Drugs / Desloratadine
Desloratadine
also known as
MK-4117 · Aerius · Aerus · Allex · Azomyr · Clarinex · Clarinex, SCH 34117 · Dasselta · +20 more
Small molecule targets HRH1 via inhibition
Regulatory milestones approvals, filings & regulatory actions · 2 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Approved | US (FDA) | CLARINEX | — | 2001-12-21 | fda.gov ↗ |
| Approved | EU (EMA) | Aerius | — | 2001-01-15 | europa.eu ↗ |
Trials 48
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 12 trials | ||||||
| Phase 1 | NCT01314339 | Dec 2005 | — | Dr. Reddy's Laboratories Limited | Completed | No outcome recorded |
| Phase 1 | NCT01314352 | Dec 2005 | — | Dr. Reddy's Laboratories Limited | Completed | No outcome recorded |
| Phase 26 trials | ||||||
| Phase 2 | NCT07836712 | Nov 2026 → Nov 2027 expected | hepatocellular carcinoma, metastatic melanoma | University of Southern California | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT07109817 | Jun 2026 → Sep 2029 expected | breast cancer, peripheral neuropathy | Montefiore Medical Center | Recruiting | No outcome recorded |
| Phase 2 | NCT07632872 | May → Nov 2026 expected | rheumatoid arthritis | Horus University | Recruiting | No outcome recorded |
| Phase 2 | NCT07566351 | Apr 2026 → Jun 2027 expected | rheumatoid arthritis | Horus University | Recruiting | No outcome recorded |
| Phase 2 | NCT06268470 | Jun 2018 → Mar 2024 | chronic urticaria | Chulalongkorn University | Unknown | No outcome recorded |
| Phase 2 | NCT00816972 | Apr → Jun 2005 | seasonal allergic rhinitis | Organon and Co | Completed | No outcome recorded |
| Phase 317 trials · 4 met primary · 1 missed | ||||||
| Phase 3 | NCT02904304 | Dec 2020 → Jul 2021 | — | Ache Laboratorios Farmaceuticos S.A. | Suspended | No outcome recorded |
| Phase 3 | NCT02320396 | Jan → Apr 2015 | seasonal allergic rhinitis | Organon and Co | Completed | Met primary |
| Phase 3 | NCT01529242 | Feb 2014 → Aug 2016 | hypersensitivity reaction disease | EMS | Terminated | No outcome recorded Stop: Enrollment |
| Phase 3 | NCT01529229 | Nov 2013 → Oct 2014 | allergic rhinitis | EMS | Completed | No outcome recorded |
| Phase 3 | NCT01720485 | Oct → Dec 2013 | allergic rhinitis | EMS | Unknown | No outcome recorded |
| Phase 3 | NCT01916967 | Aug 2013 → Feb 2014 | urticaria | Organon and Co | Completed | Met primary |
| Phase 3 | NCT01916980 | Aug 2013 → Mar 2014 | atopic eczema | Organon and Co | Completed | No outcome recorded |
| Phase 3 | NCT01918033 | Aug 2013 → Jan 2014 | perennial allergic rhinitis | Organon and Co | Completed | Missed primary |
| Phase 3 | NCT00405964 | Sep 2006 → Apr 2008 | allergic rhinitis | Organon and Co | Completed | Met primary |
| Phase 3 | NCT00406783 | Aug 2006 → Nov 2007 | perennial allergic rhinitis, seasonal allergic rhinitis | Organon and Co | Completed | Met primary |
| Phase 3 | NCT00794794 | Nov 2004 | allergic rhinitis | Organon and Co | Completed | No outcome recorded |
| Phase 3 | NCT00794378 | Nov 2004 | allergic rhinitis | Organon and Co | Completed | No outcome recorded |
| Phase 3 | NCT00789152 | Dec 2003 → May 2004 | allergic rhinitis | Organon and Co | Completed | No outcome recorded |
| Phase 3 | NCT00805324 | May → Aug 2003 | asthma, seasonal allergic rhinitis | Organon and Co | Completed | No outcome recorded |
| Phase 3 | NCT00817076 | Mar → Jul 2003 | atopic eczema | Organon and Co | Completed | No outcome recorded |
| Phase 3 | NCT00757562 | Nov 2002 → Oct 2003 | allergic disease, chronic idiopathic urticaria | Organon and Co | Completed | No outcome recorded |
| Phase 3 | NCT00795158 | Nov 2002 → Jan 2004 | urticaria | Organon and Co | Completed | No outcome recorded |
| Phase 419 trials · 2 met primary · 2 missed | ||||||
| Phase 4 | NCT06217367 | Dec 2023 → Jun 2024 | allergic rhinitis, dysautonomia-like disorder | Lakehead University | Unknown | No outcome recorded |
| Phase 4 | NCT01444196 | Aug 2009 → Apr 2010 | urticaria | Marcus Maurer | Completed | No outcome recorded |
| Phase 4 | NCT00536380 | Sep 2007 → Apr 2009 | chronic idiopathic urticaria | Organon and Co | Completed | Missed primary |
| Phase 4 | NCT00359138 | Feb → May 2006 | hypersensitivity reaction disease | Organon and Co | Completed | No outcome recorded |
| Phase 4 | NCT00346606 | Jan 2006 → ? | chronic idiopathic urticaria | Lotus Pharmaceutical | Unknown | No outcome recorded |
| Phase 4 | NCT00311844 | Mar → May 2005 | atopic conjunctivitis | Organon and Co | Completed | Missed primary |
| Phase 4 | NCT00783211 | Aug → Oct 2004 | seasonal allergic rhinitis | Organon and Co | Completed | No outcome recorded |
| Phase 4 | NCT00783146 | Aug → Oct 2004 | seasonal allergic rhinitis | Organon and Co | Completed | Met primary |
| Phase 4 | NCT00751166 | Mar 2004 → May 2005 | urticaria | Organon and Co | Terminated | No outcome recorded |
| Phase 4 | NCT00779636 | Jul 2003 → Nov 2004 | allergic respiratory disease | Organon and Co | Completed | No outcome recorded |
| Phase 4 | NCT00795522 | Jul 2003 → Feb 2005 | chronic idiopathic urticaria | Organon and Co | Completed | No outcome recorded |
| Phase 4 | NCT00805584 | May → Jun 2003 | seasonal allergic rhinitis | Organon and Co | Completed | No outcome recorded |
| Phase 4 | NCT00783354 | Apr 2003 → Feb 2004 | chronic idiopathic urticaria | Organon and Co | Completed | Met primary |
| Phase 4 | NCT00794599 | Dec 2002 → Aug 2003 | perennial allergic rhinitis, seasonal allergic rhinitis | Organon and Co | Completed | No outcome recorded |
| Phase 4 | NCT00794846 | Dec 2002 → May 2003 | perennial allergic rhinitis, seasonal allergic rhinitis | Organon and Co | Completed | No outcome recorded |
| Phase 4 | NCT00794495 | Dec 2002 → Jul 2003 | perennial allergic rhinitis, seasonal allergic rhinitis | Organon and Co | Completed | No outcome recorded |
| Phase 4 | NCT00783133 | Nov 2002 → Jun 2003 | seasonal allergic rhinitis | Organon and Co | Completed | No outcome recorded |
| Phase 4 | NCT00794768 | Nov 2002 → Jul 2003 | seasonal allergic rhinitis | Organon and Co | Completed | No outcome recorded |
| Phase 4 | NCT00794248 | Nov 2002 → May 2003 | seasonal allergic rhinitis | Organon and Co | Completed | No outcome recorded |
| Phase not applicable4 trials | ||||||
| — | NCT05446480 | Jul 2022 → Aug 2023 | exercise-induced malignant hyperthermia, inflammatory disease | University of Victoria | Unknown | No outcome recorded |
| — | NCT04399525 | Oct 2019 → Mar 2020 | — | Universitaire Ziekenhuizen KU Leuven | Completed | No outcome recorded |
| — | NCT04399148 | Jun → Sep 2019 | — | Universitaire Ziekenhuizen KU Leuven | Completed | No outcome recorded |
| — | NCT00424580 | Jan → Aug 2007 | asthma | University of Saskatchewan | Completed | No outcome recorded |
| Comparator or background therapy25 trials | ||||||
| Phase 2 | NCT07821320 Comparator | Feb 2027 → Feb 2028 expected | endometriosis | Medical University of Vienna | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT07333716 Comparator | Jan 2026 → Feb 2027 expected | ulcerative colitis | Tanta University | Recruiting | No outcome recorded |
| Phase 2 | NCT02646020 Comparator | Dec 2015 → Oct 2020 | non-small cell lung carcinoma | Sun Yat-sen University | Completed | Met primary |
| Phase 2 | NCT00866788 Background | Mar 2009 → Jan 2010 | chronic idiopathic urticaria | Genentech, Inc. | Completed | Met primary |
| Phase 2/3 | NCT00633919 Comparator | Jul 2006 → Dec 2008 | allergic disease | ALK-Abelló A/S | Completed | No outcome recorded |
| Phase 3 | NCT07835074 Comparator | Jun 2027 → Dec 2028 expected | perennial allergic rhinitis | EMS | Not yet recruiting | No outcome recorded |
| Phase 3 | NCT07486583 Background | Apr → Sep 2026 overdue | chronic idiopathic urticaria | Cairo University | Not yet recruiting | No outcome recorded |
| Phase 3 | NCT06272409 Comparator | Feb → Mar 2025 overdue | allergic rhinitis | EMS | Not yet recruiting | No outcome recorded |
| Phase 3 | NCT06916884 Comparator | Nov 2024 → May 2025 overdue | allergic rhinitis | Laboratorios Silanes S.A. de C.V. | Recruiting | No outcome recorded |
| Phase 3 | NCT05214911 Comparator | Jul 2024 → Mar 2025 | allergic rhinitis | Eurofarma Laboratorios S.A. | Completed | No outcome recorded |
| Phase 3 | NCT05232825 Background | May 2022 → Mar 2023 | primary progressive multiple sclerosis | Hoffmann-La Roche | Completed | No outcome recorded |
| Phase 3 | NCT01400828 Comparator | Jun 2011 → Jun 2013 | seasonal allergic rhinitis | Yuhan Corporation | Completed | No outcome recorded |
| Phase 3 | NCT01740284 Comparator | Sep 2008 → Jan 2009 | allergic disease | ALK-Abelló A/S | Completed | No outcome recorded |
| Phase 3 | NCT00598611 Comparator | Sep 2007 → Aug 2009 | chronic urticaria | Charite University, Berlin, Germany | Completed | No outcome recorded |
| Phase 3 | NCT01108783 Comparator | Apr → Aug 2003 | seasonal allergic rhinitis | Faes Farma, S.A. | Completed | Met primary |
| Phase 4 | NCT01985789 Comparator | Nov 2013 → May 2014 | asthma | Don Cockcroft | Completed | No outcome recorded |
| Phase 4 | NCT01940393 Comparator | Aug → Dec 2013 | urticaria | Grupo de Alergología Clínica y Experimental | Completed | No outcome recorded |
| Phase 4 | NCT02507635 Comparator | Feb 2009 → Nov 2011 | allergic rhinitis | Iuliu Hatieganu University of Medicine and Pharmacy | Completed | No outcome recorded |
| Phase 4 | NCT00600847 Comparator | Nov 2006 → Nov 2007 | cold urticaria | Charite University, Berlin, Germany | Completed | No outcome recorded |
| Phase 4 | NCT00264303 Comparator | Dec 2005 → Jan 2007 | chronic idiopathic urticaria | UCB Pharma | Completed | Met primary |
| Phase 4 | NCT00779116 Comparator | Sep → Oct 2005 | allergic disease | Organon and Co | Completed | No outcome recorded |
| Phase 4 | NCT00780403 Comparator | Aug → Oct 2005 | allergic disease | Organon and Co | Completed | No outcome recorded |
| Phase 4 | NCT00751218 Comparator | May 2004 → May 2005 | chronic idiopathic urticaria | Organon and Co | Completed | No outcome recorded |
| Phase 4 | NCT00867191 Comparator | Feb 2002 → Apr 2003 | seasonal allergic rhinitis | Organon and Co | Completed | No outcome recorded |
| — | NCT00967967 Background | Mar 2009 → Jun 2014 | allergic rhinitis, asthma | Laval University | Suspended | No outcome recorded |
Press releases naming this drug 3 releases
| Date | Issuer | Release |
|---|---|---|
| 2011-12-27 | Perrigo Company | Perrigo Announces FDA Final Approval for Desloratadine perrigo.com ↗ |
| 2010-11-18 | Sun Pharmaceutical Industries, Inc. | Sun Pharma announces USFDA approval for generic Clarinex® sunpharma.com ↗ |
| 2008-12-04 | Perrigo Company | Perrigo Settles Desloratadine Patent Litigation perrigo.com ↗ |
Evidence & citations 33 cited values
Every value below carries the sentence it was read from. 75 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Desloratadine | “Patients received one of the following: Cetirizine 10 mg once per day (QD), Levocetirizine dihydrochloride 5 mg QD, Fexofenadine 60 mg twice per day or 180 mg QD, Loratadine 10...” NCT00866788 ↗71“Objective: To compare the efficacy of desloratadine 5mg (Denosin®) and levocetirizine 5mg (Xyzal®) once daily in the treatment of patients with CIU over 6 weeks.” NCT00346606 ↗ “Desloratadine is a long- acting tricyclic histamine antagonist with selective H1-receptor histamine antagonist activity.” NCT07109817 ↗ |
| Known as | Aerius | ClinicalTrials.gov intervention name — accepted as the source's own label NCT01740284 ↗ |
| Known as | Aerus | “Desloratadine tablet (5 mg per tablet; anti-histamine; Aerus®).” NCT00633919 ↗ |
| Known as | Allex | ChEMBL registry synonym — accepted as the source's own label CHEMBL1172 ↗ |
| Known as | Azomyr | ChEMBL registry synonym — accepted as the source's own label CHEMBL1172 ↗ |
| Known as | Clarinex | ChEMBL registry synonym — accepted as the source's own label CHEMBL1172 ↗ |
| Known as | Clarinex, SCH 34117 | “Clarinex, SCH 34117” NCT00794768 ↗ |
| Known as | Dasselta | ChEMBL registry synonym — accepted as the source's own label CHEMBL1172 ↗ |
| Known as | Denosin | “Objective: To compare the efficacy of desloratadine 5mg (Denosin®) and levocetirizine 5mg (Xyzal®) once daily in the treatment of patients with CIU over 6 weeks.” NCT00346606 ↗ |
| Known as | Desalex | “Desloratadine 0.5 mg/mL (Desalex® - Eurofarma Laboratórios SA)” NCT05214911 ↗ |
| Known as | Descarboethoxyloratadine | ChEMBL registry synonym — accepted as the source's own label CHEMBL1172 ↗ |
| Known as | Desloratadina | ChEMBL registry synonym — accepted as the source's own label CHEMBL1172 ↗ |
| Known as | Desloratadine (Aerius) | “Desloratadine (Aerius)” NCT05446480 ↗ |
| Known as | Desloratadine actavis | ChEMBL registry synonym — accepted as the source's own label CHEMBL1172 ↗ |
| Known as | Desloratadine actavis (authorized: rhinitis, urticaria) | ChEMBL registry synonym — accepted as the source's own label CHEMBL1172 ↗ |
| Known as | Desloratadine component of clarinex-d | ChEMBL registry synonym — accepted as the source's own label CHEMBL1172 ↗ |
| Known as | Desloratadine ratiopharm | ChEMBL registry synonym — accepted as the source's own label CHEMBL1172 ↗ |
| Known as | Desloratadine ratiopharm (authorized: rhinitis, urticaria) | ChEMBL registry synonym — accepted as the source's own label CHEMBL1172 ↗ |
| Known as | Desloratadine teva | ChEMBL registry synonym — accepted as the source's own label CHEMBL1172 ↗ |
| Known as | Desloratadine teva (authorized: rhinitis, urticaria) | ChEMBL registry synonym — accepted as the source's own label CHEMBL1172 ↗ |
| Known as | desloratidine | “1 tablet (melting tablet)of Aerius (desloratidine) 2.5 mg” NCT01740284 ↗ |
| Known as | Loratadine related compound a | ChEMBL registry synonym — accepted as the source's own label CHEMBL1172 ↗ |
| Known as | Loratadine related compound a rs | ChEMBL registry synonym — accepted as the source's own label CHEMBL1172 ↗ |
| Known as | Midetorin | ChEMBL registry synonym — accepted as the source's own label CHEMBL1172 ↗ |
| Known as | MK-4117 | “This is a study to evaluate the efficacy and safety of desloratadine (MK-4117) in Japanese participants with chronic urticaria.” NCT01916967 ↗1“This is an efficacy and safety study of desloratadine (MK-4117) in Japanese participants with seasonal allergic rhinitis (SAR).” NCT02320396 ↗ |
| Known as | Neoclarityn | ChEMBL registry synonym — accepted as the source's own label CHEMBL1172 ↗ |
| Known as | NSC-759824 | ChEMBL registry synonym — accepted as the source's own label CHEMBL1172 ↗ |
| Known as | Opulis | ChEMBL registry synonym — accepted as the source's own label CHEMBL1172 ↗ |
| Known as | SCH 34117 | “SCH 34117: desloratadine RediTabs, 1 tablet (2.5 mg), oral administration, single dose, single day” NCT00779116 ↗ |
| Action | Inhibit | “Desloratadine, an H1-receptor antagonist, has been shown to be effective against nasal and nonnasal AR symptoms” PMID 23676577 ↗ May 20131“Histamine H1 receptor antagonist” CHEMBL1172 ↗ |
| Modality | Small molecule | — CHEMBL1172 ↗ |
| Route | Oral | “5mg oral capsules, once daily, 4 week duration” NCT00264303 ↗ |
| Target | HRH1 | “Histamine H1 receptor antagonist” CHEMBL1172 ↗ |