Qbrexza

(Glycopyrronium)

ApprovedSmall molecule

Qbrexza is one of 66 small molecule programs targeting Chronic Obstructive Pulmonary Disease. It is currently in Approved.

Indications

Total Trials

Active Trials

Competitors

FDA Application

NDA/BLA/ANDA regulatory filings

Patents

Pipeline

Status by Indication[3][1]

Indication

Chronic Obstructive Pulmonary DiseaseActive, not recruiting

Nausea and VomitingActive, not recruiting

Chronic Obstructive Pulmonary DiseasePhase 3

Active, not recruiting

Nausea and VomitingApproved

Active, not recruiting

Competition

Competitive Landscape

557 competitors in Chronic Obstructive Pulmonary Disease

#DrugCompanyPhaseTrials

Qbrexza

PPeking Union Medical College Hospital

Approved

3 2

Veramyst

GSK

Preclinical

26 3

Flovent

GSK

Preclinical

6 4

Spiriva

Boehringer Ingelheim

Preclinical

15 5

Formoterol Fumarate

AstraZeneca

Preclinical

11 6

Proventil

Mylan Pharmaceuticals Inc

Preclinical

3 7

Duragesic

CCephalon

Preclinical

2 8

Narcan

SScienture

Preclinical

1 9

Coumadin

AAbbott

Preclinical

1 10

Zoloft

VViatris Specialty LLC

Preclinical

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

Clinical

Trials by Indication[1]

Chronic Obstructive Pulmonary Disease3 trials

A 12-week Study to Evaluate the Efficacy and Safety of Umeclidinium 62.5 Microgram (mcg) Compared With Glycopyrronium 44 mcg in Subjects With Chronic Obstructive Pulmonary Disease (COPD)

Completed· GSK logo

GSK·Phase 4·NCT02236611·1,036 enrolled

Effects of Long Acting Bronchodilators on CARDiac Autonomic Control in Chronic Obstructive Pulmonary Disease (COPD)

Completed·—·Phase 4·NCT02872090·42 enrolled

A Study to Assess the Efficacy, Safety and Tolerability of Once-daily (q.d.) QVA149 in Patients With Moderate to Severe Chronic Obstructive Pulmonary Disease (COPD)

Completed· Novartis logo

Novartis·Phase 3·NCT01202188·2,144 enrolled

Effectiveness1 trial

Prospective Cohort Study for the Real - Life Effectiveness Evaluation of GlycOpyrronium With IndacatERol Combination in the Management of COPD in Canada (POWER Study)

Completed· Novartis logo

Novartis·Phase 4·NCT02202616·401 enrolled

Nausea and vomiting1 trial

Comparison of Postoperative Anti-nausea and Vomiting Effect Between Glycopyrronium and Ondansetron

Unknown status·TThe Second Affiliated Hospital of Chongqing Medical University·Phase 4·NCT05265507·480 enrolled

Moderate to Severe COPD1 trial

Effect of Glycopyrronium on Morning Symptoms and Pulmonary Function in Patients With Moderate to Severe COPD

Completed· Novartis logo

Novartis·Phase 4·NCT01959516·124 enrolled

Efficacy and Safety1 trial

Study to Evaluate the Efficacy and Safety of Glycopyrronium or Indacaterol Maleate and Glycopyrronium Bromide Fixed-dose Combination Regarding Symptoms and Health Status in Patients With Moderate COPD Switching From Treatment With Any Standard COPD Regimen

Completed· Novartis logo

Novartis·Phase 4·NCT01985334·4,389 enrolled

3 more indications

Cough Suppression1 trial

A RCT to Compare the Effectiveness of Nebulized Anticholinergics for Cough Suppression During Flexible Bronchoscopy

Not yet recruiting·PPost Graduate Institute of Medical Education and Research, Chandigarh·Phase 2/3·NCT06376942·1,050 enrolled

LAM1 trial

Effect of a LAMA and a uLABA on the Methacholine Dose-response Curve

Completed·UUniversity of Saskatchewan·Phase 4·NCT02953041·31 enrolled

CHOP1 trial

Duration of Long Acting Muscarinic Antagonist (LAMA) Bronchoprotection Against Methacholine Challenge

Completed·UUniversity of Saskatchewan·Phase 4·NCT02622243·13 enrolled

Regulatory

FDA Approval Timeline[4]

Jun 28, 2018

QBREXZA

NDA NDA210361

Sources

References

[1]
ClinicalTrials.gov — 10 trial records for Glycopyrronium. U.S. National Library of Medicine, National Institutes of Health.
[2]
ChEMBL — Glycopyrronium compound record. European Bioinformatics Institute (EMBL-EBI).
[3]
Open Targets Platform — Drug–disease associations for Glycopyrronium. EMBL-EBI & Wellcome Sanger Institute.
[4]
OpenFDA — FDA approval records (NDA NDA210361). U.S. Food & Drug Administration.
[5]
FDA Orange Book — Patent and exclusivity data for Qbrexza. U.S. Food & Drug Administration.
[6]
SEC EDGAR — Peking Union Medical College Hospital company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Modality: Small molecule[2]
Highest Phase: Approved[1]
Company: PPeking Union Medical College Hospital

Patent Landscape[5]

Patent Cliff

Oct 17, 2028

Earliest patent expiration — generic entry possible after this date

Patent #Expires

10052267Oct 17, 2028

8618160Dec 10, 2029

9744105Jul 18, 2030

10004717Feb 28, 2033

10548875Feb 28, 2033

3 more patents

10543192Feb 28, 2033

8859610Feb 28, 2033

9259414Feb 28, 2033

Qbrexza

Status by Indication[3][1]

Competitive Landscape

Trials by Indication[1]

Chronic Obstructive Pulmonary Disease3 trials

Effectiveness1 trial

Nausea and vomiting1 trial

Moderate to Severe COPD1 trial

Efficacy and Safety1 trial

Cough Suppression1 trial

LAM1 trial

CHOP1 trial

FDA Approval Timeline[4]

References

Drug Info

Quick Facts

Patent Landscape[5]

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