Data updated: Jun 28, 2026
TRIMBOW (beclomethasone dipropionate) · CHIESI
Approved 2026-05-14
1
Indication
--
Phase 3 Trials
0
Years on Market
Details
- Status
- Prescription
- First Approved
- 2026-05-14
- Routes
- INHALATION
- Dosage Forms
- AEROSOL, METERED
Companies
Website: ↗
TRIMBOW Approval History
Original
New Indication
New Form
Label Update
2 FDA actions from 2026 to 2026
What TRIMBOW Treats
1 FDA approvalsOriginally approved for its first indication in 2026 .
- Other (1)
CHIESI's other novel FDA approvals
Other CDER-designated drugs from the same sponsor (2016–2025).
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Clinical Trial Registry
11 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 |
| 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 |
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Pro Active Pipeline
Ongoing clinical trials by development phase
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Pro Key Completed Trials
Completed studies with published results, ranked by significance
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Trial Timeline
Full development history with FDA approval milestones
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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.
TRIMBOW FDA Label Details
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.