June 25, 2024: Bodor Laboratories Inc. Announces FDA Approval of SofdraTM for primary axillary hyperhidrosis.
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April 3, 2024: Bodor Laboratories Inc. Announces Leadership Evolution with Erik Bodor as CEO and Highlights Milestones in Sofpironium Bromide Development.
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June 4, 2023: Bodor Laboratories’ Licensee Botanix Pharmaceuticals secures new sublicense and distribution agreement for Sofpironium Bromide in Korea through its partner Kaken Pharmaceutical Co., Ltd. (Japan).
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April 3, 2023: The U.S. Food and Drug Administration (FDA) conducts the mid-cycle review meeting for Sofpironium Bromide, with no major clinical safety issues, no risk management issues or advisory board requirements identified.
December 27, 2022: Dr. Nicholas Bodor awarded U.S. Patent 11,534,422, “Methods and Compositions for Soft Anticholinergic Esters” for treatment of sialorrhea. European counterpart Patent No. 3347007 issued March 29, 2023.
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December 8, 2022: Bodor Laboratories’ Licensee Botanix Pharmaceuticals receives notice from the U.S. Food and Drug Administration (FDA) that their New Drug Application (NDA) for Sofpironium Bromide is now under formal review.
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September 26, 2022: Bodor Laboratories’ Licensee Botanix Pharmaceuticals submits the New Drug Application (NDA) for Sofpironium Bromide with the U.S. Food and Drug Administration (FDA), for treatment of Hyperhidrosis; approval anticipated for Fall 2023.
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September 20, 2022: Dr. Nicholas Bodor awarded U.S. Patent 11,447,522, “Potent Soft Anti-Inflammatory Corticosteroid Compounds and Uses Thereof” for treatment of a wide variety of disease states.
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May 3, 2022: Bodor Laboratories’ Licensee Brickell BioTech sells its Sofpironium Bromide license for Hyperhidrosis to Botanix Pharmaceuticals.
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November 22, 2021: Dr. Nicholas Bodor awarded Japan Patent 6981694, and also Japan Patent 6968457 on October 29, 2021, both for treatment of Myopia.
October 7, 2021: Bodor Laboratories’ Licensee Brickell BioTech announces positive topline results from its pivotal Phase 3 clinical “Cardigan I” and “Cardigan II” studies of Sofpironium Bromide Gel 15%, demonstrating its potential as a best-in-class treatment for Primary Axillary Hyperhidrosis.
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September 21, 2021: Dr. Nicholas Bodor et. al., awarded U.S. Patent 11,123,325; also U.S. Patent 11,084,788 on August 10, 2021; U.S. Patent 11,052,067 on July 6, 2021; U.S. Patent 11,034,652 on June 15, 2021 and U.S. Patent 11,026,919 on June 8, 2021. All are continuation patents titled, “Formulation for Soft Anticholinergic Analogs,” to be used to bring a product to market in the U.S. by its licenses to treat Primary Axillary Hyperhidrosis.
June 1, 2021: Bodor Laboratories’ Licensee Brickell BioTech announces publication of Japan Phase 3 Long-Term Safety and Efficacy Study Results for Sofpironium Bormide Gel 15% (ECCLOCK®) in the Journal of Dermatology, available at: https://onlinelibrary.wiley.com/doi/10.1111/1346-8138.15927?af=R.
April 23, 2021: Bodor Laboratories’ Licensee Brickell BioTech reports positive results from U.S. Phase 3 open-label, long-term safety study on chronic use of Sofpironium Bromide Gel as potential treatment for primary axillary hyperhidrosis. Daily treatment with Sofpironium Bromide gel was generally well-tolerated and showed a clinically meaningful and sustained improvement in sweat severity through 48 weeks of treatment.
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March 30, 2021: Dr. Nicholas Bodor et. al., awarded U.S. Patents 10,961,191 and 10,959,983; also U.S. Patent 10,952,990 on March 23, 2021; and U.S. Patent 10,947,192 on March 16, 2021. All are continuation patents titled, “Formulation for Soft Anticholinergic Analogs,” to be used to bring a product to market in the U.S. by its licenses to treat Primary Axillary Hyperhidrosis.
January 19, 2021: Bodor Laboratories’ Licensee Brickell BioTech announces publication of Japan pivotal Phase 3 study results for Sofpironium Gel 5% (ECCLOCK®) in the Journal of Dermatology, available at: https://onlinelibrary.wiley.com/doi/10.1111/1346-8138.15668. The commercialization of ECCLOCK® in Japan continues by sublicensee KAKEN Pharmaceutical Co., Ltd. as a potential best-in-class treatment for patients with Primary Axillary Hyperhidrosis.
November 26, 2020: Bodor Laboratories’ Sublicensee Kaken Pharmaceuticals Co., Ltd. launches sales of ECCLOCK® (Sofpironium Bromide) in Japan for treatment of primary axillary (underarm) hyperhidrosis. The product is listed on the National Health Insurance (NHI) Drug Reimbursement Pricelist in Japan as of November 18, 2020
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September 25, 2020: Sofpironium Bromide Gel 5% for treatment of primary axillary hyperhidrosis is approved for sale in Japan; approval received by Bodor Laboratories Sublicensee KAKEN Pharmaceutical Co., Ltd.
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August 17, 2020: Dr. Nicholas Bodor is awarded Japan Patent 6750900, and also Japan Patent 6732356 on July 10, 2020. Both patents, titled, “Use of Selected Anticholinergic Zwitterions” are for treatment of Myopia.
June 15, 2020: Positive Confirmatory Phase 3 study results with Sofpironium Bromide for the topical treatment of primary axillary hyperhidrosis were presented at both the 119th Annual Meeting of the Japanese Dermatological Association and also at the 2020 Annual Meeting of the American Academy of Dermatology in June 2020, as announced by Bodor Laboratories’ sublicensee KAKEN Pharmaceutical Co., Ltd.
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April 28, 2020: Dr. Nicholas Bodor is awarded U.S. Patent 10,632,067 titled, “Use of Selected Anticholinergic Zwitterions,” for use in treatment of Myopia.
April 20, 2020: Dr. Nicholas Bodor is elected to the Academy of Science, Engineering and Medicine of Florida (ASEMFL) inaugural membership class “…for inventing unique retrometabolic drug design/targeting concepts, leading to numerous safe and effective drugs, positively impacting millions globally.”
March 24, 2020: Positive Phase III pivotal study results of Sofpironium Bromide in Japanese patients with Primary Axillary Hyperhidrosis were presented at the Late-Breaking Research Program during the American Academy of Dermatology Annual Meeting held March 20-24, 2020 in Denver, CO
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March 5, 2020: Dr. Nicholas Bodor is elected as a 2020 inductee to the Florida Inventors Hall of Fame; https://floridainvents.org/nicholas-bodor/. Dr. Bodor is also a 2012 inductee of the American Chemical Society Hall of Fame, Medicinal Chemistry Division
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February 14, 2020: The paper, “Efficacy and Safety of Topical Sofpironium Bromide Gel for the Treatment of Axillary Hyperhidrosis: A Phase 2, Randomized, Controlled, Double-Blinded Trial,” reporting positive results, is published in the peer reviewed Journal of the American Academy of Dermatology.
Read More
January 10, 2020: Bodor Laboratories’ sublicensee Kaken Pharmaceutical C. Ltd. submits New Drug Application for Sofpironium Bromide in Japan for Primary Axillary Hyperhidrosis.
January 10, 2020: N. Bodor et. al., awarded China Patent ZL2015800136220, titled “Formulation for Soft Anticholinergic Analogs,” for use in treatment of Hyperhidrosis.
August 20, 2019: Dr. Nicholas Bodor, et. al., is awarded U.S. Patent 10,383,846, titled, “Method of Dosing and Use of Soft Anticholinergic Esters,” for use in treatment of Hyperhidrosis.
July 2, 2019: Dr. Nicholas Bodor is awarded U.S. Patent 10,335,367 titled, “Use of Selected Anticholinergic Zwitterions” for treatment of Myopia.
January 11, 2019: Dr. Nicholas Bodor, et. al., is awarded two patents for the treatment of Hyperhidrosis – Japan Patent 6461214, “Method of Dosing and Use of Soft Anticholinergic Esters,” and Japan Patent 6461267, “Formulation for Soft Anticholinergic Analogs.”
December 12, 2018: Dr. Nicholas Bodor, et. al., is awarded European Patent 3116498 titled, “Formulation for Soft Anticholinergic Analogs,” for use in treatment of Hyperhidrosis.
April 25, 2018: Dr. Nicholas Bodor, et. al., is awarded European Patent 2968267 titled, “Soft Anticholinergic Esters for the Treatment of Hyperhidrosis.”
February 23, 2018: Dr. Nicholas Bodor, et. al., is awarded Japan Patent 6293919, titled, “Formulation for Soft Anticholinergic Analogs,” for use in treatment of Hyperhidrosis.
February 20, 2018: Confirmatory Phase 2b Study results were presented at the 76th American Academy of Dermatology Annual Meeting in San Diego, CA. The study demonstrated the promising potential of Sofpironium Bromide as a safe and effective first-line treatment for Primary Axillary Hyperhidrosis.
Read More
February 20, 2018: Dr. Nicholas Bodor, et. al., is awarded U.S. Patent 9,895,350, titled, “Method and Dosing and Use of Soft Anticholinergic Esters” for treatment of Hyperhidrosis.
October 24, 2017: Bodor Laboratories’ licensee Brickell BioTech announces positive Phase 2b study results for Sofpironium Bromide in subjects with Primary Axillary Hyperhidrosis
Read More
October 13, 2017: Dr. Nicholas Bodor, et. al., is awarded Japan Patent 6223543, titled, “Method of Dosing and Use of Soft Anticholinergic Esters,” for use in treatment of Hyperhidrosis.
N. Bodor, Z. Zubovics, I. Kurucz, S. Sólyom and E. Bodor, “Potent Analogs of Etiprednol Dicloacetate, a Second Generation of Soft Corticosteroids,” J. Pharm. Pharmacol., 69(12), 1745-1753, (2017).
Read More
June 4, 2023: Bodor Laboratories' Licensee Botanix Pharmaceuticals secures new sublicense and distribution agreement for Sofpironium Bromide in Korea through its partner Kaken Pharmaceutical Co., Ltd. (Japan). Read More
June 4, 2023: Bodor Laboratories’ Licensee Botanix Pharmaceuticals secures new sublicense and distribution agreement for Sofpironium Bromide in Korea through its partner Kaken Pharmaceutical Co., Ltd. (Japan). Read More
April 3, 2023: The U.S. Food and Drug Administration (FDA) conducts the mid-cycle review meeting for Sofpironium Bromide, with no major clinical safety issues, no risk management issues or advisory board requirements identified.
December 27, 2022: Dr. Nicholas Bodor awarded U.S. Patent 11,534,422, “Methods and Compositions for Soft Anticholinergic Esters” for treatment of sialorrhea. European counterpart Patent No. 3347007 issued March 29, 2023.
Read More
December 8, 2022: Bodor Laboratories’ Licensee Botanix Pharmaceuticals receives notice from the U.S. Food and Drug Administration (FDA) that their New Drug Application (NDA) for Sofpironium Bromide is now under formal review.
Read More
September 26, 2022: Bodor Laboratories’ Licensee Botanix Pharmaceuticals submits the New Drug Application (NDA) for Sofpironium Bromide with the U.S. Food and Drug Administration (FDA), for treatment of Hyperhidrosis; approval anticipated for Fall 2023.
Read More
September 20, 2022: Dr. Nicholas Bodor awarded U.S. Patent 11,447,522, “Potent Soft Anti-Inflammatory Corticosteroid Compounds and Uses Thereof” for treatment of a wide variety of disease states.
Read More
May 3, 2022: Bodor Laboratories’ Licensee Brickell BioTech sells its Sofpironium Bromide license for Hyperhidrosis to Botanix Pharmaceuticals.
Read More
November 22, 2021: Dr. Nicholas Bodor awarded Japan Patent 6981694, and also Japan Patent 6968457 on October 29, 2021, both for treatment of Myopia.
October 7, 2021: Bodor Laboratories’ Licensee Brickell BioTech announces positive topline results from its pivotal Phase 3 clinical “Cardigan I” and “Cardigan II” studies of Sofpironium Bromide Gel 15%, demonstrating its potential as a best-in-class treatment for Primary Axillary Hyperhidrosis.
Read More
September 21, 2021: Dr. Nicholas Bodor et. al., awarded U.S. Patent 11,123,325; also U.S. Patent 11,084,788 on August 10, 2021; U.S. Patent 11,052,067 on July 6, 2021; U.S. Patent 11,034,652 on June 15, 2021 and U.S. Patent 11,026,919 on June 8, 2021. All are continuation patents titled, “Formulation for Soft Anticholinergic Analogs,” to be used to bring a product to market in the U.S. by its licenses to treat Primary Axillary Hyperhidrosis.
June 1, 2021: Bodor Laboratories’ Licensee Brickell BioTech announces publication of Japan Phase 3 Long-Term Safety and Efficacy Study Results for Sofpironium Bormide Gel 15% (ECCLOCK®) in the Journal of Dermatology, available at: https://onlinelibrary.wiley.com/doi/10.1111/1346-8138.15927?af=R.
April 23, 2021: Bodor Laboratories’ Licensee Brickell BioTech reports positive results from U.S. Phase 3 open-label, long-term safety study on chronic use of Sofpironium Bromide Gel as potential treatment for primary axillary hyperhidrosis. Daily treatment with Sofpironium Bromide gel was generally well-tolerated and showed a clinically meaningful and sustained improvement in sweat severity through 48 weeks of treatment.
Read More
March 30, 2021: Dr. Nicholas Bodor et. al., awarded U.S. Patents 10,961,191 and 10,959,983; also U.S. Patent 10,952,990 on March 23, 2021; and U.S. Patent 10,947,192 on March 16, 2021. All are continuation patents titled, “Formulation for Soft Anticholinergic Analogs,” to be used to bring a product to market in the U.S. by its licenses to treat Primary Axillary Hyperhidrosis.
January 19, 2021: Bodor Laboratories’ Licensee Brickell BioTech announces publication of Japan pivotal Phase 3 study results for Sofpironium Gel 5% (ECCLOCK®) in the Journal of Dermatology, available at: https://onlinelibrary.wiley.com/doi/10.1111/1346-8138.15668. The commercialization of ECCLOCK® in Japan continues by sublicensee KAKEN Pharmaceutical Co., Ltd. as a potential best-in-class treatment for patients with Primary Axillary Hyperhidrosis.
November 26, 2020: Bodor Laboratories’ Sublicensee Kaken Pharmaceuticals Co., Ltd. launches sales of ECCLOCK® (Sofpironium Bromide) in Japan for treatment of primary axillary (underarm) hyperhidrosis. The product is listed on the National Health Insurance (NHI) Drug Reimbursement Pricelist in Japan as of November 18, 2020
Read More
September 25, 2020: Sofpironium Bromide Gel 5% for treatment of primary axillary hyperhidrosis is approved for sale in Japan; approval received by Bodor Laboratories Sublicensee KAKEN Pharmaceutical Co., Ltd.
Read More
August 17, 2020: Dr. Nicholas Bodor is awarded Japan Patent 6750900, and also Japan Patent 6732356 on July 10, 2020. Both patents, titled, “Use of Selected Anticholinergic Zwitterions” are for treatment of Myopia.
June 15, 2020: Positive Confirmatory Phase 3 study results with Sofpironium Bromide for the topical treatment of primary axillary hyperhidrosis were presented at both the 119th Annual Meeting of the Japanese Dermatological Association and also at the 2020 Annual Meeting of the American Academy of Dermatology in June 2020, as announced by Bodor Laboratories’ sublicensee KAKEN Pharmaceutical Co., Ltd.
Read More
April 28, 2020: Dr. Nicholas Bodor is awarded U.S. Patent 10,632,067 titled, “Use of Selected Anticholinergic Zwitterions,” for use in treatment of Myopia.
April 20, 2020: Dr. Nicholas Bodor is elected to the Academy of Science, Engineering and Medicine of Florida (ASEMFL) inaugural membership class “…for inventing unique retrometabolic drug design/targeting concepts, leading to numerous safe and effective drugs, positively impacting millions globally.”
March 24, 2020: Positive Phase III pivotal study results of Sofpironium Bromide in Japanese patients with Primary Axillary Hyperhidrosis were presented at the Late-Breaking Research Program during the American Academy of Dermatology Annual Meeting held March 20-24, 2020 in Denver, CO
Read More
March 5, 2020: Dr. Nicholas Bodor is elected as a 2020 inductee to the Florida Inventors Hall of Fame; https://floridainvents.org/nicholas-bodor/. Dr. Bodor is also a 2012 inductee of the American Chemical Society Hall of Fame, Medicinal Chemistry Division
Read More
February 14, 2020: The paper, “Efficacy and Safety of Topical Sofpironium Bromide Gel for the Treatment of Axillary Hyperhidrosis: A Phase 2, Randomized, Controlled, Double-Blinded Trial,” reporting positive results, is published in the peer reviewed Journal of the American Academy of Dermatology.
Read More
January 10, 2020: Bodor Laboratories’ sublicensee Kaken Pharmaceutical C. Ltd. submits New Drug Application for Sofpironium Bromide in Japan for Primary Axillary Hyperhidrosis.
January 10, 2020: N. Bodor et. al., awarded China Patent ZL2015800136220, titled “Formulation for Soft Anticholinergic Analogs,” for use in treatment of Hyperhidrosis.
August 20, 2019: Dr. Nicholas Bodor, et. al., is awarded U.S. Patent 10,383,846, titled, “Method of Dosing and Use of Soft Anticholinergic Esters,” for use in treatment of Hyperhidrosis.
July 2, 2019: Dr. Nicholas Bodor is awarded U.S. Patent 10,335,367 titled, “Use of Selected Anticholinergic Zwitterions” for treatment of Myopia.
January 11, 2019: Dr. Nicholas Bodor, et. al., is awarded two patents for the treatment of Hyperhidrosis – Japan Patent 6461214, “Method of Dosing and Use of Soft Anticholinergic Esters,” and Japan Patent 6461267, “Formulation for Soft Anticholinergic Analogs.”
December 12, 2018: Dr. Nicholas Bodor, et. al., is awarded European Patent 3116498 titled, “Formulation for Soft Anticholinergic Analogs,” for use in treatment of Hyperhidrosis.
April 25, 2018: Dr. Nicholas Bodor, et. al., is awarded European Patent 2968267 titled, “Soft Anticholinergic Esters for the Treatment of Hyperhidrosis.”
February 23, 2018: Dr. Nicholas Bodor, et. al., is awarded Japan Patent 6293919, titled, “Formulation for Soft Anticholinergic Analogs,” for use in treatment of Hyperhidrosis.
February 20, 2018: Confirmatory Phase 2b Study results were presented at the 76th American Academy of Dermatology Annual Meeting in San Diego, CA. The study demonstrated the promising potential of Sofpironium Bromide as a safe and effective first-line treatment for Primary Axillary Hyperhidrosis.
Read More
February 20, 2018: Dr. Nicholas Bodor, et. al., is awarded U.S. Patent 9,895,350, titled, “Method and Dosing and Use of Soft Anticholinergic Esters” for treatment of Hyperhidrosis.
October 24, 2017: Bodor Laboratories’ licensee Brickell BioTech announces positive Phase 2b study results for Sofpironium Bromide in subjects with Primary Axillary Hyperhidrosis
Read More
October 13, 2017: Dr. Nicholas Bodor, et. al., is awarded Japan Patent 6223543, titled, “Method of Dosing and Use of Soft Anticholinergic Esters,” for use in treatment of Hyperhidrosis.
N. Bodor, Z. Zubovics, I. Kurucz, S. Sólyom and E. Bodor, “Potent Analogs of Etiprednol Dicloacetate, a Second Generation of Soft Corticosteroids,” J. Pharm. Pharmacol., 69(12), 1745-1753, (2017).
Read More