Drugs / Ciclesonide
Ciclesonide
also known as
Alvesco · BI54903 · XRP1526 · CIC-HFA · Alvesco 160 · Alvesco 80 · Alvesco Inhalant Product · Aservo equihaler · +6 more
Other / unclassified targets NR3C1 via activation
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 54 · a red edge is where a trial was stopped
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 13 trials | ||||||
| Phase 1 | NCT06589245 | Sep 2025 → Aug 2026 overdue | bronchopulmonary dysplasia | Venkatesh Sampath | Recruiting | No outcome recorded |
| 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 | ||||||
| Phase 2 | NCT04381364 | May 2020 → Aug 2021 | COVID-19, viral pneumonia | Ola Blennow, MD, PhD | Unknown | No outcome recorded |
| Phase 2 | NCT04330586 | Apr 2020 → Mar 2021 | COVID-19 | Korea University Guro Hospital | Completed | No outcome recorded |
| Phase 2 | NCT01458886 | Nov 2011 → May 2013 | asthma | Boehringer Ingelheim | Withdrawn | No outcome recorded |
| Phase 2 | NCT01458912 | Nov 2011 → May 2013 | asthma | Boehringer Ingelheim | Withdrawn | No outcome recorded |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 | NCT01397201 | 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 | 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 | ||||||
| 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 | No outcome recorded |
| Phase 3 | NCT01401465 | Jul → Nov 2011 | perennial allergic rhinitis | Sumitomo Pharma America, Inc. | Completed | No outcome recorded |
| 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 | No outcome recorded |
| Phase 3 | NCT00953147 | Aug 2009 → Jan 2010 | perennial allergic rhinitis | Sumitomo Pharma America, Inc. | Completed | No outcome recorded |
| Phase 3 | NCT00790023 | Nov 2008 → Feb 2009 | seasonal allergic rhinitis | Sumitomo Pharma America, Inc. | Completed | No outcome recorded |
| 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 | No outcome recorded |
| 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 | NCT00163371 | Sep → Dec 2005 | asthma | AstraZeneca | Completed | No outcome recorded |
| Phase 3 | NCT00174720 | Sep 2005 → Feb 2007 | asthma | Sanofi | Completed | No outcome recorded |
| Phase 3 | NCT00163436 | Sep 2005 → Jan 2006 | asthma | AstraZeneca | Completed | No outcome recorded |
| Phase 3 | NCT00174733 | Jul 2005 → Feb 2006 | asthma | Sanofi | Completed | No outcome recorded |
| Phase 3 | NCT00163488 | Jan → Aug 2005 | perennial allergic rhinitis, seasonal allergic rhinitis | AstraZeneca | Completed | No outcome recorded |
| Phase 3 | NCT00163423 | Nov 2004 → Jan 2006 | asthma | AstraZeneca | Completed | No outcome recorded |
| Phase 3 | NCT00163319 | Nov 2004 → Nov 2005 | 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 | NCT00254956 | Jan 2004 → Jun 2005 | allergic respiratory disease, asthma | Sanofi | Completed | No outcome recorded |
| Phase 3 | NCT00163397 | Jan 2004 → Jul 2005 | asthma | AstraZeneca | Completed | No outcome recorded |
| 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 | No outcome recorded |
| 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 |
Also used as a comparator or background therapy in 31 trials
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 12 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 22 trials | ||||||
| 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 2/32 trials | ||||||
| Phase 2/3 | NCT04870333 Comparator | Feb 2021 → Apr 2025 | COVID-19 | Cambridge University Hospitals NHS Foundation Trust | Completed | No outcome recorded |
| 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 317 trials | ||||||
| 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 | No outcome recorded |
| 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 48 trials | ||||||
| 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 |
Evidence & citations 20 cited values
Every value below carries the sentence it was read from. 90 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 ↗ |
| 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 | Alvesco Inhalant Product | ClinicalTrials.gov intervention name — accepted as the source's own label NCT06589245 ↗ |
| 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 ↗ |
| 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 20101“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)” NCT00254956 ↗ |
| 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 ↗ |