Ciclesonide

also known as Alvesco · BI54903 · XRP1526 · CIC-HFA · Alvesco 160 · Alvesco 80 · Aservo equihaler · CIC160 · +5 more

Other / unclassified targets NR3C1 via activation

Developed for: asthma · perennial allergic rhinitis · seasonal allergic rhinitis · COVID-19 · allergic rhinitis · chronic obstructive pulmonary disease · chronic rhinosinusitis · viral pneumonia
Investigated by: AstraZeneca · Sumitomo Pharma America, Inc. · Boehringer Ingelheim · Sanofi · Takeda · University of Bordeaux
+19 more
· ANRS, Emerging Infectious Diseases · Allergy & Asthma Medical Group & Research Center · Alliance for International Medical Action · Barcelona Institute for Global Health · Centrallasarettet Västerås · Centre Muraz · Danderyd Hospital · French National Institute of Health and Medical Research · GlaxoSmithKline · Handok Inc. · Hvidovre University Hospital · Karolinska University Hospital · Korea University Guro Hospital · Ola Blennow, MD, PhD · PACCI Program · Tehran University of Medical Sciences · University Hospital, Bordeaux · University of Alberta · West Penn Allegheny Health System

Regulatory milestones approvals, filings & regulatory actions · 4 recorded

Milestone	Jurisdiction	Brand	Indication	Date	Sentence it was read from
Label expansion	US (FDA)	ZETONNA	—	2014-10-23	fda.gov ↗
Label expansion	US (FDA)	OMNARIS	—	2013-03-22	fda.gov ↗
Label expansion	US (FDA)	ALVESCO	—	2012-12-17	fda.gov ↗
Approved	US (FDA)	OMNARIS	—	2006-10-20	fda.gov ↗

Trials 53

today

US approved 2006

NCT03141424 · Ph 4 NCT04920838 · Ph 2/3 NCT04356495 · Ph 2/3 NCT04381364 · Ph 2 NCT04330586 · Ph 2 NCT02665806 · Ph 3 NCT02155881 · Ph 3 NCT01654536 · Ph 4 NCT01550471 · Ph 4 NCT01458912 · Ph 2 NCT01458886 · Ph 2 NCT01397162 · Ph 2 NCT01401465 · Ph 3 NCT01378429 · Ph 3 NCT01396278 · Ph 2 NCT01397201 · Ph 2 NCT01371786 · Ph 1 NCT01309139 · Ph 1 NCT01287364 · Ph 3 NCT01430260 · Ph 4 NCT01067105 · Ph 3 NCT01033825 · Ph 3 NCT01010971 · Ph 3 NCT00953147 · Ph 3 NCT00790023 · Ph 3 NCT00535366 · Ph 2 NCT00367263 · not/applicable NCT00395239 · Ph 4 NCT00384475 · Ph 3 NCT00392288 · Ph 3 NCT00305487 · Ph 3 NCT00261287 · Ph 3 NCT00163436 · Ph 3 NCT00174720 · Ph 3 NCT00163371 · Ph 3 NCT00314509 · Ph 2 NCT00174733 · Ph 3 NCT00174746 · Ph 2 NCT00163488 · Ph 3 NCT00163319 · Ph 3 NCT00163423 · Ph 3 NCT00163462 · Ph 3 NCT00163514 · Ph 3 NCT00163384 · Ph 3 NCT00163397 · Ph 3 NCT00254956 · Ph 3 NCT00163501 · Ph 3 NCT00163345 · Ph 3 NCT00163358 · Ph 3 NCT00163410 · Ph 3 NCT00163332 · Ph 3 NCT00546520 · Ph 3 NCT00270348 · Ph 3

200120022003200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027

Phase	Registry id	Dates	Indication	Sponsor	Status	Outcome
Phase 12 trials
Phase 1	NCT01371786	Jun → Aug 2011	allergic rhinitis	Sumitomo Pharma America, Inc.	Completed	No outcome recorded
Phase 1	NCT01309139	Mar → Jun 2011	—	Boehringer Ingelheim	Completed	No outcome recorded
Phase 210 trials · 1 met primary · 1 missed
Phase 2	NCT04381364	May 2020 → Aug 2021	COVID-19, viral pneumonia	Ola Blennow, MD, PhD	Unknown	Missed primary
Phase 2	NCT04330586	Apr 2020 → Mar 2021	COVID-19	Korea University Guro Hospital	Completed	Met primary
Phase 2	NCT01458912	Nov 2011 → May 2013	asthma	Boehringer Ingelheim	Withdrawn	No outcome recorded
Phase 2	NCT01458886	Nov 2011 → May 2013	asthma	Boehringer Ingelheim	Withdrawn	No outcome recorded
Phase 2	NCT01397162	Jul → Dec 2011	asthma	Boehringer Ingelheim	Terminated	No outcome recorded
Phase 2	NCT01396278	Jul → Dec 2011	asthma	Boehringer Ingelheim	Terminated	No outcome recorded
Phase 2	NCT01397201	Jul → Dec 2011	asthma	Boehringer Ingelheim	Terminated	No outcome recorded
Phase 2	NCT00535366	Oct 2007 → Sep 2008	chronic obstructive pulmonary disease	Boehringer Ingelheim	Completed	No outcome recorded
Phase 2	NCT00314509	Jul 2005 → Jan 2006	asthma	AstraZeneca	Completed	No outcome recorded
Phase 2	NCT00174746	Mar → Nov 2005	asthma	Sanofi	Completed	No outcome recorded
Phase 2/32 trials
Phase 2/3	NCT04920838	Apr 2021 → Aug 2023	COVID-19	ANRS, Emerging Infectious Diseases	Unknown	No outcome recorded
Phase 2/3	NCT04356495	Jul 2020 → Oct 2021	COVID-19	University Hospital, Bordeaux	Completed	No outcome recorded
Phase 333 trials · 8 met primary · 2 missed
Phase 3	NCT02665806	Jan → Feb 2016	chronic rhinosinusitis	Tehran University of Medical Sciences	Unknown	No outcome recorded
Phase 3	NCT02155881	Aug → Oct 2014	seasonal allergic rhinitis	AstraZeneca	Completed	Missed primary
Phase 3	NCT01401465	Jul → Nov 2011	perennial allergic rhinitis	Sumitomo Pharma America, Inc.	Completed	Met primary
Phase 3	NCT01378429	Jul → Nov 2011	perennial allergic rhinitis	Sumitomo Pharma America, Inc.	Completed	No outcome recorded
Phase 3	NCT01287364	Feb → Apr 2011	perennial allergic rhinitis	Sumitomo Pharma America, Inc.	Completed	No outcome recorded
Phase 3	NCT01067105	Feb → Nov 2010	perennial allergic rhinitis	Sumitomo Pharma America, Inc.	Completed	No outcome recorded
Phase 3	NCT01033825	Jan → May 2010	perennial allergic rhinitis	Sumitomo Pharma America, Inc.	Completed	No outcome recorded
Phase 3	NCT01010971	Dec 2009 → Feb 2010	seasonal allergic rhinitis	Sumitomo Pharma America, Inc.	Completed	Met primary
Phase 3	NCT00953147	Aug 2009 → Jan 2010	perennial allergic rhinitis	Sumitomo Pharma America, Inc.	Completed	Met primary
Phase 3	NCT00790023	Nov 2008 → Feb 2009	seasonal allergic rhinitis	Sumitomo Pharma America, Inc.	Completed	Met primary
Phase 3	NCT00384475	Oct 2006 → Jan 2007	seasonal allergic rhinitis	AstraZeneca	Completed	No outcome recorded
Phase 3	NCT00392288	Sep 2006 → Feb 2008	asthma	AstraZeneca	Completed	Missed primary
Phase 3	NCT00305487	Mar → Oct 2006	seasonal allergic rhinitis	AstraZeneca	Completed	No outcome recorded
Phase 3	NCT00261287	Nov 2005 → Jun 2006	perennial allergic rhinitis	AstraZeneca	Completed	No outcome recorded
Phase 3	NCT00163436	Sep 2005 → Jan 2006	asthma	AstraZeneca	Completed	No outcome recorded
Phase 3	NCT00174720	Sep 2005 → Feb 2007	asthma	Sanofi	Completed	Met primary
Phase 3	NCT00163371	Sep → Dec 2005	asthma	AstraZeneca	Completed	No outcome recorded
Phase 3	NCT00174733	Jul 2005 → Feb 2006	asthma	Sanofi	Completed	Met primary
Phase 3	NCT00163488	Jan → Aug 2005	perennial allergic rhinitis, seasonal allergic rhinitis	AstraZeneca	Completed	No outcome recorded
Phase 3	NCT00163319	Nov 2004 → Nov 2005	asthma	AstraZeneca	Completed	No outcome recorded
Phase 3	NCT00163423	Nov 2004 → Jan 2006	asthma	AstraZeneca	Completed	No outcome recorded
Phase 3	NCT00163462	Oct 2004 → Nov 2005	asthma	AstraZeneca	Completed	No outcome recorded
Phase 3	NCT00163514	May 2004 → Jul 2005	perennial allergic rhinitis	AstraZeneca	Completed	No outcome recorded
Phase 3	NCT00163384	Jan 2004 → May 2005	asthma	AstraZeneca	Completed	No outcome recorded
Phase 3	NCT00163397	Jan 2004 → Jul 2005	asthma	AstraZeneca	Completed	No outcome recorded
Phase 3	NCT00254956	Jan 2004 → Jun 2005	allergic respiratory disease, asthma	Sanofi	Completed	Met primary
Phase 3	NCT00163501	Dec 2003 → Apr 2005	perennial allergic rhinitis, seasonal allergic rhinitis	AstraZeneca	Completed	No outcome recorded
Phase 3	NCT00163345	Sep 2003 → May 2006	asthma	AstraZeneca	Completed	No outcome recorded
Phase 3	NCT00163358	Sep 2003 → Oct 2005	asthma	AstraZeneca	Completed	No outcome recorded
Phase 3	NCT00163410	Apr 2003 → Dec 2004	asthma	AstraZeneca	Completed	No outcome recorded
Phase 3	NCT00163332	Mar 2003 → ?	asthma	AstraZeneca	Completed	No outcome recorded
Phase 3	NCT00546520	Apr → Jun 2002	asthma	AstraZeneca	Completed	No outcome recorded
Phase 3	NCT00270348	Dec 2000 → Sep 2004	asthma	Sanofi	Completed	Met primary

Phase 45 trials
Phase 4	NCT03141424	Jun 2022 → Oct 2024	asthma	Hvidovre University Hospital	Completed	No outcome recorded
Phase 4	NCT01654536	Sep 2012 → Jul 2013	perennial allergic rhinitis	Sumitomo Pharma America, Inc.	Completed	No outcome recorded
Phase 4	NCT01550471	Mar 2012 → Aug 2015	allergic rhinitis, asthma	West Penn Allegheny Health System	Completed	No outcome recorded
Phase 4	NCT01430260	Jan 2011 → Jul 2012	allergic rhinitis	Handok Inc.	Completed	No outcome recorded
Phase 4	NCT00395239	Oct 2006 → Oct 2015	asthma	University of Alberta	Terminated	No outcome recorded
Phase not applicable1 trial
—	NCT00367263	Oct → Nov 2006	asthma	Allergy & Asthma Medical Group & Research Center	Completed	No outcome recorded
Comparator or background therapy31 trials
Phase 1	NCT02665754 Background	Jul 2016 → Dec 2019	allergic rhinitis	Gachon University Gil Medical Center	Completed	No outcome recorded
Phase 1	NCT02221375 Comparator	Jun → Sep 2008	—	Boehringer Ingelheim	Completed	No outcome recorded
Phase 2	NCT01428622 Background	Oct 2011 → ?	asthma	Boehringer Ingelheim	Withdrawn	No outcome recorded
Phase 2	NCT00807053 Comparator	Apr → Jun 2007	seasonal allergic rhinitis	AstraZeneca	Completed	No outcome recorded
Phase 2/3	NCT04870333 Comparator	Feb 2021 → Apr 2025	COVID-19	Cambridge University Hospitals NHS Foundation Trust	Completed	Missed primary
Phase 2/3	NCT04435795 Comparator	Sep 2020 → Jun 2021	COVID-19	McGill University Health Centre/Research Institute of the McGill University Health Centre	Terminated	No outcome recorded
Phase 3	NCT04377711 Comparator	Jun 2020 → Jan 2021	COVID-19	Covis Pharma S.à.r.l.	Completed	No outcome recorded
Phase 3	NCT01455194 Comparator	Nov 2011 → Aug 2014	asthma	AstraZeneca	Completed	No outcome recorded
Phase 3	NCT01458275 Comparator	Nov 2011 → Mar 2013	seasonal allergic rhinitis	Sumitomo Pharma America, Inc.	Completed	No outcome recorded
Phase 3	NCT01451541 Comparator	Oct 2011 → Dec 2012	perennial allergic rhinitis	Sumitomo Pharma America, Inc.	Completed	No outcome recorded
Phase 3	NCT01248065 Background	Apr 2011 → Jan 2014	asthma	Milton S. Hershey Medical Center	Completed	Missed primary
Phase 3	NCT00384189 Comparator	Sep 2006 → Aug 2007	asthma	AstraZeneca	Completed	No outcome recorded
Phase 3	NCT00306163 Comparator	May 2006 → Aug 2008	asthma	AstraZeneca	Completed	No outcome recorded
Phase 3	NCT00305461 Comparator	Feb 2006 → Mar 2007	asthma	AstraZeneca	Completed	No outcome recorded
Phase 3	NCT00163449 Comparator	Nov 2005 → Nov 2006	asthma	AstraZeneca	Completed	No outcome recorded
Phase 3	NCT00659503 Comparator	Feb → Apr 2005	seasonal allergic rhinitis	AstraZeneca	Completed	No outcome recorded
Phase 3	NCT00163293 Comparator	Jan 2005 → Jun 2009	asthma	AstraZeneca	Completed	No outcome recorded
Phase 3	NCT00659048 Comparator	Dec 2004 → Apr 2005	perennial allergic rhinitis	AstraZeneca	Completed	No outcome recorded
Phase 3	NCT00659594 Comparator	Nov 2004 → Feb 2005	seasonal allergic rhinitis	AstraZeneca	Completed	No outcome recorded
Phase 3	NCT00658918 Comparator	Sep 2004 → Apr 2005	perennial allergic rhinitis	AstraZeneca	Completed	No outcome recorded
Phase 3	NCT00659841 Comparator	Dec 2003 → Dec 2004	seasonal allergic rhinitis	AstraZeneca	Completed	No outcome recorded
Phase 3	NCT00659750 Comparator	Dec 2003 → May 2004	perennial allergic rhinitis	AstraZeneca	Completed	No outcome recorded
Phase 3	NCT00525772 Comparator	Nov 2001 → Nov 2007	asthma	Hamilton Health Sciences Corporation	Completed	No outcome recorded
Phase 4	NCT01333800 Comparator	Jul → Dec 2010	asthma	Grünenthal Colombiana S.A.	Completed	No outcome recorded
Phase 4	NCT01171365 Comparator	Jan 2010 → Oct 2013	asthma	University of Nottingham	Completed	No outcome recorded
Phase 4	NCT00793858 Comparator	Feb → Sep 2009	allergic rhinitis	University of Chicago	Withdrawn	No outcome recorded
Phase 4	NCT00826969 Comparator	Sep 2008 → Jul 2010	asthma	AstraZeneca	Completed	No outcome recorded
Phase 4	NCT03839433 Comparator	Jun 2007 → Aug 2008	asthma	Cantonal Hosptal, Baselland	Completed	No outcome recorded
Phase 4	NCT00458835 Comparator	Apr 2007 → Apr 2008	allergic rhinitis	Covis Pharma S.à.r.l.	Completed	No outcome recorded
Phase 4	NCT00404547 Comparator	Nov 2006 → Apr 2008	asthma	AstraZeneca	Completed	No outcome recorded
Phase 4	NCT00806754 Comparator	Nov 2006 → May 2007	perennial allergic rhinitis	AstraZeneca	Completed	No outcome recorded

News releases announcing trial results or a regulatory action · 1

Date	Issuer	Release
2021-04-15	Covis Pharma S.à.r.l.	Results COVIS PHARMA GROUP Announces Top-line Safety and Efficacy Data from a Phase 3 Placebo Controlled COVID-19 Study Using Inhaled Corticosteroid (ciclesonide) covispharma.com ↗ A sub-group analysis showed that time to alleviation of cough was the most improved symptom in the ciclesonide arm compared to the placebo arm by 6 days in 75% of the population.

All press releases naming this drug 3 releases

Date	Issuer	Release
2021-04-15	Covis Pharma S.à.r.l.	COVIS PHARMA GROUP Announces Top-line Safety and Efficacy Data from a Phase 3 Placebo Controlled COVID-19 Study Using Inhaled Corticosteroid (ciclesonide) covispharma.com ↗
2018-11-06	AstraZeneca	Divestment of rights to Alvesco, Omnaris and Zetonna to Covis Pharma astrazeneca.com ↗
2018-11-06	AstraZeneca	Divestment of rights to Alvesco, Omnaris and Zetonna to Covis Pharma astrazeneca.com ↗

Evidence & citations 19 cited values

Every value below carries the sentence it was read from. 89 sources stand behind the page.

Field	Value	Cited text
Known as	ciclesonide	“Subjects are requested to administer oral antihistamine (cetirizine) or nasal glucocorticosteroid (ciclesonide) as rescue medication for allergic rhinitis in accordance with...” NCT02665754 ↗ 76 “Dose Response Study of Inhaled Ciclesonide (Glucocorticosteroid) to Patients With Persistent Asthma” NCT00174746 ↗ “Fluticasone; Budesonide; Ciclesonide Dosage and frequency is patient dependant.” NCT00395239 ↗ “Ciclesonide, Beclomethasone, Placebo” NCT01550471 ↗ “ciclesonide” NCT03141424 ↗ NCT00254956 ↗ NCT00163332 ↗ NCT00659841 ↗ NCT00163410 ↗ NCT00163397 ↗ NCT00790023 ↗ Show 66 more sources
Known as	Alvesco	“An Open-Label Randomized, Multicenter Study in Patients With Asthma to Evaluate the Effectiveness of Alvesco® (Ciclesonide) Compared to Asthma Usual Care in a Primary Practice Setting” NCT00404547 ↗ 6 “It is a pressurised solution, intended for inhalation use and commercialised under the brand Alvesco.” NCT04870333 ↗ “single dose Alvesco® (ciclesonide) administered via HFA-134a propellant metered dose inhaler (MDI)” NCT02221375 ↗ “Patients in this arm will receive ciclesonide (Alvesco® 160 µg ) during 10 days” NCT04356495 ↗ “ciclezonide (Alvesco® 160 µg ) / nitazoxanide (Netazox® 500 mg)” NCT04920838 ↗ “Ciclesonide Metered Dose Inhaler [Alvesco]” NCT04330586 ↗ “Alvesco (Ciclesonide) 160 ug/day” NCT00367263 ↗
Known as	Alvesco 160	ChEMBL registry synonym — accepted as the source's own label CHEMBL2040682 ↗
Known as	Alvesco 80	ChEMBL registry synonym — accepted as the source's own label CHEMBL2040682 ↗
Known as	Aservo equihaler	ChEMBL registry synonym — accepted as the source's own label CHEMBL2040682 ↗
Known as	BI54903	ClinicalTrials.gov intervention name — accepted as the source's own label NCT01428622 ↗ 6 NCT01458912 ↗ NCT01458886 ↗ NCT01309139 ↗ NCT01397162 ↗ NCT01396278 ↗ NCT01397201 ↗
Known as	CIC-HFA	“A new nasal aerosol formulation of ciclesonide containing a hydrofluoroalkane propellant delivered via a metered-dose inhaler (CIC-HFA) is currently in clinical development as...” PMID 21130386 ↗ Dec 2010 1 “This study evaluates patient preference and satisfaction with ciclesonide hydrofluoroalkane nasal aerosol (CIC-HFA) compared with mometasone furoate aqueous nasal spray (MFNS).” PMID 24169063 ↗ Nov 2013
Known as	CIC160	“After run-in, patients were randomized to ciclesonide 160 μg once daily (CIC160), fluticasone propionate/salmeterol 100/50 μg bid (FP200/S100), or placebo for 52 weeks.” PMID 21088114 ↗ Nov 2010
Known as	Ciclesonida	ChEMBL registry synonym — accepted as the source's own label CHEMBL2040682 ↗
Known as	ciclesonide (Alvesco)	“ciclesonide (Alvesco)” NCT00525772 ↗
Known as	OMNARIS	“The purpose of this study is to compare the systemic des-ciclesonide exposure of OMNARIS™ (ciclesonide) nasal spray, ciclesonide HFA nasal aerosol, and orally inhaled...” NCT00458835 ↗
Known as	RPR-251526	ChEMBL registry synonym — accepted as the source's own label CHEMBL2040682 ↗
Known as	XRP1526	“Ciclesonide (XRP1526)” NCT00174733 ↗ 2 “ciclesonide (XRP1526)” NCT00254956 ↗ “Ciclesonide (XRP1526)” NCT00174720 ↗
Known as	Zetonna	ChEMBL registry synonym — accepted as the source's own label CHEMBL2040682 ↗
Action	Activate	“Glucocorticoid receptor agonist” CHEMBL2040682 ↗
Action	Inhibit	“Ciclesonide inhibits in vitro SARS-CoV-2 replication in cultured human bronchial epithelial cells via a novel mechanism on non-structural protein 15 (NSP-15).” NCT04870333 ↗
Modality	Other / unclassified	“small-particle inhaled corticosteroid (ICS) ciclesonide” PMID 20595155 ↗ Jul 2010
Route	Inhaled	“ciclesonide will be inhaled once daily” NCT00163293 ↗
Target	NR3C1	“Glucocorticoid receptor agonist” CHEMBL2040682 ↗