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Drug

Desloratadine

Approved · EMA
Emerging researchLate-stage development
Also known as Clarinex, Clarinex-D, Descarboethoxyloratadine, Desloratadina+1 more

Clarinex, Clarinex-D, Descarboethoxyloratadine, Desloratadina, 8-chloro-6,11-dihydro-11-(4-piperidinylidene)-5H-benzo(5,6)cyclohepta(1,2-b)pyridine.

RxNorm275635ChEMBLCHEMBL1172UNIIFVF865388R
1
Research papers
5
Active clinical trials
7
Regulatory events
Latest activity
beta

Recent clinical, regulatory, research and industry developments relating to this drug.

Effect of Desloratadine as Add-On Therapy in Rheumatoid Arthritis

Clinical trial2026-06-08Results expected Q4 2026 · ClinicalTrials.gov

Clinical Study to Compare the Possible Efficacy and Safety of Roflumilast and Desloratadine as Adjuvant Therapy for Rheumatoid Arthritis

Clinical trial2026-05-12Results expected Q2 2027 · ClinicalTrials.gov

Autologous Whole Blood Therapy in Autologous Serum Skin Test (ASST) Positive and Negative Chronic Idiopathic Urticaria Patients, a Clinical and Biochemical Randomized Controlled Trial.

Clinical trial2026-03-20Results expected Q3 2026 · ClinicalTrials.gov

Efficacy and Safety of Desloratadine as Adjuvant Therapy in Patients With Ulcerative Colitis

Clinical trial2026-01-29Results expected Q1 2027 · ClinicalTrials.gov

Confirmatory Study on the Efficacy and Safety of the Fixed-dose Combination of Desloratadine/Betamethasone Versus Desloratadine as Treatment in Patients With Allergic Rhinitis

Clinical trial2025-05-11Primary completion · ClinicalTrials.gov

Multicenter,Randomized, Parallel,Double-blind, Comparative Study of the Superiority of the Desloratadine 0.5mg/mL and Prednisolone 4 mg/mL Versus Desloratadine 0.5mg/mL in the Treatment of Persistent Allergic Rhinitis in Children (DESPRED)

Clinical trial2025-03-23Completed · ClinicalTrials.gov

A Phase III Multicentre, Parallel-group, Randomized, Placebo-controlled, Double-blind Clinical Trial to Study the Efficacy and Safety of MK-4117 in Japanese Subjects With Chronic Urticaria.

Clinical trial2024-06-18Results posted · ClinicalTrials.gov

Approval: Desloratadine Actavis (EMA)

Regulatory2012-01-13EMA

Approval: Desloratadine ratiopharm (EMA)

Regulatory2012-01-13EMA

Approval: Dasselta (EMA)

Regulatory2011-11-28EMA

Approval: Desloratadine Teva (EMA)

Regulatory2011-11-24EMA

Desloratadine therapy improves allergic rhinitis symptoms in latin american children aged 6 to 12 years.

Research2009-04-01The World Allergy Organization journal

Profile

Identifiers & mechanism

Canonical identifiers, marketed brand names and mechanism, resolved across RxNorm, ChEMBL and ATC.

Canonical name
Desloratadine
Aliases & brands
ClarinexClarinex-DDescarboethoxyloratadineDesloratadina8-chloro-6,11-dihydro-11-(4-piperidinylidene)-5H-benzo(5,6)cyclohepta(1,2-b)pyridine
RxNorm CUI
275635
ChEMBL ID
CHEMBL1172
UNII
FVF865388R
Regulatory jurisdictions
ema

Regulatory timeline

7 events

The complete regulatory record, grouped by authority — approvals, safety advisories and label changes. Each authority shows its most recent events; expand one to read its full history.

Earliest approval
2001-01-15
Latest approval
2012-01-13
Authorities
EMA
Total events
7
emaEuropean Medicines Agency· 7 events
2012-01-13Approval
Approval: Desloratadine Actavis (EMA)

Indication: Treatment of allergic rhinitis and urticaria.

Evidence ↗
2012-01-13Approval
Approval: Desloratadine ratiopharm (EMA)

Indication: Desloratadine ratiopharm is indicated in adults for the relief of symptoms associated with: allergic rhinitis chronic idiopathic urticaria as initially diagnosed by a physician

Evidence ↗
2011-11-28Approval
Approval: Dasselta (EMA)

Indication: Dasselta is indicated for the relief of symptoms associated with: allergic rhinitis; urticaria.

Evidence ↗

Contains information from the European Medicines Agency (European Medicines Agency), © EMA, reused under CC BY 4.0.

Clinical trials

56 trials

The current development programme across all trial phases — status mix, phase distribution and the late-stage studies shaping the evidence base.

Development programme
CLINICALTRIALS.GOV · LIVE REGISTRY
56
registered trials across all phases
LATEST COMPLETION 2025
5
Active studies
5
Recruiting
46
Late-stage (III+)
47
Completed
4
Discontinued
PHASE DISTRIBUTIONn = 56
Phase 14Phase 26Phase 2 / 31Phase 317Phase 426Phase N / A2

Late-stage studies

Phase III+ trials still open or recently active — where late-stage evidence is being generated.

Do Common Over-the-counter Antihistamine Medications Modify Thermoregulatory Responses During Passive Heat Stress?

Unknown statusPH IVLakehead Universityn=162024

The Effect of Antihistamines on Methacholine Challenge Testing in Asthma Patients

CompletedPH IVDon Cockcroftn=122014

Evaluation of the Inhibitory Effect of 5 Anti-Histamines in Urticaria

CompletedPH IVGrupo de Alergología Clínica y Experimentaln=1502014

In Vivo Anti-inflammatory Effect of H1 Antihistamines in Allergic Rhinitis

CompletedPH IVIuliu Hatieganu University of Medicine and Pharmacyn=1152013

Multi-center, Double Blind, Dose Escalating Study to Compare the Effects of 5 mg, 10mg and 20mg of Desloratadine in Patients With Acquired Cold Urticaria (ACU)

CompletedPH IVMarcus Maurern=302010

Recent completions

Trials that read out recently, adding to the completed evidence base.

Multicenter,Randomized, Parallel,Double-blind, Comparative Study of the Superiority of the Desloratadine 0.5mg/mL and Prednisolone 4 mg/mL Versus Desloratadine 0.5mg/mL in the Treatment of Persistent Allergic Rhinitis in Children (DESPRED)

CompletedPH IIIEurofarma Laboratorios S.A.n=2622025

Aprepitant vs. Desloratadine in Non-small Cell Lung Cancer Patients With Epidermal Growth Factor Receptor Tyrosine Kinase Inhibitors Related Pruritus: A Prospective, Randomized Control, Double-blinded, Phase II Clinical Trial

CompletedPH IISun Yat-sen Universityn=1382020

Influence of Antipruritics on the Dermal Blood Flow Response After a Histamine Skin Prick as Well as After the Topical Application of Cinnamaldehyde and Capsaicin

CompletedN/AUniversitaire Ziekenhuizen KU Leuvenn=132019

A Phase III, Multi-Center, Randomized, Placebo-Controlled, Double-Blind Trial to Study the Efficacy and Safety of MK-4117 in Japanese Subjects With Seasonal Allergic Rhinitis

CompletedPH IIIOrganon and Con=4492015

The Effect of Antihistamines on Methacholine Challenge Testing in Asthma Patients

CompletedPH IVDon Cockcroftn=122014

Randomized, Double-blind, Placebo/Active-controlled, Multi-center Clinical Trial to Investigate the Safety/Tolerability and Efficacy of Bilastine 20mg After 14-day Oral Administration in Patients With Seasonal Allergic Rhinitis

CompletedPH IIIYuhan Corporationn=2392014

Research activity

1 papers

Key research shaping understanding of this drug, combining the latest publications with the most influential evidence.

Most influential

Desloratadine therapy improves allergic rhinitis symptoms in latin american children aged 6 to 12 years.

The World Allergy Organization journal · 2009 · 1 cites
Recent papers

Desloratadine therapy improves allergic rhinitis symptoms in latin american children aged 6 to 12 years.

The World Allergy Organization journal · 2009 · 1 cites
Journals, researchers & institutions
Top journals
  • The World Allergy Organization journal1
Leading researchers
  • Aguirre-Mariscal H1
  • Centeno J1
  • Gonzálezdíaz SN1
  • Jerves AF1
  • Suárez NR1
  • Tassinari P1
  • Velásquez JV1
Leading institutions
free-text, unnormalised
  • From the 1Instituto de Immunología1
References & data sources
  • RxNorm (U.S. National Library of Medicine) — drug identity
  • ChEMBL (EMBL-EBI) & UniProt — pharmacology and targets
  • Europe PMC — research literature
  • ClinicalTrials.gov — clinical trials
  • Regulatory event sources are credited in the Regulatory Timeline above.