NDATOPICALGEL, METERED
Approved
Jun 2024
Lifecycle
Growth
Competitive Pressure
0/100
Clinical Trials
2
Data completeness
3/8 — Basic
Drug data last refreshed 3h ago · AI intelligence enriched 1mo ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
SOFDRA (sofpironium bromide) is a topical metered gel approved by the FDA in June 2024 for an indication in dermatology. The drug acts as an anticholinergic agent targeting sweat gland function. It represents Botanix Pharmaceuticals' first major commercial launch in the topical therapeutics space.
Growth13.5 years to LOE
Early-stage topical launch with no established market share yet; team building and market entry execution will be critical in 2024–2025.
Mechanism of Action
Mechanism of action data is being enriched from DailyMed and FDA sources. Check back soon for updated drug intelligence.
Indications
Indication data is being enriched from DailyMed and FDA labeling. Check back soon for approved therapeutic uses.
Clinical Trials (2)
Safety and Efficacy Study of Sofpironium Bromide in Subjects With Axillary Hyperhidrosis (BBI-4000-CL-302)
Started Dec 2020
351 enrolled
Axillary Hyperhidrosis
Safety and Efficacy Study of Sofpironium Bromide in Subjects With Axillary Hyperhidrosis (BBI-4000-CL-301)
Started Oct 2020
350 enrolled
Axillary Hyperhidrosis
Career Relevance
SOFDRA is a newly launched topical therapy with significant career opportunity in market build-out, commercial infrastructure development, and payer engagement. Professionals joining now will shape the product's launch trajectory and establish foundational commercial teams.
Brand Manager
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Data Sources
- Drug label: DailyMed / FDA
- Clinical trials: ClinicalTrials.gov
- Patent data: FDA Orange Book
- Spending data: CMS Medicare
The information on this page is for informational purposes only and should not be used as a substitute for professional medical advice. Drug information is sourced from FDA, DailyMed, and other government databases. Adverse event data from FAERS does not establish causation. Always consult a healthcare professional for medical decisions.