Population Pharmacokinetics of Topical Timolol Maleate Gel in Healthy Volunteers and Infants With Superficial Infantile Hemangioma.
CPT Pharmacometrics Syst PharmacolSep 22, 2026
Li Li, Yanming Li, Fan Hu et al.
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In 30 seconds
This study developed a population pharmacokinetic model for topical timolol maleate gel in healthy adults and infants with superficial infantile hemangioma. Utilizing data from Phase I-III clinical trials involving 138 subjects, the model indicated that systemic exposure to timolol was limited, supporting its safety profile in this population.
Key findings
- A total of 810 plasma concentration measurements were analyzed from 138 subjects.
- Timolol pharmacokinetics were well described by a one-compartment model.
- No significant covariates influencing clearance were identified.
- No apparent associations were found between timolol exposure and safety outcomes.
Why it matters
Understanding the pharmacokinetics and safety profile of topical timolol maleate gel is crucial for clinicians considering its use in treating superficial infantile hemangioma, particularly given the limited systemic exposure observed.