NDAINJECTIONINJECTABLE
Approved
Jul 1964
Lifecycle
LOE Approaching
Competitive Pressure
30/100
Clinical Trials
20
Data completeness
3/8 — Basic
MANNITOL 20% (mannitol) by B. Braun is osmotic activity [moa]. First approved in 1964.
Drug data last refreshed 4d ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
Mannitol 20% is an intravenous osmotic diuretic that reduces intracranial pressure and manages acute symptoms in cystic fibrosis patients. It works through osmotic activity, drawing fluid from tissues into the intravascular space to decrease cerebral edema and improve airway clearance. The drug has been in clinical use since 1964 and remains a standard-of-care agent for elevated ICP management.
LOE Approaching
Product approaching loss of exclusivity with moderate competitive pressure (30/100); team focus likely shifting toward cost optimization and retention rather than growth initiatives.
Mechanism of Action
Osmotic Activity
Indications
Indication data is being enriched from DailyMed and FDA labeling. Check back soon for approved therapeutic uses.
Clinical Trials (20)
Inhaled Mannitol on Mucociliary Clearance in Moderate to Severe Cystic Fibrosis
Started Mar 2023
14 enrolled
Cystic Fibrosis
PT027 Compared to PT007 in Patients With Asthma With Mannitol-induced Acute Airway Obstruction
Started Sep 2022
190 enrolled
Asthma
Mannitol-Induced Cough Challenge in Healthy Controls and Subjects With Mild Allergic Asthma
Started Jan 2019
40 enrolled
AsthmaCough
A Study Comparing Picoprep With Mannitol and Bisacodyl for Colon Cleansing in Preparation for Colonoscopy
Started Feb 2015
184 enrolled
Bowel Preparation
A Safety and Efficacy Trial of Inhaled Mannitol in Adult Cystic Fibrosis Subjects
Started Sep 2014
423 enrolled
Cystic Fibrosis
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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.