Robinul

(Glycopyrrolate)

ApprovedSmall molecule

Alnylam Pharmaceuticals

Robinul is one of 191 small molecule programs targeting Arrhythmia. It is currently in Approved.

Indications

Total Trials

Active Trials

190

Competitors

FDA Applications

NDA/BLA/ANDA regulatory filings

Patents

Pipeline

Status by Indication[3][1]

Indication

ArrhythmiaActive, not recruiting

BradycardiaActive, not recruiting

Urinary RetentionActive, not recruiting

ParalysisActive, not recruiting

Chronic Obstructive Pulmonary DiseaseActive, not recruiting

Nausea and VomitingActive, not recruiting

Coronary Artery BypassActive, not recruiting

HypotensionActive, not recruiting

ArrhythmiaPreclinical

Active, not recruiting

BradycardiaPreclinical

Active, not recruiting

Urinary RetentionApproved

Active, not recruiting

ParalysisApproved

Active, not recruiting

Chronic Obstructive Pulmonary DiseasePhase 1

Active, not recruiting

Nausea and VomitingApproved

Active, not recruiting

Coronary Artery BypassApproved

Active, not recruiting

HypotensionApproved

Active, not recruiting

Competition

Competitive Landscape

557 competitors in Chronic Obstructive Pulmonary Disease

#DrugCompanyPhaseTrials

Robinul

Alnylam Pharmaceuticals

Approved

3 2

Veramyst

GSK

Preclinical

26 3

Flovent

GSK

Preclinical

6 4

Aclidinium Bromide

AstraZeneca

Preclinical

21 5

Formoterol Fumarate

AstraZeneca

Preclinical

11 6

Atrovent

Boehringer Ingelheim

Preclinical

5 7

Calciferol

Alnylam Pharmaceuticals

Preclinical

—8

Proventil

Mylan Pharmaceuticals Inc

Preclinical

3 9

Duragesic

CCephalon

Preclinical

2 10

Narcan

SScienture

Preclinical

Ranked by pipeline maturity and clinical activity. Current drug highlighted in teal.

Timeline

Expected Milestones

Q4 2027

Phase 2Recruiting

Headache

NCT05116930

Clinical

Trials by Indication[1]

Glycopyrrolate5 trials

Pharmacokinetic Interaction Study of Glycopyrrolate and Formoterol in Healthy Volunteers

Completed· Chiesi Farmaceutici S.p.A. logo

Chiesi Farmaceutici S.p.A.·Phase 1·NCT01398111·44 enrolled

A Phase IIb Study of Glycopyrrolate Inhalation Solution Over 1 Week in Subjects With COPD

Completed·VVerona Pharma plc·Phase 2·NCT06545500·46 enrolled

A Phase IIb Ensifentrine-glycopyrrolate Fixed-dose Combination Dose Ranging Study in Subjects With COPD

Recruiting·VVerona Pharma plc·Phase 2·NCT07016412·480 enrolled

Show 2 more trials

Benefits of Glycopyrrolate on Intubation With Rigid-videostylet (OptiScope®)

Completed·—·N/A·NCT03050242·78 enrolled

Effect of Glycopyrrolate and Atropine on Catheter-Related Bladder Discomfort

Unknown status·SSeoul National University Hospital·N/A·NCT02228473·76 enrolled

Sedation3 trials

Dexmedetomidine and Propofol for Pediatric MRI Sedation

Completed·MMedical College of Wisconsin·Phase 4·NCT03513757·40 enrolled

Effectiveness of Atropine and Glycopyrrolate to Reduce Hyper Salivation With Ketamine Sedation

Completed·—·N/A·NCT01191398·52 enrolled

Patient-controlled Sedation With Propofol Versus Combined Sedation During Bronchoscopy

Completed·LLena Nilsson·N/A·NCT03357393·150 enrolled

Chronic Obstructive Pulmonary Disease3 trials

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

Completed·VVerona Pharma plc·Phase 2·NCT07132983·33 enrolled

Study to Determine the Amount of Glycopyrrolate Absorbed in the Lungs After Taking the Medicine With a eFlow Nebulizer and Seebri® Breezhaler® With and Without Activated Charcoal in Subjects With Moderate to Severe Chronic Obstructive Pulmonary Disease (COPD).

Completed·SSunovion Respiratory Development Inc.·Phase 1·NCT02512302·30 enrolled

Safety and Tolerability of QVA149 (Indacaterol/Glycopyrrolate) Compared to Placebo and to Indacaterol in Patients With Moderate to Severe Stable Chronic Obstructive Pulmonary Disease (COPD)

Completed· Novartis logo

Novartis·Phase 2·NCT00558285·257 enrolled

Sugammadex2 trials

Study to Determine if Administration of Sugammadex Impacts Hospital Efficiency

Completed·UUniversity of South Florida·Phase 4·NCT02860507·50 enrolled

Investigation of Sugammadex in Outpatient Urological Procedures

Completed·MM.D. Anderson Cancer Center·Phase 4·NCT03138967·54 enrolled

Nausea and vomiting2 trials

Effect of Glycopyrrolate on Nausea and Vomiting After ERCP Operation

Completed·JJie Chen·Phase 1/2·NCT06045364·130 enrolled

Minimizing Nausea and Vomiting During Spinals for CS

Terminated·KKokila N Thenuwara·Phase 4·NCT02872935·22 enrolled

29 more indications

Neuromuscular Blockade2 trials

Comparison of Reversal of Neuromuscular Blockade With Sugammadex Versus Neostigmine Plus Glycopyrolate in Patients Undergoing Burn Surgery

Completed·UUniversity of Kansas Medical Center·Phase 3·NCT03513406·7 enrolled

"Low Dose Sugammadex Combined With Neostigmine and Glycopyrrolate Versus Full Dose Sugammadex for Reversal of Rocuronium-induced Neuromuscular Blockade: a Cost Saving Strategy"

Completed·—·Phase 4·NCT02375217·56 enrolled

Neostigmine2 trials

Sugammadex Versus Neostigmine for Reversal of Rocuronium Neuromuscular

Completed·TThe Cleveland Clinic·Phase 4·NCT03322657·69 enrolled

Comparison of Sugammadex (MK-8616/Org 25969) With Neostigmine Administered at 1-2 Post-tetanic Counts (PTCs) After Administration of Rocuronium or Vecuronium (19.4.302/P05945/MK-8616-025)

Completed· Merck & Co. logo

Merck & Co.·Phase 3·NCT00473694·182 enrolled

Bradycardia2 trials

Effect of Atropine or Glycopyrrolate on the Prevention of Bradycardia During Sedation Using Dexmedetomidine in Geriatric Patients Undergoing Total Knee Replacement Under Spinal Anesthesia

Completed·YYonsei University·N/A·NCT03322098·54 enrolled

Effect of Atropine or Glycopyrrolate on the Prevention of Bradycardia During Sedation Using Dexmedetomidine in Adult Patients Undergoing Lower Extremity Surgery Under Spinal Anesthesia

Terminated·YYonsei University·N/A·NCT03322150·2 enrolled

Anesthesia1 trial

Study of Sugammadex Versus Usual Care on Incidence of Residual Blockade at Post Anesthesia Care Unit Admission (P07981)

Completed· Merck & Co. logo

Merck & Co.·Phase 3·NCT01479764·154 enrolled

Headache1 trial

Neostigmine and Glycopyrrolate for the Treatment of Headache After Dural Puncture

Recruiting·MMayo Clinic·Phase 2·NCT05116930·18 enrolled

Hypotension1 trial

Atropine Versus Glycopyrrolate in Preventing Spinal Anesthesia Induced Hypotension in Lower Limb Surgeries

Unknown status·—·Phase 4·NCT03580889·138 enrolled

Heart Rate Variability1 trial

Effects of Glycopyrrolate on Heart Rate and Heart Rate Variability in Patients With Different Basic Heart Rate

Completed·ZZhuan Zhang·N/A·NCT06237478·54 enrolled

Polyp1 trial

Antiperistaltic Effect and Safety of Glycopyrronium for Colonoscopic Polypectomy

Unknown status·JJie Chen·Phase 1/2·NCT06041984·150 enrolled

Antidepressants1 trial

Excessive Sweating Caused by Antidepressants: Measurement and Treatment With Glycopyrrolate (AIDES-G)

Terminated·TThomas Jefferson University·Phase 1·NCT01588717·5 enrolled

Efficacy and Safety1 trial

Randomized Cross Over Study to Assess Efficacy and Safety of BDP/FF and Glycopyrrolate

Completed· Chiesi Farmaceutici S.p.A. logo

Chiesi Farmaceutici S.p.A.·Phase 2·NCT01476813·281 enrolled

General Anesthesia1 trial

Effect of Perioperative Use of Glycopyrrolate on Lung Function in Patients Under General Anesthesia

Unknown status·ZZhuan Zhang·N/A·NCT05693246·90 enrolled

Coronary Artery Bypass1 trial

Role of Sugammadex as Reversal Agent in Patients Extubated Immediately After Isolated Coronary Artery Bypass Grafting Surgery

Completed·WWest Virginia University·Phase 4·NCT03939923·84 enrolled

Paralysis1 trial

Use of Sugammadex for Reversal of Paralysis in Microlaryngoscopy

Completed·WWest Virginia University·Phase 4·NCT03111121·79 enrolled

HFpEF1 trial

Chronotropic Incompetence in Patients With HFpEF

Completed·UUniversity of Texas Southwestern Medical Center·N/A·NCT02524145·40 enrolled

Parkinson's Disease1 trial

Study of Glycopyrrolate for Moderate-to-severe Sialorrhea in Parkinson's Disease

Unknown status·OOttawa Hospital Research Institute·Phase 2·NCT02382198·28 enrolled

Laparoscopic Cholecystectomy1 trial

Intraoperative Lidocaine Infusion vs. Esmolol Infusion for Postoperative Analgesia in Laparoscopic Cholecystectomy

Completed·—·Phase 4·NCT02327923·90 enrolled

Urinary retention1 trial

Sugammadex vs Neostigmine/Glycopyrrolate on Urinary Retention After Spine Surgery

Enrolling by invitation·UUniversity of Missouri-Columbia·Phase 4·NCT05887375·118 enrolled

Intraoperative1 trial

Intraoperative Video Laryngoscopy as Adjunct for Nerve Monitoring

Completed·IIcahn School of Medicine at Mount Sinai·N/A·NCT03742141·125 enrolled

Intensive Care Unit1 trial

The Off Label Use of Glycopyrrolate in the Adults Intensive Care Unit.

Unknown status·TTanta University·Phase 1·NCT04554589·80 enrolled

Clozapine-induced Hypersalivation1 trial

Clozapine-induced Hypersalivation - Feasibility Trial

Completed·MMersey Care NHS Trust·Phase 1/2·NCT02613494·29 enrolled

Premedication1 trial

Anticholinergic Premedication Induced Fever in Pediatric Ambulatory Anesthesia With Ketamine

Completed·IInje University·N/A·NCT02430272·84 enrolled

Blood Pressure1 trial

Decision Support for Intraoperative Low Blood Pressure

Completed·VVanderbilt University Medical Center·N/A·NCT02726620·22,435 enrolled

Arrhythmia1 trial

Glycopyrrolate Prophylaxis for Prevention of Bradyarrhythmia During Laparoscopic Cholecystectomy

Completed·NNational Academy of Medical Sciences, Nepal·N/A·NCT05997004·62 enrolled

Safety and Efficacy1 trial

Safety and Efficacy Study of Glyco pMDI After Single and Repeated Administration

Completed· Chiesi Farmaceutici S.p.A. logo

Chiesi Farmaceutici S.p.A.·Phase 1/2·NCT01176903·65 enrolled

Tics1 trial

Anesthetics in Rhytidoplasty - A Comparison Study

Completed·MMercy Facial Plastic Surgery Center·N/A·NCT02410460·30 enrolled

Critically Ill1 trial

The Use of Sugammadex in the Critically Ill

Unknown status·MMcGill University Health Centre/Research Institute of the McGill University Health Centre·N/A·NCT03791801·50 enrolled

Neuromuscular Block1 trial

Impact of Anesthetic Choice (Sevoflurane Versus Desflurane) on Airway Reflex Recovery in the Context of Antagonized Neuromuscular Block

Completed·UUniversity of California, San Francisco·Phase 4·NCT01199237·107 enrolled

MACE1 trial

Biopharmaceutical Study of Glyco pMDI With or Without Charcoal Block vs IV Bolus in Healthy Volunteers

Completed· Chiesi Farmaceutici S.p.A. logo

Chiesi Farmaceutici S.p.A.·Phase 1·NCT01176851·20 enrolled

Unspecified1 trial

Use of High Resolution Colonic Manometry in Studying Motility

Withdrawn·JJames J. Peters Veterans Affairs Medical Center·Phase 1·NCT02574611

Regulatory

FDA Approval Timeline[4]

Jan 1, 1982

ROBINUL

NDA NDA012827

Jan 1, 1982

ROBINUL

NDA NDA014764

Jan 1, 1982

ROBINUL

NDA NDA017558

Jul 28, 2010

CUVPOSA

NDA NDA022571

Oct 29, 2015

SEEBRI NEOHALER

NDA NDA207923

Dec 5, 2017

LONHALA MAGNAIR KIT

NDA NDA208437

Jul 11, 2018

GLYRX-PF

NDA NDA210997

Apr 21, 2022

GLYCOPYRROLATE

NDA NDA214919

Oct 11, 2023

DARTISLA ODT

NDA NDA215019

Sources

References

[1]
ClinicalTrials.gov — 47 trial records for Glycopyrrolate. U.S. National Library of Medicine, National Institutes of Health.
[2]
ChEMBL — Glycopyrrolate compound record. European Bioinformatics Institute (EMBL-EBI).
[3]
Open Targets Platform — Drug–disease associations for Glycopyrrolate. EMBL-EBI & Wellcome Sanger Institute.
[4]
OpenFDA — FDA approval records (NDA NDA215019). U.S. Food & Drug Administration.
[5]
FDA Orange Book — Patent and exclusivity data for Robinul. U.S. Food & Drug Administration.
[6]
SEC EDGAR — Alnylam Pharmaceuticals company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Modality: Small molecule[2]
Highest Phase: Approved[1]
Company: Alnylam Pharmaceuticals

Patent Landscape[5]

Patent Cliff

Aug 16, 2026

Earliest patent expiration — generic entry possible after this date

Patent #Expires

11278683Aug 16, 2026

9265900Dec 7, 2028

10940110Feb 26, 2029

9789270Oct 30, 2030

9168556Sep 1, 2032

4 more patents

9604018May 16, 2033

10376661Sep 14, 2035

10688518Nov 12, 2036

10744277Dec 7, 2036

Robinul

Status by Indication[3][1]

Competitive Landscape

Expected Milestones

Q4 2027

Trials by Indication[1]

Glycopyrrolate5 trials

Sedation3 trials

Chronic Obstructive Pulmonary Disease3 trials

Sugammadex2 trials

Nausea and vomiting2 trials

Neuromuscular Blockade2 trials

Neostigmine2 trials

Bradycardia2 trials

Anesthesia1 trial

Headache1 trial

Hypotension1 trial

Heart Rate Variability1 trial

Polyp1 trial

Antidepressants1 trial

Efficacy and Safety1 trial

General Anesthesia1 trial

Coronary Artery Bypass1 trial

Paralysis1 trial

HFpEF1 trial

Parkinson's Disease1 trial

Laparoscopic Cholecystectomy1 trial

Urinary retention1 trial

Intraoperative1 trial

Intensive Care Unit1 trial

Clozapine-induced Hypersalivation1 trial

Premedication1 trial

Blood Pressure1 trial

Arrhythmia1 trial

Safety and Efficacy1 trial

Tics1 trial

Critically Ill1 trial

Neuromuscular Block1 trial

MACE1 trial

Unspecified1 trial

FDA Approval Timeline[4]

References

Drug Info

Quick Facts

Patent Landscape[5]

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