[{"orgOrder":0,"company":"Fresh Tracks Therapeutics","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Brickell Bio\u2019s Development Partner, Kaken Pharmaceutical, Submits New Drug Application for Sofpironium Bromide in Japan for Primary Axillary Hyperhidrosis","therapeuticArea":"Dermatology","highestDevelopmentStatus":"Phase III","country":"U.S.A","productType":"Small molecule","productStatus":"New Molecular Entity","date":"January 2020","url1":"","url2":"","graph1":"Dermatology","graph2":"Phase III"},{"orgOrder":0,"company":"Fresh Tracks Therapeutics","sponsor":"Bodor Laboratories","pharmaFlowCategory":"D","amount":"$3.5 million","upfrontCash":"$1.0 million","newsHeadline":"Brickell Biotech Announces Settlement of Dispute with Bodor Labs","therapeuticArea":"Dermatology","highestDevelopmentStatus":"Phase II","country":"U.S.A","productType":"Small molecule","productStatus":"New Molecular 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Portion of Phase 1 Study of DYRK1A Inhibitor FRTX-02","therapeuticArea":"Dermatology","highestDevelopmentStatus":"Phase I","country":"U.S.A","productType":"Small molecule","productStatus":"New Molecular Entity","date":"September 2022","url1":"","url2":"","graph1":"Dermatology","graph2":"Phase I"},{"orgOrder":0,"company":"Fresh Tracks Therapeutics","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Fresh Tracks Therapeutics Announces Publication of Preclinical Data for FRTX-02, a Potential First-in-Class Oral DYRK1A Inhibitor, in the Peer-Reviewed Journal of Translational Autoimmunity","therapeuticArea":"Dermatology","highestDevelopmentStatus":"Phase I","country":"U.S.A","productType":"Small molecule","productStatus":"New Molecular Entity","date":"January 2023","url1":"","url2":"","graph1":"Dermatology","graph2":"Phase I"},{"orgOrder":0,"company":"Fresh Tracks Therapeutics","sponsor":"Not 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2023","url1":"","url2":"","graph1":"Dermatology","graph2":"Phase III"}]
Find Clinical Drug Pipeline Developments & Deals by Fresh Tracks Therapeutics
Under the agreement, Fresh Tracks provided consulting services as an independent contractor to Botanix in support of and through filing and approval of the U.S. new drug application for BBI-4000 (sofpironium bromide gel).
FRTX-02 is a potential dual specificity tyrosine-phosphorylation-regulated kinase 1A inhibitor that aims to restore immune balance by modulating both adaptive and innate immune responses in patients with autoimmune and inflammatory diseases.
FRTX-02 is a highly selective, and orally bioavailable potential first-in-class dual specificity tyrosine-phosphorylation-regulated kinase 1A inhibitor that is currently being evaluated in Phase 1 clinical trial for atopic dermatitis and rheumatoid arthritis.
FRTX-02 is potent, highly selective, and orally bioavailable potential first-in-class DYRK1A inhibitor that aims to restore immune balance by modulating both adaptive and innate immune responses in patients with autoimmune and inflammatory diseases.
BBI-02 is a highly selective and orally bioavailable DYRK1A (dual specificity tyrosine-phosphorylation-regulated kinase 1A) inhibitor that has demonstrated promising results in various preclinical models, including atopic dermatitis and rheumatoid arthritis.
The results from the Cardigan I and Cardigan II studies, along with all previously completed clinical studies, will form the basis for a U.S. NDA for sofpironium bromide gel, 15%, which is expected to submit to the FDA in mid-2022.
Brickell Biotech completed patient enrollment in the Phase 3 pivotal Cardigan I study and that the Cardigan II study has surpassed 50% enrollment. Both studies are evaluating sofpironium bromide gel, 15% in patients with primary axillary (underarm) hyperhidrosis.
The ARGYLE study assessed the long-term safety and efficacy of topical, once-daily treatment with sofpironium bromide gel, 5% and 15% for 48 weeks in patients nine years and older with primary axillary hyperhidrosis/excessive underarm sweating.
First patient in its second U.S. pivotal Phase 3 clinical study (“Cardigan II study”) evaluating sofpironium bromide gel, 15% in approximately 350 subjects aged nine and older with primary axillary (underarm) hyperhidrosis.
The Cardigan I Study is a multicenter, randomized, double-blinded, vehicle (placebo)-controlled Phase 3 study to evaluate the safety and efficacy of topically applied sofpironium bromide gel, 15%.
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