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

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

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 (AAD 2022) - No abstract available

Clinical • Late-breaking abstract • P3 data • Dermatology

Sofpironium bromide: an investigational agent for the treatment of axillary hyperhidrosis. (PubMed, Expert Opin Investig Drugs) - "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."

Journal • Dermatology

Cardigan II: Safety and Efficacy Study of Sofpironium Bromide in Subjects With Axillary Hyperhidrosis (BBI-4000-CL-302) (clinicaltrials.gov) - P3; N=351; Completed; Sponsor: Brickell Biotech, Inc.; Active, not recruiting ➔ Completed

Clinical • Trial completion • Dermatology

A Safety Study of BBI-4000 Gel in Pediatric Patients With Axillary Hyperhidrosis (clinicaltrials.gov) - P2; N=25; Completed; Sponsor: Brickell Biotech, Inc.; Active, not recruiting ➔ Completed

Clinical • Trial completion • Dermatology • Pediatrics

Cardigan II: Safety and Efficacy Study of Sofpironium Bromide in Subjects With Axillary Hyperhidrosis (BBI-4000-CL-302) (clinicaltrials.gov) - P3; N=351; Active, not recruiting; Sponsor: Brickell Biotech, Inc.; Recruiting ➔ Active, not recruiting

Clinical • Enrollment closed • Dermatology

Cardigan I: Safety and Efficacy Study of Sofpironium Bromide in Subjects With Axillary Hyperhidrosis (BBI-4000-CL-301) (clinicaltrials.gov) - P3; N=350; Completed; Sponsor: Brickell Biotech, Inc.; Active, not recruiting ➔ Completed

Clinical • Trial completion • Dermatology

[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 (SDDS 2021) - No abstract available

Clinical • PK/PD data • Dermatology

[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 (SBS 2021) - "There was no evidence of drug accumulation. There was clinically meaningful improvement in axillary hyperhidrosis."

Clinical • PK/PD data • Dermatology • Dry Eye Disease • Ophthalmology • Pediatrics • Pruritus • Xerostomia

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, J Dermatol) - "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."

Clinical • Journal • P3 data • Dermatitis • Dermatology • Immunology

Cardigan I: Safety and Efficacy Study of Sofpironium Bromide in Subjects With Axillary Hyperhidrosis (BBI-4000-CL-301) (clinicaltrials.gov) - P3; N=350; Active, not recruiting; Sponsor: Brickell Biotech, Inc.; Recruiting ➔ Active, not recruiting

Clinical • Enrollment closed • Dermatology

Hyperhidrosis Disease Severity Measure-Axillary (HDSM-Ax): Evaluation of Measurement Performance. (PubMed, J Drugs Dermatol) - "HDSM-Ax is a well-defined and reliable measure of AHH severity. A 1-point change in HDSM-Ax score is clinically meaningful. J Drugs Dermatol.20(4):410-418. doi:10.36849/JDD.5569."

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, J Dermatol) - "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."

Clinical • Journal • P3 data • Dermatitis • Dermatology • Immunology