GLYRX-PF (glycopyrrolate)
GLYRX-PF is an anticholinergic indicated for use in anesthesia (adult and pediatric patients) to reduce salivary, tracheobronchial, and pharyngeal secretions, as well as the volume and acidity of gastric secretions. It is used to block cardiac inhibitory reflexes during induction and intubation and to counteract surgically or drug-induced arrhythmias intraoperatively. Additionally, it is used to protect against the peripheral muscarinic side effects of cholinergic agents (such as neostigmine) during the reversal of neuromuscular blockade. In adults, it is indicated as an adjunct treatment for peptic ulcer symptoms when a rapid anticholinergic effect is needed or oral medication is not tolerated. It is not indicated as monotherapy for peptic ulcer treatment as its effectiveness in ulcer healing has not been established.
How GLYRX-PF Works
Glycopyrrolate is a competitive antimuscarinic agent that inhibits the action of acetylcholine on structures innervated by postganglionic cholinergic nerves. It acts on muscarinic receptors located in smooth muscle, cardiac muscle (specifically the SA and AV nodes), and exocrine glands. By inhibiting these receptors, the drug diminishes the volume and free acidity of gastric secretions and controls excessive secretions in the pharyngeal, tracheal, and bronchial airways.
Details
- Status
- Prescription
- First Approved
- 2018-07-11
- Routes
- INTRAMUSCULAR, INTRAVENOUS
- Dosage Forms
- SOLUTION
GLYRX-PF Approval History
What GLYRX-PF Treats
3 indicationsGLYRX-PF is approved for 3 conditions since its original approval in 2018. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Anesthesia
- Arrhythmias
- Peptic Ulcer
GLYRX-PF Competitive Set
ProThree rings of competition based on shared molecular targets and treated indications.
MoA expansion candidates
Same target(s), different indications — where else is this mechanism being explored?
Indication competitors
Same indication, different mechanism — what else might this patient receive?
Filters applied: drops same-active-ingredient (505(b)(2) reformulations), route-mismatch (topical vs systemic), and cross-therapeutic-area matches in same-indication rings.
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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 |
Active Pipeline
Ongoing clinical trials by development phase
Key Completed Trials
Completed studies with published results, ranked by significance
Trial Timeline
Full development history with FDA approval milestones
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.
GLYRX-PF FDA Label Details
Indications & Usage
FDA Label (PDF)GLYRX-PF is indicated for the treatment of Anesthesia; Arrhythmias; Peptic Ulcer.
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.