NDAINJECTIONINJECTABLE
Approved
Dec 1967
Lifecycle
LOE Approaching
Competitive Pressure
30/100
Clinical Trials
20
Data completeness
4/8 — Partial
MANNITOL 15% (mannitol) by Pfizer is osmotic activity [moa]. First approved in 1967.
Drug data last refreshed 4d ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
Mannitol 15% is an osmotic diuretic administered via injection that works through osmotic activity to reduce intracranial pressure and treat cerebral edema. It is indicated for a broad range of conditions including traumatic brain injury, intracranial hypertension, cystic fibrosis, bronchiectasis, bowel preparation, and various malignancies. The drug creates an osmotic gradient that draws fluid from tissues into the intravascular space, reducing fluid accumulation in critical organ systems.
LOE Approaching
As an older established product approaching loss of exclusivity with moderate competitive pressure (30), the brand team is likely focused on defending market share in niche indications rather than growth expansion.
Mechanism of Action
Osmotic Activity
Pharmacologic Class:
Osmotic Diuretic
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.