Ciclesonide

Overview

Ciclesonide is a glucocorticoid used to treat obstructive airway diseases. It is marketed under the brand name Alvesco.

Indication

For the treatment of nasal symptoms associated with seasonal and perennial allergic rhinitis in adults and adolescents 12 years of age and older.

Associated Conditions

Asthma
Bronchoconstriction
Chronic Obstructive Pulmonary Disease (COPD)
Perennial Allergic Rhinitis (PAR)
Seasonal Allergic Rhinitis

Clinical Trials

Title	Posted	Study ID	Phase	Status	Sponsor
Inhaled Ciclesonide Study in Preterm Infants	2024/09/19	NCT06589245	Phase 1	Recruiting	Children's Mercy Hospital Kansas City
PROphylaxis for paTiEnts at Risk of COVID-19 infecTion -V	2021/05/03	NCT04870333	Phase 2	Completed	Cambridge University Hospitals NHS Foundation Trust
Inhaled Ciclesonide for Outpatients With COVID19	2020/06/17	NCT04435795	Phase 2	Terminated	McGill University Health Centre/Research Institute of the McGill University Health Centre
Inhalation of Ciclesonide for Patients With COVID-19: A Randomised Open Treatment Study (HALT COVID-19)	2020/05/08	NCT04381364	Phase 2	UNKNOWN	Ola Blennow, MD, PhD
A Study of the Safety and Efficacy of Ciclesonide in the Treatment of Non-hospitalized COVID-19 Patients	2020/05/06	NCT04377711	Phase 3	Completed	Covis Pharma S.à.r.l.
Trial of COVID-19 Outpatient Treatment in Individuals With Risk Factors for Aggravation	2020/04/22	NCT04356495	Phase 2	Completed	University Hospital, Bordeaux
A Trial of Ciclesonide in Adults With Mild-to-moderate COVID-19	2020/04/01	NCT04330586	Phase 2	Completed	Korea University Guro Hospital
The Mannitol-Asthma-Ciclesonide-Study	2019/02/15	NCT03839433	Phase 4	Completed	Cantonal Hosptal, Baselland
Ciclesonide vs Fluticasone Nasal Sprays in Nasal Poplyposis	2016/01/28	NCT02665806	Phase 3	UNKNOWN	Tehran University of Medical Sciences
A Study Comparing The Bioequivalence Of Ciclesonide Nasal Spray (Apotex, Inc.) To That Of Omnaris™ Nasal Spray (Sepracor, Inc.) In The Treatment Of Seasonal Allergic Rhinitis	2014/10/24	NCT02273817	Phase 3	Completed	Apotex Inc.

FDA Drug Approvals

Approved Product	Manufacturer	NDC Code	Route	Strength	Effective Date
Omnaris	Physicians Total Care, Inc.	54868-6020	NASAL	50 ug in 1 1	5/24/2010
Zetonna	Covis Pharma US, Inc	70515-737	NASAL	37 ug in 1 1	12/19/2022
Alvesco	Physicians Total Care, Inc.	54868-5989	RESPIRATORY (INHALATION)	80 ug in 1 1	11/15/2010
Alvesco	Physicians Total Care, Inc.	54868-5990	RESPIRATORY (INHALATION)	160 ug in 1 1	11/15/2010
Omnaris	Covis Pharma US, Inc	70515-701	NASAL	50 ug in 1 1	3/14/2018
Alvesco	Sixarp, LLC	59368-101	RESPIRATORY (INHALATION)	160 ug in 1 1	3/12/2024
Alvesco	Covis Pharma US, Inc	70515-712	RESPIRATORY (INHALATION)	160 ug in 1 1	12/19/2022
Alvesco	Covis Pharma US, Inc	70515-711	RESPIRATORY (INHALATION)	80 ug in 1 1	12/19/2022

EMA Drug Approvals

Approved Product	Authorization Holder	Status	Issued Date
No EMA approvals found for this drug.

HSA Drug Approvals

Approved Product	Manufacturer	Approval Number	Dosage Form	Strength	Approval Date
No HSA approvals found for this drug.

NMPA Drug Approvals

Approved Product	Company	Approval Number	Drug Type	Dosage Form	Approval Date
No NMPA approvals found for this drug.

PPB Drug Approvals

Approved Product	Registration No.	Company	Licence No.	Strength	Registration Date
ALVESCO 80 INHALER 80MCG/ACTUATION	N/A	DKSH Hong Kong Limited	N/A	N/A	2/12/2005

TGA Drug Approvals

Approved Product	ARTG ID	Sponsor	Registration Type	Status	Registration Date
OMNARIS ciclesonide 50 microgram per actuation nasal spray bottle	167910	Chiesi Australia Pty Ltd	Medicine	A	12/16/2011
ALVESCO ciclesonide 160 micrograms per actuation aerosol can	93725	Chiesi Australia Pty Ltd	Medicine	A	2/24/2004
ALVESCO ciclesonide 80 micrograms per actuation aerosol can	93724	Chiesi Australia Pty Ltd	Medicine	A	2/24/2004

Health Canada Drug Approvals

Approved Product	Company	DIN	Dosage Form	Strength	Market Date
ALVESCO	takeda canada inc	02285592	Aerosol, Metered Dose - Inhalation	50 MCG / ACT	N/A
ALVESCO	Covis Pharma GmbH	02285614	Aerosol, Metered Dose - Inhalation	200 MCG / ACT	9/27/2006
APO-CICLESONIDE	Apotex Inc	02417316	Spray, Metered Dose - Nasal	50 MCG / ACT	11/25/2016
OMNARIS HFA	takeda canada inc	02404311	Aerosol, Metered Dose - Nasal	50 MCG / ACT	8/7/2013
ALVESCO	Covis Pharma GmbH	02285606	Aerosol, Metered Dose - Inhalation	100 MCG / ACT	9/27/2006

CIMA AEMPS Drug Approvals

Approved Product	Company	Registration Number	Pharmaceutical Form	Prescription Type	Status
ALVESCO 160 microgramos/INHALACION SOLUCION PARA INHALACION EN ENVASE A PRESION	Covis Pharma Europe B.V.	70372	SOLUCIÓN PARA INHALACIÓN EN ENVASE A PRESIÓN	Medicamento Sujeto A Prescripción Médica	Commercialized
ALVESCO 160 MICROGRAMOS/INHALACION SOLUCION PARA INHALACION EN ENVASE A PRESION	Takeda Gmbh	05-0019	SOLUCIÓN PARA INHALACIÓN EN ENVASE A PRESIÓN	Medicamento Sujeto A Prescripción Médica	Not Commercialized

Philippines FDA Drug Approvals

Approved Product	Company	License Number	Dosage Form	Strength	Approval Date
No Philippines FDA approvals found for this drug.

Saudi SFDA Drug Approvals

Approved Product	Company	License Number	Dosage Form	Strength	Approval Date
No Saudi SFDA approvals found for this drug.

Malaysia NPRA Drug Approvals

Approved Product	Company	Registration Number	Dosage Form	Strength	Approval Date
No Malaysia NPRA approvals found for this drug.

UK EMC Drug Information

Medicine Name	MA Holder	MA Number	Pharmaceutical Form	Active Ingredient	Authorization Date
No UK EMC drug information found for this drug.

AI-Powered Research

Premium Access