TheraRadar
Data updated: May 26, 2026

DARTISLA ODT (glycopyrrolate)

Gastrointestinal Approved 2021-12-16
Jump to: Indications Approvals Trials Competitors Safety Patents
1
Indication
--
Phase 3 Trials
4
Years on Market

Details

Status
Discontinued
First Approved
2021-12-16
Routes
ORAL
Dosage Forms
TABLET, ORALLY DISINTEGRATING

Companies

EDENBRIDGE PHARMS
Active Ingredient: GLYCOPYRROLATE

DARTISLA ODT Approval History

2022
2023
2024
2025
2026
Original
New Indication
New Form
Label Update
4 FDA actions from 2021 to 2023
Oct 2023 SUPPL
Mfg · Manufacturing (CMC)
Label
Dec 2021 ORIGINAL
New Form · Type 3 - New Dosage Form
FDA Letter Label

What DARTISLA ODT Treats

1 FDA approvals

Originally approved for its first indication in 2021 .

  • Other (1)
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Clinical Trial Registry

22 trials
Trial Sponsor ID Phase Status Title
NCT05887375 2096001 MISP Database number 101357 Ph 4 completed Sugammadex vs Neostigmine/Glycopyrrolate on Urinary Retention After Spine Surgery
NCT05116930 21-009530 Ph 2 recruiting Neostigmine and Glycopyrrolate for the Treatment of Headache After Dural Puncture
NCT03111121 results posted 1610312153 Ph 4 completed Use of Sugammadex for Reversal of Paralysis in Microlaryngoscopy
NCT06045364 2023-115 Ph 1, Ph 2 completed Effect of Glycopyrrolate on Nausea and Vomiting After ERCP Operation
NCT03939923 results posted 1806161309 Ph 4 completed Role of Sugammadex as Reversal Agent in Patients Extubated Immediately After Isolated Coronary Artery Bypass Grafting Surgery
NCT03513406 STUDY00141829 Ph 3 completed Comparison of Reversal of Neuromuscular Blockade With Sugammadex Versus Neostigmine Plus Glycopyrolate in Patients Undergoing Burn Surgery
NCT03322657 results posted 17-764 Ph 4 completed Sugammadex Versus Neostigmine for Reversal of Rocuronium Neuromuscular
NCT01176851 Gly1 CCD-0915-PR-0031 Ph 1 completed Biopharmaceutical Study of Glyco pMDI With or Without Charcoal Block vs IV Bolus in Healthy Volunteers
NCT01476813 CCD-1106-PR-0066 Ph 2 completed Randomized Cross Over Study to Assess Efficacy and Safety of BDP/FF and Glycopyrrolate
NCT01176903 GLY2 CCD-0916-PR-0032 2010-018668-18 Ph 1, Ph 2 completed Safety and Efficacy Study of Glyco pMDI After Single and Repeated Administration
NCT01398111 TRIPLE 1 CCD-1101-PR-0056 2011-001552-11 Ph 1 completed Pharmacokinetic Interaction Study of Glycopyrrolate and Formoterol in Healthy Volunteers
NCT02574611 KOR-15-026 Ph 1 withdrawn Use of High Resolution Colonic Manometry in Studying Motility
NCT03138967 results posted 2015-1007 Ph 4 completed Investigation of Sugammadex in Outpatient Urological Procedures
NCT02872935 results posted 201301793 Ph 4 terminated Minimizing Nausea and Vomiting During Spinals for CS
NCT03513757 results posted CHW 959242-5 Ph 4 completed Dexmedetomidine and Propofol for Pediatric MRI Sedation
NCT02860507 results posted TGH015 Ph 4 completed Study to Determine if Administration of Sugammadex Impacts Hospital Efficiency
NCT02327923 IERB/284/014 Ph 4 completed Intraoperative Lidocaine Infusion vs. Esmolol Infusion for Postoperative Analgesia in Laparoscopic Cholecystectomy
NCT02375217 ANES.MA.14 Ph 4 completed "Low Dose Sugammadex Combined With Neostigmine and Glycopyrrolate Versus Full Dose Sugammadex for Reversal of Rocuronium-induced Neuromuscular Blockade: a Cost Saving Strategy"
NCT02613494 GOTHIC1 2015-GOTHIC1 Ph 1, Ph 2 completed Clozapine-induced Hypersalivation - Feasibility Trial
NCT01479764 results posted P07981 MK-8616-064 Ph 3 completed Study of Sugammadex Versus Usual Care on Incidence of Residual Blockade at Post Anesthesia Care Unit Admission (P07981)
NCT01588717 AIDES-G AIDES-G Ph 1 terminated Excessive Sweating Caused by Antidepressants: Measurement and Treatment With Glycopyrrolate (AIDES-G)
NCT01199237 results posted H10722-35629-01 Ph 4 completed Impact of Anesthetic Choice (Sevoflurane Versus Desflurane) on Airway Reflex Recovery in the Context of Antagonized Neuromuscular Block
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Active Pipeline

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Ongoing clinical trials by development phase

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Key Completed Trials

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Completed studies with published results, ranked by significance

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Trial Timeline

ClinicalTrials.gov ↗ Pro

Full development history with FDA approval milestones

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Understanding FDA Approval Types
Count Type What it means
- ORIG Original approval - drug first enters market
- SUPPL - Efficacy New indication (new disease/condition approved)
- SUPPL - Labeling Label text changes (warnings, dosing updates)
- SUPPL - Manufacturing Production changes (new facility)
- SUPPL - Chemistry Formulation changes (new dosage strength)

Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.

DARTISLA ODT FDA Label Details

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Data Sources

FDA Approval: NDA215019 → Patents: FDA Orange Book → Trials: ClinicalTrials.gov →

Data sourced from official FDA and NIH databases. Click links to verify on original sources.