 240 participants across multiple countries, now active but not recruiting.

Is deupirfenidone the same as LYT-100?

Yes, deupirfenidone is also known as LYT-100. The Phase 3 trial is titled to evaluate LYT-100 (deupirfenidone) compared to pirfenidone in adults with idiopathic pulmonary fibrosis, and the Phase 2 trial is listed as LYT-100 in patients with IPF. Both names refer to the same investigational small molecule.

How is the deupirfenidone Phase 3 trial designed?

The Phase 3 trial, NCT07284602, is a randomized, double-blind, placebo-controlled study evaluating the efficacy and safety of deupirfenidone compared to pirfenidone in adults with idiopathic pulmonary fibrosis. It is recruiting participants aged 40 years and older in the United States and Canada, with planned enrollment of 1,100.