Effectiveness of sofpironium bromaide gel for clozapine-induced hypersalivation in patients with treatment-ressistant schizophrenia:A double-blind comparative study (Effectiveness of ECCLOCKgel for clozapine-induced hypersalivation)

Start Date17 Jun 2021

Sponsor / Collaborator-

JPRN-jRCT1041210028

/ RecruitingPhase 3IIT

Effectiveness of sofpironium bromaide gel for clozapine-induced hypersalivation in patients with treatment-ressistant schizophrenia:A double-blind comparative study - Effectiveness of ECCLOCKgel for clozapine-induced hypersalivation

Start Date03 Jun 2021

Sponsor / Collaborator-

100 Clinical Results associated with Sofpironium Bromide

100 Translational Medicine associated with Sofpironium Bromide

100 Patents (Medical) associated with Sofpironium Bromide

Literatures (Medical) associated with Sofpironium Bromide

01 Sep 2026·JOURNAL OF DERMATOLOGY

Clinical Characteristics and Treatment Patterns of Hyperhidrosis in Northern Hokkaido: A Single‐Center Retrospective Descriptive Study

Article

Author: Matsuya, Marika ; Matsumoto, Kou ; Kishibe, Mari ; Noguchi, Aiko ; Fujita, Yasuyuki ; Igawa, Satomi

ABSTRACT:

Hyperhidrosis is a common condition associated with a substantial negative impact on the quality of life. Several studies have described the clinical characteristics and disease burden of patients with hyperhidrosis in Japan. However, comparable real‐world clinical data on hyperhidrosis from Hokkaido remain limited. We therefore evaluated real‐world clinical practice patterns at our institution before and after the establishment of a specialized outpatient clinic for hyperhidrosis. In this retrospective study, we analyzed the data of 144 patients who presented with hyperhidrosis between November 2013 and March 2025. Patient characteristics, pathways to care, treatment modalities, and treatment continuation were evaluated using data from electronic medical records. The sex distribution, age at presentation, and subtype distribution of hyperhidrosis in our cohort were largely consistent with those reported in a prior nationwide survey. Primary axillary and/or palmar hyperhidrosis accounted for 87.5% of all cases. After launching a specialized clinic in April 2023, we observed a substantial increase in the number of patients who consulted for hyperhidrosis during visits for other dermatologic conditions; this finding may suggest the presence of previously unrecognized patients. However, changes in hospital access policies may also have influenced consultation patterns. The treatment continuation rates for axillary and palmar hyperhidrosis were both approximately 40%. Among the treatments for axillary hyperhidrosis, sofpironium bromide gel was prescribed most frequently, whereas glycopyrronium tosylate hydrate wipes showed a higher treatment continuation rate. In conclusion, the presence of a specialized outpatient clinic may improve access to care for patients with primary focal hyperhidrosis and facilitate the identification of previously unrecognized patients. However, treatment continuation remained suboptimal, highlighting the importance of improving continuity of care in hyperhidrosis management at our institution.

08 Jul 2026·Journal of the American Chemical Society

Direct Access to Chiral Tertiary Alcohols via Copper-Catalyzed Enantioconvergent O -Alkylation of Water with Racemic α-Tertiary Haloamides

Article

Author: Zhang, Yu-Feng ; Chen, Si-Yuan ; Luan, Cheng ; Yang, Chang-Jiang ; Gu, Qiang-Shuai ; Liu, Xin-Yuan ; Wang, Biao ; Huang, Pei-Jie ; Zhang, Jia-Yong ; Chen, Ji-Jun

Chiral tertiary alcohols are ubiquitous structural motifs in pharmaceutical agents and bioactive molecules, as well as versatile building blocks in organic synthesis, yet general catalytic enantioselective routes to these compounds remain limited. Direct transition-metal-catalyzed enantioconvergent C-O cross-coupling of racemic tertiary alkyl halides with water would provide an attractive entry to these structures, but this strategy remains largely unexplored because water can deactivate metal catalysts and presents a formidable challenge for enantiocontrol. Herein, we report a copper-catalyzed enantioconvergent O-alkylation of water with racemic α-tertiary haloamides through a radical-polar crossover pathway. Central to this process is the use of chiral anionic N,N,N-ligands, which promote the formation of coordinatively saturated Cu(III) intermediates that undergo enantioselective outer-sphere nucleophilic substitution by water, thereby enabling direct C(sp³)-O bond formation. This method provides practical and complementary access to a broad range of enantioenriched, sterically congested tertiary alcohols under mild conditions with good functional-group compatibility. The synthetic utility of this protocol is further demonstrated by the efficient preparation of diverse chiral tertiary alcohol building blocks and by concise syntheses of pharmaceutically relevant molecules, including sofpironium bromide and (S)-oxybutynin.

01 Jun 2026·Clinical Drug Investigation

Efficacy and Safety of Topical Anticholinergics in the Treatment of Primary Axillary Hyperhidrosis: A Systematic Review and Meta-analysis

Review

Author: Staatz, Christine E ; Baek, In-Hwan ; Han, Nayoung ; Kim, Younghwa ; Kim, Min-Soo ; Hwang, Eun Jung ; Koo, Hyunji ; Kim, Jiah

BACKGROUND:

Topical anticholinergic agents are non-invasive treatment options for primary axillary hyperhidrosis (PAH). Sofpironium bromide was recently approved by the US Food and Drug Administration (FDA). A comprehensive evaluation of the efficacy and safety of available topical anticholinergics may inform clinical practice.

OBJECTIVES:

To assess the efficacy and safety of topical anticholinergic therapies for PAH through systematic review and meta-analysis of randomized controlled trials (RCTs).

METHODS:

Five databases were searched on September 9, 2024. Primary outcomes included a ≥2-point improvement in the Hyperhidrosis Disease Severity Scale (HDSS) and ≥50% reduction in gravimetric sweat production (GSP). Secondary outcomes included subjective symptom improvement and objective sweat reduction. Safety outcomes included treatment-emergent adverse events (TEAEs), anticholinergic-related adverse events, and local application site reactions. The review protocol was registered in PROSPERO (CRD42024583376).

RESULTS:

Eight RCTs (n = 1921) that evaluated glycopyrronium, sofpironium bromide, and umeclidinium were included. Topical agents significantly outperformed placebos for HDSS ≥2-point improvement (risk ratio [RR]: 2.40; 95% confidence interval [CI]: 2.01-2.86) and GSP ≥50% reduction (RR: 1.43; 95% CI: 1.21-1.70). Sofpironium was the most effective HDSS treatment, whereas glycopyrronium showed highest efficacy against GSP. Topical agents were associated with increased risk of TEAEs (RR: 1.43; 95% CI: 1.14-1.79), with sofpironium associated with highest risk of dry mouth and glycopyrronium with highest risks for mydriasis and constipation.

CONCLUSIONS:

Topical anticholinergic agents are effective for PAH treatment, with distinct efficacy and safety profiles. Although the available evidence is limited by the small number of trials, short follow-up durations, and heterogeneity in outcome reporting, these findings support the role of topical anticholinergic therapy as an effective non-invasive option for PAH.

News (Medical) associated with Sofpironium Bromide

22 Oct 2026

·www.prnewswire.com

Hyperhidrosis Market: Over 60% of Treated Axillary Patients in Japan Discontinue Therapy, Creating an Opening for Topical Pipeline | DelveInsight

.release-content span.prnews_span{font-size:8pt;font-family:"Arial";color:black}.release-content a.prnews_a{color:blue}.release-content li.prnews_li{font-size:8pt;font-family:"Arial";color:black}.release-content p.prnews_p{font-size:0.62em;font-family:"Arial";color:black;margin:0in}.release-content .prngen2{padding-right:0.17em;padding-left:0.17em;vertical-align:BOTTOM;border-top:black 0.5pt solid;border-right:black 0.5pt solid;border-bottom:black 0.5pt solid;border-left:black 0.5pt solid}.release-content .prnml4{margin-top:0em;margin-right:0em;margin-bottom:0em;margin-left:0.33em !important}.release-content .prnbcc{border-collapse:COLLAPSE} DelveInsight's report sizes the hyperhidrosis market at USD 545 million across the 7MM in 2025, with a 6.6% CAGR forecast through 2036. Only 0.7% of patients with primary focal hyperhidrosis in Japan remained under active medical care, and 62.3% of patients with previously treated primary axillary hyperhidrosis had discontinued treatment, according to DelveInsight's latest Hyperhidrosis Market report. That gap points to a large unmet need that emerging therapies are being developed to address, including ET-01 (Eirion Therapeutics), DMT410 (Dermata Therapeutics/Revance Therapeutics), AT-5214 (dexmecamylamine HCl; Atacama Therapeutics), Oxybutynin/Pilocarpine (ANHYDRIX; Theravida), and others. LAS VEGAS, Oct. 22, 2026 /PRNewswire/ -- Recently published Hyperhidrosis Market Insights report includes a comprehensive understanding of current treatment practices, hyperhidrosis emerging drugs, market share of individual therapies, and current and forecasted market size from 2022 to 2036, segmented into leading markets [the United States, the EU4 (Germany, France, Italy, and Spain), the United Kingdom, and Japan]. Hyperhidrosis Market Summary The market size for hyperhidrosis was found to be USD 545 million in the 7MM in 2025. The United States accounted for about 51% of the 7MM market in 2025, the largest share of any market covered. The 7MM had about 13.6 million diagnosed prevalent cases of hyperhidrosis in 2025; Japan had the highest number. Leading hyperhidrosis companies, such as Eirion Therapeutics, Dermata Therapeutics, Revance Therapeutics, Atacama Therapeutics, Theravida, and others, are developing new hyperhidrosis treatment drugs that can be available in the hyperhidrosis market in the coming years. The promising hyperhidrosis therapies in clinical trials include ET-01, DMT410, AT-5214 (dexmecamylamine HCl), Oxybutynin/Pilocarpine (ANHYDRIX), and others. Discover new treatments for hyperhidrosis @ As per Aparna Thakur, Project Manager of Forecasting at DelveInsight, "ET-01 continues to strengthen its position within Eirion Therapeutics' dermatology pipeline, supported by sustained corporate investment, strategic collaborations, and ongoing clinical development. ET-01's noninvasive topical delivery platform has the potential to address the limitations of injectable botulinum therapies." Key Factors Driving the Growth of the Hyperhidrosis Market Rising Prevalence of Hyperhidrosis: Growing recognition of primary focal and secondary hyperhidrosis is expanding the addressable patient population. Increasing diagnosis of excessive sweating, particularly axillary, palmar, plantar, and craniofacial hyperhidrosis, is supporting market demand. Advancements in Topical Therapies: Development of newer topical formulations with targeted mechanisms and improved convenience is creating alternatives to conventional antiperspirants. These therapies may encourage treatment initiation among patients seeking non-invasive management options. Rising Adoption of Minimally Invasive Procedures: Increasing use of botulinum toxin injections and device-based treatments is supporting market expansion, particularly among patients with moderate-to-severe focal hyperhidrosis. Preference for outpatient and minimally invasive approaches is further driving procedural adoption. Launch of Emerging Hyperhidrosis Drugs: The dynamics of the hyperhidrosis market are expected to change in the coming years due to the launch of emerging therapies such as ET-01 (Eirion Therapeutics), DMT410 (Dermata Therapeutics/Revance Therapeutics), AT-5214 (dexmecamylamine HCl; Atacama Therapeutics), Oxybutynin/Pilocarpine (ANHYDRIX; Theravida), and others. Download the report to understand the top emerging hyperhidrosis drugs @ Hyperhidrosis Clinical Trials Hyperhidrosis Market Analysis The management of hyperhidrosis remains challenging due to the limited durability of available treatments, adverse effects associated with systemic therapies, and differences in treatment efficacy across various anatomical sites. Treatment persistence continues to represent a significant challenge in the Japanese market. Despite the availability of treatment options, only 0.7% of patients with primary focal hyperhidrosis remained under active medical care, while 62.3% of patients with previously treated primary axillary hyperhidrosis had discontinued treatment. These findings highlight a substantial unmet need for improving treatment continuation and long-term patient engagement. In July 2018, the U.S. FDA approved glycopyrronium (QBREXZA) for the treatment of primary axillary hyperhidrosis in both pediatric and adult patients. Subsequently, in February 2022, Japan's Ministry of Health, Labour and Welfare approved QBREXZA for the same indication under the brand name RAPIFORT Wipes 2.5% (glycopyrronium tosylate hydrate), with Maruho serving as the exclusive licensing partner. Currently approved therapies for hyperhidrosis include sofpironium (SOFDRA) topical gel and glycopyrronium (QBREXZA), both indicated for the treatment of primary axillary hyperhidrosis. The hyperhidrosis pipeline comprises several key assets currently under development, with major players including Theravida, Eirion Therapeutics, and others. Notable emerging therapies include oxybutynin/pilocarpine (ANHYDRIX), being developed for primary focal hyperhidrosis, and topical ET-01 for primary axillary hyperhidrosis, among other candidates. The emergence of these novel therapies is anticipated to support a positive evolution of the hyperhidrosis treatment landscape by expanding therapeutic options and addressing limitations associated with existing treatments. Hyperhidrosis Competitive Landscape Some of the hyperhidrosis drugs under development include ET-01 (Eirion Therapeutics), DMT410 (Dermata Therapeutics/Revance Therapeutics), AT-5214 (dexmecamylamine HCl; Atacama Therapeutics), Oxybutynin/Pilocarpine (ANHYDRIX; Theravida), and others. Eirion Therapeutics' ET-01 is an investigational topical botulinum toxin formulation being developed by Eirion Therapeutics for the treatment of primary axillary hyperhidrosis. The product employs a proprietary nanoemulsion-based transdermal delivery technology intended to facilitate the passage of botulinum toxin through the skin. This approach may eliminate the pain, bleeding, and bruising commonly associated with injectable botulinum toxin therapies. ET-01 is currently undergoing Phase II development for primary axillary hyperhidrosis. Its mechanism of action involves blocking acetylcholine release from cholinergic nerve terminals, thereby decreasing stimulation of the eccrine sweat glands and reducing excessive sweating. Dermata Therapeutics/Revance Therapeutics' DMT410 is an investigational, needle-free topical botulinum toxin delivery platform being developed by Dermata Therapeutics in collaboration with Revance Therapeutics for primary axillary hyperhidrosis (AHH). The treatment integrates Dermata's proprietary XYNGARI technology with Revance's botulinum toxin product, DAXXIFY, to facilitate the topical transport of botulinum toxin across the skin. DMT410 is being developed as a non-invasive alternative to injectable botulinum toxin treatments, with the potential to reduce injection-related pain, bruising, and discomfort. Preliminary clinical studies have shown promising efficacy and a favorable safety profile, supporting further development of DMT410 as a potential treatment for patients with primary axillary hyperhidrosis. Theravida's Oxybutynin/pilocarpine is an investigational oral, systemically acting therapy being developed for primary focal hyperhidrosis (PFH), with Phase II clinical development completed. The treatment is formulated as a fixed-dose combination of oxybutynin, a muscarinic receptor antagonist, and pilocarpine, a muscarinic receptor agonist, using proprietary controlled-release technology intended to improve tolerability without compromising efficacy. The combination is designed to mitigate oxybutynin-associated adverse effects, particularly dry mouth, through the precisely timed release of pilocarpine. By addressing this tolerability concern, oxybutynin/pilocarpine aims to improve treatment adherence and clinical outcomes. In Phase II studies, the therapy demonstrated efficacy across multiple endpoints and produced a statistically significant reduction in dry mouth compared with oxybutynin alone. The anticipated launch of these emerging therapies are poised to transform the hyperhidrosis market landscape in the coming years. As these cutting-edge therapies continue to mature and gain regulatory approval, they are expected to reshape the hyperhidrosis market landscape, offering new standards of care and unlocking opportunities for medical innovation and economic growth. See the hyperhidrosis pipeline by phase and company @ Hyperhidrosis Medications What's the Hyperhidrosis Market Report Includes? DelveInsight's Hyperhidrosis Market Report delivers executive-level intelligence on the evolving market landscape, integrating epidemiology (total, diagnosed, type-, gender-, age- and site-specific prevalent cases), treatment practices, competitive dynamics, emerging therapies, and market forecasts across the major markets through 2036. Built on a rigorous methodology combining comprehensive secondary research, primary interviews with key opinion leaders and industry experts, and proprietary patient-based forecasting models, the report provides a reliable foundation for strategic planning. Designed for pharmaceutical and biotech executives, it enables informed decisions on portfolio strategy, business development, market entry, investment prioritization, and commercial planning. Request a free sample @ Hyperhidrosis Market Report Table of Contents Related Reports Hyperhidrosis Clinical Trial Analysis Hyperhidrosis Pipeline Insight – 2026 report provides comprehensive insights about the pipeline landscape, pipeline drug profiles, including clinical and non-clinical stage products, and the key hyperhidrosis companies, including Eirion Therapeutics, Dermata Therapeutics, Revance Therapeutics, Atacama Therapeutics, Theravida, Journey Medical Corporation/ Maruho, Dr. Wolff Group, Axunio Pharma GmbH, Botanix Pharmaceuticals, Kaken Pharmaceutical, AbbVie, Allergan, Hisamitsu Pharmaceutical, and others. Axillary Hyperhidrosis Market Axillary Hyperhidrosis Market Insights, Epidemiology, and Market Forecast – 2036 report delivers an in-depth understanding of the disease, historical and forecasted epidemiology, as well as the market trends, market drivers, market barriers, and key axillary hyperhidrosis companies, including SweatBlock, Certain Dri, Duradry, Zerosweat, Allergan plc., Dermavant Sciences Inc., Botanix Pharmaceuticals Ltd, Dermata Therapeutics Inc, Dr. August Wolff GmbH & Co KG Arzneimittel, Medytox Inc, Revance Therapeutics Inc. , and others. Palmar Hyperhidrosis Market Palmar Hyperhidrosis Market Insights, Epidemiology, and Market Forecast – 2036 report delivers an in-depth understanding of the disease, historical and forecasted epidemiology, as well as the market trends, market drivers, market barriers, and key palmar hyperhidrosis companies, including GlaxoSmithKline plc., Ulthera, Inc., TheraVida, Dermira, Inc., Brickell Biotech, Inc., Dr. August Wolff GmbH & Co., Revance Therapeutics, Inc., Allergan, Miramar Labs, Inc. , and others. Primary Axillary Hyperhidrosis Market Primary Axillary Hyperhidrosis Market Insights, Epidemiology, and Market Forecast – 2036 report delivers an in-depth understanding of the disease, historical and forecasted epidemiology, as well as the market trends, market drivers, market barriers, and key primary axillary hyperhidrosis companies, including Brickell Biotech Inc., Dermata Therapeutics LLC, Dr. August Wolff GmbH & Co. KG Arzneimittel, and others. About DelveInsight DelveInsight is a leading Business Consultant and Market Research firm focused exclusively on life sciences. It supports pharma companies by providing comprehensive end-to-end solutions to improve their performance. Get hassle-free access to all the healthcare and pharma market research reports through our subscription-based platform PharmDelve . Contact Us Shruti Thakur [email protected] +14699457679 SOURCE DelveInsight Business Research, LLP

Phase 2Drug ApprovalClinical Result

08 Sep 2026

·www.biospace.com

4 CDMOs to consider when outsourcing manufacturing

iStock, Anton Vierietin Contract development and manufacturing organizations looking to do business with biopharmas include Lonza, which has more than 30 sites, and Samsung Biologics, which recently announced a planned acquisition of another CDMO. With the demand for outside help with development and manufacturing expected to rise soon , biopharmas may be thinking about potential partners for bringing their drugs to market. Below is a look at four contract development and manufacturing organizations (CDMOs) that offer a range of services through facilities located around the world. Lonza Based in Basel, Switzerland, Lonza is one of the world’s largest CDMOs. Its network employs about 20,000 people across more than 30 sites on five continents. Lonza has 11 U.S. locations, including Cambridge, Massachusetts; Durham, North Carolina; Morristown, New Jersey; and Vacaville, California. The CDMO’s biopharma customers range from emerging biotechs to global pharmaceutical companies. Lonza offers them three business platforms: integrated biologics, advanced synthesis and specialized modalities. Services range from early development to drug substance and drug product manufacturing. Lonza’s technologies include mammalian biologics, small molecules, highly potent active pharmaceutical ingredients (APIs), bioconjugates, mRNA, microbial products, and cell and gene therapies.  Lonza has sealed multiple deals with biopharmas this summer. For example, in early July, the CDMO announced it had expanded a strategic collaboration with an unnamed “leading US-based biopharmaceutical company.” According to Lonza, the expansion adds two biologics programs to be produced commercially, with the option for two more. Later that month, Lonza and Engitix announced a licensing agreement to advance the development of antibody-drug conjugates (ADCs) and deliver therapies to patients with chronic diseases. In other recent news, the CDMO last week announced Samanta Cimitan as its chief commercial officer, senior vice president and member of the extended executive committee. The newly created role is meant to make it easy for customers to engage with, access and navigate Lonza’s full end-to-end offering globally and across its business platforms, according to the announcement. Samsung Biologics Samsung Biologics has a biomanufacturing capacity of 845,000 liters, more than 5,800 employees and over 145 global clients. The Incheon, South Korea–based CDMO’s network includes four manufacturing campuses: two biomanufacturing campuses in Incheon, a dedicated ADC facility in Incheon and a biologics manufacturing site in Rockville, Maryland. Samsung also has global offices in Amsterdam, Boston, Tokyo and Ridgefield Park, New Jersey. The company provides end-to-end development services from drug discovery and lead optimization to investigational new drug filing, covering cell line, bioprocess and analytical development, as well as drug formulation. Samsung also provides cGMP biologics manufacturing services from clinical to commercial scale, including drug substance manufacturing, drug product and aseptic fill-finish and comprehensive laboratory testing services. In recent news, Samsung announced in mid-July that it had offered to buy PolyPeptide, a Switzerland-based CDMO, for CHF 1.46 billion ($1.8 billion), allowing it to move into peptide manufacturing. PolyPeptide’s projects include GLP-1s, orals, multiple agonists and combination therapies. Last week, Samsung announced a rights offering expected to raise KRW 3 trillion ($2.2 billion). The CDMO plans to use most of the funds toward its acquisition of PolyPeptide, with the remainder (KRW 290 billion, or $210 million) designated for expanding its Bio Campus II in Incheon. While one manufacturing plant at that location is operational, the overall campus, which will have a total capacity of 720,000 liters, won’t be completed until 2032. Recipharm Stockholm, Sweden–based Recipharm has 16 facilities in eight countries: France, Germany, India, Portugal, Spain, Sweden, the United Kingdom and the United States. The global CDMO’s U.S. location is in Watertown, Massachusetts. Recipharm has over 4,000 employees worldwide, with customers ranging from Big Pharma to smaller research and development companies. The CDMO provides manufacturing services for solid, semisolid and liquid dosage forms, including sterile fill and finish; clinical trial material development and manufacturing services; and pharmaceutical product development. Its Recipharm Advanced Bio segment works with customers to develop and commercialize advanced therapeutics using technologies based on live viruses and viral vectors, live-microbial biopharmaceutical products, nucleic acid–based mRNA and plasmid DNA production. In mid-June, the company announced a multimillion-dollar investment in its U.S. operations. The move is aimed at strengthening its ability to support pharmaceutical and biotech businesses with advanced sterile fill and finish services for biologics and advanced therapies. Recipharm did not specify the exact amount of its investment. It noted that the announcement follows the signing of a clinical biologics fill and finish agreement with a major global pharmaceutical company, which it did not name. In late May, Recipharm announced a multimillion-dollar investment in a new blow-fill-seal manufacturing line to expand its capacity to support ophthalmic product programs from development through commercial supply. It did not specify the exact amount of that investment. Piramal Pharma Solutions Piramal Pharma Solutions has a network of 15 facilities across North America, Europe and Asia. Nine of those sites are in India, and three are in the U.S., located in Riverview, Michigan; Sellersville, Pennsylvania; and Lexington, Kentucky. The Mumbia, India–based global CDMO has between 1,000 and 5,000 employees, according to its LinkedIn profile , while parent company Piramal Pharma has a workforce of over 7,000. Piramal offers a range of services including drug discovery solutions, process and pharmaceutical development services, clinical trial supplies, commercial supply of APIs and finished dosage forms. It also provides specialized services such as the development and manufacture of highly potent APIs and sterile fill/finish. In addition, Piramal offers development and manufacturing services for biologics including vaccines and gene therapies through Yapan Bio Private. In mid-May, Piramal Pharma Solutions announced it had entered a manufacturing and supply arrangement with Botanix SB, a subsidiary of Botanix Pharmaceuticals. Piramal will handle development and validation services for sofpironium bromide, the API in Sofdra, at its Michigan facility. Around the same time, the company debuted its new state-of-the-art payload-linker development and manufacturing suite at its Riverview drug substance facility. The company considers the launch a key element of its $90 million investment plan to extend U.S.-based manufacturing capabilities, announced last year.

License out/inAcquisition

13 Jul 2026

·www.einpresswire.com

Botanix receives additional patent allowance for Sofdra®

The patent is expected to add to existing patent protections against unauthorised commercial manufacturing of Sofdra's drug substance into May 2040 Botanix Pharmaceuticals (ASX:BOT) Strengthening the company's intellectual property estate around Sofdra® remained an important strategic priority...” — Dr Howie McKibbon, Chief Executive Officer of Botanix PHOENIX, AZ, UNITED STATES, July 12, 2026 / EINPresswire.com / -- Botanix Pharmaceuticals Limited (ASX:BOT, "Botanix" or "the Company") is pleased to announce that the United States Patent and Trademark Office ("USPTO") has issued a Notice of Allowance for US patent application Serial No. 17/611,158, "Crystalline Form of Sofpironium Bromide and Preparation Method Thereof." The application covers commercially relevant intellectual property protecting the drug substance underpinning Sofdra ® (sofpironium), Botanix's FDA-approved treatment for primary axillary hyperhidrosis in adults and paediatric patients aged nine and older. The allowed claims relate to proprietary aspects of the sofpironium drug substance technology used in Sofdra ® 's commercial manufacture. Once issued, the patent is expected to strengthen Botanix's intellectual property protection surrounding Sofdra ® in the United States, protecting against unauthorized commercial manufacturing of the drug substance into May 2040. The actual chemical entity itself (in this case, the crystalline form of sofpironium bromide), is generally considered the hardest to design around. That's why this type of patent is highly valued by companies and investors alike. Dr Howie McKibbon, Chief Executive Officer of Botanix, said strengthening the company's intellectual property estate around Sofdra ® remained an important strategic priority, and that the Notice of Allowance further expanded its US patent portfolio, supporting the long-term commercial opportunity for Sofdra ® out to 2040. Having multiple issued patents providing protection to 2040 gives Botanix a long window of market exclusivity for Sofdra ® , which supports long-term revenue, makes the asset more attractive for potential licensing or partnership deals, and reduces the risk profile for investors. Botanix is committed to protecting the innovations underpinning its lead commercial product as it continues to build out its US dermatology offering. Jane Morgan Investor and Media Relations +61 405 555 618 email us here Visit us on social media: LinkedIn Legal Disclaimer: EIN Presswire provides this news content "as is" without warranty of any kind. We do not accept any responsibility or liability for the accuracy, content, images, videos, licenses, completeness, legality, or reliability of the information contained in this article. If you have any complaints or copyright issues related to this article, kindly contact the author above.

100 Deals associated with Sofpironium Bromide

External Link

KEGG	Wiki	ATC	Drug Bank
D10989	Sofpironium Bromide	M03AX D11AA02	-

R&D Status

Approved

10 top approved records.

to view more data

Indication	Country/Location	Organization	Date
Primary Axilary Hyperhidrosis	Japan	Kaken Pharmaceutical Co., Ltd.	25 Sep 2020

Developing

10 top R&D records.

to view more data

Indication	Highest Phase	Country/Location	Organization	Date
Hyperhidrosis	Phase 3	United States	Fresh Tracks Therapeutics, Inc.	05 Sep 2018
Hyperhidrosis Palmaris Et Plantaris	Phase 1	Japan	Kaken Pharmaceutical Co., Ltd.	-

Clinical Result

Indication

Phase

Evaluation

View All Results

Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


Cardigan I (AAD2026)	Phase 3	Primary Axilary Hyperhidrosis	701	Sofpironium Gel, 12.45% (<17 years)	hohzmtcdbl(sfpsrqgjjt) = czfxohdekb rkjmdpkoap (kruvrhtuwx, -102.373) View more	Positive	27 Mar 2026
				Sofpironium Gel, 12.45% (17–30 years)	hohzmtcdbl(sfpsrqgjjt) = ekxijyyrma rkjmdpkoap (kruvrhtuwx, -110.036) View more
NCT03836287 (CARDIGAN 1, FDA_CDER) Manual	Phase 3	Primary Axilary Hyperhidrosis	-	SOFDRA	fmpyndfrdb(tmgoexgpug) = yedlpcgmnq oyjhwanulc (hhxiicmkjr ) View more	Positive	18 Jun 2024
				Vehicle	fmpyndfrdb(tmgoexgpug) = cbtljtixep oyjhwanulc (hhxiicmkjr ) View more
NCT03948646 (CARDIGAN 2, FDA_CDER) Manual	Phase 3	Primary Axilary Hyperhidrosis	-	SOFDRA	vroxwzdjvh(wlxloqxzvr) = jkcrdpmmfd iajbzkgonq (ljpecwmmbc ) View more	Positive	18 Jun 2024
				Vehicle	vroxwzdjvh(wlxloqxzvr) = jdmoteyziz iajbzkgonq (ljpecwmmbc ) View more
NCT03836287 (BBI-4000-CL-301 \| CARDIGAN 1 \| CardiganI, CTgov)	Phase 3	Primary Axilary Hyperhidrosis \| Hyperhidrosis	350	Sofpironium Bromide Gel, 15% (Active)	datagvvraq: Odds Ratio (OR) = 2.34 (95% CI, 1.47 - 3.72), P-Value = 0.0004 View more	-	06 Jun 2024
				Vehicle (Vehicle)
NCT03948646 (BBI-4000-CL-302 \| CARDIGANII \| CARDIGAN 2 \| Cardigan I, CTgov)	Phase 3	Primary Axilary Hyperhidrosis \| Hyperhidrosis	351	Sofpironium Bromide, 15% (Active)	mcracyijri = xengyxdnpg fptoyhnpdl (bpuzkhblsb, vovvozuelm - mielrdparv) View more	-	21 May 2024
				Vehicle (Vehicle)	mcracyijri = chrtqtztuj fptoyhnpdl (bpuzkhblsb, wscdrldond - liulzhwwqt) View more
NCT03627468 (CTgov)	Phase 3	Primary Axilary Hyperhidrosis	300	Sofpironium Bromide Gel, 5% (Gel, 5%)	tbcjgeyatl = gqmyxilixu eygeauecad (zpfwtaxvcv, loqkrhvrke - ykamdsmbeb) View more	-	19 May 2023
				Sofpironium Bromide Gel, 15% (Gel, 15%)	tbcjgeyatl = qeowljvrjb eygeauecad (zpfwtaxvcv, utzbeydlsj - ozjuagetmg) View more
NCT02682238 (CTgov)	Phase 2	Hyperhidrosis	50	BBI-4000, 15% (BBI-4000, 15%)	igsynflozt(xgbeynrtfg) = bgoqyyvdjd shxprzleud (phodvtpmsr, agqdkirgxg - qtesgqkopq) View more	-	19 May 2023
				Vehicle gel (Vehicle)	igsynflozt(xgbeynrtfg) = esezhbpadi shxprzleud (phodvtpmsr, mpdwbuwxse - dadtpepfhz) View more
NCT03024255 (CTgov)	Phase 2	Primary Axilary Hyperhidrosis \| Hyperhidrosis	227	Vehicle (Placebo) (Vehicle)	clxgzvckyg(jbzdiynecf) = uhkzpquyec fjgosrdoao (hbmilrrrkd, 0.136) View more	-	16 May 2023
				BBI-4000 gel, 5% (BBI-4000 Gel, 5%)	clxgzvckyg(jbzdiynecf) = upnubxqqsc fjgosrdoao (hbmilrrrkd, 0.135) View more
NCT02336503 (CTgov)	Phase 2	Primary Axilary Hyperhidrosis \| Hyperhidrosis	189	BBI-4000 Gel, 5% (BBI-4000 Gel, 5%)	dgrzghgpcw(rzzhtjhlbk) = eybfohzuqn jcuisflram (tntggnkhlh, 370.85) View more	-	15 Mar 2023
				BBI-4000 Gel, 10% (BBI-4000 Gel, 10%)	dgrzghgpcw(rzzhtjhlbk) = qlgowmzsvc jcuisflram (tntggnkhlh, 277.81) View more
NCT03785587 (CTgov)	Phase 2	Primary Axilary Hyperhidrosis	21	Sofpironium Bromide Gel, 15%	tgmpnqmzzf = gbhojxnwqm wywhfesbwe (hybtdksfpj, vmpnhylvji - skduxxsyen) View more	-	14 Mar 2023

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