NDAORALTABLET, ORALLY DISINTEGRATING
Approved
Dec 2021
Lifecycle
Peak
Competitive Pressure
30/100
Clinical Trials
13
Data completeness
3/8 — Basic
DARTISLA ODT (glycopyrrolate) by Bridge Therapeutics is glycopyrrolate, an anticholinergic (antimuscarinic) agent, inhibits the action of acetylcholine on parietal cells in the stomach and decreases the volume and acidity of gastric secretions. First approved in 2021.
Drug data last refreshed 9h ago · AI intelligence enriched 1w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
DARTISLA ODT is an orally disintegrating tablet formulation of glycopyrrolate, an anticholinergic agent that inhibits acetylcholine action on gastric parietal cells to reduce gastric acid secretion and volume. Approved in December 2021 by Bridge Therapeutics, this product addresses patients requiring rapid-onset gastric acid suppression with improved dosing convenience. The ODT formulation enhances patient compliance by eliminating the need for water during administration.
Peak
Product is in peak commercial stage with moderate competitive pressure (30%), positioning for stable revenue and smaller-to-mid-sized commercial team investment.
Mechanism of Action
Glycopyrrolate, an anticholinergic (antimuscarinic) agent, inhibits the action of acetylcholine on parietal cells in the stomach and decreases the volume and acidity of gastric secretions.
Indications
Indication data is being enriched from DailyMed and FDA labeling. Check back soon for approved therapeutic uses.
Clinical Trials (13)
A Phase II Study to Assess the Pharmacokinetics, Pharmacodynamics, and Safety of Single Inhaled Doses of Ensifentrine-glycopyrrolate Fixed Dose Combination, Ensifentrine, and Glycopyrrolate in Subjects With Chronic Obstructive Pulmonary Disease
Started Oct 2025
33 enrolled
Chronic Obstructive Pulmonary Disease
A Phase IIb Ensifentrine-glycopyrrolate Fixed-dose Combination Dose Ranging Study in Subjects With COPD
Started Jul 2025
480 enrolled
Chronic Obstructive Pulmonary Disease
A Phase IIb Study of Glycopyrrolate Inhalation Solution Over 1 Week in Subjects With COPD
Started Aug 2024
46 enrolled
Chronic Obstructive Pulmonary Disease
Sugammadex vs Neostigmine/Glycopyrrolate on Urinary Retention After Spine Surgery
Started Aug 2023
118 enrolled
Spine SurgeryReversal of Neuromuscular BlockadeUrinary Retention Postoperative
Efficacy and Safety of Glycopyrrolate Bromide of COPD Patients
Started Jun 2014
100 enrolled
Chronic Obstructive Pulmonary Disease
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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.