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Tazarotene

Phase 2

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

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindCONTROLLEDDMC
Total Trials1
Total Enrollment35

FDA Designations

No designations recorded

Clinical trial landscape

Tazarotene · 1 trial · 2 indications

Phase 2 1
NCT06331624Biomarker Modulation and the Inhibition of NKT1 Cells by Oral GRI-0621 in Patients With IPFIdiopathic Pulmonary Fibrosis
COMPLETED35 Analytics
PHASE2COMPLETED
Biomarker Modulation and the Inhibition of NKT1 Cells by Oral GRI-0621 in Patients With IPF
Idiopathic Pulmonary FibrosisUnlock trial analytics

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 to 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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Frequently asked questions about Tazarotene

What is Tazarotene used for in Idiopathic Pulmonary Fibrosis?

Tazarotene is an investigational small molecule being studied for the treatment of Idiopathic Pulmonary Fibrosis (IPF). It is being developed by GRI Bio, Inc. and is currently in Phase 2 clinical development. The drug is intended to modulate biomarkers and inhibit NKT1 cells in patients with IPF.

What does Tazarotene target?

Tazarotene targets NKT1 cells, a type of immune cell involved in the pathogenesis of Idiopathic Pulmonary Fibrosis. By inhibiting NKT1 cells, the drug aims to modulate biomarkers associated with the disease. This mechanism is being evaluated in a Phase 2 clinical trial.

Who makes Tazarotene?

Tazarotene is being developed by GRI Bio, Inc., a biopharmaceutical company. The company is conducting clinical trials to evaluate the drug for the treatment of Idiopathic Pulmonary Fibrosis. GRI Bio, Inc. is the sponsor of the ongoing Phase 2 study.

What phase is Tazarotene in?

Tazarotene is in Phase 2 clinical development for Idiopathic Pulmonary Fibrosis. It is an investigational drug and has not been approved by regulatory authorities. A Phase 2 clinical trial has been completed to assess its safety and efficacy in patients with IPF.

What clinical trials is Tazarotene in?

Tazarotene has been studied in a Phase 2 clinical trial with the identifier NCT06331624. This trial, titled 'Biomarker Modulation and the Inhibition of NKT1 Cells by Oral GRI-0621 in Patients With IPF,' enrolled 35 participants and was conducted in the United States, Australia, and the United Kingdom. The study has been completed.

Is Tazarotene the same as GRI-0621?

Yes, Tazarotene is also known as GRI-0621. In clinical trials, the drug is referred to as GRI-0621, as seen in the Phase 2 study NCT06331624. Both names refer to the same investigational small molecule being developed for Idiopathic Pulmonary Fibrosis.