NDAINHALATIONGAS
Approved
Jul 2021
Lifecycle
Peak
Competitive Pressure
30/100
Clinical Trials
20
Data completeness
3/8 — Basic
Drug data last refreshed 18h ago · AI intelligence enriched 1mo ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
HELIUM, USP is an inhaled gas product approved by FDA in July 2021 for use as a medical gas therapeutic. The product is a non-pharmacological inhalation agent with no traditional mechanism of action or pharmacologic class. Patient populations and clinical indications are not publicly detailed in available regulatory records.
Peak
Product is at peak lifecycle stage with moderate competitive pressure (30), suggesting stable commercial operations but limited growth runway for team expansion.
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)
Establishment of Biobank of Nasal Epithelium Samples From Healthy Volunteers
Started Nov 2026
120 enrolled
Healthy
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
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.