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Label indication ARAZLO ® (tazarotene) lotion, 0.045% is indicated for the topical treatment of acne vulgaris in patients 9 years of age and older. ARAZLO is a retinoid indicated for the topical treatment of acne vulgaris in patients 9 years of age and older. ( 1 ) FDA label
Also known as Tazarotene (GRI-0621)
Tazarotene · 1 trial · 2 indications
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)
| Arm | Type | Description |
|---|---|---|
| GRI-0621 | EXPERIMENTAL | GRI-0621 (tazarotene) 4.5mg, administered orally once daily (QD) |
| Placebo | EXPERIMENTAL | Placebo 4.5mg, administered orally once daily (QD) |
| Name | Type | Description |
|---|---|---|
| Tazarotene (GRI-0621) | DRUG | Oral 4.5mg soft gel capsule |
| Placebo | DRUG | Oral 4.5mg soft gel capsule |
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 ...
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Tazarotene is being developed as an oral treatment for idiopathic pulmonary fibrosis, a progressive scarring disease of the lungs. In this program it is studied under the name GRI-0621. It is an investigational small molecule and is not approved for idiopathic pulmonary fibrosis.
Tazarotene targets the retinoic acid receptors RARA, RARB, and RARG, where it acts as an agonist. By activating these receptors, the drug is designed to modulate biomarkers and inhibit NKT1 cells, a mechanism being explored in idiopathic pulmonary fibrosis.
GRI Bio, Inc., which trades under the ticker GRI, is developing Tazarotene for idiopathic pulmonary fibrosis under the designation GRI-0621. The company is the sponsor of the clinical program evaluating the oral small molecule in this indication.
Tazarotene is in Phase 2 development for idiopathic pulmonary fibrosis as GRI-0621. The program's Phase 2 trial has been completed. The drug is investigational and has not been approved for idiopathic pulmonary fibrosis.
Tazarotene has been evaluated in the Phase 2 trial NCT06331624, titled Biomarker Modulation and the Inhibition of NKT1 Cells by Oral GRI-0621 in Patients With IPF. The completed trial enrolled 35 participants across the United States, Australia, and the United Kingdom.
Yes, GRI-0621 is the development name used by GRI Bio, Inc. for Tazarotene in idiopathic pulmonary fibrosis. Searches for either name refer to the same oral small molecule retinoic acid receptor agonist being studied in the Phase 2 IPF program.