Flovent

(Fluticasone)

ApprovedSmall molecule

Fluticasone is used to reduce inflammation and control symptoms of asthma and allergies, such as sneezing, nasal congestion, and itchy eyes.[2] Flovent is currently approved and in use across 13 indications[4].[1]

Flovent is one of 286 small molecule programs targeting Rhinitis. It is currently in Approved.

Indications

Total Trials

Active Trials

285

Competitors

FDA Applications

NDA/BLA/ANDA regulatory filings

Patents

Pipeline

Status by Indication[4][1]

Indication

RhinitisActive, not recruiting

Cystic FibrosisActive, not recruiting

Respiratory System DiseaseActive, not recruiting

CroupApproved

Atopic EczemaApproved

Diabetes MellitusApproved

Allergic ConjunctivitisActive, not recruiting

PsoriasisActive, not recruiting

Endothelial DysfunctionActive, not recruiting

SinusitisActive, not recruiting

RhinitisPreclinical

Active, not recruiting

Cystic FibrosisPreclinical

Active, not recruiting

Respiratory System DiseasePreclinical

Active, not recruiting

CroupApproved

Approved

Atopic EczemaApproved

Approved

Diabetes MellitusApproved

Approved

Allergic ConjunctivitisApproved

Active, not recruiting

PsoriasisApproved

Active, not recruiting

Endothelial DysfunctionPreclinical

Active, not recruiting

SinusitisPreclinical

Active, not recruiting

Showing 10 of 13 indications

Competition

Competitive Landscape

175 competitors in Asthma

#DrugCompanyPhaseTrials

Flovent

PParatek Pharmaceuticals Inc

Approved

14 2

Celexa

AbbVie

Preclinical

1 3

Solu-Medrol

MMassachusetts Eye and Ear Infirmary

Preclinical

1 4

DUPIXENT

Regeneron

Preclinical

1 5

Paracetamol

GSK

Preclinical

1 6

Atrovent

Boehringer Ingelheim

Preclinical

2 7

Ozone

TTanta University

Preclinical

1 8

Blood Collection

AAssistance Publique - Hôpitaux de Paris

Preclinical

1 9

Lexapro

SShirley Ryan AbilityLab

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

Q1 2027

Phase 2Recruiting

Effectiveness

NCT06705387

Q4 2027

Phase 2Recruiting

Bronchiolitis Obliterans

NCT05922761

Clinical

Trials by Indication[1]

Asthma14 trials

Fluticasone/Salmeterol (FP/SM) Versus Double the Dose Fluticasone (FP) in Patients With Mild to Moderate Asthma

Completed·UUniversity of Dundee·Phase 4·NCT00830505·38 enrolled

Responsiveness of Lower Airways in Adult Patients (18-60 Years) With Stable Asthma After Treatment With Ciclesonide and Fluticasone Propionate (BY9010/NL-101)

Completed· AstraZeneca logo

AstraZeneca·Phase 3·NCT00306163·37 enrolled

Effect of Extra- Fine Versus Coarse-Particle Inhaled Corticosteroids (ICS) on Ventilation Heterogeneity in Children With Poorly Controlled Asthma

Completed·UUniversity of Virginia·Phase 4·NCT02577497·31 enrolled

Show 11 more trials

Open-label, Safety and Efficacy Study of Pulmicort® Turbuhaler® in Japanese Children With Bronchial Asthma

Completed· AstraZeneca logo

AstraZeneca·Phase 3·NCT00504062·240 enrolled

Additive Effects of QVAR to (Seretide) on Surrogate Markers of Airway Inflammation in Refractory Asthma

Completed·UUniversity of Dundee·Phase 4·NCT00829257·15 enrolled

Inhaled Steroids at Discharge After Emergency Department Visits for Children With Uncontrolled Asthma

Terminated·RRhode Island Hospital·N/A·NCT01881412·118 enrolled

Inhaled Fluticasone Propionate: Effect on Parameters of Bone Metabolism in Patients With Mild to Moderate Asthma

Withdrawn·UUniversity of Kansas·N/A·NCT00409630

Effects of QVAR in Smokers With Asthma

Completed·UUniversity Medical Center Groningen·Phase 4·NCT01741285·40 enrolled

Airway Microbiome in Asthma: Relationships to Asthma Phenotype and Inhaled Corticosteroid Treatment

Completed·MMilton S. Hershey Medical Center·N/A·NCT01537133·84 enrolled

Should Non-eosinophilic Asthmatic Subjects be Treated With Inhaled Corticosteroids?

Terminated·UUniversité de Montréal·N/A·NCT00509197·12 enrolled

Dose Response Effects of Inhaled Fluticasone on Airway Effects of Hypertonic-saline in Asthma

Completed·UUniversity of California, San Francisco·Phase 4·NCT00606242·44 enrolled

Repeated High-dose Inhaled Corticosteroids for Asthma

Withdrawn·UUniversity of Chicago·Phase 2·NCT00695604

A Study Comparative of Formoterol/Fluticasone Foraseq® and Fluticasone in Asthma Patients

Completed·EEurofarma Laboratorios S.A.·Phase 3·NCT01202084·222 enrolled

Leukotriene Receptor Antagonists or Steroids in Pre-School Asthma

Completed·JJohann Wolfgang Goethe University Hospital·Phase 2·NCT00543686·100 enrolled

Eosinophilic Esophagitis5 trials

Topical Steroid Treatment for Eosinophilic Esophagitis

Completed·MMayo Clinic·Phase 2·NCT00275561·42 enrolled

Eosinophilic Esophagitis Treatment: Montelukast vs Fluticasone

Withdrawn·MMedical College of Wisconsin·Phase 3·NCT01702701

Comparison of Esomeprazole to Aerosolized, Swallowed Fluticasone for Eosinophilic Esophagitis

Completed·UUniversity of Utah·Phase 2·NCT00123656·30 enrolled

Show 2 more trials

Dietetic Versus Topical Steroids for Pediatric Eosinophilic Esophagitis

Completed·AAzienda Policlinico Umberto I·Phase 4·NCT01846962·64 enrolled

New Serological Markers for Eosinophilic Esophagitis

Unknown status·TTechnical University of Munich··NCT01624129·20 enrolled

Salmeterol3 trials

The Effect of Salmeterol on Eosinophil (EOS) Function

Completed·UUniversity of Wisconsin, Madison·N/A·NCT00214019·36 enrolled

The Leukotriene Modifier Or Corticosteroid or Corticosteroid-Salmeterol Trial

Completed·JJHSPH Center for Clinical Trials·Phase 4·NCT00156819·500 enrolled

Interactive Acute Smooth Muscle Effects of Salmeterol and Fluticasone in the Airway

Completed·UUniversity of Miami·N/A·NCT01231230·14 enrolled

Rhinitis2 trials

Safety, Tolerability and Pharmacokinetics of Multiple Doses of VAK694 in Atopic Subjects With Seasonal Rhinitis

Completed· Novartis logo

Novartis·Phase 2·NCT00929968·35 enrolled

Effects of Broccoli Sprout Extract on Allergy Rhinitis

Completed·VVA Office of Research and Development·Phase 2·NCT02885025·47 enrolled

Drug2 trials

Special Drug Use Investigation for ALLERMIST (Long Term)

Completed· GSK logo

GSK··NCT01420822·500 enrolled

Drug Use Investigation for ALLERMIST

Completed· GSK logo

GSK··NCT01376206·2,000 enrolled

29 more indications

Allergic Rhinitis2 trials

A Study to Assess Efficacy and Safety of Nasacort® Nasal Spray in Comparison With Flixonase® Nasal Spray in Adults Suffering From Perennial Allergic Rhinitis (PAR)

Completed· Sanofi logo

Sanofi·Phase 3·NCT03317015·260 enrolled

A Comparative Study of Mometasone Furoate Nasal Spray and Fluticasone Propionate Nasal Spray in Patients With Perennial Allergic Rhinitis (Study P04512)

Completed·OOrganon and Co·Phase 3·NCT00783224·351 enrolled

COVID-192 trials

ACTIV-6: COVID-19 Study of Repurposed Medications

Completed·—·Phase 3·NCT04885530·10,956 enrolled

ACTIV-6: COVID-19 Study of Repurposed Medications - Arm C (Fluticasone)

Completed·—·Phase 3·NCT05736874·1,407 enrolled

Patient Preference2 trials

Single Dose Crossover Study of Patient Preference for Unscented Nasonex® Nasal Spray Versus Scented Flonase® Nasal Spray (Study P04207)

Completed·OOrganon and Co·Phase 4·NCT00817050·100 enrolled

Single Dose Crossover Study of Patient Preference for Unscented Nasonex® Nasal Spray Versus Scented Flonase® Nasal Spray (Study P04208)

Completed·OOrganon and Co·Phase 4·NCT00783458·100 enrolled

Endothelial Dysfunction1 trial

Effect of an Inhaled Glucocorticosteroid (ICS) on Endothelial Dysfunction in Cigarette Smokers

Completed·UUniversity of Miami·N/A·NCT01216735·32 enrolled

Drug Repurposing1 trial

Data Analysis for Drug Repurposing for Effective Alzheimer's Medicines (DREAM) - Montelukast vs Fluticasone

Completed·—··NCT05457855·51,533 enrolled

EoE1 trial

EoE RCT Fluticasone and Omeprazole vs Fluticasone Alone

Unknown status·CClaire Daniels·Phase 4·NCT03781596·100 enrolled

Systemic Inflammation1 trial

Effects of Inhaled Corticosteroids in the Systemic Inflammation Induced by Exercise in Patients With COPD

Completed·—·Phase 4·NCT02209974·23 enrolled

Psoriasis1 trial

Elocon vs Fluticasone in Localized Psoriasis (P03197)

Completed·OOrganon and Co·Phase 4·NCT00763529·245 enrolled

Single Dose1 trial

Single Dose Pharmacokinetics of Intranasal Fluticasone Delivered by a Fixed Combination With Azelastine (MP29 02) in Comparison to Two Different Fluticasone Nasal Sprays

Completed·MMEDA Pharma GmbH & Co. KG·Phase 1·NCT01194622·30 enrolled

CLE1 trial

Ciclesonide vs Fluticasone Nasal Sprays in Nasal Poplyposis

Unknown status·TTehran University of Medical Sciences·Phase 3·NCT02665806·32 enrolled

Effectiveness1 trial

Dupilumab Versus Topical Corticosteroid Effectiveness - Comparison in the Treatment of Stenotic EoE

Recruiting·UUniversity of Colorado, Denver·Phase 2·NCT06705387·72 enrolled

Allergic Conjunctivitis1 trial

A Comparison of Olopatadine and Fluticasone in Patients With Allergic Conjunctivitis

Completed·GGreiner, Jack V., OD DO PhD·Phase 4·NCT00655109·60 enrolled

Dendritic Cell1 trial

Impact of Fluticasone and Salmeterol on Airway Dendritic Cells (DCs) in Smokers

Completed·UUniversity of Rostock·Phase 1·NCT00908362·45 enrolled

Bronchiolitis Obliterans1 trial

BElumosudil for Bronchiolitis Obliterans Prevention/Therapy (BEBOP)

Recruiting·—·Phase 2·NCT05922761·45 enrolled

Budesonide1 trial

Study to Evaluate Efficacy/Safety of Combination Budesonide/Indacaterol vs Fluticasone/Salmeterol in Patients With COPD

Completed· Novartis logo

Novartis·Phase 4·NCT02055352·222 enrolled

Tics1 trial

A Study Designed to Determine if the Drugs Albuterol (Salbutamol) and Fluticasone Have an Effect on the Pharmacokinetics of the Investigational Product Technosphere® Insulin Inhalation Powder in Healthy Volunteers

Completed·MMannkind Corporation·Phase 1·NCT00674050·13 enrolled

Chronic Obstructive Pulmonary Disease1 trial

Exercise Study in Patient With Chronic Obstructive Pulmonary Disease (0000-036)

Terminated· Merck & Co. logo

Merck & Co.·Phase 2·NCT00387036·12 enrolled

Atopic Asthma1 trial

A Study to Assess the Effect of QAW039 in Non-atopic Asthmatic Patients

Completed· Novartis logo

Novartis·Phase 2·NCT01836471·345 enrolled

Atopic Dermatitis1 trial

Efficacy Study of Topical Twice Weekly Fluticasone Treatment to Reduce Relapse in Atopic Dermatitis in Children

Terminated·EElena Rubio Gomis·Phase 3·NCT01772056·54 enrolled

Outcome1 trial

Modification Of Disease Outcome In COPD

Terminated·LLeiden University Medical Center·Phase 4·NCT00158847·200 enrolled

Pediatric1 trial

Steroids for Pediatric Apnea Research in Kids

Completed·—·Phase 3·NCT02180672·211 enrolled

Sinusitis1 trial

Radiologic Scoring of Patients With Chronic Sinusitis and Nasal Polyps

Unknown status·—·N/A·NCT03174483·60 enrolled

Corticosteroids1 trial

Step-up Yellow Zone Inhaled Corticosteroids to Prevent Exacerbations

Completed·MMilton S. Hershey Medical Center·Phase 3·NCT02066129·254 enrolled

Steroid1 trial

Comparison of Nasal Steroids After FESS in CRSwNP

Completed·YYale University·N/A·NCT02194062·32 enrolled

Efficacy and Safety1 trial

Efficacy and Safety Comparison of Steroid or Placebo in Combination With Salmeterol and Tiotropium in COPD

Completed· Boehringer Ingelheim logo

Boehringer Ingelheim·Phase 2·NCT00535366·103 enrolled

Allergic Asthma1 trial

Efficacy and Safety of Omalizumab in Children (6 - < 12 Years) With Moderate-severe, Inadequately Controlled Allergic Asthma

Completed· Novartis logo

Novartis·Phase 3·NCT00079937·628 enrolled

Recurrent1 trial

Management of Recurrent Croup

Terminated·UUniversity of Michigan·Phase 3·NCT01748162·10 enrolled

Montelukast1 trial

Effects of Intranasal Corticosteroid and Montelukast On Nasal Allergen Challenges*

Completed·—·N/A·NCT01240889·60 enrolled

CHOP1 trial

MethaCholine Bronchoprovocation Study (MeCIS)

Completed·JJohns Hopkins Bloomberg School of Public Health·Phase 4·NCT00705341·219 enrolled

Regulatory

FDA Approval Timeline[5]

Dec 14, 1990

CUTIVATE

NDA NDA019957

Dec 18, 1990

CUTIVATE

NDA NDA019958

Oct 19, 1994

FLONASE

NDA NDA020121

Mar 27, 1996

FLOVENT

NDA NDA020548

Nov 7, 1997

FLOVENT

NDA NDA020549

Sep 29, 2000

FLOVENT DISKUS 100

NDA NDA020833

May 14, 2004

FLOVENT HFA

NDA NDA021433

Mar 31, 2005

CUTIVATE

NDA NDA021152

Jul 23, 2014

FLONASE ALLERGY RELIEF

NDA NDA205434

Aug 2, 2016

FLONASE SENSIMIST ALLERGY RELIEF

NDA NDA022051

Sep 18, 2017

XHANCE

NDA NDA209022

May 17, 2018

ARNUITY ELLIPTA

NDA NDA205625

Apr 8, 2022

ARMONAIR DIGIHALER

NDA NDA208798

Sources

References

[1]
ClinicalTrials.gov — 58 trial records for Fluticasone. U.S. National Library of Medicine, National Institutes of Health.
[2]
MedlinePlus Drug Information — Flovent drug information. U.S. National Library of Medicine, National Institutes of Health.
[3]
ChEMBL — Fluticasone compound record. European Bioinformatics Institute (EMBL-EBI).
[4]
Open Targets Platform — Drug–disease associations for Fluticasone. EMBL-EBI & Wellcome Sanger Institute.
[5]
OpenFDA — FDA approval records (NDA NDA208798). U.S. Food & Drug Administration.
[6]
FDA Orange Book — Patent and exclusivity data for Flovent. U.S. Food & Drug Administration.
[7]
SEC EDGAR — Paratek Pharmaceuticals Inc company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Modality: Small molecule[3]
Highest Phase: Approved[1]
Company: PParatek Pharmaceuticals Inc

Patent Landscape[6]

Patent Cliff

Jul 15, 2028

Earliest patent expiration — generic entry possible after this date

Patent #Expires

7500444Feb 26, 2026

8062264Apr 5, 2026

7500444*PEDAug 26, 2026

8347879Jul 15, 2028

8147461Oct 15, 2028

5 more patents

12083270Apr 4, 2031

10918816Dec 14, 2035

12616806Feb 23, 2036

11554229Feb 23, 2036

11344685Sep 26, 2039

Flovent

Status by Indication[4][1]

Competitive Landscape

Expected Milestones

Q1 2027

Q4 2027

Trials by Indication[1]

Asthma14 trials

Eosinophilic Esophagitis5 trials

Salmeterol3 trials

Rhinitis2 trials

Drug2 trials

Allergic Rhinitis2 trials

COVID-192 trials

Patient Preference2 trials

Endothelial Dysfunction1 trial

Drug Repurposing1 trial

EoE1 trial

Systemic Inflammation1 trial

Psoriasis1 trial

Single Dose1 trial

CLE1 trial

Effectiveness1 trial

Allergic Conjunctivitis1 trial

Dendritic Cell1 trial

Bronchiolitis Obliterans1 trial

Budesonide1 trial

Tics1 trial

Chronic Obstructive Pulmonary Disease1 trial

Atopic Asthma1 trial

Atopic Dermatitis1 trial

Outcome1 trial

Pediatric1 trial

Sinusitis1 trial

Corticosteroids1 trial

Steroid1 trial

Efficacy and Safety1 trial

Allergic Asthma1 trial

Recurrent1 trial

Montelukast1 trial

CHOP1 trial

FDA Approval Timeline[5]

References

Drug Info

Quick Facts

Patent Landscape[6]

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