PREVDUO (glycopyrrolate)
PREVDUO is a fixed-dose combination of neostigmine methylsulfate, a cholinesterase inhibitor, and glycopyrrolate, an antimuscarinic agent. It is indicated in patients aged two years and older for the reversal of the effects of nondepolarizing neuromuscular blocking agents (NMBAs) after surgery. The combination is specifically designed to restore neuromuscular function while simultaneously mitigating the peripheral muscarinic side effects—such as bradycardia and excessive pharyngeal and bronchial secretions—associated with neostigmine administration.
How PREVDUO Works
PREVDUO utilizes two synergistic mechanisms of action. Neostigmine methylsulfate is a competitive cholinesterase inhibitor that reduces the breakdown of acetylcholine, increasing its concentration at the synaptic cleft to compete with nondepolarizing NMBAs and restore neuromuscular transmission. Glycopyrrolate functions as a competitive antimuscarinic agent, blocking the action of acetylcholine at muscarinic receptors in the heart and exocrine glands. This antagonizes the cholinergic side effects induced by neostigmine, thereby preventing bradycardia and reducing the volume of gastric and respiratory secretions.
Details
- Status
- Prescription
- First Approved
- 2023-02-23
- Patent Cliff
- 2038
- Routes
- INTRAVENOUS
- Dosage Forms
- SOLUTION
PREVDUO Approval History
What PREVDUO Treats
2 indicationsPREVDUO is approved for 2 conditions since its original approval in 2023. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Neuromuscular Blockade
- Bradycardia
PREVDUO Competitive Set
ProThree rings of competition based on shared molecular targets and treated indications.
Direct competitors
Same target(s) AND same indication — head-to-head.
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.
Drugs Similar to PREVDUO
FDA-approved drugs for similar conditions. Compare mechanisms and indications to understand treatment alternatives.
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.
PREVDUO FDA Label Details
Indications & Usage
FDA Label (PDF)PREVDUO is indicated for the treatment of Neuromuscular Blockade; Bradycardia.
PREVDUO Patents & Exclusivity
Patents (5 active)
Pro Intelligence Preview
Deep insights for PREVDUO
Revenue Insights
- • Quarterly revenue tracking
- • Historical trend analysis
Patent Timeline
- • Cliff: 2038
- • 5 active patents
Trial Analysis
- • Clinical trial tracking
- • Development stage analysis
Competitive Landscape
- • 3 similar drugs
- • Same target/indication analysis
Full approval history • All patents • Revenue trends • Competitor analysis
Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.