Data updated: May 26, 2026
ZETONNA (ciclesonide)
Respiratory
Approved 2012-01-20
2
Indications
--
Phase 3 Trials
14
Years on Market
Details
- Status
- Discontinued
- First Approved
- 2012-01-20
- Patent Cliff
- 2028
- Routes
- NASAL
- Dosage Forms
- AEROSOL, METERED
ZETONNA Approval History
2013
2014
2015
2016
2017
2018
2019
2020
2021
2022
2023
2024
2025
2026
Original
New Indication
New Form
Label Update
8 FDA actions from 2012 to 2023 · 1 indication expansions
Apr 2014 SUPPL
Mfg · Manufacturing (CMC)
What ZETONNA Treats
2 FDA approvalsOriginally approved for its first indication in 2012 . Covers 2 distinct patient populations.
- Other (2)
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Clinical Trial Registry
13 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT04356495 COVERAGEFrance | CHUBX 2020/12 2020-001435-27 | Ph 2, Ph 3 | completed | Trial of COVID-19 Outpatient Treatment in Individuals With Risk Factors for Aggravation |
| NCT04870333 PROTECT-V | CCTU0307 2020-004144-28 | Ph 2, Ph 3 | completed | PROphylaxis for paTiEnts at Risk of COVID-19 infecTion -V |
| NCT04377711 results posted | ALV-020-001 | Ph 3 | completed | A Study of the Safety and Efficacy of Ciclesonide in the Treatment of Non-hospitalized COVID-19 Patients |
| NCT04435795 CONTAIN results posted | 2021-6696 | Ph 2, Ph 3 | terminated | Inhaled Ciclesonide for Outpatients With COVID19 |
| NCT01455194 CONTRAST results posted | CL-9709-301-RD 2011-000683-99, U1111-1133-6333 | Ph 3 | completed | Effect of High Dose Ciclesonide on Asthma Control |
| NCT02155881 results posted | CIC-RR-001 U1111-1152-9472 | Ph 3 | completed | Efficacy and Safety of Ciclesonide Nasal Spray in Participants With Seasonal Allergic Rhinitis (SAR) in Russia |
| NCT00826969 | BY9010/CH-101 U1111-1137-3949 | Ph 4 | completed | Ciclesonide for the Treatment of Airway Hyperresponsiveness |
| NCT02221375 | 1256.1 | Ph 1 | completed | Safety, Tolerability and Pharmacokinetics of Multiple Rising Doses of Butylated Hydroxytoluene and BI 54903 XX Via Respimat® Soft MistTM Inhaler B in Healthy Male Volunteers |
| NCT01248065 VIDA results posted | AsthmaNet 001 1U10HL098115 | Ph 3 | completed | Study of the Effect of Vitamin D as an Add-on Therapy to Corticosteroids in Asthma |
| NCT01171365 SPIRA | 09115 | Ph 4 | completed | Small Particle Steroids in Refractory Asthma |
| NCT01401465 results posted | 060-302 | Ph 3 | completed | Study To Evaluate Patient Preference, Satisfaction And Efficacy Of a Nasal Aerosol Versus an Aqueous Nasal Spray |
| NCT01430260 | HANDOK2010.07 | Ph 4 | completed | Omnaris Versus Levocetirizine Phase 4 Study |
| NCT01333800 | CO-AL-FE-001 | Ph 4 | completed | Cost-effectiveness Study of Beclomethasone Versus Ciclesonide as Controller Medications in Pediatric Asthma |
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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.
ZETONNA FDA Label Details
View full patent landscape →
1 OB patents · 1 families ·
25 international docs across 11 countries
ZETONNA Patents & Exclusivity
Latest Patent: Feb 2028
Patents (1 active)
US8371292
Expires Feb 1, 2028
Source: FDA Orange Book
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- • Historical trend analysis
Patent Timeline
- • Cliff: 2028
- • 1 active patents
Trial Analysis
- • Clinical trial tracking
- • Development stage analysis
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- • Competitor tracking
- • Same target/indication analysis
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.