NDAINTRAPLEURALAEROSOLPriority Review
Approved
Dec 1997
Lifecycle
LOE Approaching
Competitive Pressure
30/100
Clinical Trials
6
Data completeness
2/8 — Basic
Priority Review
Drug data last refreshed 16h ago · AI intelligence enriched 1mo ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
SCLEROSOL is an intrapleural talc aerosol approved in 1997 for pleural sclerosis, a procedure used to prevent recurrent pleural effusions by creating adhesions between pleural layers. Talc acts as a sclerosing agent with no defined pharmacologic mechanism of action in classical terms. It is administered directly into the pleural space as an aerosol to treat malignant and non-malignant pleural effusions.
LOE Approaching
As a mature product approaching LOE, the commercial team is likely lean with focus on retention and cost management rather than growth initiatives.
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 (6)
Study on Hydrotalcite for Relief of Acid Symptoms Due to Acid Rebound After Stopping Long-Term PPI Therapy
Started Nov 2025
167 enrolled
Gastroesophageal Reflux
AMPLE-3: IPC Plus Talc vs VATS in Management of Malignant Pleural Effusion
Started May 2018
158 enrolled
Malignant Pleural EffusionRespiratory DiseaseCancer
Out Patient Talc Slurry Via Indwelling Pleural Catheter for Malignant Pleural Effusion Vs Usual Inpatient Management
Started Aug 2015
142 enrolled
Pleural Effusion, Malignant
Placebo Controlled Phase IV Study to Compare the Efficacy and Safety of a Single Dose of Oral Talcid, a Single Dose of Oral Famotidine and a Single Dose of Placebo in Patients With Acute Heartburn Episodes
Started May 2003
559 enrolled
Heartburn
Evaluating ABX-EGF in Patients With Metastatic ColorectalCarcinoma
Started Mar 2002
150 enrolled
Colorectal CancerCarcinoma
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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.