Clarinex

(desloratadine)

ApprovedSmall molecule

Desloratadine is used to relieve allergy symptoms like sneezing, runny nose, itchy eyes, and itchy throat caused by allergies.[2] Clarinex is currently approved and in use across 19 indications[4].[1]

Clarinex is one of 327 small molecule programs targeting Allergy. It is currently in Approved.

Indications

Total Trials

Active Trials

326

Competitors

FDA Applications

NDA/BLA/ANDA regulatory filings

Pipeline

Status by Indication[4][1]

Indication

AllergyActive, not recruiting

Common ColdApproved

Atopic EczemaActive, not recruiting

Allergic ConjunctivitisApproved

RhinitisActive, not recruiting

Rhinitis, Allergic, PerennialActive, not recruiting

Eczematoid DermatitisActive, not recruiting

UrticariaActive, not recruiting

Allergic RhinitisActive, not recruiting

Cold UrticariaActive, not recruiting

AllergyPhase 3

Active, not recruiting

Common ColdApproved

Approved

Atopic EczemaApproved

Active, not recruiting

Allergic ConjunctivitisApproved

Approved

RhinitisPreclinical

Active, not recruiting

Rhinitis, Allergic, PerennialApproved

Active, not recruiting

Eczematoid DermatitisApproved

Active, not recruiting

UrticariaApproved

Active, not recruiting

Allergic RhinitisApproved

Active, not recruiting

Cold UrticariaApproved

Active, not recruiting

Showing 10 of 18 indications

Competition

Competitive Landscape

1050 competitors in Asthma

#DrugCompanyPhaseTrials

Clarinex

OOrganon and Co

Approved

1 2

Aciphex

Akero Therapeutics

Preclinical

2 3

Atrovent

Boehringer Ingelheim

Preclinical

2 4

Blood Withdrawn

Emergent BioSolutions

Preclinical

1 5

Blood Collection

AAssistance Publique - Hôpitaux de Paris

Preclinical

1 6

Lexapro

SShirley Ryan AbilityLab

Preclinical

1 7

Ozone

TTanta University

Preclinical

1 8

Spiriva

Boehringer Ingelheim

Preclinical

3 9

Allergen Immunotherapy Extract

JJohns Hopkins University

Preclinical

1 10

Biological Drug

UUniversitaire Ziekenhuizen KU Leuven

Preclinical

Ranked by pipeline maturity and clinical activity. Current drug highlighted in teal.

Timeline

Expected Milestones

Q4 2026

Phase 3Not yet recruiting

Chronic Idiopathic Urticaria

NCT07486583

Q1 2027

Phase 2Recruiting

Ulcerative Colitis

NCT07333716

Clinical

Trials by Indication[1]

Chronic Idiopathic Urticaria8 trials

Safety of Aerius Syrup in Pediatric Patients Aged 1-5 Years Old With Allergic Rhinitis or Chronic Idiopathic Urticaria (Study P04446AM1)(COMPLETED)

Completed·OOrganon and Co··NCT00723736·100 enrolled

A Comparative Double-Blind, Double- Dummy Study of Desloratadine (DL) 5 MG Once Daily, Cetirizine 10 MG Once Daily, and Placebo Once Daily in Patients With Chronic Idiopathic Urticaria (Study P03735)

Completed·OOrganon and Co·Phase 4·NCT00751218·174 enrolled

A Comparative Double-blind, Double-dummy Study of Desloratadine (DL) 5 mg Once Daily, Cetirizine 10 mg Once Daily, and Placebo Once Daily in Patients With Chronic Idiopathic Urticaria (Study P03736)

Terminated·OOrganon and Co·Phase 4·NCT00751166·149 enrolled

Show 5 more trials

A Comparison of Aerius Continuous Treatment Versus Aerius PRN for Chronic Idiopathic Urticaria (Study P03147)

Completed·OOrganon and Co·Phase 4·NCT00783354·129 enrolled

An Open-Label Study of the Effects of Desloratadine (Aerius.) Treatment on the Quality of Life of Patients With Chronic Idiopathic Urticaria (Study P02540)

Completed·OOrganon and Co·Phase 4·NCT00795522·51 enrolled

How Desloratadine (Clarinex, Aerius) Affects Quality of Life in Patients With Chronic Idiopathic Urticaria (Have Had Hives for 6 Weeks or Longer)(Study P02988)

Completed·OOrganon and Co·Phase 3·NCT00795158·282 enrolled

Evaluation of Desloratadine When Used in Patients With Either Allergic Rhinitis or Chronic Idiopathic Urticaria

Completed·OOrganon and Co··NCT00724698·3,011 enrolled

Autologous Whole Blood Therapy in Chronic Idiopathic Urticaria Patients.

Not yet recruiting·—·Phase 3·NCT07486583·40 enrolled

Seasonal Allergic Rhinitis7 trials

Comparison of the Effects of Desloratadine and Placebo in the Relief of Nasal Symptom Scores in Subjects With Seasonal Allergic Rhinitis to Cypress Pollen (Study P02836)

Completed·OOrganon and Co·Phase 4·NCT00867191·233 enrolled

Efficacy and Safety Study of Desloratadine (MK-4117) in Japanese Participants With Seasonal Allergic Rhinitis (MK-4117-204)

Completed·OOrganon and Co·Phase 3·NCT02320396·449 enrolled

Desloratadine With Oxybutynin for the Treatment of Seasonal Allergic Rhinitis and Post-Nasal Drip (Study P04258)(COMPLETED)

Completed·OOrganon and Co·Phase 2·NCT00816972·540 enrolled

Show 4 more trials

Efficacy and Safety of Desloratadine vs. Fexofenadine 180 mg. vs. Placebo for Treating Seasonal Allergic Rhinitis (SAR)(Study P04053)(COMPLETED)

Completed·OOrganon and Co·Phase 4·NCT00783211·722 enrolled

A Phase III Efficacy Study of the Symptomatic Treatment of Seasonal Allergic Rhinitis With Bilastine

Completed·FFaes Farma, S.A.·Phase 3·NCT01108783·720 enrolled

Efficacy and Safety of Desloratadine vs. Fexofenadine 180 mg. vs. Placebo for Treating Seasonal Allergic Rhinitis (SAR) (Study P04054)

Completed·OOrganon and Co·Phase 4·NCT00783146·728 enrolled

Investigate the Safety/Tolerability and Efficacy of Bilastine 20mg in Korean Patients With Seasonal Allergic Rhinitis

Completed·YYuhan Corporation·Phase 3·NCT01400828·239 enrolled

Allergies6 trials

Preference for Clarinex Tablets vs. Allegra Tablets in Patients With Seasonal Allergies (Study P03179)

Completed·OOrganon and Co·Phase 4·NCT00794248·122 enrolled

Preference for Clarinex Tablets vs. Zyrtec Tablets in Patients With Allergies (P03181)

Completed·OOrganon and Co·Phase 4·NCT00794495·122 enrolled

Preference for Clarinex Tablets vs. Zyrtec Tablets in Patients With Allergies (P03182)

Completed·OOrganon and Co·Phase 4·NCT00794599·118 enrolled

Show 3 more trials

Preference for Clarinex Tablets vs Allegra Tablets in Patients With Seasonal Allergies (P03178)

Completed·OOrganon and Co·Phase 4·NCT00794768·118 enrolled

Preference for Clarinex Tablets vs. Allegra Tablets in Patients With Seasonal Allergies (Study P03177)

Completed·OOrganon and Co·Phase 4·NCT00783133·131 enrolled

Preference for Clarinex Tablets vs. Zyrtec Tablets in Patients With Allergies (P03180)

Completed·OOrganon and Co·Phase 4·NCT00794846·124 enrolled

Urticaria5 trials

An Efficacy and Safety Study of Desloratadine (MK-4117) in Japanese Participants With Chronic Urticaria (MK-4117-201)

Completed·OOrganon and Co·Phase 3·NCT01916967·239 enrolled

Antiplatelet Therapy in Chronic Urticaria

Unknown status·—·Phase 2·NCT06268470·12 enrolled

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

Completed·GGrupo de Alergología Clínica y Experimental·Phase 4·NCT01940393·150 enrolled

Show 2 more trials

CUTE (Chronic Urticaria Treatment Evaluation)

Completed· UCB logo

UCB·Phase 4·NCT00264303·886 enrolled

Effects of 5 mg vs. 20 mg Desloratadine on Skin Lesions in Patients With Chronic Urticaria (CU)

Completed·—·Phase 3·NCT00598611·29 enrolled

Allergic Rhinitis4 trials

Anti-inflammatory H1 Antihistamines Allergic Rhinitis

Completed·IIuliu Hatieganu University of Medicine and Pharmacy·Phase 4·NCT02507635·115 enrolled

Fixed Dose Combination of Desloratadine / Prednisolone in the Treatment of Moderate Severe Allergic Rhinitis in Children

Completed·EEurofarma Laboratorios S.A.·Phase 3·NCT05214911·262 enrolled

A Study of the Efficacy and Safety of Desloratadine (MK-4117) in Japanese Participants With Perennial Allergic Rhinitis (MK-4117-200)

Completed·OOrganon and Co·Phase 3·NCT01918033·608 enrolled

Show 1 more trial

Response of Desloratadine Syrup in the Relief of Symptoms Associated With Perennial Allergic Rhinitis in Pediatric Patients (Study P04299)

Completed·OOrganon and Co··NCT00704769·591 enrolled

22 more indications

Medication2 trials

Multi-Center, Pediatric, Open-Label, Preference Study of Desloratadine 2.5 mg Reditab (SCH34117) and Zyrtec ® 5.0 mg Chewable Tablet Medications (Study P04573) (Completed)

Completed·OOrganon and Co·Phase 4·NCT00780403·220 enrolled

Multi-center, Pediatric, Open-label, Preference Study of Desloratadine 2.5 mg Reditab (SCH34117) and Zyrtec 5.0 mg Chewable Tablet Medications (Study P04574)(COMPLETED)

Completed·OOrganon and Co·Phase 4·NCT00779116·217 enrolled

Acute Lymphoblastic Leukemia2 trials

A Study of the Effects of Desloratadine on Conjunctival Allergen Challenge-induced Ocular Signs and Symptoms (Study P04209)

Completed·OOrganon and Co·Phase 4·NCT00311844·41 enrolled

Anti-histamines and Methacholine Challenges.

Completed·DDon Cockcroft·Phase 4·NCT01985789·12 enrolled

Children2 trials

Taste Test Between Desloratadine and Cetirizine Syrup in Children (Study P03826)

Completed·OOrganon and Co·Phase 3·NCT00794794·204 enrolled

Taste Test Between Desloratadine and Cetirizine Syrup in Children (Study P03829)(COMPLETED)

Completed·OOrganon and Co·Phase 3·NCT00794378·202 enrolled

Cold Urticaria2 trials

Desloratadine 5, 10 and 20mg in Patients With Cold Urticaria

Completed·MMarcus Maurer·Phase 4·NCT01444196·30 enrolled

A Study to Assess and Compare the Effects of 5 mg vs. 20 mg Desloratadine on the Development of Cold Urticaria Lesions

Completed·—·Phase 4·NCT00600847·33 enrolled

Fed2 trials

Bioequivalence Study for Desloratadine OD Tablets 5 mg Under Fed Condition

Completed·—·Phase 1·NCT01506037·36 enrolled

Bioavailability Study of Desloratadine 5 mg Tablet of Dr. Reddy's Under Fed Conditions

Completed·—·Phase 1·NCT01314352·28 enrolled

Nasal Obstruction1 trial

The Effect of Desloratadine and Levocetirizine on Nasal Obstruction (Study P03609)

Completed·OOrganon and Co·Phase 3·NCT00789152·81 enrolled

Ulcerative Colitis1 trial

Desloratadine in Patients With Ulcerative Colitis

Recruiting·TTanta University·Phase 2·NCT07333716·44 enrolled

Efficacy and Safety1 trial

Confirmatory Study on the Efficacy and Safety of the Fixed-dose Combination of Desloratadine/Betamethasone Versus Desloratadine

Recruiting·LLaboratorios Silanes S.A. de C.V.·Phase 3·NCT06916884·70 enrolled

Pruritus1 trial

Aprepitant vs. Desloratadine in EGFR-TKIs Related Pruritus Treatment

Completed·SSun Yat-sen University·Phase 2·NCT02646020·138 enrolled

Allergy1 trial

Safety of Desloratadine in Children With Allergy Sensitivity and Chronic Hives, Who Are Poor Metabolizers of Desloratadine (Study P02994)

Completed·OOrganon and Co·Phase 3·NCT00757562·97 enrolled

Airway Disease1 trial

Effectiveness and Safety of Desloratadine in Patients With Allergic Airway Disease During the Pollen Season (Study P03284)

Completed·OOrganon and Co·Phase 4·NCT00779636·506 enrolled

Tics1 trial

Influence of Antipruritics on the Dermal Blood Flow Response to Histamine, Cinnamaldehyde and Capsaicin.

Completed·UUniversitaire Ziekenhuizen KU Leuven·N/A·NCT04399148·13 enrolled

Effectiveness1 trial

Observation of Side Effects and Effectiveness of Desloratadine (Aerius) Syrup in Filipino Children (Study P05634)

Completed·OOrganon and Co··NCT00761527·2,980 enrolled

Dermatitis1 trial

Efficacy and Safety Study of Desloratadine (MK-4117) in Japanese Participants With Eczema/Dermatitis and Dermal Pruritus (MK-4117-202)

Completed·OOrganon and Co·Phase 3·NCT01916980·94 enrolled

Efficacy1 trial

Efficacy of SLITone in House Dust Mite Allergic Patients

Completed·AALK-Abelló A/S·Phase 2/3·NCT00633919·124 enrolled

Fasting Conditions1 trial

Bioavailability Study of Dr. Reddy's Desloratadine Tablets, 5 mg Under Fasting Conditions.

Completed·—·Phase 1·NCT01314339·28 enrolled

Inflammation1 trial

Role of Desloratadine in Reducing Inflammation From Occupational Heat Strain

Unknown status·—·N/A·NCT05446480·12 enrolled

ESS1 trial

The Duration of the Suppressive Effects of Desloratadine on Allergen Prick Tests After Discontinuation (P04441)

Completed·OOrganon and Co·Phase 4·NCT00359138·36 enrolled

Skin Inflammation1 trial

Study of the Effectiveness and Safety of Desloratadine (Aerius) Syrup in Children With Allergic Skin Inflammation (P03475)

Completed·OOrganon and Co·Phase 3·NCT00817076·40 enrolled

Asthma1 trial

Study of the Effectiveness and Safety of Desloratadine (Aerius) Syrup in Children With Hayfever With or Without Asthma (P03472)

Completed·OOrganon and Co·Phase 3·NCT00805324·54 enrolled

Side Effects1 trial

Study of Nasal Symptom Relief and Side Effects in Hayfever Patients Treated With Aerius (Desloratadine)(P03442)

Completed·OOrganon and Co·Phase 4·NCT00805584·311 enrolled

Unspecified1 trial

Bioequivalence Study for Desloratadine OD Tablets 5 mg Under Fasting Condition

Completed·—·Phase 1·NCT01506050·35 enrolled

Regulatory

FDA Approval Timeline[5]

Dec 21, 2001

CLARINEX

NDA NDA021165

Sep 1, 2004

CLARINEX

NDA NDA021300

Jul 14, 2005

CLARINEX

NDA NDA021312

Sources

References

[1]
ClinicalTrials.gov — 57 trial records for desloratadine. U.S. National Library of Medicine, National Institutes of Health.
[2]
MedlinePlus Drug Information — Clarinex drug information. U.S. National Library of Medicine, National Institutes of Health.
[3]
ChEMBL — desloratadine compound record. European Bioinformatics Institute (EMBL-EBI).
[4]
Open Targets Platform — Drug–disease associations for desloratadine. EMBL-EBI & Wellcome Sanger Institute.
[5]
OpenFDA — FDA approval records (NDA NDA021312). U.S. Food & Drug Administration.
[6]
SEC EDGAR — Organon and Co company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Mechanism of Action: Histamine H1 Receptor Antagonist[3]
Modality: Small molecule[3]
Highest Phase: Approved[1]
Company: OOrganon and Co

Clarinex

Status by Indication[4][1]

Competitive Landscape

Expected Milestones

Q4 2026

Q1 2027

Trials by Indication[1]

Chronic Idiopathic Urticaria8 trials

Seasonal Allergic Rhinitis7 trials

Allergies6 trials

Urticaria5 trials

Allergic Rhinitis4 trials

Medication2 trials

Acute Lymphoblastic Leukemia2 trials

Children2 trials

Cold Urticaria2 trials

Fed2 trials

Nasal Obstruction1 trial

Ulcerative Colitis1 trial

Efficacy and Safety1 trial

Pruritus1 trial

Allergy1 trial

Airway Disease1 trial

Tics1 trial

Effectiveness1 trial

Dermatitis1 trial

Efficacy1 trial

Fasting Conditions1 trial

Inflammation1 trial

ESS1 trial

Skin Inflammation1 trial

Asthma1 trial

Side Effects1 trial

Unspecified1 trial

FDA Approval Timeline[5]

References

Drug Info

Quick Facts

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