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Tazarotene

Phase 2

Idiopathic Pulmonary Fibrosis | Small molecule | Respiratory |GRI Bio, Inc.|Last Updated: Oct 30, 2025

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
RandomizedDouble-BlindCONTROLLEDDMCBiomarker
Total Trials1
Total Enrollment35
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT06331624Biomarker Modulation and the Inhibition of NKT1 Cells by Oral GRI-0621 in Patients With IPFPHASE2 COMPLETED 35Apr 24, 2024Sep 30, 2025Oct 30, 202516 United States, Australia +1
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Study Endpoints
Primary Endpoints
Safety and Tolerability of oral GRI-0621
12 Weeks

General overall safety and tolerability of oral GRI-0621 as compared to placebo will be assessed by evaluating the following safety parameters: * Adverse events (occurrence and type) * Clinical Laboratory Measurements (normal/abnormal) * Vital signs (normal/abnormal)

Secondary Endpoints
Change from baseline biomarkers
12 Weeks
Plasma concentrations of GRI-0621
12 Weeks
Pharmacodynamics of GRI-0621 in blood (Study Population)
6 Weeks and 12 Weeks
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Study Design & Arms
AllocationRANDOMIZED
MaskingTRIPLE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
GRI-0621EXPERIMENTALGRI-0621 (tazarotene) 4.5mg, administered orally once daily (QD)
PlaceboEXPERIMENTALPlacebo 4.5mg, administered orally once daily (QD)
Interventions
NameTypeDescription
Tazarotene (GRI-0621)DRUGOral 4.5mg soft gel capsule
PlaceboDRUGOral 4.5mg soft gel capsule
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Eligibility Criteria
Age Range40 Years — 85 Years
SexALL
Healthy VolunteersNo
Study Sites16

Inclusion Criteria: 1. Male or female subjects 40 through 85 years of age, inclusive. 2. Confirmed diagnosis of IPF with clinical features consistent with the current clinical practice guidelines for IPF. 3. FVC \> 50% predicted value within 4 weeks of Screening. 4. FEV1/FVC ratio \> 0.65 within 4 ...

Countries:United StatesAustraliaUnited Kingdom
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