NDAINHALATIONGAS
Approved
Oct 2019
Lifecycle
Peak
Competitive Pressure
30/100
Clinical Trials
20
Data completeness
3/8 — Basic
Drug data last refreshed 14h ago · AI intelligence enriched 1mo ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
HELIUM, USP is an inhaled gas product approved by the FDA in October 2019 for inhalation use. The product is a medical gas with no specified pharmacologic mechanism of action or indication in available labeling. It is currently in peak lifecycle stage as a specialty inhalation therapy.
Peak
Product is at peak commercial stage with moderate competitive pressure (30%), indicating stable market presence and potential for established commercial team support.
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 (20)
Evaluate the Safety and Feasibility of Same-Day Bilateral Epithelium-On Corneal Cross-Linking for Keratoconus
Started May 2026
15 enrolled
Keratoconus
Epithelium-On Corneal Cross-linking in Subjects 8 to 45 Years of Age With Keratoconus
Started Nov 2023
398 enrolled
Keratoconus
Establishment of Biobank of Nasal Epithelium Samples From Healthy Volunteers
Started Nov 2023
120 enrolled
Healthy
Epithelium-On Corneal Cross-linking in Subjects 8 to 45 Years of Age With Keratoconus
Started Oct 2023
396 enrolled
Keratoconus
C2 Esophageal Squamous Epithelium Dysplasia
Started Nov 2022
129 enrolled
Esophageal Squamous Epithelium Dysplasia
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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.