NDATOPICALSHAMPOO
Approved
Aug 1990
Lifecycle
LOE Approaching
Competitive Pressure
30/100
Clinical Trials
16
Data completeness
3/8 — Basic
CAPEX (fluocinolone acetonide) by Galderma is signaling, immune function, inflammation, and protein regulation; however, the precise mechanism of action in eczematous external otitis is unknown. First approved in 1990.
Drug data last refreshed 9h ago · AI intelligence enriched 1w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
CAPEX is a topical fluocinolone acetonide shampoo indicated for eczematous external otitis and related inflammatory scalp conditions. It works through anti-inflammatory and immune-modulating mechanisms, though the precise action in external otitis remains incompletely understood. This is a legacy small-molecule corticosteroid product approved over 30 years ago.
LOE Approaching
Mature product with limited growth runway; teams are typically focused on defending market share and managing transition to generic competition.
Mechanism of Action
signaling, immune function, inflammation, and protein regulation; however, the precise mechanism of action in eczematous external otitis is unknown.
Indications
Indication data is being enriched from DailyMed and FDA labeling. Check back soon for approved therapeutic uses.
Clinical Trials (16)
Intravitreal Faricimab Injections or Fluocinolone Acetonide (0.19 mg) Intravitreal Implants vs Observation for Prevention of VA Loss Due to Radiation Retinopathy
Started Nov 2023
600 enrolled
Radiation RetinopathyVisual Impairment
Fluocinolone Acetonide Intravitreal Implant 0.18 mg in the Treatment of Chronic Non-Infectious Posterior Segment Uveitis
Started Jun 2022
125 enrolled
Uveitis, Posterior
Corneal Endothelial Cell Density in Eyes Treated With a Fluocinolone Acetonide Intravitreal Implant
Started Jul 2017
3 enrolled
Uveitis, Posterior
Evaluation of Corneal Endothelial Cell Density in Subjects Who Have Had a Fluocinolone Acetonide Implant
Started Feb 2016
98 enrolled
InflammationUveitis
Fluocinolone Acetonide in Diabetic Macular Edema (FAME) Extension Study
Started Apr 2011
120 enrolled
Diabetic Macular Edema
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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.