Claritin

(Loratadine)

ApprovedSmall molecule

Loratadine is used to relieve allergy symptoms like sneezing, runny nose, itchy eyes, and itchy throat caused by allergies.[2] Claritin is currently approved and in use across 15 indications[4].[1]

Claritin is one of 262 small molecule programs targeting Bone pain. It is currently in Approved.

Indications

Total Trials

Active Trials

261

Competitors

FDA Applications

NDA/BLA/ANDA regulatory filings

Pipeline

Status by Indication[4][1]

Indication

Bone PainTerminated

Rhinitis, Allergic, PerennialActive, not recruiting

Allergic DiseaseActive, not recruiting

Back PainApproved

AsthmaApproved

Hematologic MalignancyRecruiting

Allergic ConjunctivitisActive, not recruiting

Chronic Spontaneous UrticariaActive, not recruiting

Solid TumorRecruiting

Fasting ConditionsCompleted

Bone PainPhase 2

Terminated

Rhinitis, Allergic, PerennialApproved

Active, not recruiting

Allergic DiseaseApproved

Active, not recruiting

Back PainApproved

Approved

AsthmaApproved

Approved

Hematologic MalignancyPreclinical

Recruiting

Allergic ConjunctivitisApproved

Active, not recruiting

Chronic Spontaneous UrticariaApproved

Active, not recruiting

Solid TumorPhase 2

Recruiting

Fasting ConditionsPreclinical

Completed

Showing 10 of 14 indications

Competition

Competitive Landscape

348 competitors in Solid Tumor

#DrugCompanyPhaseTrials

Claritin

PPerrigo Company

Approved

1 2

Sporanox

SSebela Pharmaceuticals Development LLC

Preclinical

2 3

Zejula

GGlaxo Dba Glaxosmithkline

Preclinical

2 4

Augtyro

KKaruna Therapeutics, Inc., a Bristol Myers Squibb company

Preclinical

2 5

Paxil

SSebela Pharmaceuticals Development LLC

Preclinical

1 6

Soc

Pfizer

Preclinical

1 7

Chemotherapy Drug

Chia Tai Tianqing Pharmaceutical Group Co., Ltd.

Preclinical

2 8

SAR445877

Sanofi

Preclinical

1 9

Cadonilimab

SShanghai Pharmaceuticals Holding Co., Ltd

Preclinical

1 10

Immune Checkpoint Inhibitors

PPeking Union Medical College Hospital

Preclinical

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

Timeline

Expected Milestones

Q4 2026

Phase 2Recruiting

Bone Pain

NCT05421416

Q3 2027

PreclinicalRecruiting

Hematologic Malignancy

NCT07300735

Phase 2Recruiting

Solid Tumor

NCT07661459

Q4 2027

ApprovedRecruiting

Multiple Myeloma

NCT07101445

Clinical

Trials by Indication[1]

Allergic Rhinitis6 trials

Effectivness and Safety of Acupuncture Combined With Moxibustion for Allergic Rhinitis

Completed·ZZhao Hong·Phase 2·NCT02339714·98 enrolled

Benjakul Extract and Loratadine for Treatment Allergic Rhinitis Patients

Completed·TThammasat University·Phase 2·NCT03376594·60 enrolled

Effectiveness of Qufeng Shengshi Fang on Treatment of Allergic Rhinitis.

Unknown status·PPeking Union Medical College Hospital·N/A·NCT02653339·180 enrolled

Show 3 more trials

Efficacy & Safety of Loratadine-Betamethasone Oral Solution for Treatment of Severe Perennial Allergic Rhinitis in Children (Study P03428)

Completed· Merck & Co. logo

Merck & Co.·Phase 4·NCT00963573·100 enrolled

Quality of Life in Patients With Allergic Rhinitis: Clinical Trial With Bilastine or Loratadine

Completed·—·Phase 4·NCT02513290·73 enrolled

Study of Efficacy and Safety of Ginger Extract Compared With Loratadine for Treatment of Allergic Rhinitis

Completed·TThai Traditional Medical Knowledge Fund·Phase 2·NCT02576808·80 enrolled

Seasonal Allergic Rhinitis4 trials

A Study of Onset of Action of Loratadine and Fexofenadine in Participants With Seasonal Allergic Rhinitis (P08712)

Completed· Bayer logo

Bayer·Phase 4·NCT01469234·255 enrolled

Effects of Phenylephrine on Nasal Congestion in Participants With Seasonal Allergic Rhinitis (P08156 AM2)(Completed)

Completed· Bayer logo

Bayer·Phase 2·NCT01330017·539 enrolled

Randomized, Double Blind, Parallel Group, Placebo Controlled, Multi-Center Study of the Efficacy and Safety of Cetirizine HCl Syrup vs. Loratadine Syrup vs. Placebo in Treatment of Children With Seasonal Allergic Rhinitis (SAR)

Completed·JJohnson & Johnson Consumer and Personal Products Worldwide·Phase 4·NCT02932774·683 enrolled

Show 1 more trial

Safety and Efficacy of Mometasone Furoate Nasal Spray With the Addition of Loratadine Versus Placebo in Participants With Seasonal Allergic Rhinitis (C94-145)

Completed·OOrganon and Co·Phase 3·NCT03855228·704 enrolled

Bone pain4 trials

Loratadine for Improvement of Bone Pain in Patients With Chronic Granulocyte-Colony Stimulating Factor (G-CSF) Use

Terminated·UUniversity of Michigan·Phase 2·NCT03883386·3 enrolled

Loratadine for the Prevention of G-CSF-related Bone Pain

Recruiting·AAHS Cancer Control Alberta·Phase 2·NCT05421416·78 enrolled

Study of Loratadine for Pegfilgrastim Induced Bone Pain in Patients With Aggressive Lymphoma

Terminated·MM.D. Anderson Cancer Center·Phase 1·NCT02392039·1 enrolled

Show 1 more trial

Evaluation of Loratadine for G-CSF Induced Bone Pain in Patients With Hematologic Malignancies

Completed·WWake Forest University Health Sciences··NCT02305979·61 enrolled

Multiple Myeloma2 trials

Loratadine for the Reduction of G-CSF Induced Bone Pain in Patients With Multiple Myeloma Undergoing Stem Cell Mobilization

Unknown status·RRutgers, The State University of New Jersey·Phase 1·NCT04211259·70 enrolled

Prevent Allergic Reactions to Aphexda With Dexamethasone (PARADE)

Recruiting·EEmory University·Approved·NCT07101445·94 enrolled

ART2 trials

A Study to Assess the Relative Bioavailability of Xisimin (Loratadine) Tablets Under Fasting and Fed Conditions in Healthy Participants Compared to Clarityne Tablets

Completed· Johnson & Johnson logo

Johnson & Johnson·Phase 1·NCT03151720·28 enrolled

A Study to Assess the Bioequivalence of Xisimin (Loratadine) Tablets Under Fasting and Fed Conditions in Healthy Participants Compared With Clarityne Tablets

Completed· Johnson & Johnson logo

Johnson & Johnson·Phase 1·NCT03196531·108 enrolled

27 more indications

Oral2 trials

Bioequivalence Study of Loratadine Orally Disintegrating Tablets 10 mg Under Fed Conditions

Completed·RRanbaxy Laboratories Limited·N/A·NCT00776282·80 enrolled

To Assess Bioequivalence of Loratadine Oral Solution/Syrup Versus Claritin Peach Syrup

Completed· Bayer logo

Bayer·Phase 1·NCT02593747·54 enrolled

Biological Availability1 trial

A Study to Assess Drug Levels, Tolerability and Absolute Biological Availability of Single-dose of BMS-986446 in Healthy Participants

Completed· Bristol-Myers Squibb logo

Bristol-Myers Squibb·Phase 1·NCT06955741·46 enrolled

Nasal congestion1 trial

Effects of Phenylephrine Extended-Release Tablets on Allergy-Related Nasal Congestion (P08498 AM1)

Completed· Bayer logo

Bayer·Phase 3·NCT01413958·575 enrolled

Kidney Transplant1 trial

Effects of Inhibiting Early Inflammation in Kidney Transplant Patients

Completed·NNational Institute of Allergy and Infectious Diseases (NIAID)·Phase 2·NCT02495077·290 enrolled

Prevention1 trial

Evaluation of Loratadine for Prevention of Pegfilgrastim-Induced Pain

Unknown status·UUniversity of Vermont·Phase 2·NCT01311336·55 enrolled

Chronic Spontaneous Urticaria1 trial

Efficacy and Safety of Histamine Human Immunoglobulin in the Treatment of Chronic Spontaneous Urticaria (CSU)

Unknown status·HHangzhou Grand Biologic Pharmaceutical, Inc.·Phase 4·NCT06250400·252 enrolled

Stress1 trial

Over-the-Counter Antihistamines & Heat Stress

Unknown status·LLakehead University·Phase 4·NCT06217367·16 enrolled

Adverse Effect1 trial

Efficacy and Adverse Effects of Prapchompoothaweep Remedy and Loratadine for Treatment in AR Patients

Completed·TThammasat University·Phase 2·NCT03640273·72 enrolled

Allergy1 trial

A Study to Evaluate Cooling Sensation of an Allergy Product in Adults With a History of Allergies

Completed· Bayer logo

Bayer·Phase 4·NCT04162795·468 enrolled

Fasting Conditions1 trial

Bioequivalence Study on Loratadine Orally Disintegrating Tablets 10 mg Under Fasting Conditions

Completed·RRanbaxy Laboratories Limited·N/A·NCT00776217·80 enrolled

Allergic Conjunctivitis1 trial

A Study Comparing the Efficacy of Pataday® Once Daily Relief Extra Strength to Claritin® Tablets 24-Hour in Subjects With Allergic Conjunctivitis

Completed·AAndover Research Eye Institute·Phase 4·NCT05265910·58 enrolled

Conjunctivitis1 trial

Efficacy and Safety Study of RAGWITEK™ (MK-3641) in Children With Ragweed-Induced Rhinoconjunctivitis With or Without Asthma (MK-3641-008)

Completed· Merck & Co. logo

Merck & Co.·Phase 3·NCT02478398·1,025 enrolled

COVID-191 trial

Combined Antihistaminics Therapy in COVID 19 Patients

Completed·—·Phase 2/3·NCT05043350·214 enrolled

Multiple Sclerosis1 trial

A Study to Characterize Subcutaneous or Intravenous Alemtuzumab in Patients With Progressive Multiple Sclerosis

Completed· Sanofi logo

Sanofi·Phase 1·NCT02583594·24 enrolled

Lymphangioleiomyomatosis1 trial

Effect of Loratadine in Lymphangioleiomyomatosis

Unknown status·IInstitut d'Investigació Biomèdica de Bellvitge·Phase 2·NCT05190627·62 enrolled

Urticaria1 trial

Efficacy and Safety of Omalizumab in Adults (18-70 Years) With Moderate to Severe Chronic Urticaria

Completed· Novartis logo

Novartis·Phase 2·NCT00481676·49 enrolled

Tics1 trial

A Study of the Pharmacokinetics and Safety of MK-8808 (MK-8808-002)

Terminated· Merck & Co. logo

Merck & Co.·Phase 1·NCT01390441·100 enrolled

Prospective1 trial

A Prospective Study to Investigate Safety and Tolerability of Shorter Infusion of Fabrazyme

Completed· Sanofi logo

Sanofi·Phase 4·NCT06019728·8 enrolled

Efficacy and Safety1 trial

Efficacy and Safety in the Combination of Ibuprofen / Loratadine Versus Ibuprofen Versus Loratadine

Recruiting·LLaboratorios Silanes S.A. de C.V.·Phase 3·NCT06531707·177 enrolled

Eosinophilic Esophagitis1 trial

Antihistamines in Eosinophilic Esophagitis

Terminated·MMayo Clinic·Phase 2·NCT04248712·1 enrolled

Neuropathy1 trial

Evaluation of The Effect of Loratadine Versus Diosmin/Hesperidin Combination on Vinca Alkaloids Induced Neuropathy

Unknown status·—·Phase 3·NCT05243706·90 enrolled

Children1 trial

Observation of Use of Claritin (Loratadine) Tablet, RediTabs, and Dry Syrup in Children (Study P05834)(COMPLETED)

Completed· Merck & Co. logo

Merck & Co.··NCT00762983·1,003 enrolled

Pediatric1 trial

Post Approval Pharmacokinetic Study of Loratadine in Japanese Pediatric and Adult Patients (Study P05539)

Completed· Merck & Co. logo

Merck & Co.·Phase 4·NCT00730912·261 enrolled

Pruritus1 trial

Gabapentin Versus Loratadine in Uremic Pruritus

Completed·KKing Edward Medical University·Phase 4·NCT05750875·64 enrolled

Solid Tumor1 trial

Optimizing Ancillary Therapies (Acetaminophen, Cannabis, Antihistamines, and NSAIDS) With Immune Checkpoint Inhibitors for Solid Tumors (OAT ICI)

Recruiting·VVal Adams·Phase 2·NCT07661459·98 enrolled

Hematologic Malignancy1 trial

A Comparative Study of Diosmin-Hesperidin and Loratadine for the Prevention of G-CSF Induced Bone Pain in Patients With Hematological Malignancies

Recruiting·AAlexandria University·Preclinical·NCT07300735·88 enrolled

Unspecified2 trials

Patient Experience Study of Deoxycholic Acid Injection

Completed·KKythera Biopharmaceuticals·Phase 3·NCT02007434·84 enrolled

NOLAN: Naproxen or Loratadine and Neulasta

Completed· Amgen logo

Amgen·Phase 2·NCT01712009·600 enrolled

Regulatory

FDA Approval Timeline[5]

Nov 27, 2002

CLARITIN

NDA NDA019658

Nov 27, 2002

CLARITIN

NDA NDA020641

Dec 19, 2002

ALAVERT

NDA NDA021375

Nov 19, 2003

CLARITIN HIVES RELIEF REDITAB

NDA NDA020704

Jun 24, 2004

LORATADINE

NDA NDA021512

Oct 4, 2005

LORATADINE

NDA NDA021734

Aug 23, 2006

CHILDREN'S CLARITIN

NDA NDA021891

Dec 12, 2006

CLARITIN REDITABS

NDA NDA021993

Jun 16, 2008

CLARITIN

NDA NDA021952

Sources

References

[1]
ClinicalTrials.gov — 47 trial records for Loratadine. U.S. National Library of Medicine, National Institutes of Health.
[2]
MedlinePlus Drug Information — Claritin drug information. U.S. National Library of Medicine, National Institutes of Health.
[3]
ChEMBL — Loratadine compound record. European Bioinformatics Institute (EMBL-EBI).
[4]
Open Targets Platform — Drug–disease associations for Loratadine. EMBL-EBI & Wellcome Sanger Institute.
[5]
OpenFDA — FDA approval records (NDA NDA021952). U.S. Food & Drug Administration.
[6]
SEC EDGAR — Perrigo Company 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: PPerrigo Company

Claritin

Status by Indication[4][1]

Competitive Landscape

Expected Milestones

Q4 2026

Q3 2027

Q4 2027

Trials by Indication[1]

Allergic Rhinitis6 trials

Seasonal Allergic Rhinitis4 trials

Bone pain4 trials

Multiple Myeloma2 trials

ART2 trials

Oral2 trials

Biological Availability1 trial

Nasal congestion1 trial

Kidney Transplant1 trial

Prevention1 trial

Chronic Spontaneous Urticaria1 trial

Stress1 trial

Adverse Effect1 trial

Allergy1 trial

Fasting Conditions1 trial

Allergic Conjunctivitis1 trial

Conjunctivitis1 trial

COVID-191 trial

Multiple Sclerosis1 trial

Lymphangioleiomyomatosis1 trial

Urticaria1 trial

Tics1 trial

Prospective1 trial

Efficacy and Safety1 trial

Eosinophilic Esophagitis1 trial

Neuropathy1 trial

Children1 trial

Pediatric1 trial

Pruritus1 trial

Solid Tumor1 trial

Hematologic Malignancy1 trial

Unspecified2 trials

FDA Approval Timeline[5]

References

Drug Info

Quick Facts

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