MANNITOL 25%

Post-LOE

mannitol

Otsuka

ANDAINJECTIONINJECTABLE

Approved

May 1987

Lifecycle

Post-LOE

Competitive Pressure

30/100

Clinical Trials

Data completeness

4/8 — Partial

MANNITOL 25% (mannitol) by Otsuka is osmotic activity [moa]. Approved for asthma. First approved in 1987.

Drug data last refreshed 18h ago

Mechanism of Action

Osmotic Activity

Indications (1)

asthma

Clinical Trials (20)

NCT05740618Phase 4Completed

Inhaled Mannitol on Mucociliary Clearance in Moderate to Severe Cystic Fibrosis

Started Mar 2023

14 enrolled

Cystic Fibrosis

NCT05555290Phase 3Completed

PT027 Compared to PT007 in Patients With Asthma With Mannitol-induced Acute Airway Obstruction

Started Sep 2022

190 enrolled

Asthma

NCT03620422N/ACompleted

Mannitol-Induced Cough Challenge in Healthy Controls and Subjects With Mild Allergic Asthma

Started Jan 2019

40 enrolled

AsthmaCough

NCT02386449Phase 4Completed

A Study Comparing Picoprep With Mannitol and Bisacodyl for Colon Cleansing in Preparation for Colonoscopy

Started Feb 2015

184 enrolled

Bowel Preparation

NCT02134353Phase 3Completed

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.