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3 Trials |  |
62 News |  |
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- | Sofdra (sofpironium bromide) / Botanix Pharma
Journal: Sofpironium bromide: a novel solution in the battle against primary axillary hyperhidrosis. (Pubmed Central) - May 8, 2025
No abstract available
- ||| Sofdra (sofpironium bromide) / Botanix Pharma
P3 data, Journal: Sofpironium topical gel, 12.45%, for the treatment of axillary hyperhidrosis: pooled efficacy and safety results from 2 phase 3 randomized, controlled, double-blind studies. (Pubmed Central) - Mar 9, 2025
No abstract available Sofpironium topical gel, 12.45%, applied topically once daily before bedtime is effective and well-tolerated for treatment of primary axillary hyperhidrosis in patients ?9 years old.
- | Sofdra (sofpironium bromide) / Botanix Pharma
Journal: Catalytic Asymmetric Barbier Reaction of Ketones with Unactivated Alkyl Electrophiles. (Pubmed Central) - Oct 3, 2024
This enantioselective protocol is applied for the expedient synthesis of core structure of Sofdra, a very recent FDA-approved drug in 2024. The newly developed bisoxazolinephosphine (NPN) ligand enables high enantioselectivity in this asymmetric reductive addition process.
- | Sofdra (sofpironium bromide) / Botanix Pharma
Journal: Sofpironium (Sofdra) for primary axillary hyperhidrosis. (Pubmed Central) - Aug 13, 2024
The newly developed bisoxazolinephosphine (NPN) ligand enables high enantioselectivity in this asymmetric reductive addition process. No abstract available
- | Ecclock (sofpironium bromide) / Fresh Tracks Therap, Kaken Pharma
Retrospective data, Journal: Efficacy of 5% sofpironium bromide gel in Duchenne muscular dystrophy with palmoplantar hyperhidrosis: A retrospective case study. (Pubmed Central) - Jan 3, 2024
Treatment using 5% sofpironium bromide gel showed beneficial efficacy against palmoplantar hyperhidrosis in patients with advanced DMD. These findings warrant further investigation in future studies.
- | Ecclock (sofpironium bromide) / Brickell, Kaken Pharma
Journal: Efficacy of sofpironium bromide gel on clozapine-induced hypersalivation in patients with treatment-resistant schizophrenia: double-blind, controlled crossover study. (Pubmed Central) - Jan 14, 2023
These findings warrant further investigation in future studies. We suggest that sofpironium bromide gel is effective in treating clozapine-induced hypersalivation in patients with treatment-resistant schizophrenia.
- || Ecclock (sofpironium bromide) / Brickell, Kaken Pharma, Incruse Ellipta (umeclidinium) / GSK
Review, Journal: Hyperhidrosis: A Review of Recent Advances in Treatment with Topical Anticholinergics. (Pubmed Central) - Nov 5, 2022
Knowledge of topical anticholinergic treatment options is important for patient care when managing HH. This review shows that while available safety data thus far are limited, emerging topical anticholinergics pose minimal known human risks.
- | Ecclock (sofpironium bromide) / Brickell, Kaken Pharma
Observational data, Journal: Two-week prospective observational study of 5% sofpironium bromide gel in Japanese patients with primary axillary hyperhidrosis. (Pubmed Central) - Jun 8, 2022
Safety was evaluated in 92 patients in the safety analysis set, and no adverse events were reported during the study period of 2 weeks. These results suggest that after 1-week treatment with sofpironium for patients with a HDSS score of 3 or 4, approximately 50% of the patients can achieve a HDSS score of 1 or 2, which is a clinically significant improvement for the patients.
- || Ecclock (sofpironium bromide) / Brickell, Kaken Pharma
Review, Journal: Hyperhidrosis: disease aetiology, classification and management in the light of modern treatment modalities. (Pubmed Central) - Jun 4, 2022
Therefore, the researchers continue a robust pursuit of novel therapy modalities such as topical treatment methods, oral agents, minimally-invasive medical approach and surgical techniques. In this review article authors summarise the disease outline with the emphasis on the new era of hyperhidrosis treatment methods.
- | Ecclock (sofpironium bromide) / Brickell, Kaken Pharma
Journal: SUPPLEMENT ARTICLE: A Novel Drug Delivery Method: Retrometabolic Drug Design. (Pubmed Central) - Apr 14, 2022
Soft drugs have been approved for use in multiple medical specialties, such as the soft corticosteroid loteprednol etabonate for treatment of inflammatory ophthalmic disorders and soft beta-blocker derivatives for treatment of hypertensive emergencies in cardiology...The soft anticholinergic sofpironium bromide represents the latest expansion of soft drug use in dermatology for the treatment of primary axillary hyperhidrosis (PAH)...J Drugs Dermatol. 2022;21:4(Suppl 2):s5-10.
- Ecclock (sofpironium bromide) / Brickell, Kaken Pharma
Topically Applied Sofpironium Bromide Gel, 15% for the Treatment of Primary Axillary Hyperhidrosis: Results from the Cardigan I and Cardigan II Phase 3 Multicenter, Randomized, Placebo Controlled Tria (210A) - Mar 6, 2022 - Abstract #AAD2022AAD_1716;
- | Ecclock (sofpironium bromide) / Brickell, Kaken Pharma
Journal: Sofpironium bromide: an investigational agent for the treatment of axillary hyperhidrosis. (Pubmed Central) - Feb 26, 2022
However, this therapy still offers a temporary control of PAH, compared to sympathectomy or device-based treatments, such as microwave thermolysis. Hence, physicians should balance the effectiveness against adverse events of each therapeutic modality and use a personalized approach based on patient's needs.
- ||||||| Sofdra (sofpironium bromide) / Botanix Pharma
Trial completion: Cardigan II: Safety and Efficacy Study of Sofpironium Bromide in Subjects With Axillary Hyperhidrosis (BBI-4000-CL-302) (clinicaltrials.gov) - Oct 6, 2021
P3, N=351, Completed, Sponsor: Brickell Biotech, Inc.
Hence, physicians should balance the effectiveness against adverse events of each therapeutic modality and use a personalized approach based on patient's needs. Active, not recruiting --> Completed
- || Ecclock (sofpironium bromide) / Brickell, Kaken Pharma
Review, Journal: Sofpironium Bromide: First Approval. (Pubmed Central) - Aug 28, 2021
Clinical studies are currently ongoing in the USA to assess the safety and efficacy of sofpironium bromide gel 15% in PAH. This article summarizes the milestones in the development of sofpironium bromide gel leading to this first approval for the treatment of PAH.
- || Sofdra (sofpironium bromide) / Botanix Pharma
Trial completion: A Safety Study of BBI-4000 Gel in Pediatric Patients With Axillary Hyperhidrosis (clinicaltrials.gov) - Aug 24, 2021
P2, N=25, Completed, Sponsor: Brickell Biotech, Inc.
This article summarizes the milestones in the development of sofpironium bromide gel leading to this first approval for the treatment of PAH. Active, not recruiting --> Completed
- ||| Ecclock (sofpironium bromide) / Brickell, Kaken Pharma
Clinical, P3 data, Journal: A phase III, 52-week, open-label study to evaluate the safety and efficacy of 5% sofpironium bromide (BBI-4000) gel in Japanese patients with primary axillary hyperhidrosis. (Pubmed Central) - Aug 5, 2021
Serious AEs occurred in three patients, but none were considered related to the study drug. In this study, the efficacy of sofpironium was maintained during 52-week treatment, and no new safety risk was observed.
- || Ecclock (sofpironium bromide) / Brickell, Kaken Pharma, Incruse Ellipta (umeclidinium) / GSK
Clinical, Journal: Investigational topical anticholinergics in clinical development for the treatment of hyperhidrosis. (Pubmed Central) - Jul 29, 2021
In this study, the efficacy of sofpironium was maintained during 52-week treatment, and no new safety risk was observed. No abstract available
- | Ecclock (sofpironium bromide) / Brickell, Kaken Pharma
Journal: Hyperhidrosis Disease Severity Measure-Axillary (HDSM-Ax): Evaluation of Measurement Performance. (Pubmed Central) - Jul 21, 2021
J Drugs Dermatol.20(4):410-418. doi:10.36849/JDD.5569.
- ||||| Sofdra (sofpironium bromide) / Botanix Pharma
Enrollment closed: Cardigan II: Safety and Efficacy Study of Sofpironium Bromide in Subjects With Axillary Hyperhidrosis (BBI-4000-CL-302) (clinicaltrials.gov) - Jul 7, 2021
P3, N=351, Active, not recruiting, Sponsor: Brickell Biotech, Inc.
doi:10.36849/JDD.5569. Recruiting --> Active, not recruiting
- ||||||| Sofdra (sofpironium bromide) / Botanix Pharma
Trial completion: Cardigan I: Safety and Efficacy Study of Sofpironium Bromide in Subjects With Axillary Hyperhidrosis (BBI-4000-CL-301) (clinicaltrials.gov) - Jul 7, 2021
P3, N=350, Completed, Sponsor: Brickell Biotech, Inc.
Recruiting --> Active, not recruiting Active, not recruiting --> Completed
- Ecclock (sofpironium bromide) / Brickell, Kaken Pharma
[VIRTUAL] An Open-Label, Repeat-Dose, Maximum-Use Study to Evaluate the Pharmacokinetics of Sofpironium Bromide Gel, 15% Topically Applied in Subjects with Primary Axillary Hyperhidrosis () - Jun 23, 2021 - Abstract #SDDS2021SDDS_71;
- Ecclock (sofpironium bromide) / Brickell, Kaken Pharma
[VIRTUAL] A Multi-Center, Open-Label Study to Assess the Long-term Safety/Tolerability, and Pharmacokinetics, and Explore the Efficacy of Sofpironium Bromide Gel, 15% Applied Topically to Children and Adolescents, 9 to 16 Years of Age, with Primary Axillary Hyperhidrosis () - May 29, 2021 - Abstract #SBS2021SBS_154;
There was no evidence of drug accumulation. There was clinically meaningful improvement in axillary hyperhidrosis.
- ||| Ecclock (sofpironium bromide) / Brickell, Kaken Pharma
Clinical, P3 data, Journal: A phase 3, multicenter, randomized, double-blind, vehicle-controlled, parallel-group study of 5% sofpironium bromide (BBI-4000) gel in Japanese patients with primary axillary hyperhidrosis. (Pubmed Central) - May 15, 2021
In the sofpironium group, common events (incidence, ≥5%) were nasopharyngitis (14.2%) and dermatitis/erythema at the application site (8.5%/5.7%), with no serious adverse events reported. This study demonstrated the efficacy and safety of 5% sofpironium.
- ||||| Sofdra (sofpironium bromide) / Botanix Pharma
Enrollment closed: Cardigan I: Safety and Efficacy Study of Sofpironium Bromide in Subjects With Axillary Hyperhidrosis (BBI-4000-CL-301) (clinicaltrials.gov) - May 4, 2021
P3, N=350, Active, not recruiting, Sponsor: Brickell Biotech, Inc.
This study demonstrated the efficacy and safety of 5% sofpironium. Recruiting --> Active, not recruiting
- | methylphenidate tablet / Generic mfg.
Journal: Soft drugs: design principles, success stories, and future perspectives. (Pubmed Central) - Mar 13, 2021
Recruiting --> Active, not recruiting No abstract available
- || Ecclock (sofpironium bromide) / Brickell, Kaken Pharma
Clinical, P2 data, Journal: Efficacy and Safety of Topical Sofpironium Bromide Gel for the Treatment of Axillary Hyperhidrosis: A Phase II, Randomized, Controlled, Double-Blinded Trial. (Pubmed Central) - Jan 23, 2021
No abstract available Sofpironium bromide gel produced meaningful reductions in hyperhidrosis severity and had an acceptable safety profile.
- |||||| Sofdra (sofpironium bromide) / Botanix Pharma
Enrollment open, Trial completion date, Trial primary completion date: Cardigan II: Safety and Efficacy Study of Sofpironium Bromide in Subjects With Axillary Hyperhidrosis (BBI-4000-CL-302) (clinicaltrials.gov) - Dec 3, 2020
P3, N=350, Recruiting, Sponsor: Brickell Biotech, Inc.
Sofpironium bromide gel produced meaningful reductions in hyperhidrosis severity and had an acceptable safety profile. Not yet recruiting --> Recruiting | Trial completion date: Oct 2020 --> Sep 2021 | Trial primary completion date: Oct 2020 --> Sep 2021
- sofpironium bromide (BBI-4000) / Brickell, Kaken
[VIRTUAL] A Multi-Center, Open-Label Extension Study to Assess the Long-Term Safety, Tolerability and Pharmacokinetics, and Explore the Efficacy of Sofpironium Bromide Gel, 15% Applied Topically to Children/Adolescents, 9-16 Years, with Primary Axillary Hyperhidrosis () - Nov 25, 2020 - Abstract #FCDC2020FCDC_264;
Not yet recruiting --> Recruiting | Trial completion date: Oct 2020 --> Sep 2021 | Trial primary completion date: Oct 2020 --> Sep 2021 Abstract not available.
- sofpironium bromide (BBI-4000) / Brickell, Kaken
[VIRTUAL] A Four-Way, Cross-Over Design, Randomized, Double-Blinded, Placebo-&Active-Controlled Study for the Evaluation of the Effect of a Supratherapeutic Dose of Sofpironium Bromide Gel, 15% Applied Topically on the QT/QTc Intervals in Adult Healthy Volunteers () - Nov 25, 2020 - Abstract #FCDC2020FCDC_259;
Abstract not available. Abstract not available.
- ||| sofpironium bromide (BBI-4000) / Brickell, Kaken
Launch Japan: $BBI Brickell Biotech Announces Launch Date for Sofpironium Bromide Gel, 5% (ECCLOCK®) in Japan by its Development Partner, Kaken Pharmaceutical https://t.co/4sJsdwn0m1 (Twitter) - Nov 18, 2020
- |||||| Sofdra (sofpironium bromide) / Botanix Pharma
Enrollment open, Trial completion date, Trial primary completion date: Cardigan I: Safety and Efficacy Study of Sofpironium Bromide in Subjects With Axillary Hyperhidrosis (BBI-4000-CL-301) (clinicaltrials.gov) - Oct 12, 2020
P3, N=350, Recruiting, Sponsor: Brickell Biotech, Inc.
Abstract not available. Not yet recruiting --> Recruiting | Trial completion date: Oct 2020 --> Jul 2021 | Trial primary completion date: Oct 2020 --> Jul 2021
- ||||||| Sofdra (sofpironium bromide) / Botanix Pharma
Trial completion: A Safety Study of BBI-4000 Gel in Patients With Axillary Hyperhidrosis (clinicaltrials.gov) - Aug 30, 2020
P3, N=300, Completed, Sponsor: Brickell Biotech, Inc.
Not yet recruiting --> Recruiting | Trial completion date: Oct 2020 --> Jul 2021 | Trial primary completion date: Oct 2020 --> Jul 2021 Active, not recruiting --> Completed
- sofpironium bromide (BBI-4000) / Brickell, Kaken
[VIRTUAL] A Phase 3, Randomized, Double-Blinded, Vehicle-Controlled Study to Evaluate the Safety and Efficacy of Topically Applied Sofpironium Bromide Gel, 5% in Japanese Patients with Primary Axillary Hyperhidrosis () - May 27, 2020 - Abstract #AADVMX2020AAD-VMX_111;
- || sofpironium bromide (BBI-4000) / Brickell, Kaken, loteprednol etabonate / Generic mfg.
Clinical, Journal: Development and clinical success of novel soft drugs (Pubmed Central) - Mar 8, 2020
Sofpironium bromide, a highly effective molecule but without the typical anticholinergic side effects, was first developed to treat hyperhidrosis, an unmet need...Orv Hetil. 2020; 161(10): 363-373.
- | Sofdra (sofpironium bromide) / Botanix Pharma
Trial completion date, Trial initiation date, Trial primary completion date: Cardigan I: Safety and Efficacy Study of Sofpironium Bromide in Subjects With Axillary Hyperhidrosis (BBI-4000-CL-301) (clinicaltrials.gov) - Jul 11, 2019
P3, N=450, Not yet recruiting, Sponsor: Brickell Biotech, Inc.
2020; 161(10): 363-373. Trial completion date: Feb 2020 --> Oct 2020 | Initiation date: Jun 2019 --> Oct 2019 | Trial primary completion date: Feb 2020 --> Oct 2020
- | Sofdra (sofpironium bromide) / Botanix Pharma
Trial completion date, Trial initiation date, Trial primary completion date: Cardigan II: Safety and Efficacy Study of Sofpironium Bromide in Subjects With Axillary Hyperhidrosis (BBI-4000-CL-302) (clinicaltrials.gov) - Jul 10, 2019
P3, N=450, Not yet recruiting, Sponsor: Brickell Biotech, Inc.
Trial completion date: Feb 2020 --> Oct 2020 | Initiation date: Jun 2019 --> Oct 2019 | Trial primary completion date: Feb 2020 --> Oct 2020 Trial completion date: Feb 2020 --> Oct 2020 | Initiation date: Jun 2019 --> Oct 2019 | Trial primary completion date: Feb 2020 --> Oct 2020
- |||||||||| Sofdra (sofpironium bromide) / Botanix Pharma
New P3 trial: Cardigan II: Safety and Efficacy Study of Sofpironium Bromide in Subjects With Axillary Hyperhidrosis (BBI-4000-CL-302) (clinicaltrials.gov) - May 13, 2019
P3, N=450, Not yet recruiting, Sponsor: Brickell Biotech, Inc.
- ||||| Sofdra (sofpironium bromide) / Botanix Pharma
Enrollment closed: A Safety Study of BBI-4000 Gel in Patients With Axillary Hyperhidrosis (clinicaltrials.gov) - Mar 13, 2019
P3, N=300, Active, not recruiting, Sponsor: Brickell Biotech, Inc.
Trial completion date: Feb 2020 --> Oct 2020 | Initiation date: Jun 2019 --> Oct 2019 | Trial primary completion date: Feb 2020 --> Oct 2020 Recruiting --> Active, not recruiting
- | Sofdra (sofpironium bromide) / Botanix Pharma
Enrollment closed: A Safety Study of BBI-4000 Gel in Pediatric Patients With Axillary Hyperhidrosis (clinicaltrials.gov) - Mar 13, 2019
P2, N=25, Active, not recruiting, Sponsor: Brickell Biotech, Inc.
Recruiting --> Active, not recruiting Enrolling by invitation --> Active, not recruiting
- |||||||||| Sofdra (sofpironium bromide) / Botanix Pharma
New P3 trial: Cardigan I: Safety and Efficacy Study of Sofpironium Bromide in Subjects With Axillary Hyperhidrosis (BBI-4000-CL-301) (clinicaltrials.gov) - Feb 10, 2019
P3, N=496, Not yet recruiting, Sponsor: Brickell Biotech, Inc.
- || Sofdra (sofpironium bromide) / Botanix Pharma
New P2 trial: A Safety Study of BBI-4000 Gel in Pediatric Patients With Axillary Hyperhidrosis (clinicaltrials.gov) - Dec 23, 2018
P2, N=24, Enrolling by invitation, Sponsor: Brickell Biotech, Inc.
- | Sofdra (sofpironium bromide) / Botanix Pharma
Enrollment open: A Safety Study of BBI-4000 Gel in Patients With Axillary Hyperhidrosis (clinicaltrials.gov) - Oct 16, 2018
P3, N=300, Recruiting, Sponsor: Brickell Biotech, Inc.
Enrolling by invitation --> Active, not recruiting Not yet recruiting --> Recruiting
- | Sofdra (sofpironium bromide) / Botanix Pharma
New P3 trial: A Safety Study of BBI-4000 Gel in Patients With Axillary Hyperhidrosis (clinicaltrials.gov) - Aug 13, 2018
P3, N=300, Not yet recruiting, Sponsor: Brickell Biotech, Inc.
- |||| Sofdra (sofpironium bromide) / Botanix Pharma
Trial completion: A Confirmatory Safety and Efficacy Study of BBI-4000 in Subjects With Axillary Hyperhidrosis (clinicaltrials.gov) - Jan 19, 2018
P2, N=227, Completed, Sponsor: Brickell Biotech, Inc.
Not yet recruiting --> Recruiting Active, not recruiting --> Completed
- ||| Sofdra (sofpironium bromide) / Botanix Pharma
Enrollment closed: A Confirmatory Safety and Efficacy Study of BBI-4000 in Subjects With Axillary Hyperhidrosis (clinicaltrials.gov) - Jul 17, 2017
P2, N=220, Active, not recruiting, Sponsor: Brickell Biotech, Inc.
Active, not recruiting --> Completed Recruiting --> Active, not recruiting
- ||||| Sofdra (sofpironium bromide) / Botanix Pharma
New P2 trial: A Confirmatory Safety and Efficacy Study of BBI-4000 in Subjects With Axillary Hyperhidrosis (clinicaltrials.gov) - Jan 18, 2017
P2, N=220, Recruiting, Sponsor: Brickell Biotech, Inc.
- | Sofdra (sofpironium bromide) / Botanix Pharma
Trial completion: A Safety, Tolerability and Preliminary Efficacy Study of BBI-4000 Gel in Subjects With Palmar Hyperhidrosis (clinicaltrials.gov) - Aug 24, 2016
P2, N=50, Completed, Sponsor: Brickell Biotech, Inc.
Recruiting --> Active, not recruiting Active, not recruiting --> Completed
- | Sofdra (sofpironium bromide) / Botanix Pharma
Enrollment closed, Enrollment change: A Safety, Tolerability and Preliminary Efficacy Study of BBI-4000 Gel in Subjects With Palmar Hyperhidrosis (clinicaltrials.gov) - Jun 9, 2016
P2, N=50, Active, not recruiting, Sponsor: Brickell Biotech, Inc.
Active, not recruiting --> Completed Not yet recruiting --> Active, not recruiting | N=40 --> 50
- | Sofdra (sofpironium bromide) / Botanix Pharma
New P2 trial: A Safety, Tolerability and Preliminary Efficacy Study of BBI-4000 Gel in Subjects With Palmar Hyperhidrosis (clinicaltrials.gov) - Feb 16, 2016
P2, N=40, Not yet recruiting, Sponsor: Brickell Biotech, Inc.
- |||| Sofdra (sofpironium bromide) / Botanix Pharma
Trial completion: A Safety and Efficacy Study of BBI-4000 in Subjects With Axillary Hyperhidrosis (clinicaltrials.gov) - Dec 18, 2015
P2, N=189, Completed, Sponsor: Brickell Biotech, Inc.
Not yet recruiting --> Active, not recruiting | N=40 --> 50 Active, not recruiting --> Completed