Sofdra (sofpironium)
Research Synopsis
- Sofdra (sofpironium bromide) is a novel topical gel approved in Japan for treating primary axillary hyperhidrosis (PAH) as of September 2020, offering a noninvasive option for excessive sweating management.! * The drug's development utilizes retrometabolic drug design principles, which optimize drug effectiveness while minimizing side effects by enhancing metabolism through targeted actions.! * Clinical trials have demonstrated significant efficacy; a phase II trial indicated a marked improvement in sweat severity compared to placebo, with most adverse effects being mild to moderate.! * In phase 3 studies, the 5% formulation of sofpironium gel achieved a 53.9% success rate in treating PAH, considerably higher than the control group, reaffirming its effectiveness.! * Long-term studies showed consistent efficacy over 52 weeks, with a majority of participants experiencing significant reductions in sweat production, alongside a favorable safety profile.! * Sofpironium's design facilitates minimal systemic absorption, which reduces potential side effects and enhances patient adherence compared to traditional treatments.! * Recent research highlighted its use in managing clozapine-induced hypersalivation in schizophrenia patients, marking its versatility beyond just hyperhidrosis treatment.! * Additional studies explored its effectiveness for secondary hyperhidrosis in patients with Duchenne muscular dystrophy, showing promising results and suggesting further research potential.! * Ongoing clinical studies in the U.S. are evaluating an even stronger formulation of sofpironium, indicating continued interest in advancing its therapeutic application.! * Overall, sofpironium represents a significant advancement in the treatment landscape for hyperhidrosis, with favorable efficacy and safety outcomes supported by extensive clinical research.!
Sofdra (sofpironium)
[Development and clinical success of novel soft drugs].
London, UK
2 hours ago
1 Received
- Retrometabolic drug design merges structure-activity and structure-metabolism relationships to enhance the therapeutic index by minimizing side effects while maximizing effectiveness.
- This approach strategically incorporates metabolism into the drug design through two methods: chemical drug-targeting systems and soft drugs, which focus on utilizing hydrolytic enzymes for targeted actions.
- The text emphasizes successful examples of soft drugs, including loteprednol etabonate for ophthalmic use and sofironium bromide for treating hyperhidrosis, both of which show improved safety profiles and effectiveness.
$100 - $150
Hourly Rate
Efficacy and safety of topical sofpironium bromide gel for the treatment of axillary hyperhidrosis: A phase II, randomized, controlled, double-blinded trial.
London, UK
2 hours ago
1 Received
- Primary axillary hyperhidrosis has few effective noninvasive treatments, prompting a study on sofpironium bromide as a topical solution.
- A phase II trial involved participants receiving daily treatment over 42 days, assessing improvement in sweat severity using the HDSM-Ax score.
- Results showed significant improvement in sweat severity for those using sofpironium bromide compared to a placebo, with most side effects being mild to moderate.
$100 - $150
Hourly Rate
Soft drugs: design principles, success stories, and future perspectives.
London, UK
2 hours ago
1 Received
$100 - $150
Hourly Rate
Sofpironium Bromide: First Approval.
London, UK
2 hours ago
1 Received
- Sofpironium bromide (marketed as ECCLOCK in Japan) is a topical gel that helps reduce excessive sweating by blocking specific receptors in sweat glands.
- The gel gained its first approval in Japan in September 2020 for treating primary axillary hyperhidrosis (PAH).
- Ongoing clinical studies in the USA aim to evaluate the safety and effectiveness of a stronger 15% formulation of the gel for PAH treatment.
$100 - $150
Hourly Rate
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.
London, UK
2 hours ago
1 Received
- A phase 3 study tested the effectiveness and safety of 5% sofpironium bromide gel over 6 weeks in Japanese patients with severe underarm sweating (primary axillary hyperhidrosis).
- Out of 281 patients, those using sofpironium showed a 53.9% success rate in meeting the treatment goals compared to 36.4% in the control group, indicating a statistically significant improvement.
- While adverse events occurred in 44.0% of the sofpironium group (mainly mild), serious side effects were not reported, confirming that sofpironium is both effective and relatively safe for treating this condition.
$100 - $150
Hourly Rate
Hyperhidrosis Disease Severity Measure-Axillary (HDSM-Ax): Evaluation of Measurement Performance.
London, UK
2 hours ago
1 Received
- Clinical trials for primary axillary hyperhidrosis (AHH) need effective ways to measure severity from the patient's viewpoint, leading to the development of the Hyperhidrosis Disease Severity Measure-Axillary (HDSM-Ax) scale.
- The objective of this study was to assess the HDSM-Ax's psychometric performance and determine what constitutes a significant change in AHH severity during a clinical trial for sofpironium bromide gel.
- Findings show that HDSM-Ax meets psychometric standards and that a change of 1 point on the severity scale is clinically meaningful for patients experiencing AHH.
$100 - $150
Hourly Rate
Investigational topical anticholinergics in clinical development for the treatment of hyperhidrosis.
London, UK
2 hours ago
1 Received
$100 - $150
Hourly Rate
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.
London, UK
2 hours ago
1 Received
- A long-term study on Japanese patients with primary axillary hyperhidrosis evaluated the safety and efficacy of 5% sofpironium bromide gel over 52 weeks, following a brief confirmatory study.
- Out of 185 participants, a majority were female (73%) with a median age of 38; efficacy results showed 57.4% in the switching group and 58.2% in the extension group achieved significant sweat reduction at the end of the study.
- Adverse events were common but generally mild, with application site dermatitis and nasopharyngitis being the most frequent; no serious complications related to the drug were reported.
$100 - $150
Hourly Rate
Sofpironium bromide: an investigational agent for the treatment of axillary hyperhidrosis.
London, UK
2 hours ago
1 Received
- Increased understanding of primary hyperhidrosis has led to new treatment options, including topical and systemic anticholinergic agents, though the latter carries a risk of side effects.
- The paper focuses on sofpironium bromide (SB), a topical anticholinergic gel recently approved in Japan, highlighting its benefits, efficacy, and safety based on clinical trials.
- SB's design minimizes systemic absorption, which reduces side effects and improves patient adherence, but it provides only temporary relief compared to more permanent solutions like sympathectomy or microwave thermolysis, necessitating a tailored approach from physicians.
$100 - $150
Hourly Rate
Hyperhidrosis: disease aetiology, classification and management in the light of modern treatment modalities.
London, UK
2 hours ago
1 Received
- - Hyperhidrosis is a condition where the sweat glands produce excessive sweat, which doesn't meet the body's temperature control needs.
- - Current treatments for hyperhidrosis are inadequate, creating significant social and economic challenges for those affected.
- - Researchers are exploring new treatment options, including topical treatments, oral medications, minimally-invasive procedures, and surgery, aiming to improve patient outcomes.
$100 - $150
Hourly Rate
SUPPLEMENT ARTICLE: A Novel Drug Delivery Method: Retrometabolic Drug Design.
London, UK
2 hours ago
1 Received
- Soft drugs are specially designed to quickly break down in the body after achieving their therapeutic effects, reducing overall toxicity and side effects while improving effectiveness in targeted areas.
- They have been successfully used across various medical fields, particularly in treating conditions like eye inflammation and hypertension, as well as in dermatology to minimize systemic absorption.
- The latest soft drug, sofpironium bromide, effectively treats excessive sweating with fewer side effects compared to traditional options, showing promising results in clinical trials in both Japan and the U.S.
$100 - $150
Hourly Rate
Two-week prospective observational study of 5% sofpironium bromide gel in Japanese patients with primary axillary hyperhidrosis.
London, UK
2 hours ago
1 Received
- In 2020, sofpironium bromide gel was approved in Japan for treating primary axillary hyperhidrosis, and a phase III study confirmed its efficacy and safety, but early effectiveness at less than 6 weeks had not been examined.
- A 2-week exploratory study involving 80 Japanese patients (mostly women, average age 33.3) assessed the early effectiveness of sofpironium, finding a significant decrease in the Hyperhidrosis Disease Severity Scale score from 3.5 to 2.4 by day 7.
- The results indicated that about 50% of patients improved to a score of 1 or 2 after just 1 week, and the treatment was deemed safe with no
$100 - $150
Hourly Rate
Hyperhidrosis: A Review of Recent Advances in Treatment with Topical Anticholinergics.
London, UK
2 hours ago
1 Received
- * A search of PubMed and Embase revealed several anticholinergics under investigation for HH, including glycopyrrolate, oxybutynin, sofpironium bromide, and umeclidinium, with glycopyrrolate being the only FDA-approved option.
- * The findings suggest that understanding these topical treatments is crucial for managing HH, and although safety data is limited, the emerging treatments have minimal known risks for patients.
$100 - $150
Hourly Rate
Efficacy of sofpironium bromide gel on clozapine-induced hypersalivation in patients with treatment-resistant schizophrenia: double-blind, controlled crossover study.
London, UK
2 hours ago
1 Received
- Hypersalivation linked to clozapine is a common issue for patients with treatment-resistant schizophrenia, prompting a search for effective treatments.
- A study tested sofpironium bromide gel against a placebo in a double-blind, controlled crossover format involving 16 patients, measuring saliva production and salivation severity over a series of weeks.
- Results showed a significant reduction in saliva volume, over 40% decrease in later weeks, and effects persisted even after stopping treatment, suggesting the gel is an effective option for managing this side effect.
$100 - $150
Hourly Rate
Efficacy of 5% sofpironium bromide gel in Duchenne muscular dystrophy with palmoplantar hyperhidrosis: A retrospective case study.
London, UK
2 hours ago
1 Received
- * A study examined the effectiveness of 5% sofpironium bromide gel in treating secondary hyperhidrosis in three patients aged 28 to 32 with advanced DMD and showed promising results.
- * After 5 weeks of treatment, patients demonstrated significant reductions in hyperhidrosis severity and sweat production, with an average decrease of 53.7% in palm sweat over 7 weeks and no major side effects, suggesting potential for further research in this area.
$100 - $150
Hourly Rate
Sofpironium (Sofdra) for primary axillary hyperhidrosis.
London, UK
2 hours ago
1 Received
$100 - $150
Hourly Rate
Catalytic Asymmetric Barbier Reaction of Ketones with Unactivated Alkyl Electrophiles.
London, UK
2 hours ago
1 Received
- The Barbier reaction is a method for adding aldehydes or ketones to organic electrophiles, forming carbon-carbon bonds without needing moisture-sensitive reagents.* -
- This study introduces a new photoredox-assisted cobalt-catalyzed version of the Barbier reaction, addressing challenges in creating complex chiral tertiary alcohols using unactivated alkyl electrophiles.* -
- The process can use various alkyl halides and redox-active esters, leading to diverse enantioenriched products, and demonstrates its effectiveness by synthesizing a core structure of a recently FDA-approved drug from 2024.*
$100 - $150
Hourly Rate