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Qvar

(beclomethasone dipropionate)

ApprovedSmall molecule

SSchering-Plough

Beclomethasone is an inhaled steroid used to prevent and control asthma symptoms and reduce inflammation in the airways. It's also used as a nasal spray to treat allergies and nasal inflammation.[2] Qvar is currently approved and in use across 23 indications[4].[1]

Qvar is one of 479 small molecule programs targeting Bronchopulmonary Dysplasia. It is currently in Approved.

23

Indications

29

Total Trials

0

Active Trials

478

Competitors

11

FDA Applications

NDA/BLA/ANDA regulatory filings

20

Patents

Pipeline

Status by Indication[4][1]

Indication

Bronchopulmonary DysplasiaApproved

SinusitisApproved

BronchiectasisApproved

Airway ObstructionActive, not recruiting

Rhinitis, Allergic, PerennialActive, not recruiting

FolliculitisApproved

Acute Graft Vs. Host DiseaseApproved

Nasal Cavity PolypApproved

Chronic Obstructive Pulmonary DiseaseActive, not recruiting

Nasal CongestionActive, not recruiting

Bronchopulmonary DysplasiaApproved

Approved

SinusitisApproved

Approved

BronchiectasisApproved

Approved

Airway ObstructionApproved

Active, not recruiting

Rhinitis, Allergic, PerennialApproved

Active, not recruiting

FolliculitisApproved

Approved

Acute Graft Vs. Host DiseaseApproved

Approved

Nasal Cavity PolypApproved

Approved

Chronic Obstructive Pulmonary DiseaseApproved

Active, not recruiting

Nasal CongestionApproved

Active, not recruiting

Showing 10 of 22 indications

Competition

Competitive Landscape

1050 competitors in Asthma

#DrugCompanyPhaseTrials

Qvar

SSchering-Plough

Xolair

Singulair

Dupixent

AAzienda U.S.L. 1 di Massa e Carrara

Asmanex

Arcoxia

Atrovent

Boehringer Ingelheim

Aciphex

Akero Therapeutics

Aclidinium Bromide

Lexapro

SShirley Ryan AbilityLab

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

Clinical

Trials by Indication[1]

Asthma11 trials

(CARE Network Trial - Treating Children to Prevent Exacerbations of Asthma (TREXA)

Completed·MMilton S. Hershey Medical Center·Phase 3·NCT00394329·288 enrolled

Study of Asthma Phenotypes and Pharmacogenomic Interactions by Race-Ethnicity (SAPPHIRE)

Completed·HHenry Ford Health System·N/A·NCT01142947·362 enrolled

Evaluation of Two Doses of QVAR by Breath Operated and Metered Dose Inhalers in Asthmatic Children

Completed· Teva logo

Teva·Phase 3·NCT00094016·440 enrolled

Show 8 more trials

Study of Fluticasone Propionate MDPI Compared With Fluticasone/Salmeterol MDPI in Adolescent and Adult Patients With Persistent Asthma

Completed· Teva logo

Teva·Phase 3·NCT02139644·787 enrolled

An 8-week Dose Ranging Study of CHF 718 pMDI in Asthmatic Subjects

Completed· Chiesi Farmaceutici S.p.A. logo

Chiesi Farmaceutici S.p.A.·Phase 2·NCT03084718·610 enrolled

Evaluation of Two Doses of QVAR Versus Placebo by Breath Operated and Metered Dose Inhalers in Moderate Asthmatic Adolescents and Adults on a Stable Regimen of Inhaled Corticosteroids

Completed· Teva logo

Teva·Phase 3·NCT00109668·415 enrolled

A Safety and Efficacy Study of Beclomethasone Dipropionate Delivered Via Breath-Actuated Inhaler (BAI) or Metered-Dose Inhaler (MDI) in Participants >=12 Years Old With Persistent Asthma

Completed· Teva logo

Teva·Phase 3·NCT02031640·1,113 enrolled

Real-world Effectiveness and Cost-effectiveness of Leading Inhaled Corticosteroids in Asthma Management

Completed·RResearch in Real-Life Ltd··NCT01141439·815,377 enrolled

Efficacy and Safety of Nebulised Beclomethasone Dipropionate Plus as Needed Salbutamol vs as Needed Salbutamol or as Needed Salbutamol/Beclomethasone Fixed Combination in Young Children With Asthma Symptoms

Completed· Chiesi Farmaceutici S.p.A. logo

Chiesi Farmaceutici S.p.A.·Phase 3·NCT00497523·283 enrolled

A Study Testing the Superiority of CHF 1535 pMDI 800/24µg Total Daily Dose Compared With CHF 718 pMDI 800µg Total Daily Dose in Adults With Asthma on Medium or High-Dose Inhaled Corticosteroid

Completed· Chiesi Farmaceutici S.p.A. logo

Chiesi Farmaceutici S.p.A.·Phase 3·NCT05292586·1,377 enrolled

Asthma Clinical Research Network (ACRN) Trial - Tiotropium Bromide as an Alternative to Increased Inhaled Corticosteroid in Patients Inadequately Controlled on a Lower Dose of Inhaled Corticosteroid (TALC)

Completed·MMilton S. Hershey Medical Center·Phase 3·NCT00565266·210 enrolled

Allergic Rhinitis4 trials

Long Term Safety and Efficacy Trial of Beclomethasone Dipropionate - Hydrofluoroalkane (BDP-HFA) 320 mcg in Allergic Rhinitis

Completed· Teva logo

Teva·Phase 3·NCT00988247·529 enrolled

Validation Of Preference Module Of Experience With Allergic Rhinitis Nasal Sprays Questionnaire (EARNS-Q)

Completed· GSK logo

GSK·Phase 3·NCT00346775·97 enrolled

Hypothalamic-Pituitary-Adrenal (HPA) Axis Study in Adult and Adolescent Subjects With Perennial Allergic Rhinitis (PAR)

Completed· Teva logo

Teva·Phase 3·NCT01133626·107 enrolled

Show 1 more trial

Nebulized Beclometasone Dipropionate Improves Nasal Patency in Children With Allergic Rhinitis

Completed·SStefania La Grutta, MD·Phase 4·NCT02646904·68 enrolled

Seasonal Allergic Rhinitis4 trials

Dose-Ranging Study of Mometasone Furoate (MK-0887/SCH 032088) Nasal Spray in the Treatment of Children (Ages 6-11) With Seasonal Allergic Rhinitis (C95-161)

Completed·OOrganon and Co·Phase 3·NCT03879772·679 enrolled

Safety and Efficacy of Mometasone Furoate (SCH 032088) vs Beclomethasone Dipropionate or Placebo in Seasonal Allergic Rhinitis (C93-013)

Completed·OOrganon and Co·Phase 3·NCT03855189·345 enrolled

7 Day Study of Mast Cell Inhibitor, R926112, in Patients With Symptomatic Seasonal Allergic Rhinitis

Completed·RRigel Pharmaceuticals·Phase 2·NCT00115089·375 enrolled

Show 1 more trial

Study in Adult and Adolescent Subjects With Seasonal Allergic Rhinitis (SAR)

Completed· Teva logo

Teva·Phase 3·NCT01024608·340 enrolled

Graft Versus Host Disease3 trials

Compassionate Use of Beclomethasone in Treating Patients With Graft-Versus-Host Disease of the Gastrointestinal Tract

Completed·RRoswell Park Cancer Institute·N/A·NCT00055666·51 enrolled

Beclomethasone in Treating Patients With Graft-Versus-Host Disease of the Esophagus, Stomach, Small Intestine, or Colon

Completed·FFred Hutchinson Cancer Center·Phase 1/2·NCT00010283

Beclomethasone Plus Prednisone in Treating Patients With Graft-Versus-Host Disease

Completed·MMemorial Sloan Kettering Cancer Center·Phase 3·NCT00043147

Eosinophilic Esophagitis1 trial

A Randomized Double Blind Placebo Controlled Study of the Effect of Swallowed Beclomethasone Dipropionate on Inflammatory Markers in Adult Patients With Eosinophilic Esophagitis

Completed·PPenn State University·Phase 1·NCT01016223·20 enrolled

6 more indications

Systemic1 trial

Evaluation of Systemic Bioavailability and Effects on 24-Hour Plasma Cortisol Profile of 6 mg Delivered Once Daily Versus 3 mg Delivered Twice Daily in Healthy Adult Male Volunteers

Completed·SSOFAR S.p.A.·Phase 1·NCT04873063·28 enrolled

Efficacy1 trial

A Study Comparing Efficacy, Safety and Tolerability of the Fixed Dose Triple Combination CHF 5993 With the Fixed Dose Dual Combination CHF 1535 in Subjects With COPD

Completed· Chiesi Farmaceutici S.p.A. logo

Chiesi Farmaceutici S.p.A.·Phase 3·NCT04320342·3,433 enrolled

Gastrointestinal1 trial

Randomized Study of Oral Beclomethasone Dipropionate With Ten Days of Prednisone for Treatment of Gastrointestinal GVHD

Completed·EEnteron Pharmaceuticals·Phase 3·NCT00233896·130 enrolled

Infections1 trial

Preventing Frequent Sinus Infections in HIV-Infected Patients

Withdrawn·NNational Institute of Allergy and Infectious Diseases (NIAID)·Phase 2·NCT00000752

Acute Graft Versus Host Disease1 trial

Beclomethasone Dipropionate in Preventing Acute Graft-Versus-Host Disease in Patients Undergoing a Donor Stem Cell Transplant for Hematologic Cancer

Completed·FFred Hutchinson Cancer Center·Phase 2·NCT00489203·140 enrolled

Oxidative Stress1 trial

Assessment of Oxidative Stress Markers in the Upper and Lower Airways of Atopic Children Treated With Nebulized Beclomethasone

Completed·FFondazione C.N.R./Regione Toscana "G. Monasterio", Pisa, Italy·Phase 3·NCT01113489·32 enrolled

Regulatory

FDA Approval Timeline[5]

Jan 1, 1982

BECONASE

NDA NDA018584

Jan 1, 1982

VANCERIL

NDA NDA017573

Jan 1, 1982

BECLOVENT

NDA NDA018153

Jan 1, 1982

VANCENASE

NDA NDA018521

Jul 27, 1987

BECONASE AQ

NDA NDA019389

Dec 23, 1987

VANCENASE AQ

NDA NDA019589

Jun 26, 1996

VANCENASE AQ

NDA NDA020469

Dec 24, 1996

VANCERIL DOUBLE STRENGTH

NDA NDA020486

Sep 15, 2000

QVAR 40

NDA NDA020911

Dec 17, 2014

QNASL

NDA NDA202813

Aug 3, 2017

QVAR REDIHALER

NDA NDA207921

Sources

References

[1]
ClinicalTrials.gov — 29 trial records for beclomethasone dipropionate. U.S. National Library of Medicine, National Institutes of Health.
[2]
MedlinePlus Drug Information — Qvar drug information. U.S. National Library of Medicine, National Institutes of Health.
[3]
ChEMBL — beclomethasone dipropionate compound record. European Bioinformatics Institute (EMBL-EBI).
[4]
Open Targets Platform — Drug–disease associations for beclomethasone dipropionate. EMBL-EBI & Wellcome Sanger Institute.
[5]
OpenFDA — FDA approval records (NDA NDA207921). U.S. Food & Drug Administration.
[6]
FDA Orange Book — Patent and exclusivity data for Qvar. U.S. Food & Drug Administration.
[7]
SEC EDGAR — Schering-Plough company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Mechanism of Action: Glucocorticoid Receptor Agonist[3]
Modality: Small molecule[3]
Highest Phase: Approved[1]
Company: SSchering-Plough

Patent Landscape[6]

Patent Cliff

Sep 7, 2028

Earliest patent expiration — generic entry possible after this date

Patent #Expires

8132712Sep 7, 2028

10022510May 18, 2031

9808587May 18, 2031

10086156May 18, 2031

10022509May 18, 2031

15 more patents

11395889May 18, 2031

10695512May 18, 2031

9463289May 18, 2031

8931476Jul 17, 2031

10188811Oct 21, 2031

10561808Jan 1, 2032

11793953Jan 26, 2038

11395888Jan 26, 2038

11865247Jan 26, 2038

12296089Jan 26, 2038

11896759Jan 26, 2038

10792447Jan 25, 2039

11559637Jul 21, 2039

11957832May 5, 2041

11583643Aug 19, 2041

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