Sofdra (sofpironium bromide) / Fresh Tracks Therap, Kaken Pharma, Botanix Pharma, Dong Wha - LARVOL DELTA

Derivatization-Assisted Lipase-Mediated Separation of Optically Pure α-Cyclopentylmandelic Acid Through Enhanced Substrate Recognition. (PubMed, Molecules) - "The resulting (R)-CPMA was successfully used to synthesize sofpironium bromide, thereby validating the practical feasibility of this process. This strategy provides an effective, environmentally friendly enzymatic route to highly sterically hindered chiral α-hydroxycarboxylic acids."

Journal

Post-marketing Safety Surveillance of Sofpironium Gel, 12.45%, A Novel Treatment for Primary Axillary Hyperhidrosis in Patients ≥9 Years. (PubMed, J Am Acad Dermatol) - No abstract available

Journal • P4 data • Dermatology

Clinical Characteristics and Treatment Patterns of Hyperhidrosis in Northern Hokkaido: A Single-Center Retrospective Descriptive Study. (PubMed, J Dermatol) - "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."

Journal • Retrospective data • Dermatology

Direct Access to Chiral Tertiary Alcohols via Copper-Catalyzed Enantioconvergent O-Alkylation of Water with Racemic α-Tertiary Haloamides. (PubMed, J Am Chem Soc) - "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."

Journal

Efficacy and safety of topical sofpironium bromide in treating primary axillary hyperhidrosis: systematic review and meta-analysis of randomized controlled trials. (PubMed, Dermatol Reports) - "The incidences of anticholinergic adverse events (AEs) and application site AEs were statistically higher in patients treated with sofpironium. Sofpironium is an effective treatment for PAH associated with significant improvements in sweat reduction and QOL for patients, although the drug also has risks of anticholinergic or application-site AEs."

Journal • Retrospective data • Dermatology

Sofpironium Bromide for the Treatment of Primary Axillary Hyperhidrosis: A Systematic Review and Meta-Analysis of Randomized Controlled Trials. (PubMed, Cureus) - "No significant increase in serious adverse events was observed. Overall, this meta-analysis supports the efficacy of sofpironium bromide for primary axillary hyperhidrosis, while treatment decisions should be weighed against potential side effects."

Journal • Retrospective data • Review • Dermatitis • Dermatology • Immunology • Pain • Pruritus • Xerostomia

Efficacy and Safety of Topical Anticholinergics in the Treatment of Primary Axillary Hyperhidrosis: A Systematic Review and Meta-analysis. (PubMed, Clin Drug Investig) - "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."

Journal • Retrospective data • Review • Constipation • Dermatology • Gastroenterology • Gastrointestinal Disorder • Ophthalmology • Xerostomia

Efficacy and Safety of Topical Sofpironium Bromide Gel for the Treatment of Primary Axillary Hyperhidrosis: A Systematic Review and Meta-analysis of Randomized Controlled Trials (AAD 2026) - "TSB effectively reduces sweat production in primary axillary hyperhidrosis, with increased local anticholinergic side effects."

Retrospective data • Review • Dermatitis • Dermatology • Immunology • Pruritus • Xerostomia

Efficacy, Safety and Tolerability of Sofpironium Gel, 12.45% in Adolescents and Young Adults with Primary Axillary Hyperhidrosis: Subgroup Analysis from Two Pivotal Phase 3 Trials (AAD 2026) - "Sofpironium was efficacious and generally well tolerated among adolescents and young adults."

Clinical • P3 data • Dermatology

Advances in the Management of Hyperhidrosis. (PubMed, Skin Therapy Lett) - "New treatments have emerged including glycopyrronium bromide, sofpironium bromide, targeted alkali thermolysis, and microwave devices. This paper reviews the mechanism of action, efficacy, safety, and practical considerations associated with these treatments."

Journal • Review • Dermatology

Sofpironium Topical Gel Is Effective for Axillary Hyperhidrosis. (PubMed, Am Fam Physician) - No abstract available

Journal • Dermatology

Dongwha Pharm secures approval for hyperhidrosis drug Ecracgel in Korea (Chosun Biz)

Korea approval • Dermatology

Sofpironium bromide: a novel solution in the battle against primary axillary hyperhidrosis. (PubMed, Ann Med Surg (Lond)) - No abstract available

Journal • Dermatology

Effectiveness of Sofpironium Bromide in Patients with Primary Axillary Hyperhidrosis Who Experienced Residual or Recurrence of Axillary Odor after Surgery for Axillary Osmidrosis. (PubMed, J Plast Reconstr Surg) - "These results suggest that sofpironium bromide is effective in patients with axillary hyperhidrosis after the surgery. Since this study was conducted with a small number of patients in a retrospective single-arm design, it is necessary to validate the results in a prospective controlled study with a large number of patients."

Journal • Dermatology

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, J Am Acad Dermatol) - "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."

Journal • P3 data • Dermatology

The Drug Update: Recent drug approvals, winter 2025 edition. (PubMed, Nurse Pract) - "In the first half of 2024, the US FDA approved several new drugs that have relevance for those practicing in primary care. This article, the winter 2025 edition of the journal's biannual Drug Update, highlights the following new medications: sotatercept-csrk (Winrevair), aprocitentan (Tryvio), resmetirom (Rezdiffra), berdazimer (Zelsuvmi), ceftobiprole medocaril sodium (Zevtera), sofpironium (Sofdra), and ensifentrine (Ohtuvayre)."

Journal

Efficacy and safety of sofpironium in treatment of primary hyperhidrosis: a systematic review. (PubMed, J Dermatolog Treat) - "Serious adverse events were not observed in the intervention group. Sofpironium gel provides notable improvements in symptom severity, sweat reduction, and quality of life, with mostly mild localized adverse events.Hyperhidrosis is relatively common, affecting 4.8% of the US population and negatively affects physical, social, and psychological well-being.Sofpironium bromide is recently approved by the FDA for the treatment of primary axillary hyperhidrosisSofpironium bromide showed promising results in terms of safety and efficacy for treating hyperhidrosisWe systematically assessed the use of sofpironium gel reported in five studies (752 patients)Sofpironium gel provides notable improvements in symptom severity, sweat reduction and quality of life, with mostly mild localized adverse events."

Journal • Review • Dermatology

Catalytic Asymmetric Barbier Reaction of Ketones with Unactivated Alkyl Electrophiles. (PubMed, J Am Chem Soc) - "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."

Journal

Sofpironium (Sofdra) for primary axillary hyperhidrosis. (PubMed, Med Lett Drugs Ther) - No abstract available

Journal • Dermatology

Efficacy of 5% sofpironium bromide gel in Duchenne muscular dystrophy with palmoplantar hyperhidrosis: A retrospective case study. (PubMed, J Dermatol) - "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."

Journal • Retrospective data • Dermatology • Duchenne Muscular Dystrophy • Genetic Disorders • Muscular Dystrophy

Efficacy of sofpironium bromide gel on clozapine-induced hypersalivation in patients with treatment-resistant schizophrenia: double-blind, controlled crossover study. (PubMed, BJPsych Open) - "We suggest that sofpironium bromide gel is effective in treating clozapine-induced hypersalivation in patients with treatment-resistant schizophrenia."

Journal • CNS Disorders • Psychiatry • Schizophrenia

Hyperhidrosis: A Review of Recent Advances in Treatment with Topical Anticholinergics. (PubMed, Dermatol Ther (Heidelb)) - "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."

Journal • Review • Dermatology

Hyperhidrosis: disease aetiology, classification and management in the light of modern treatment modalities. (PubMed, Postepy Dermatol Alergol) - "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."

Journal • Review • Dermatology

Two-week prospective observational study of 5% sofpironium bromide gel in Japanese patients with primary axillary hyperhidrosis. (PubMed, J Dermatol) - "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."

Journal • Observational data • Dermatology

SUPPLEMENT ARTICLE: A Novel Drug Delivery Method: Retrometabolic Drug Design. (PubMed, J Drugs Dermatol) - "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."

Journal • Cardiovascular • Dermatology • Immunology • Ophthalmology