Allegra

(Fexofenadine)

ApprovedSmall molecule

Fexofenadine is used to relieve allergy symptoms such as sneezing, itching, watery eyes, and runny nose caused by hay fever and other allergies.[2] Allegra is currently approved and in use across 15 indications[4].[1]

Allegra is one of 265 small molecule programs targeting Edema. It is currently in Approved.

Indications

Total Trials

Active Trials

264

Competitors

FDA Applications

NDA/BLA/ANDA regulatory filings

Patents

Pipeline

Status by Indication[4][1]

Indication

Allergic DiseaseActive, not recruiting

Non-Small Cell Lung CancerApproved

Atopic EczemaApproved

Gastroesophageal Reflux DiseaseApproved

Diabetic NephropathyApproved

Rhinitis, Allergic, PerennialApproved

Renal ColicActive, not recruiting

UrticariaActive, not recruiting

Relapsing-Remitting Multiple SclerosisActive, not recruiting

Seasonal Allergic RhinitisCompleted

Allergic DiseaseApproved

Active, not recruiting

Non-Small Cell Lung CancerApproved

Approved

Atopic EczemaApproved

Approved

Gastroesophageal Reflux DiseaseApproved

Approved

Diabetic NephropathyApproved

Approved

Rhinitis, Allergic, PerennialApproved

Approved

Renal ColicPreclinical

Active, not recruiting

UrticariaApproved

Active, not recruiting

Relapsing-Remitting Multiple SclerosisPhase 3

Active, not recruiting

Seasonal Allergic RhinitisApproved

Completed

Showing 10 of 13 indications

Competition

Competitive Landscape

449 competitors in Non-Small Cell Lung Cancer

#DrugCompanyPhaseTrials

Allegra

CChattem

Approved

58 2

Trodelvy

Gilead

Phase 3

11 3

Dato-Dxd

AstraZeneca

Phase 3

4 4

HD204

PPrestige Biopharma Limited

Phase 3

1 5

Remeron

OOrganon and Co

Preclinical

1 6

Aqupla

Jiangsu Simcere Pharmaceutical Co., Ltd.

Preclinical

—7

Ftorafur

TThe First Affiliated Hospital with Nanjing Medical University

Preclinical

—8

Vibramycin

PPfizer's Upjohn has merged with Mylan to form Viatris Inc.

Treatment

1 10

Valemetostat Tosylate

Daiichi Sankyo

Preclinical

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

Timeline

Expected Milestones

Q4 2026

Phase 2/3Recruiting

Parkinson Disease

NCT06785298

Q2 2027

Phase 3Recruiting

Zhejiang University

NCT07381803

Q3 2027

Phase 3Recruiting

Pruritus

NCT05263206

Q2 2029

Phase 3Active, not recruiting

Relapsing-Remitting Multiple Sclerosis

NCT04688788

Clinical

Trials by Indication[1]

Seasonal Allergic Rhinitis7 trials

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

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

A Placebo-controlled Study of 2-day Pre-treatment With Fexofenadine in Seasonal Allergic Rhinitis

Completed·OOpella Healthcare Group SAS, a Sanofi Company·Phase 3·NCT05692154·95 enrolled

Show 4 more trials

Fexofenadine HCL - Pseudoephedrine HCL Combination Versus Allegra in Patients With Seasonal Allergic Rhinitis

Completed· Sanofi logo

Sanofi·Phase 3·NCT01306721·520 enrolled

Single-Center, Double-Blind, Randomized , Parallel Study Comparing Onset of Action, Efficacy & Safety of a Single-Dose of Fexofenadine HCl 180 mg vs Montelukast Na 10 mg & Placebo in Treating Seasonal Allergic Rhinitis Subjects in an Allergen Exposure Unit

Completed· Sanofi logo

Sanofi·Phase 4·NCT00637611·1,010 enrolled

Study Evaluating the Efficacy and Safety of Fexofenadine in Subjects Suffering From Seasonal Allergic Rhinitis in Presence of Pollutants

Completed· Sanofi logo

Sanofi·Phase 3·NCT03664882·240 enrolled

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

Interaction4 trials

An Open-Label Drug-Drug Interaction Study of Telotristat Etiprate and Fexofenadine in Healthy Subjects

Completed·LLexicon Pharmaceuticals·Phase 1·NCT02157558·24 enrolled

Do Furanocoumarins Mediate the Fexofenadine-grapefruit Juice Interaction?

Completed·UUniversity of North Carolina, Chapel Hill·N/A·NCT01526213·18 enrolled

A Drug Interaction Study Between Danicopan and Midazolam, Fexofenadine, and Mycophenolate Mofetil in Healthy Participants

Completed· AstraZeneca logo

AstraZeneca·Phase 1·NCT03108274·35 enrolled

Show 1 more trial

Evaluation of the Potential Pharmacokinetic Interactions Between Probe Drugs in the Geneva Phenotyping Cocktail

Completed·JJules Desmeules·Phase 1·NCT02391688·30 enrolled

Allergies3 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 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

Fasting Conditions3 trials

Fexofenadine Hydrochloride 180 mg Tablets Under Fasting Conditions

Completed· Teva logo

Teva·Phase 1·NCT00835276·60 enrolled

Fexofenadine Hydrochloride 180 mg Tablets Under Non-Fasting Conditions

Completed· Teva logo

Teva·Phase 1·NCT00835640·24 enrolled

Bioequivalence Study of Dr.Reddy's Fexofenadine Hydrochloride 180 mg Tablets Under Fasting Conditions

Completed·—·Phase 1·NCT01066754·44 enrolled

Pruritus3 trials

Aprepitant in the Management of Biological Therapies-related Severe Pruritus

Completed·—·Phase 2·NCT01683552·45 enrolled

Fexofenadine Versus Gabapentin for Uremic Pruritus in Patients on Regular Hemodialysis

Completed·TTanta University·Phase 4·NCT06466421·60 enrolled

Master Protocol of Two Randomized, Double Blind, Placebo-controlled, Multi-center, Parallel Group Studies to Evaluate the Efficacy and Safety of Dupilumab in Adult Patients With Chronic Pruritus of Unknown Origin (CPUO)

Recruiting· Sanofi logo

Sanofi·Phase 3·NCT05263206·284 enrolled

31 more indications

Allergic Rhinitis3 trials

Fexofenadine Study On Filipino Children for The Relief of Perennial And Intermittent Allergic Rhinitis

Completed· Sanofi logo

Sanofi·Phase 4·NCT00741897·264 enrolled

Study to Assess Safety and Efficacy of Fexofenadine Hydrochloride (HCL) + Pseudoephedrine HCL Fixed Dose Combination in Indian Male and Female Participants With Allergic Rhinitis (AR) Who Are 12 Years and Above

Completed· Sanofi logo

Sanofi·Phase 4·NCT05720455·203 enrolled

Montelukast and Fexofenadine Versus Montelukast and Levocetrizine Combination in Allergic Rhinitis

Completed·IIndira Gandhi Medical College, Shimla·Phase 4·NCT02551536·70 enrolled

Asthma2 trials

Efficacy and Safety of Fexofenadine in Mild to Moderate Persistent Asthma

Completed· Sanofi logo

Sanofi·Phase 3·NCT00044811·1,000 enrolled

Efficacy and Safety of Fexofenadine in Mild to Moderate Persistent Asthma

Completed· Sanofi logo

Sanofi·Phase 3·NCT00044824·1,000 enrolled

Acute Lymphoblastic Leukemia2 trials

Food Study of Fexofenadine Tablets 180 mg and Allegra® Tablets 180 mg

Completed· Mylan Pharmaceuticals Inc logo

Mylan Pharmaceuticals Inc·Phase 1·NCT00647985·28 enrolled

Fasting Study of Fexofenadine Tablets 180 mg and Allegra® Tablets 180 mg

Completed· Mylan Pharmaceuticals Inc logo

Mylan Pharmaceuticals Inc·Phase 1·NCT00649376·68 enrolled

Tics2 trials

Study to Evaluate the Pharmacokinetics and Pharmacodynamics of JMI-001

Unknown status·SSen-Jam Pharmaceutical·Phase 1·NCT03183297·48 enrolled

Assessment of the Safety, Tolerability and Pharmacokinetics of AV078 in Healthy Volunteers

Completed·AAeovian Pharmaceuticals, Inc.·Phase 1·NCT06205381·89 enrolled

Double-blind2 trials

A Randomized, Double-Blind, 4-way Crossover Study to Evaluate the Efficacy of Bilastine in the Vienna Challenge Chamber

Completed·FFaes Farma, S.A.·Phase 2·NCT00420082·75 enrolled

Single Center, Randomized, Double-Blind,Crossover Study Comparing Effects Of Single-Dose Fexofenadine HCl 180 mg, Cetirizine 10 mg, and Placebo on Cognitive Performance in Naval Flight Personnel

Completed· Sanofi logo

Sanofi·Phase 4·NCT00637455·72 enrolled

TIA1 trial

Dose Proportionality of Fexofenadine in Healthy Human Egyptian Volunteers

Completed·—·N/A·NCT01767272·25 enrolled

Montelukast1 trial

Fexofenadine HCl 180 mg, Montelukast Sodium 10 mg and Placebo in Suppression of Wheal and Flare Induced by Seasonal Allergen

Completed· Sanofi logo

Sanofi·Phase 4·NCT00638118·48 enrolled

Oral1 trial

Oral Pharmacokinetics of Sulfasalazine, Paracetamol, Fexofenadine and Valsartan Using Different Administration Mediums

Completed·UUniversity Medicine Greifswald·Phase 1·NCT03012763·9 enrolled

Concentration1 trial

Relation Between Blood Concentration of Colchicine and Response to Colchicine Treatment in Gout Flare

Terminated·AAssistance Publique - Hôpitaux de Paris·Phase 4·NCT03933007·26 enrolled

Renal Colic1 trial

Role of Antihistaminic in Acute Renal Colic Prevent Pain Recurrence and Expulsion of Ureteric Stone ≤ 1cm

Unknown status·—··NCT05150899·100 enrolled

Clinical Trial1 trial

Clinical Trials on Evaluate the Red Ginseng and Fermented-Red Ginseng Affect to Drug Metabolizing Enzyme and Transporter in Healthy Volunteers

Completed·—·Phase 1·NCT02056743·30 enrolled

Absorption1 trial

Relative Bioavailability of Dabigatran Etexilate Capsules With and Without Quinidine Sulfate Tablets and to Measure the Effect of Quinidine on the Absorption of Fexofenadine in Healthy Male and Female Volunteers

Terminated· Boehringer Ingelheim logo

Boehringer Ingelheim·Phase 1·NCT02171546·42 enrolled

Gastroesophageal Reflux1 trial

Fexofenadine Use in Gastroesophageal Reflux Symptoms

Terminated·SStanford University·Phase 2·NCT03425097·11 enrolled

Parkinson disease1 trial

Fexofenadine as Adjuvant Therapy in Parkinson Disease

Recruiting·TTanta University·Phase 2/3·NCT06785298·46 enrolled

Rheumatoid Arthritis1 trial

Fexofenadine in Patients With Active Rheumatoid Arthritis

Recruiting·OOctober 6 University·Phase 1/2·NCT05264025·80 enrolled

Single Dose1 trial

A Study to Assess the Effect of BMS-986419 on the Single Dose Drug Levels of Probe Substrates in Healthy Participants

Completed· Bristol-Myers Squibb logo

Bristol-Myers Squibb·Phase 1·NCT05932277·22 enrolled

Urticaria1 trial

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

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

Uncontrolled Gout1 trial

Study of KRYSTEXXA® (Pegloticase) Plus Methotrexate in Participants With Uncontrolled Gout

Completed· Amgen logo

Amgen·Phase 4·NCT03994731·152 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

Adult1 trial

Fexofenadine (Allegra®) in Healthy Adults Who Have Been Identified as Slow Metabolizers for Desloratadine

Completed· Sanofi logo

Sanofi·Phase 4·NCT00636870·220 enrolled

Dialysis1 trial

The Effect Dialysis on the Pharmacokinetics of Fexofenadine

Unknown status·LLondon Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's·Phase 4·NCT03078777·30 enrolled

ESS1 trial

Fexofenadine HCl 180 mg, Desloratadine 5 mg and Placebo in Suppression of Wheal and Flare Induced by Histamine

Completed· Sanofi logo

Sanofi·Phase 4·NCT00637585·42 enrolled

Treatment1 trial

Topical Treatment of Under Eye Dark Circles and Swelling

Completed·TThe Connecticut Sinus Center, PC·Phase 2·NCT01172522·30 enrolled

Skin Disease1 trial

Fexofenadine in Pruritic Skin Disease

Completed·HHandok Inc.·Phase 4·NCT00261079·435 enrolled

Labor1 trial

Bioequivalence Study of Dr. Reddy's Laboratories Limited Fexofenadine Hydrochloride 180 mg Tablets Under Fed Conditions

Completed·—·Phase 1·NCT01066767·30 enrolled

Efficacy1 trial

Evaluation of Efficacy of Dellegra in Exposure Unit

Completed· Sanofi logo

Sanofi·Phase 4·NCT02175485·24 enrolled

Allergy1 trial

A Single-Center, Randomized, Double-Blind, Placebo-Controlled, Two-Way Crossover Study Designed to Evaluate the Efficacy of Fexofenadine HCl 180 mg for Preventing and Controlling Cat Allergy Symptoms

Completed· Sanofi logo

Sanofi·Phase 4·NCT00637884·70 enrolled

Skin1 trial

Comparative Study Evaluating the Effects of Fexofenadine HCI 180 mg With Orange Juice Versus Placebo With Orange Juice in a Skin Wheal and Flare Challenge Model.

Completed· Sanofi logo

Sanofi·Phase 4·NCT00547768·36 enrolled

Relapsing-Remitting Multiple Sclerosis1 trial

Danish Non-inferiority Study of Ocrelizumab and Rituximab in MS (DanNORMS): A Randomized Study Comparing the Efficacy of Ocrelizumab and Rituximab in Active Multiple Sclerosis

Active, not recruiting·RRigshospitalet, Denmark·Phase 3·NCT04688788·600 enrolled

Zhejiang University1 trial

The Impact of Fexofenadine Hydrochloride on the Prognosis of Patients Post-Acute Myocardial Infarction: A Randomized Clinical Trial (FEND Ⅱ)

Recruiting·SSecond Affiliated Hospital, School of Medicine, Zhejiang University·Phase 3·NCT07381803·2,804 enrolled

Unspecified2 trials

Safety Study of Levocetirizine and Fexofenadine

Completed·—·Phase 4·NCT01586091·18 enrolled

A Phase 1, 3-part, Open-label Study to Evaluate the Effects of KarXT Administration on the Pharmacokinetics of Midazolam, Fexofenadine, and Digoxin in Healthy Adult Participants

Completed·KKaruna Therapeutics·Phase 1·NCT07118215·62 enrolled

Regulatory

FDA Approval Timeline[5]

Jul 25, 1996

ALLEGRA

NDA NDA020625

Oct 16, 2006

ALLEGRA

NDA NDA021963

Jan 24, 2011

CHILDREN'S ALLEGRA ALLERGY

NDA NDA201373

Jan 24, 2011

CHILDREN'S ALLEGRA ALLERGY

NDA NDA021909

Jan 24, 2011

ALLEGRA ALLERGY

NDA NDA020872

Sources

References

[1]
ClinicalTrials.gov — 58 trial records for Fexofenadine. U.S. National Library of Medicine, National Institutes of Health.
[2]
MedlinePlus Drug Information — Allegra drug information. U.S. National Library of Medicine, National Institutes of Health.
[3]
ChEMBL — Fexofenadine compound record. European Bioinformatics Institute (EMBL-EBI).
[4]
Open Targets Platform — Drug–disease associations for Fexofenadine. EMBL-EBI & Wellcome Sanger Institute.
[5]
OpenFDA — FDA approval records (NDA NDA201373). U.S. Food & Drug Administration.
[6]
FDA Orange Book — Patent and exclusivity data for Allegra. U.S. Food & Drug Administration.
[7]
SEC EDGAR — Chattem 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: CChattem

Patent Landscape[6]

Patent Cliff

Aug 2, 2030

Earliest patent expiration — generic entry possible after this date

Patent #Expires

8933097Aug 2, 2030

Allegra

Status by Indication[4][1]

Competitive Landscape

Expected Milestones

Q4 2026

Q2 2027

Q3 2027

Q2 2029

Trials by Indication[1]

Seasonal Allergic Rhinitis7 trials

Interaction4 trials

Allergies3 trials

Fasting Conditions3 trials

Pruritus3 trials

Allergic Rhinitis3 trials

Asthma2 trials

Acute Lymphoblastic Leukemia2 trials

Tics2 trials

Double-blind2 trials

TIA1 trial

Montelukast1 trial

Oral1 trial

Concentration1 trial

Renal Colic1 trial

Clinical Trial1 trial

Absorption1 trial

Gastroesophageal Reflux1 trial

Parkinson disease1 trial

Rheumatoid Arthritis1 trial

Single Dose1 trial

Urticaria1 trial

Uncontrolled Gout1 trial

Prospective1 trial

Adult1 trial

Dialysis1 trial

ESS1 trial

Treatment1 trial

Skin Disease1 trial

Labor1 trial

Efficacy1 trial

Allergy1 trial

Skin1 trial

Relapsing-Remitting Multiple Sclerosis1 trial

Zhejiang University1 trial

Unspecified2 trials

FDA Approval Timeline[5]

References

Drug Info

Quick Facts

Patent Landscape[6]

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