TheraRadar
Data updated: Jun 28, 2026

ZETONNA (ciclesonide) · AZURITY

Respiratory Approved 2012-01-20

ZETONNA is FDA-approved to treat 1 condition (same as ALVESCO).

Source: FDA Label
Jump to: Indications Approvals Trials Competitors Safety Patents
2
Indications
--
Phase 3 Trials
14
Years on Market

Details

Status
Discontinued
First Approved
2012-01-20
Patent Cliff
2028

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Routes
NASAL
Dosage Forms
AEROSOL, METERED

Companies

AZURITY
Active Ingredient: CICLESONIDE

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
Feb 2023 SUPPL
Label · Labeling
FDA Letter Label
Oct 2014 SUPPL
Efficacy
FDA Letter Label
Apr 2014 SUPPL
Mfg · Manufacturing (CMC)

What ZETONNA Treats

1 indications

ZETONNA is approved for 1 conditions since its original approval in 2012. These indications span multiple therapeutic areas including oncology, immunology, and more.

Same approved indications as ALVESCO (same active ingredient).

Source: FDA Label
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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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Active Pipeline

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Ongoing clinical trials by development phase

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Key Completed Trials

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Completed studies with published results, ranked by significance

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Trial Timeline

ClinicalTrials.gov ↗ Pro

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

Indications & Usage

FDA Label (PDF)

ZETONNA is FDA-approved to treat 1 condition — same approved indications as ALVESCO.

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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Revenue Insights

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Patent Timeline

  • • Cliff: 2028
  • • 1 active patents

Trial Analysis

  • • Clinical trial tracking
  • • Development stage analysis

Competitive Landscape

  • • Competitor tracking
  • • Same target/indication analysis
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Data Sources

FDA Approval: NDA202129 → Patents: FDA Orange Book → Trials: ClinicalTrials.gov →

Data sourced from official FDA and NIH databases. Click links to verify on original sources.