CLINICAL TRIALS PROFILE FOR SOFPIRONIUM BROMIDE

All Clinical Trials for sofpironium bromide

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT02682238 ↗	A Safety, Tolerability and Preliminary Efficacy Study of BBI-4000 Gel in Subjects With Palmar Hyperhidrosis	Completed	Brickell Biotech, Inc.	Phase 2	2016-02-01	To assess the safety and local tolerability of BBI-4000 15% gel compared with vehicle (placebo) when applied topically once daily in subjects with palmar hyperhidrosis.
NCT03024255 ↗	A Confirmatory Safety and Efficacy Study of BBI-4000 in Subjects With Axillary Hyperhidrosis	Completed	Brickell Biotech, Inc.	Phase 2	2016-12-01	This study is being conducted to assess the safety and efficacy of 3 concentrations of BBI-4000 and vehicle (4 treatment arms), applied for the treatment of axillary hyperhidrosis.
NCT03627468 ↗	A Safety Study of BBI-4000 Gel in Patients With Axillary Hyperhidrosis	Completed	Brickell Biotech, Inc.	Phase 3	2018-09-05	Hyperhidrosis is a disorder of abnormal excessive sweating. Primary hyperhidrosis (armpits, hands, and feet) affects approximately 4.8% of the US population and is believed to be caused by an overactive cholinergic response of the sweat glands. Current therapies have limited effectiveness, significant side effects, and can be invasive and costly. Sofpironium bromide (BBI-4000) is a novel soft-drug in development for the topical treatment of hyperhidrosis. This Phase 3 study will assess the long-term safety, tolerability, and efficacy of sofpironium bromide gel applied topically to subjects with axillary hyperhidrosis.
NCT03785587 ↗	A Safety Study of BBI-4000 Gel in Pediatric Patients With Axillary Hyperhidrosis	Completed	Brickell Biotech, Inc.	Phase 2	2018-12-21	Hyperhidrosis is a disorder of abnormal excessive sweating. Primary hyperhidrosis (armpits, hands, and feet) affects approximately 4.8% of the US population and is believed to be caused by an overactive cholinergic response of the sweat glands. Sofpironium bromide (BBI-4000) is a novel soft-drug in development for the topical treatment of hyperhidrosis. This Phase 2 study will assess the long-term safety, tolerability, pharmacokinetics and efficacy of sofpironium bromide gel applied topically to pediatric subjects with axillary hyperhidrosis.
NCT03836287 ↗	Safety and Efficacy Study of Sofpironium Bromide in Subjects With Axillary Hyperhidrosis (BBI-4000-CL-301)	Completed	Brickell Biotech, Inc.	Phase 3	2020-10-09	Hyperhidrosis is a disorder of abnormal excessive sweating. Primary hyperhidrosis (armpits, hands, and feet) affects approximately 4.8% of the US population and is believed to be caused by an overactive cholinergic response of the sweat glands. Current therapies have limited effectiveness, significant side effects, and can be invasive and costly. Sofpironium bromide (BBI-4000) is a novel soft-drug in development for the topical treatment of hyperhidrosis. This Phase 3 study will assess the safety and efficacy of sofpironium bromide, 15% gel versus vehicle (2 treatment arms), applied for the treatment of axillary hyperhidrosis.
NCT03948646 ↗	Safety and Efficacy Study of Sofpironium Bromide in Subjects With Axillary Hyperhidrosis (BBI-4000-CL-302)	Completed	Brickell Biotech, Inc.	Phase 3	2020-12-04	Hyperhidrosis is a disorder of abnormal excessive sweating. Primary hyperhidrosis (armpits, hands, and feet) affects approximately 4.8% of the US population and is believed to be caused by an overactive cholinergic response of the sweat glands. Current therapies have limited effectiveness, significant side effects, and can be invasive and costly. Sofpironium bromide (BBI-4000) is a novel soft-drug in development for the topical treatment of hyperhidrosis. This Phase 3 study will assess the safety and efficacy of sofpironium bromide, 15% gel versus vehicle (2 treatment arms), applied for the treatment of axillary hyperhidrosis.

Clinical Trial Conditions for sofpironium bromide

Condition Name

Condition Name for sofpironium bromide
Intervention	Trials
Axillary Hyperhidrosis	2
Hyperhidrosis	2
Primary Axillary Hyperhidrosis	2

Condition MeSH

Condition MeSH for sofpironium bromide
Intervention	Trials
Hyperhidrosis	6

Clinical Trial Locations for sofpironium bromide

Trials by Country

Trials by Country for sofpironium bromide
Location	Trials
United States	63

Trials by US State

Trials by US State for sofpironium bromide
Location	Trials
Arkansas	4
Florida	4
Alabama	3
Missouri	3
Indiana	3

Clinical Trial Progress for sofpironium bromide

Clinical Trial Phase

Clinical Trial Phase for sofpironium bromide
Clinical Trial Phase	Trials
Phase 3	3
Phase 2	3

Clinical Trial Status

Clinical Trial Status for sofpironium bromide
Clinical Trial Phase	Trials
Completed	6

Clinical Trial Sponsors for sofpironium bromide

Sponsor Name

Sponsor Name for sofpironium bromide
Sponsor	Trials
Brickell Biotech, Inc.	6

Sponsor Type

Sponsor Type for sofpironium bromide
Sponsor	Trials
Industry	6

Sofpironium bromide Market Analysis and Financial Projection

Sofpironium Bromide: Clinical Trials, Market Analysis, and Projections

Introduction to Sofpironium Bromide

Sofpironium bromide is a topical anticholinergic drug designed for the treatment of primary axillary hyperhidrosis, a condition characterized by excessive sweating in the underarm area. Developed by Brickell Biotech and partnered with companies like Kaken Pharmaceuticals, this drug has been through extensive clinical trials and is showing promising results.

Clinical Trials Update

Phase 3 Trials in the USA

Brickell Biotech has completed two pivotal Phase 3 clinical trials, known as Cardigan I and Cardigan II, in the United States. These trials involved approximately 350 subjects each, aged nine years and older, diagnosed with primary axillary hyperhidrosis. The studies were multicenter, randomized, double-blinded, and vehicle-controlled, evaluating the efficacy and safety of sofpironium bromide gel at a 15% concentration[4].

• Study Design: Participants applied sofpironium bromide gel or a placebo to their underarms once daily at bedtime for six consecutive weeks, followed by a two-week post-treatment follow-up.
• Endpoints: The co-primary efficacy endpoints included the proportion of subjects achieving at least a 2-point improvement on the Hyperhidrosis Disease Severity Measure-Axillary (HDSM-Ax) scale and the change in gravimetric sweat production (GSP) from baseline to the end of treatment[4].

Safety and Tolerability

In addition to the Phase 3 trials, Brickell Biotech conducted several studies to assess the safety and tolerability of sofpironium bromide at high doses and with different application techniques. These studies, presented at various medical meetings, found that even under extreme conditions, the drug was safe and generally well-tolerated with no significant systemic side effects[1].

Japanese Approval and Trials

Kaken Pharmaceuticals completed a Phase 3 trial in Japan, which achieved statistical significance on all primary and secondary endpoints. Based on these positive results, Kaken submitted a new drug application (NDA) for sofpironium bromide in Japan, where it has been approved and is marketed under the brand name "ECCLOCK"[3].

Market Analysis

Market Opportunity

The market for hyperhidrosis treatments is substantial and growing. In the United States alone, more than 16 million people suffer from hyperhidrosis, with the market valued at approximately $1.6 billion per annum and projected to grow to $2.8 billion by 2030[2].

Stakeholder Feedback

An initial market research study conducted by Botanix Pharmaceuticals, involving 20 independent dermatologists, 10 insurance companies, and 10 patients, highlighted a significant market opportunity for sofpironium bromide. The study revealed positive feedback from key stakeholders, indicating an unmet need for effective and accessible treatments for axillary hyperhidrosis[2].

Sales Performance in Japan

The strong sales performance of sofpironium bromide in Japan, where it is branded as "ECCLOCK," provides insights into its potential in other markets. Sales grew by 71% year-over-year to ¥700 million in Q2 2023, with Kaken upgrading its full-year sales target to ¥2.1 billion, implying a 67% year-over-year growth[5].

Market Projections

U.S. Market Potential

Given the positive Phase 3 data and the significant market opportunity, sofpironium bromide is poised to make a substantial impact in the U.S. market. If the NDA submission to the FDA is successful, which is anticipated in mid-2022 pending the outcome of the Phase 3 trials, the drug could capture a significant share of the growing hyperhidrosis treatment market[4].

Global Expansion

The approval and successful sales in Japan, combined with the ongoing clinical trials in the U.S., suggest a strong potential for global expansion. As more countries approve sofpironium bromide, the global market for this drug is expected to expand, catering to the unmet needs of patients suffering from primary axillary hyperhidrosis worldwide.

Regulatory Pathway

NDA Submission

Brickell Biotech plans to submit an NDA for sofpironium bromide gel, 15%, to the U.S. FDA in mid-2022, pending the favorable outcome of the Phase 3 trials. This submission is a critical step towards gaining regulatory approval and bringing the drug to the U.S. market[4].

Approval in Japan

Sofpironium bromide has already been approved in Japan, where it is marketed by Kaken Pharmaceuticals. This approval has de-risked the FDA approval process to some extent, as the positive Phase 3 data and regulatory approval in Japan provide strong evidence of the drug's safety and efficacy[3].

Key Takeaways

• Clinical Trials: Sofpironium bromide has completed Phase 3 trials in the U.S. and Japan, showing promising results in treating primary axillary hyperhidrosis.
• Safety and Tolerability: The drug has been found to be safe and well-tolerated, even at high doses and with different application techniques.
• Market Opportunity: The U.S. market for hyperhidrosis treatments is valued at $1.6 billion and is projected to grow to $2.8 billion by 2030.
• Stakeholder Feedback: Positive feedback from dermatologists, insurance companies, and patients indicates a significant market opportunity.
• Sales Performance: Strong sales in Japan suggest a potential for similar success in other markets.
• Regulatory Pathway: An NDA submission to the FDA is anticipated in mid-2022, pending favorable Phase 3 trial outcomes.

FAQs

What is sofpironium bromide used for?

Sofpironium bromide is used for the treatment of primary axillary hyperhidrosis, a condition characterized by excessive sweating in the underarm area.

What are the key findings from the Phase 3 trials in the U.S.?

The Phase 3 trials (Cardigan I and Cardigan II) in the U.S. have shown that sofpironium bromide gel, 15%, is effective and safe in treating primary axillary hyperhidrosis, with significant improvements in Hyperhidrosis Disease Severity Measure-Axillary (HDSM-Ax) scale and gravimetric sweat production (GSP)[4].

Is sofpironium bromide approved in any country?

Yes, sofpironium bromide has been approved in Japan under the brand name "ECCLOCK"[3].

What is the market potential for sofpironium bromide in the U.S.?

The U.S. market for hyperhidrosis treatments is substantial, valued at $1.6 billion and projected to grow to $2.8 billion by 2030, indicating a significant market opportunity for sofpironium bromide[2].

When is the NDA submission to the FDA expected?

The NDA submission for sofpironium bromide gel, 15%, to the U.S. FDA is anticipated in mid-2022, pending the favorable outcome of the Phase 3 trials[4].

Sources

1. Hyperhidrosis Research & Treatment Report 2021: Part 1 - SweatHelp.org
2. Initial Market Research Sofpironium Bromide - Aspect Huntley
3. BRICKELL BIOTECH, INC. - Annual Reports - AnnualReports.com
4. Brickell Biotech Announces Final Patient Completed Second U.S. Phase 3 Pivotal Clinical Study of Sofpironium Bromide Gel, 15 Percent for the Treatment of Primary Axillary Hyperhidrosis - BioSpace
5. Research note | Continued Strong Sales from Japanese Partner - Botanix Pharmaceuticals