Year
DEALS // DEV.
Country
Therapeutic Area
Study Phase
Deal Type
Product Type
Dosage Form
Lead Product
Target
Lead Product(s) : Sofpironium Bromide
Therapeutic Area : Dermatology
Study Phase : Approved
Sponsor : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
No sweat for dermatology specialist Botanix as hyperhidrosis gel Sofdra gains FDA approval
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
Lead Product(s) : Sofpironium Bromide
Therapeutic Area : Dermatology
Study Phase : Phase III
Sponsor : Botanix Pharma
Deal Size : $8.2 million
Deal Type : Agreement
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
Lead Product(s) : Sofpironium Bromide
Therapeutic Area : Dermatology
Study Phase : Phase III
Sponsor : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
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
Lead Product(s) : Sofpironium Bromide
Therapeutic Area : Dermatology
Study Phase : Phase III
Sponsor : H.C. Wainwright & Co.
Deal Size : $8.0 million
Deal Type : Public Offering
Brickell Biotech Closing of $8.05 Million Bought Deal Offering , Including Full Exercise
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
Lead Product(s) : Sofpironium Bromide
Therapeutic Area : Dermatology
Study Phase : Phase III
Sponsor : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
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
Lead Product(s) : Sofpironium Bromide
Therapeutic Area : Dermatology
Study Phase : Phase III
Sponsor : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
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
Lead Product(s) : Sofpironium Bromide
Therapeutic Area : Dermatology
Study Phase : Phase III
Sponsor : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
Brickell Biotech Doses First Patient in Second U.S. Pivotal Phase 3 Clinical Study
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
Lead Product(s) : Sofpironium Bromide
Therapeutic Area : Dermatology
Study Phase : Phase III
Sponsor : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
Brickell Biotech Announces Initiation of U.S. Phase 3 Program Evaluating Sofpironium Bromide Gel
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
Lead Product(s) : Sofpironium Bromide
Therapeutic Area : Dermatology
Study Phase : Approved
Sponsor : Fresh Tracks Therapeutics
Deal Size : Not Applicable
Deal Type : Not Applicable
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
Lead Product(s) : Sofpironium Bromide
Therapeutic Area : Dermatology
Study Phase : Phase III
Sponsor : Kaken Pharmaceuticals
Deal Size : Not Applicable
Deal Type : Not Applicable
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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