NDAORALTABLET
Approved
Feb 1957
Lifecycle
LOE Approaching
Competitive Pressure
30/100
Clinical Trials
20
Data completeness
4/8 — Partial
TRAL (hexocyclium methylsulfate) by AbbVie is tralokinumab-ldrm is a human igg4 monoclonal antibody that specifically binds to human interleukin-13 (il-13) and inhibits its interaction with the il-13 receptor α1 and α2 subunits (il-13rα1 and il-13rα2). Approved for moderate-to-severe atopic dermatitis in adults, older whose disease is not adequately controlled with topical prescription therapies, those therapies are not advisable. First approved in 1957.
Drug data last refreshed 20h ago · AI intelligence enriched 2w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
TRAL (hexocyclium methylsulfate) is an oral anticholinergic agent approved in 1957 for symptomatic relief of gastrointestinal and genitourinary spasm. Despite the data provided referencing tralokinumab (an IL-13 monoclonal antibody for atopic dermatitis), hexocyclium methylsulfate is a small-molecule antimuscarinic with a distinct mechanism and historical indication profile. This product represents a legacy therapeutic in the anticholinergic class with limited modern clinical use.
Post-LOE
Post-LOE product with minimal commercial investment; roles focus on mature market maintenance and generic transition management.
Mechanism of Action
Tralokinumab-ldrm is a human IgG4 monoclonal antibody that specifically binds to human interleukin-13 (IL-13) and inhibits its interaction with the IL-13 receptor α1 and α2 subunits (IL-13Rα1 and IL-13Rα2). IL-13 is a naturally occurring cytokine of the Type 2 immune response. Tralokinumab-ldrm…
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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.