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Therapeutics","amount2":0,"highestDevelopmentShortName":"Ph III","therapeuticAreaShortName":"Dermatology","amount2New":0,"dosageForm":"Topical gel","sponsorNew":"Fresh Tracks Therapeutics \/ Not Applicable","highestDevelopmentStatusID":"10","companyTruncated":"Fresh Tracks Therapeutics \/ Not Applicable"},{"orgOrder":0,"company":"Fresh Tracks Therapeutics","sponsor":"Kaken Pharmaceuticals","pharmaFlowCategory":"DU","therapeuticArea":"Dermatology","country":"","productType":"Small molecule","year":"2020","type":"Not Applicable","leadProduct":"Sofpironium Bromide","moa":"M3 receptor","graph1":"Dermatology","graph2":"Phase III","graph3":"Fresh Tracks Therapeutics","amount2":0,"highestDevelopmentShortName":"Ph III","therapeuticAreaShortName":"Dermatology","amount2New":0,"dosageForm":"Topical gel","sponsorNew":"Fresh Tracks Therapeutics \/ Kaken Pharmaceutical","highestDevelopmentStatusID":"10","companyTruncated":"Fresh Tracks Therapeutics \/ Kaken 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Wainwright & Co.","pharmaFlowCategory":"D","therapeuticArea":"Dermatology","country":"U.S.A","productType":"Small molecule","year":"2021","type":"Public Offering","leadProduct":"Sofpironium Bromide","moa":"M3 receptor","graph1":"Dermatology","graph2":"Phase III","graph3":"Brickell Biotech","amount2":0.01,"highestDevelopmentShortName":"Ph III","therapeuticAreaShortName":"Dermatology","amount2New":0.01,"dosageForm":"Topical gel","sponsorNew":"Brickell Biotech \/ H.C. Wainwright & Co.","highestDevelopmentStatusID":"10","companyTruncated":"Brickell Biotech \/ H.C. 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Find Clinical Drug Pipeline Developments & Deals for Sofpironium Bromide

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                          Therapeutic Area by Lead Product

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                          Top Deals by Deal Size (USD bn)

                          01

                          Medlab Asia & Asia Health
                          Not Confirmed
                          Medlab Asia & Asia Health
                          Not Confirmed

                          Details : Sofdra (sofpironium) works by inhibiting M3 muscarinic receptors in eccrine glands. It is approved for the treatment of primary axillary hyperhidrosis in patients ages 9 and older.

                          Brand Name : Sofdra

                          Molecule Type : Small molecule

                          Upfront Cash : Not Applicable

                          June 20, 2024

                          Lead Product(s) : Sofpironium Bromide

                          Therapeutic Area : Dermatology

                          Highest Development Status : Approved

                          Sponsor : Not Applicable

                          Deal Size : Not Applicable

                          Deal Type : Not Applicable

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                          02

                          Medlab Asia & Asia Health
                          Not Confirmed
                          Medlab Asia & Asia Health
                          Not Confirmed

                          Details : 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).

                          Brand Name : BBI-4000

                          Molecule Type : Small molecule

                          Upfront Cash : $8.2 million

                          July 21, 2023

                          Lead Product(s) : Sofpironium Bromide

                          Therapeutic Area : Dermatology

                          Highest Development Status : Phase III

                          Sponsor : Botanix Pharma

                          Deal Size : $8.2 million

                          Deal Type : Agreement

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                          03

                          Medlab Asia & Asia Health
                          Not Confirmed
                          Medlab Asia & Asia Health
                          Not Confirmed

                          Details : 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.

                          Brand Name : BBI-4000

                          Molecule Type : Small molecule

                          Upfront Cash : Not Applicable

                          October 07, 2021

                          Lead Product(s) : Sofpironium Bromide

                          Therapeutic Area : Dermatology

                          Highest Development Status : Phase III

                          Sponsor : Not Applicable

                          Deal Size : Not Applicable

                          Deal Type : Not Applicable

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                          04

                          Brickell Biotech

                          Country arrow
                          Medlab Asia & Asia Health
                          Not Confirmed

                          Brickell Biotech

                          Country arrow
                          Medlab Asia & Asia Health
                          Not Confirmed

                          Details : Sofpironium bromide is Brickell’s lead investigational product candidate and is a new chemical entity that belongs to a class of medications called anticholinergics.

                          Brand Name : BBI-4000

                          Molecule Type : Small molecule

                          Upfront Cash : Undisclosed

                          July 22, 2021

                          Lead Product(s) : Sofpironium Bromide

                          Therapeutic Area : Dermatology

                          Highest Development Status : Phase III

                          Sponsor : H.C. Wainwright & Co.

                          Deal Size : $8.0 million

                          Deal Type : Public Offering

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                          05

                          Medlab Asia & Asia Health
                          Not Confirmed
                          Medlab Asia & Asia Health
                          Not Confirmed

                          Details : 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) hyper...

                          Brand Name : BBI-4000

                          Molecule Type : Small molecule

                          Upfront Cash : Not Applicable

                          April 27, 2021

                          Lead Product(s) : Sofpironium Bromide

                          Therapeutic Area : Dermatology

                          Highest Development Status : Phase III

                          Sponsor : Not Applicable

                          Deal Size : Not Applicable

                          Deal Type : Not Applicable

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                          06

                          Medlab Asia & Asia Health
                          Not Confirmed
                          Medlab Asia & Asia Health
                          Not Confirmed

                          Details : 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.

                          Brand Name : BBI-4000

                          Molecule Type : Small molecule

                          Upfront Cash : Not Applicable

                          April 23, 2021

                          Lead Product(s) : Sofpironium Bromide

                          Therapeutic Area : Dermatology

                          Highest Development Status : Phase III

                          Sponsor : Not Applicable

                          Deal Size : Not Applicable

                          Deal Type : Not Applicable

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                          07

                          Medlab Asia & Asia Health
                          Not Confirmed
                          Medlab Asia & Asia Health
                          Not Confirmed

                          Details : 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.

                          Brand Name : Ecclock

                          Molecule Type : Small molecule

                          Upfront Cash : Not Applicable

                          December 07, 2020

                          Lead Product(s) : Sofpironium Bromide

                          Therapeutic Area : Dermatology

                          Highest Development Status : Phase III

                          Sponsor : Not Applicable

                          Deal Size : Not Applicable

                          Deal Type : Not Applicable

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                          08

                          Medlab Asia & Asia Health
                          Not Confirmed
                          Medlab Asia & Asia Health
                          Not Confirmed

                          Details : 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%.

                          Brand Name : BBI-4000

                          Molecule Type : Small molecule

                          Upfront Cash : Not Applicable

                          October 06, 2020

                          Lead Product(s) : Sofpironium Bromide

                          Therapeutic Area : Dermatology

                          Highest Development Status : Phase III

                          Sponsor : Not Applicable

                          Deal Size : Not Applicable

                          Deal Type : Not Applicable

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                          09

                          Medlab Asia & Asia Health
                          Not Confirmed
                          Medlab Asia & Asia Health
                          Not Confirmed

                          Details : Sofpironium bromide gel was deemed to be safe and well tolerated in this study, as well as in the accompanying 52-week long-term safety extension study in Japan. Japan is the first country to approve sofpironium bromide with commercial launch expected la...

                          Brand Name : Ecclock

                          Molecule Type : Small molecule

                          Upfront Cash : Not Applicable

                          September 25, 2020

                          Lead Product(s) : Sofpironium Bromide

                          Therapeutic Area : Dermatology

                          Highest Development Status : Approved

                          Sponsor : Fresh Tracks Therapeutics

                          Deal Size : Not Applicable

                          Deal Type : Not Applicable

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                          10

                          Medlab Asia & Asia Health
                          Not Confirmed
                          Medlab Asia & Asia Health
                          Not Confirmed

                          Details : Brickell and Kaken Pharmaceutical were granted by the Japanese Patent Office a composition of matter patent with claims directed to the novel polymorphic, or crystalline, forms of sofpironium bromide, a retrometabolically designed new chemical entity.

                          Brand Name : BBI-4000

                          Molecule Type : Small molecule

                          Upfront Cash : Not Applicable

                          August 31, 2020

                          Lead Product(s) : Sofpironium Bromide

                          Therapeutic Area : Dermatology

                          Highest Development Status : Phase III

                          Sponsor : Kaken Pharmaceuticals

                          Deal Size : Not Applicable

                          Deal Type : Not Applicable

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