QNASL (beclomethasone dipropionate)
QNASL is indicated for the treatment of Allergic Rhinitis.
How QNASL Works
** Beclomethasone dipropionate is a prodrug that is converted into its active metabolite, beclomethasone-17-monopropionate. While the precise mechanism of action in allergic rhinitis is unknown, it binds to glucocorticoid receptors to exert anti-inflammatory effects. It inhibits various inflammatory cells (such as mast cells and eosinophils) and blocks the release of inflammatory mediators, including histamine, eicosanoids, and cytokines.
Details
- Status
- Prescription
- First Approved
- 2012-03-23
- Patent Cliff
- 2031
- Routes
- NASAL
- Dosage Forms
- AEROSOL, METERED
QNASL Approval History
What QNASL Treats
1 indicationsQNASL is approved for 1 conditions since its original approval in 2012. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Allergic Rhinitis
QNASL 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 QNASL
3 of 18FDA-approved drugs for similar conditions. Compare mechanisms and indications to understand treatment alternatives.
Clinical Trial Registry
12 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT04320342 TRITON | CLI-05993AA3-06 2020-002389-16 | Ph 3 | completed | 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 |
| NCT05292586 FORCE2 results posted | CLI-05993AB8-02 | Ph 3 | completed | 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 |
| NCT04873063 | PSC DS BDP-Once 1 | Ph 1 | completed | 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 |
| NCT00988247 results posted | BDP-AR-303 | Ph 3 | completed | Long Term Safety and Efficacy Trial of Beclomethasone Dipropionate - Hydrofluoroalkane (BDP-HFA) 320 mcg in Allergic Rhinitis |
| NCT01024608 results posted | BDP-AR-301 | Ph 3 | completed | Study in Adult and Adolescent Subjects With Seasonal Allergic Rhinitis (SAR) |
| NCT02139644 results posted | FSS-AS-301 2014-001149-25 | Ph 3 | completed | Study of Fluticasone Propionate MDPI Compared With Fluticasone/Salmeterol MDPI in Adolescent and Adult Patients With Persistent Asthma |
| NCT02031640 results posted | BDB-AS-301 2013-003397-27 | Ph 3 | completed | 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 |
| NCT01852513 results posted | IRB 12-1812 | Ph 4 | completed | Allergic Rhinitis Changes the Sinus Microbiome |
| NCT00565266 TALC results posted | 547 U10HL074206, U10HL074208 | Ph 3 | completed | 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) |
| NCT01016223 | 32508 | Ph 1 | completed | A Randomized Double Blind Placebo Controlled Study of the Effect of Swallowed Beclomethasone Dipropionate on Inflammatory Markers in Adult Patients With Eosinophilic Esophagitis |
| NCT01133626 results posted | BDP-AR-304 | Ph 3 | completed | Hypothalamic-Pituitary-Adrenal (HPA) Axis Study in Adult and Adolescent Subjects With Perennial Allergic Rhinitis (PAR) |
| NCT01113489 | 0002565 | Ph 3 | completed | Assessment of Oxidative Stress Markers in the Upper and Lower Airways of Atopic Children Treated With Nebulized Beclomethasone |
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.
QNASL FDA Label Details
Indications & Usage
FDA Label (PDF)QNASL is indicated for the treatment of Allergic Rhinitis.
QNASL Patents & Exclusivity
Patents (1 active)
Pro Intelligence Preview
Deep insights for QNASL
Revenue Insights
- • Quarterly revenue tracking
- • Historical trend analysis
Patent Timeline
- • Cliff: 2031
- • 4 active patents
Trial Analysis
- • Clinical trial tracking
- • Development stage analysis
Competitive Landscape
- • 18 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.