RARα agonists(Retinoic acid receptor alpha agonists), RARβ2 agonists(Retinoic acid receptor beta agonists), RARγ agonists(Retinoic acid receptor gamma agonists)

Therapeutic Areas

Immune System DiseasesSkin and Musculoskeletal DiseasesOther Diseases+ [1]

Active Indication

Facial wrinklesHyperpigmentationAcne Vulgaris+ [2]

Inactive Indication

Arthritis, PsoriaticChronic liver diseasePsoriasis of nail

Originator Organization

Allergan UC

Active Organization

Bausch Health, Canada, Inc.

Chongqing Huapont Pharmaceutical Co. Ltd.

GRI Bio Operations, Inc.

+ [3]

Inactive Organization

Almirall SA

Actavis, Inc.

Valeant Pharmaceuticals Australasia Pty Ltd.

License Organization

National Institute For Health & Care Research

Allergan plc

GRI Bio Operations, Inc.

+ [1]

Drug Highest PhaseApproved

First Approval Date

United States (13 Jun 1997),

Acne VulgarisPlaque psoriasis

Regulation-

Structure/Sequence

Molecular FormulaC21H21NO2S

InChIKeyOGQICQVSFDPSEI-UHFFFAOYSA-N

CAS Registry118292-40-3

Clinical Trials associated with Tazarotene

NCT06331624

/ RecruitingPhase 2

Biomarker Modulation and the Inhibition of Natural Killer Type 1 (NKT1) Cells by Oral GRI-0621 in Patients with Idiopathic Pulmonary Fibrosis (IPF)

This is a Phase 2a, randomized, double-blind, multi-center, placebo-controlled, parallel-design, 2-arm study. Approximately 36 subjects with IPF will be randomized in a 2:1 ratio for GRI-0621 4.5mg or Placebo. GRI-0621 dose of 4.5mg will be compared with placebo following once daily oral administration for 12 weeks.
Concurrently, a Sub-Study will be conducted, examining the number and activity of NKT cells in BAL, for up to 12 eligible subjects (across various centers).
An early-stage patient variability assessment will be completed when 12 subjects have completed 2 weeks of treatment. Followed by an interim analysis performed when 24 subjects complete 6 weeks of treatment.

Start Date24 Apr 2024

Sponsor / Collaborator

GRI Bio Operations, Inc.

CTRI/2023/11/060308

/ Not yet recruitingNot ApplicableIIT

Comparative efficacy of different concentration of topical tazarotene and topical tretinoin in acne vulgaris. - NIL

Start Date05 Dec 2023

Sponsor / Collaborator-

CTRI/2023/10/059038

/ RecruitingNot ApplicableIIT

Comparative efficacy of topical methotrexate and topical tazarotene in psoriasis vulgaris - NIL

Start Date31 Oct 2023

Sponsor / Collaborator

Government Medical College

100 Clinical Results associated with Tazarotene

100 Translational Medicine associated with Tazarotene

100 Patents (Medical) associated with Tazarotene

815

Literatures (Medical) associated with Tazarotene

01 Apr 2025·International Journal of Dermatology

One Acne™: A holistic management approach to improve overall skin quality and treatment outcomes in acne with or without sensitive skin

Review

Author: Beleznay, Katie ; Chavda, Rajeev ; Kircik, Leon ; Baldwin, Hilary ; Tan, Jerry ; Layton, Alison M. ; Brinkhuizen, Tjinta ; Lachmann, Nadège ; Lain, Edward (Ted)

AbstractAcne and sensitive skin can take a profound toll on patients' well‐being, which can be exacerbated if the conditions are experienced together. This narrative review aims to identify appropriate treatments to facilitate a holistic management approach to acne (One Acne™), sensitive skin, and acne‐induced sequelae and describe the role of treatments in improving skin quality. Topical retinoids are considered the preferred first‐line option for acne treatment by dermatologists, either as monotherapy or in combination with other treatments, because of their ability to target various aspects of the disease. Tretinoin, trifarotene, adapalene, and tazarotene have all been assessed in clinical studies for managing acne‐associated scarring, with varying success, with the latter three reported to improve skin quality. Moreover, some corrective procedures, e.g., injectable non‐animal stabilized hyaluronic acid (NASHA) fillers, have proven effective for treating acne scarring. Both treatment types may complement each other to provide optimal treatment outcomes and patient satisfaction, as observed in several patients receiving concomitant treatment with NASHA fillers/topical trifarotene. Adjunctive use of cleansers, moisturizers, and photoprotection‐containing ingredients such as vitamin B3, glycerin, or pro‐vitamin B3 may also complement drug/corrective treatments to reduce skin irritation and risk of scarring, as well as improve skin hydration, tone, and overall appearance. This narrative review highlights that comprehensive skincare regimens should be used throughout acne patients' journeys to reduce treatment‐related irritation, improve treatment outcomes, adherence, and satisfaction, and enhance overall skin quality. Patients with sensitive skin should choose tailored skincare products to maintain skin barrier integrity and restore skin function.

01 Apr 2025·Journal of the European Academy of Dermatology and Venereology

Efficacy of topical treatments for mild‐to‐moderate acne: A systematic review and meta‐analysis of randomized control trials

Review

Author: Kakpovbia, Efe E. ; Milam, Emily C. ; Troxel, Andrea B. ; Nagler, Arielle R. ; Hu, Jiyuan ; Nicholson, Joey ; Yassin, Sallie ; Young, Trevor ; Qian, Yingzhi

AbstractAcne is a common skin condition, but little data exist on the comparative efficacy of topical acne therapies. We conducted a systematic review and network meta‐analysis to evaluate the efficacy of topical therapies for mild‐to‐moderate acne. Searches in PubMed/MEDLINE, Cochrane CENTRAL via Ovid, Embase via Ovid and Web of Science were conducted on 29 November 2021. Randomized controlled trials examining ≥12 weeks of topical treatments for acne vulgaris in subjects aged 12 and older were included. Main outcomes were absolute or percent change in acne lesion count and treatment success on the Investigator's Global Assessment scale. Thirty‐five randomized clinical trials with 33,472 participants comparing nine different topical agents were included. Adapalene‐benzoyl peroxide (BPO), clindamycin‐BPO and clindamycin‐tretinoin demonstrated the greatest reduction in non‐inflammatory (ratio of means [RoM] 1.76; 95% CI [1.46; 2.12], RoM 1.70; 95% CI [1.44; 2.02] and RoM 1.87; 95% CI [1.53; 2.30], respectively), inflammatory (RoM 1.56; 95% CI [1.44; 1.70], RoM 1.49; 95% CI [1.39; 1.60] and RoM 1.48; 95% CI [1.36; 1.61], respectively) and total lesion count (ROM 1.67; 95% CI [1.47; 1.90], RoM 1.59; 95% CI [1.42; 1.79] and RoM 1.64; 95% CI [1.42; 1.89], respectively) compared to placebo. All single agents outperformed placebo except tazarotene, which did not significantly outperform placebo for inflammatory and non‐inflammatory lesion count reduction. Most combination agents significantly outperformed their individual components in lesion count reduction and global assessment scores, except for clindamycin‐tretinoin and clindamycin‐BPO, which did not significantly outperform tretinoin (RoM 1.13; 95% CI [0.94; 1.36]) and BPO (RoM = 1.15, 95% CI [0.98; 1.36]), respectively, for non‐inflammatory lesion reduction. There was no significant difference amongst most single agents when evaluating lesion count reduction. Combination agents are generally most effective for mild‐to‐moderate acne; however for non‐inflammatory acne, the addition of clindamycin in topical regimens is unnecessary and should be avoided.

01 Apr 2025·Clinical Therapeutics

A Canadian Real-World Study of Fixed-DOSE combination of Halobetasol Propionate 0.01%/Tazarotene 0.045% Lotion for the Treatment of Moderate-to-Severe Plaque Psoriasis

Article

Author: Hong, Hc-H ; Prajapati, V ; Zeinab, R ; Legault, M ; Vender, R ; Barakat, M ; Lynde, C

BACKGROUNDA fixed-dose combination of HP/TAZ has demonstrated efficacy with a favorable safety profile for treating moderate-to-severe plaque psoriasis.OBJECTIVEThe present single-arm, open-label study evaluated the use of HP/TAZ in real-world practice.METHODSAdults with moderate-to-severe psoriasis were enrolled and treated with HP/TAZ according to the Canadian label. The primary endpoint was the percentage of patients with treatment success at week 8, defined as an Investigator's Global Assessment score of clear or almost clear with a minimum 2-grade improvement.RESULTS202 patients received at least one dose of HP/TAZ, 138 patients had efficacy assessments at baseline and week 8. Treatment success was achieved by 26.1% and 43.5% of patients (week 4 and 8 respectively) . Patient-rated average and worst itch were 4.5 and 5.3 points at baseline, with a subsequent reduction to 1.7 and 2.1 points, respectively, at week 8. Patients were satisfied-very satisfied with the HP/TAZ. Application site reactions (13.4%) and dermatitis/eczema (3.5%) were the most frequently reported adverse events (mild-moderate in severity) .LIMITATIONSThe study design may limit generalizability of the results as an open label real world evidence study lacking a placebo or comparator arm.CONCLUSIONResults confirm that HP/TAZ can be beneficial moderate-to-severe psoriasis patients.

News (Medical) associated with Tazarotene

01 Apr 2025

·www.globenewswire.com

GRI Bio Reports Encouraging Interim 2-Week Safety Results from Ongoing Phase 2a Study of GRI-0621 in Idiopathic Pulmonary Fibrosis (“IPF”)

The Independent Data Monitoring Committee (IDMC) has recommended to continue study as planned as there are no safety concerns seen in the data reviewed Interim results demonstrate GRI-0621 to be safe and well-tolerated in the first 12 patients evaluated Interim biomarker data on track for Q2 2025 and topline results expected Q3 2025 Currently available treatments for IPF are limited to only two approved drugs that come with significant side-effects, limited patient compliance and no impact on survival LA JOLLA, CA, April 01, 2025 (GLOBE NEWSWIRE) -- GRI Bio, Inc. (NASDAQ: GRI) (“GRI Bio” or the “Company”), a biotechnology company advancing an innovative pipeline of Natural Killer T (“NKT”) cell modulators for the treatment of inflammatory, fibrotic and autoimmune diseases, today reported interim safety results from its ongoing Phase 2a study evaluating GRI-0621 for the treatment of Idiopathic Pulmonary Fibrosis (“IPF”). GRI-0621, is the Company’s small molecule RAR-βɣ dual agonist that inhibits the activity of human Type 1 Invariant NKT (“iNKT”) cells. In preliminary clinical trials to date and previous clinical trials with the oral formulation, GRI-0621 has been shown to improve fibrosis in multiple disease models and improve liver function tests and other markers of inflammation and injury in patients. The pre-planned interim analysis for 2-week safety results from the ongoing Phase 2a biomarker study demonstrated GRI-0621 (4.5mg orally once daily) to be safe and well-tolerated in the first 12 patients evaluated per protocol. Hyperlipidemia, as assessed by LDL, HDL and triglyceride (TG) levels, was not seen in the 12 patients assessed at the 2-week visit. There were no meaningful changes in HDL, LDL or TG levels in patients receiving GRI-0621, and all subjects remained within normal ranges. The interim analysis committee recommended the study should continue as planned. The interim results show that GRI-0621’s receptor selectivity is consistent with the toxicity profile observed in earlier studies evaluating oral tazarotene in over 1,700 patients treated for up to 52 weeks. Marc Hertz, PhD, Chief Executive Officer of GRI Bio commented, “While preliminary, in the first 12 subjects evaluated these results are encouraging and in line with our expectations. We believe these results, particularly the safety data, underscore GRI-0621’s potential to provide a much needed safe and effective treatment option for the treatment of IPF, where there remains significant unmet need. The two ant-fibrotic drugs currently approved for the treatment of IPF can slow the decline of lung function but are not curative, do not improve overall survival, and both come with significant side effects which limit their use. Based on the trends seen in these interim results, as well as the consistent toxicity profile with tazarotene, we believe GRI-0621 will continue to demonstrate that the molecule is safe and inhibits NKT cell activity in this patient population, providing much needed benefit to patients. Our team remains focused on driving enrollment and treatment in the study and we look forward to reporting topline data in the third quarter of 2025.” The Phase 2a, randomized, double-blind, multi-center, placebo-controlled, parallel-design, 2-arm study will enroll approximately 36 subjects with IPF whom will be randomized in a 2:1 ratio for GRI-0621 4.5mg or a placebo. GRI-0621 dose of 4.5mg will be compared with a dose of placebo following once daily oral administration for 12 weeks. Concurrently, a sub-study will examine the number and activity of NKT cells in bronchoalveolar lavage (“BAL”) fluid for up to 12 eligible subjects (across various centers). An interim analysis will be performed when 24 subjects (of which approximately 8 will be placebo subjects) complete 6 weeks of treatment. The primary endpoint for the study is safety and tolerability of oral GRI-0621 as assessed by clinical labs, vital signs and adverse events after 12 weeks of treatment. Secondary endpoints are baseline changes in serum biomarkers collected at week 6 and week 12; an assessment of the pharmacokinetics (PK) of GRI-0621 at the week 12 visit of treatment (steady state); and a determination of the pharmacodynamic activity of oral GRI-0621 as measured by inhibition of iNKT cell activation in blood after 6 weeks and 12 weeks, and from BAL fluid after 12 weeks of treatment in a sub-study. Additional exploratory endpoints for the study are to assess the effect of GRI-0621 on pulmonary function at baseline and after 6 weeks and 12 weeks of treatment and flow cytometry and differential gene expression at various time points. The Company expects to report interim biomarker data in Q2 2025. Topline results from the Phase 2a biomarker study are expected in the third quarter of 2025. For more information about the Phase 2a study, please visit clinicaltrials.gov and reference identifier NCT06331624. About GRI Bio, Inc. GRI Bio is a clinical-stage biopharmaceutical company focused on fundamentally changing the way inflammatory, fibrotic and autoimmune diseases are treated. GRI Bio’s therapies are designed to target the activity of Natural Killer T (“NKT”) cells, which are key regulators earlier in the inflammatory cascade, to interrupt disease progression and restore the immune system to homeostasis. NKT cells are innate-like T cells that share properties of both NK and T cells and are a functional link between the innate and adaptive immune responses. Type I invariant NKT (“iNKT”) cells play a critical role in propagating the injury, inflammatory response, and fibrosis observed in inflammatory and fibrotic indications. GRI Bio’s lead program, GRI-0621, is an inhibitor of iNKT cell activity and is being developed as a novel oral therapeutic for the treatment of idiopathic pulmonary fibrosis, a serious disease with significant unmet need. The Company is also developing a pipeline of novel type 2 diverse NKT (“dNKT”) agonists for the treatment of systemic lupus erythematosus. Additionally, with a library of over 500 proprietary compounds, GRI Bio has the ability to fuel a growing pipeline. Forward-Looking Statements This press release contains “forward-looking statements” within the meaning of the “safe harbor” provisions of the Private Securities Litigation Reform Act of 1995. Forward-looking statements may be identified by the use of words such as “anticipate,” “believe,” “contemplate,” “could,” “estimate,” “expect,” “intend,” “seek,” “may,” “might,” “plan,” “potential,” “predict,” “project,” “target,” “aim,” “should,” “will,” “would,” or the negative of these words or other similar expressions. These forward-looking statements are based on the Company’s current beliefs and expectations. Forward-looking statements include, but are not limited to, statements regarding: the Company’s expectations with respect to development and commercialization of the Company’s product candidates, the timing of initiation or completion of clinical trials and availability of resulting data, the potential benefits and impact of the Company’s clinical trials and product candidates and any implication that the data or results observed in preclinical trials or earlier studies or trials will be indicative of results of later studies or clinical trials, the Company’s beliefs and expectations regarding potential shareholder value and future financial performance, the Company’s beliefs and estimates about its cash and available resources and its ability to fund its planned operations through any particular date, the Company’s beliefs about the timing and outcome of regulatory approvals and potential regulatory approval pathways, the Company’s expected milestones in 2025, and the Company’s beliefs and expectations regarding the sufficiency of its existing cash and cash equivalents to fund its planned operations, its ability to raise additional funds, which may not be available to the Company on acceptable terms, or at all, and capital expenditure requirements. Actual results may differ from the forward-looking statements expressed by the Company in this press release and consequently, you should not rely on these forward-looking statements as predictions of future events. These forward-looking statements are subject to inherent uncertainties, risks and assumptions that are difficult to predict, including, without limitation: (1) the inability to maintain the listing of the Company’s common stock on The Nasdaq Capital Market and to comply with applicable listing requirements; (2) changes in applicable laws or regulations; (3) the inability of the Company to raise financing in the future; (4) the success, cost and timing of the Company’s product development activities; (5) the inability of the Company to obtain and maintain regulatory clearance or approval for its respective products, and any related restrictions and limitations of any cleared or approved product; (6) the inability of the Company to identify, in-license or acquire additional technology; (7) the inability of the Company to compete with other companies currently marketing or engaged in the development of products and services that the Company is currently developing; (8) the size and growth potential of the markets for the Company’s products and services, and their respective ability to serve those markets, either alone or in partnership with others; (9) the failure to achieve any milestones or receive any milestone payments under any agreements; (10) inaccuracy in the Company’s estimates regarding expenses, future revenue, capital requirements and needs for and the ability to obtain additional financing; (11) the Company’s ability to protect and enforce its intellectual property portfolio, including any newly issued patents; and (12) other risks and uncertainties indicated from time to time in the Company’s filings with the U.S. Securities and Exchange Commission (the “SEC”), including the risks and uncertainties described in the “Risk Factors” section of the Company’s most recent Annual Report on Form 10-K filed with the SEC on March 14, 2025 and subsequently filed reports. In particular, the data discussed in this release is interim data and additional study and additional favorable results will be needed for development of GRI-0621 to continue; this interim data may not be indicative of later or final data for this trial. Forward-looking statements contained in this announcement are made as of this date, and the Company undertakes no duty to update such information except as required under applicable law. Investor Contact:JTC Team, LLCJenene Thomas(908) 824-0775GRI@jtcir.com

Phase 2Clinical ResultCell TherapyPhase 1Immunotherapy

31 Mar 2025

·www.globenewswire.com

GRI Bio Bolsters Intellectual Property Portfolio with Granting of Two Global Patents for Europe and Japan

Company committed to building a robust global patent estate across its innovative pipeline of NKT cell modulators for the treatment of inflammatory, fibrotic and autoimmune diseases LA JOLLA, CA, March 31, 2025 (GLOBE NEWSWIRE) -- GRI Bio, Inc. (NASDAQ: GRI) (“GRI Bio” or the “Company”), a biotechnology company advancing an innovative pipeline of Natural Killer T (“NKT”) cell modulators for the treatment of inflammatory, fibrotic and autoimmune diseases, today announced the granting of two global patents. The granted patents include: Europe patent application No. 19,166,502 titled, “Oxygenated Amino- or Ammonium-Containing Sulfonic Acid, Phosphonic Acid and Carboxylic Acid Derivatives and Their Medical Use.” The patent claims include coverage of GRI-0803, the Company’s novel activator of human type 2 diverse NKT (dNKT) cells in development for the treatment of autoimmune disorders, with an initial focus on systemic lupus erythematosus (SLE). Activation of dNKT leads to a dendritic cell-mediated inhibition of type 1 invariant NKT (iNKT) cells.Japan application No. 2023-000750 titled, “Prevention and Treatment of Inflammatory Conditions.” This patent covers claims including compositions and methods for modulating dNKT and/or iNKT cells in the prevention and treatment of inflammatory conditions. More specifically, the patent covers the prevention and treatment of inflammatory, fibrotic and autoimmune conditions through the administration of a Retinoic Acid Receptor (RAR) agonist that inhibits iNKT cells in a subject. “These granted patents represent another achievement in our initiative to bolster our global patent estate. We remain committed to expanding our intellectual property portfolio and strengthening our innovative pipeline of NKT cell modulators and library of over 500 proprietary compounds,” commented Marc Hertz, PhD, Chief Executive Officer of GRI Bio. “We believe our in highly differentiated approach to the prevention and treatment of inflammatory, fibrotic and autoimmune diseases represents a compelling opportunity to address unmet medical needs for patients.” The Company is currently advancing the development of its lead program, GRI-0621, in a Phase 2a, randomized, double-blind, multi-center, placebo-controlled, parallel-design, 2-arm study for the treatment of IPF. Interim data from the Phase 2a biomarker study is expected in the second quarter of 2025 and topline results are expected in the third quarter of 2025. For more information about the Phase 2a study, please visit clinicaltrials.gov and reference identifier NCT06331624. About GRI Bio, Inc. GRI Bio is a clinical-stage biopharmaceutical company focused on fundamentally changing the way inflammatory, fibrotic and autoimmune diseases are treated. GRI Bio’s therapies are designed to target the activity of Natural Killer T (“NKT”) cells, which are key regulators earlier in the inflammatory cascade, to interrupt disease progression and restore the immune system to homeostasis. NKT cells are innate-like T cells that share properties of both NK and T cells and are a functional link between the innate and adaptive immune responses. Type I invariant NKT (“iNKT”) cells play a critical role in propagating the injury, inflammatory response, and fibrosis observed in inflammatory and fibrotic indications. GRI Bio’s lead program, GRI-0621, is an inhibitor of iNKT cell activity and is being developed as a novel oral therapeutic for the treatment of idiopathic pulmonary fibrosis, a serious disease with significant unmet need. The Company is also developing a pipeline of novel type 2 diverse NKT (“dNKT”) agonists for the treatment of systemic lupus erythematosus. Additionally, with a library of over 500 proprietary compounds, GRI Bio has the ability to fuel a growing pipeline. Forward-Looking Statements This press release contains “forward-looking statements” within the meaning of the “safe harbor” provisions of the Private Securities Litigation Reform Act of 1995. Forward-looking statements may be identified by the use of words such as “anticipate,” “believe,” “contemplate,” “could,” “estimate,” “expect,” “intend,” “seek,” “may,” “might,” “plan,” “potential,” “predict,” “project,” “target,” “aim,” “should,” “will,” “would,” or the negative of these words or other similar expressions. These forward-looking statements are based on the Company’s current beliefs and expectations. Forward-looking statements include, but are not limited to, statements regarding: the Company’s expectations with respect to development and commercialization of the Company’s product candidates, the timing of initiation or completion of clinical trials and availability of resulting data, the potential benefits and impact of the Company’s clinical trials and product candidates and any implication that the data or results observed in preclinical trials or earlier studies or trials will be indicative of results of later studies or clinical trials, the Company’s beliefs and expectations regarding potential shareholder value and future financial performance, the Company’s beliefs and estimates about its cash and available resources and its ability to fund its planned operations through any particular date, the Company’s beliefs about the timing and outcome of regulatory approvals and potential regulatory approval pathways, the Company’s expected milestones in 2025, and the Company’s beliefs and expectations regarding the sufficiency of its existing cash and cash equivalents to fund its planned operations, its ability to raise additional funds, which may not be available to the Company on acceptable terms, or at all, and capital expenditure requirements. Actual results may differ from the forward-looking statements expressed by the Company in this press release and consequently, you should not rely on these forward-looking statements as predictions of future events. These forward-looking statements are subject to inherent uncertainties, risks and assumptions that are difficult to predict, including, without limitation: (1) the inability to maintain the listing of the Company’s common stock on The Nasdaq Capital Market and to comply with applicable listing requirements; (2) changes in applicable laws or regulations; (3) the inability of the Company to raise financing in the future; (4) the success, cost and timing of the Company’s product development activities; (5) the inability of the Company to obtain and maintain regulatory clearance or approval for its respective products, and any related restrictions and limitations of any cleared or approved product; (6) the inability of the Company to identify, in-license or acquire additional technology; (7) the inability of the Company to compete with other companies currently marketing or engaged in the development of products and services that the Company is currently developing; (8) the size and growth potential of the markets for the Company’s products and services, and their respective ability to serve those markets, either alone or in partnership with others; (9) the failure to achieve any milestones or receive any milestone payments under any agreements; (10) inaccuracy in the Company’s estimates regarding expenses, future revenue, capital requirements and needs for and the ability to obtain additional financing; (11) the Company’s ability to protect and enforce its intellectual property portfolio, including any newly issued patents; and (12) other risks and uncertainties indicated from time to time in the Company’s filings with the U.S. Securities and Exchange Commission (the “SEC”), including the risks and uncertainties described in the “Risk Factors” section of the Company’s most recent Annual Report on Form 10-K filed with the SEC on March 14, 2025 and subsequently filed reports. Forward-looking statements contained in this announcement are made as of this date, and the Company undertakes no duty to update such information except as required under applicable law. Investor Contact:JTC Team, LLCJenene Thomas(908) 824-0775GRI@jtcir.com

Phase 2Cell TherapyImmunotherapyPhase 1

18 Mar 2025

·www.globenewswire.com

GRI Bio Participates in a Virtual Investor CEO Connect Segment

Access the CEO Connect segment here LA JOLLA, CA, March 18, 2025 (GLOBE NEWSWIRE) -- GRI Bio, Inc. (NASDAQ: GRI) (“GRI Bio” or the “Company”), a biotechnology company advancing an innovative pipeline of Natural Killer T (“NKT”) cell modulators for the treatment of inflammatory, fibrotic and autoimmune diseases, today announced that Marc Hertz, President and CEO of GRI Bio participated in a Virtual Investor CEO Connect segment. As part of this segment, Dr. Hertz provided an overview of GRI’s lead program, GRI-0621, for Idiopathic Pulmonary Fibrosis (IPF), a rare chronic, progressive fibrosing interstitial lung disease with limited treatment options. Dr. Hertz highlighted near-term value driving milestones, such as interim data coming at the beginning of next quarter and topline data in the following quarter. The Virtual Investor CEO Connect featuring GRI Bio is now available here. Additional videos from the “What This Means” series are available on demand at https://virtualinvestorco.com/gri/. About GRI Bio, Inc. GRI Bio is a clinical-stage biopharmaceutical company focused on fundamentally changing the way inflammatory, fibrotic and autoimmune diseases are treated. GRI Bio’s therapies are designed to target the activity of Natural Killer T (“NKT”) cells, which are key regulators earlier in the inflammatory cascade, to interrupt disease progression and restore the immune system to homeostasis. NKT cells are innate-like T cells that share properties of both NK and T cells and are a functional link between the innate and adaptive immune responses. Type I invariant NKT (“iNKT”) cells play a critical role in propagating the injury, inflammatory response, and fibrosis observed in inflammatory and fibrotic indications. GRI Bio’s lead program, GRI-0621, is an inhibitor of iNKT cell activity and is being developed as a novel oral therapeutic for the treatment of idiopathic pulmonary fibrosis, a serious disease with significant unmet need. The Company is also developing a pipeline of novel type 2 diverse NKT (“dNKT”) agonists for the treatment of systemic lupus erythematosus. Additionally, with a library of over 500 proprietary compounds, GRI Bio has the ability to fuel a growing pipeline. Forward Looking Statements This press release contains “forward-looking statements” within the meaning of the “safe harbor” provisions of the Private Securities Litigation Reform Act of 1995. Forward-looking statements may be identified by the use of words such as “anticipate,” “believe,” “contemplate,” “could,” “estimate,” “expect,” “intend,” “seek,” “may,” “might,” “plan,” “potential,” “predict,” “project,” “target,” “aim,” “should,” “will,” “would,” or the negative of these words or other similar expressions. These forward-looking statements are based on the Company’s current beliefs and expectations. Forward-looking statements include, but are not limited to, statements regarding: the timing and effectiveness of the Reverse Split; the Company’s ability to regain compliance with the Nasdaq minimum bid price and other listing requirements; the Company’s expectations with respect to development and commercialization of the Company’s product candidates; the timing of initiation or completion of clinical trials and availability of resulting data, the potential benefits and impact of the Company’s clinical trials and product candidates and any implication that the data or results observed in preclinical trials or earlier studies or trials will be indicative of results of later studies or clinical trials. Actual results may differ from the forward-looking statements expressed by the Company in this press release and consequently, you should not rely on these forward-looking statements as predictions of future events. These forward-looking statements are subject to inherent uncertainties, risks and assumptions that are difficult to predict, including, without limitation: (1) the inability to maintain the listing of the Company’s common stock on Nasdaq and to comply with applicable listing requirements; (2) changes in applicable laws or regulations; (3) the inability of the Company to raise financing in the future; (4) the success, cost and timing of the Company’s product development activities; (5) the inability of the Company to obtain and maintain regulatory clearance or approval for its respective products, and any related restrictions and limitations of any cleared or approved product; (6) the inability of the Company to identify, in-license or acquire additional technology; (7) the inability of the Company to compete with other companies currently marketing or engaged in the development of products and services that the Company is currently developing; (8) the size and growth potential of the markets for the Company’s products and services, and their respective ability to serve those markets, either alone or in partnership with others; (9) the failure to achieve any milestones or receive any milestone payments under any agreements; (10) inaccuracy in the Company’s estimates regarding expenses, future revenue, capital requirements and needs for and the ability to obtain additional financing; (11) the Company’s ability to protect and enforce its intellectual property portfolio, including any newly issued patents; and (12) other risks and uncertainties indicated from time to time in the Company’s filings with the U.S. Securities and Exchange Commission (the “SEC”), including the risks and uncertainties described in the “Risk Factors” section of the Company’s most recent Annual Report on Form 10-K filed with the SEC on March 28, 2024 and subsequently filed reports. Forward-looking statements contained in this announcement are made as of this date, and the Company undertakes no duty to update such information except as required under applicable law. Investor Contact: JTC Team, LLCJenene Thomas(908) 824-0775GRI@jtcir.com

Cell TherapyImmunotherapy

100 Deals associated with Tazarotene

External Link

KEGG	Wiki	ATC	Drug Bank
D01132	Tazarotene	D05AX05	DB00799

R&D Status

Approved

10 top approved records.

to view more data

Indication	Country/Location	Organization	Date
Facial wrinkles	United States	Allergan, Inc.	30 Sep 2002
Hyperpigmentation	United States	Allergan, Inc.	30 Sep 2002
Acne Vulgaris	United States	Allergan, Inc.	13 Jun 1997
Plaque psoriasis	United States	Allergan, Inc.	13 Jun 1997

Developing

10 top R&D records.

to view more data

Indication	Highest Phase	Country/Location	Organization	Date
Idiopathic Pulmonary Fibrosis	Phase 2	Australia	GRI Bio Operations, Inc.	24 Apr 2024
Idiopathic Pulmonary Fibrosis	Phase 2	United Kingdom	GRI Bio Operations, Inc.	24 Apr 2024
Idiopathic Pulmonary Fibrosis	Phase 2	United States	GRI Bio Operations, Inc.	24 Apr 2024
Chronic liver disease	Phase 1	South Africa	GRI Bio Operations, Inc.	01 Sep 2015
Acne Vulgaris	Preclinical	Belize	Actavis, Inc.	01 Jun 2014
Arthritis, Psoriatic	Preclinical	Germany	Almirall SA	01 Feb 2014
Psoriasis of nail	Preclinical	Germany	Almirall SA	01 Feb 2014

Clinical Result

Indication

Phase

Evaluation

View All Results

Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT04071756 (CTgov)	Phase 2	Solid tumor \| Hand-Foot Syndrome	8	Topical Tazarotene (Topical Tazarotene 0.1% Gel Plus BPS)	zoopvqupdz(knyeghjehb) = idfqrkkuzc nobwgrtthi (coieiwnkcx, tgzvzlqkdv - pwtclhyntc) View more	-	15 Nov 2023
				Placebo (Placebo Gel Plus BPS)	zoopvqupdz(knyeghjehb) = cfgtenryhu nobwgrtthi (coieiwnkcx, yopfaflzoq - ezapsidkyp) View more
WCD2023	Not Applicable	Onychomycosis	20	Topical 0.1% tazarotene gel	kkualjvpoo(vjvryazawz) = xgyzkycukv encdbubybj (andyaedvcd )	Positive	07 Jul 2023
AAD2023	Not Applicable	Photodamaged skin	18	Tazarotene 0.045% Lotion	ofrouejsvf(sukxgkupwv) = ewywpmfscj bzbzwecxkm (jegukcldkr )	-	17 Mar 2023
AAD2023	Not Applicable	Psoriasis interleukin 17A	10	Fixed-Combination Halobetasol Propionate and Tazarotene Topical Lotion	qwwjwmhkub(pyweofdsmw) = umzxnenzvk ivfaorrzxu (mlwvobvptr )	-	17 Mar 2023
EADV2022	Not Applicable	Plaque psoriasis	-	Calcipotriol 0.005% plus betamethasone dipropionate 0.064% foam	lrkdrrrxbs(rxfjtubrji) = 0.8%/0.1% vs 7.4% shxjvgnjus (htujgolquu ) View more	-	12 May 2022
				Halobetasol propionate 0.01% plus tazarotene 0.045% lotion
NCT03168321 (CTgov)	Phase 3	Acne Vulgaris	813	IDP-123 Lotion	(xxffpdvwby) = lhbukmobgi zvisftlxpp (kdstpbbcye, gqbdjcjman - jrdqwdeduw) View more	-	01 Apr 2021
NCT03599193 (CTgov)	Phase 2	Acne Vulgaris	58	Tazarotene Lotion, 0.1% (DFD-03 Lotion)	(yteggydqff) = gvceqzlqdv ezpteppuvz (akmpreamzg, yfwbkfzchf - exrzzqbtew) View more	-	14 Sep 2020
				Tazarotene Cream, 0.1% (Tazorac Cream)	(yteggydqff) = jhovcxlkfm ezpteppuvz (akmpreamzg, zepdbajtcl - jccvfkzmse) View more
NCT03292640 (CTgov)	Phase 3	Acne Vulgaris	547	DFD-03 (0.1% tazarotene) Lotion (DFD-03 Lotion (0.1% Tazarotene))	fyxjmtcqgz(xkjrscvbmg) = nbrbbmkcgx kzqcmkcqdk (stvrkddcft, fgeboyugjl - mdvsensfaa) View more	-	09 Jun 2020
				DFD-03 (0% tazarotene) Lotion (Placebo) (DFD-03 Vehicle (0% Tazarotene))	fyxjmtcqgz(xkjrscvbmg) = xyjxhungzy kzqcmkcqdk (stvrkddcft, xrlurnhmbu - zoswutnipm) View more
NCT03290027 (DFD-03, CTgov)	Phase 3	Acne Vulgaris	550	DFD-03 (Active)	vtkyymrxig(dxbhmbwkbx) = rsuoaiisez jhsvlhfcjw (yuejadpwbt, mkmpufhghe - xutjkwqfqe) View more	-	26 May 2020
				Placebo Comparator (Vehicle)	vtkyymrxig(dxbhmbwkbx) = cdksrzyptj jhsvlhfcjw (yuejadpwbt, atziicjeah - njbvjdzohf) View more
NCT02886702 (CTgov)	Phase 3	Plaque psoriasis	855	Tazarotene Cream 0.05% (Test)	dqrnpiljyt(hafckvquhl) = aphrhfvpvq qryfnmfyfn (xgucithedn, sxbfjyhhxl - ihmmdbkwyq) View more	-	29 Aug 2018
				TAZORAC® (tazarotene) Cream 0.05% (Reference)	dqrnpiljyt(hafckvquhl) = sbhidmtpzr qryfnmfyfn (xgucithedn, furmvwacnu - qsmtcqqauu) View more

Translational Medicine

Boost your research with our translational medicine data.

view full example data

Deal

Boost your decision using our deal data.

view full example data

Core Patent

Boost your research with our Core Patent data.

view full example data

Clinical Trial

Identify the latest clinical trials across global registries.

view full example data

Approval

Accelerate your research with the latest regulatory approval information.

view full example data

Regulation

Understand key drug designations in just a few clicks with Synapse.

view full example data

Chat with Hiro

Get started for free today!

Accelerate Strategic R&D decision making with Synapse, PatSnap’s AI-powered Connected Innovation Intelligence Platform Built for Life Sciences Professionals.

Start your data trial now!

Synapse data is also accessible to external entities via APIs or data packages. Empower better decisions with the latest in pharmaceutical intelligence.

Bio

Bio Sequences Search & Analysis

Chemical

Chemical Structures Search & Analysis

Tazarotene

Overview

Basic Info

Structure/Sequence

Related

External Link

R&D Status

Clinical Result

Translational Medicine

Deal

Core Patent

Clinical Trial

Approval

Regulation