Data updated: May 26, 2026
UTIBRON NEOHALER (glycopyrrolate)
Respiratory
Approved 2015-10-29
1
Indication
--
Phase 3 Trials
10
Years on Market
Details
- Status
- Discontinued
- First Approved
- 2015-10-29
- Patent Cliff
- 2028
- Routes
- INHALATION
- Dosage Forms
- POWDER
UTIBRON NEOHALER Approval History
2016
2017
2018
2019
2020
2021
2022
2023
2024
2025
2026
Original
New Indication
New Form
Label Update
6 FDA actions from 2015 to 2021
May 2016 SUPPL
Mfg
What UTIBRON NEOHALER Treats
1 FDA approvalsOriginally approved for its first indication in 2015 .
- 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| NCT02574611 | KOR-15-026 | Ph 1 | withdrawn | Use of High Resolution Colonic Manometry in Studying Motility |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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Pro Active Pipeline
Ongoing clinical trials by development phase
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Pro Key Completed Trials
Completed studies with published results, ranked by significance
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Trial Timeline
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.
UTIBRON NEOHALER FDA Label Details
View full patent landscape →
2 OB patents · 2 families ·
73 international docs across 32 countries
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Patent Timeline
- • Cliff: 2028
- • 2 active patents
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.