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 23h ago · AI intelligence enriched 1w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
CAPEX is a topical fluocinolone acetonide shampoo approved by the FDA in 1990 for treatment of eczematous external otitis and other scalp/dermatologic conditions. The drug works through multiple pathways including immune suppression, inflammation reduction, and protein regulation, though its precise mechanism in eczematous external otitis remains incompletely characterized. It is a small-molecule corticosteroid delivered as a specialized shampoo formulation.
LOE Approaching
As a product nearing loss of exclusivity with moderate competitive pressure (30/100), commercial teams face margin compression and transition planning from growth to defensive strategies.
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
Worked on CAPEX at Galderma? Share your interview experience or compensation data (+7 days Pro)
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.