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Drug

Fluticasone propionate

Approved · FDA
Emerging researchLate-stage development
Also known as Advair, AirDuo, Aller-Flo, Armonair+12 more

Advair, AirDuo, Aller-Flo, Armonair, Beser, Clarispray, Cutivate, Dymista, Flonase, Flonase Sensimist, Flovent, Fluticare, Fluticasone, Nasopro 24, Wixela, Xhance.

RxNorm50121ChEMBLCHEMBL1473UNIIO2GMZ0LF5W
3
Research papers
7
Active clinical trials
10
Regulatory events
Latest activity
beta

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

Approval: FLUTICASONE PROPIONATE AND SALMETEROL (ANDA213087)

Regulatory2026-07-27FDA

Evaluation Of The Adjunctive Effects Of Moxibustion In The Treatment Of Cold-Syndrome Allergic Rhinitis

Clinical trial2026-07-10Results expected Q3 2026 · ClinicalTrials.gov

A Proof-of-Concept Study of a Novel Method for Removal of Residual Oropharyngeal Inhaled Corticosteroid Deposits in Asthma

Clinical trial2026-07-01Results expected Q2 2027 · ClinicalTrials.gov

An Open-Label, Phase 2 Study to Evaluate the Activity of Belumosudil in Subjects With New Onset and Incipient Bronchiolitis Obliterans Syndrome Following Allogeneic Hematopoietic Cell Transplantation

Clinical trial2026-06-10Results expected Q2 2027 · ClinicalTrials.gov

Biologics and Blistering - Using a Contact Dermatitis Model With Biologic Medications to Study Skin Inflammation Through Suction Blistering

Clinical trial2026-06-09Results expected Q1 2027 · ClinicalTrials.gov

A Randomized, Open-labelled Bronchoscopy Study to Assess the Effects of Inhaled Corticosteroids (ICS) on Adult Healthy Volunteers

Clinical trial2026-03-02Results expected Q4 2026 · ClinicalTrials.gov

Label change: FLUTICASONE PROPIONATE (NDA205434)

Regulatory2025-12-19FDA

Label change: FLUTICASONE PROPIONATE (NDA205434)

Regulatory2025-01-10FDA

Label change: FLUTICASONE PROPIONATE (NDA205434)

Regulatory2024-10-24FDA

Comparison of systemic pharmacodynamic effects of two combination pressurized metered dose inhalers that deliver salmeterol and fluticasone propionate.

Research2017-08-01British journal of clinical pharmacology

Treatment effects of low-dose theophylline combined with an inhaled corticosteroid in COPD.

Research2010-03-18Chest

Step-up therapy for children with uncontrolled asthma receiving inhaled corticosteroids.

Research2010-03-02The New England journal of medicine

Profile

Identifiers & mechanism

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

Canonical name
Fluticasone propionate
Aliases & brands
AdvairAirDuoAller-FloArmonairBeserClarisprayCutivateDymistaFlonaseFlonase SensimistFloventFluticareFluticasoneNasopro 24WixelaXhance
RxNorm CUI
50121
ChEMBL ID
CHEMBL1473
UNII
O2GMZ0LF5W
Regulatory jurisdictions
fda

Regulatory timeline

10 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
2014-07-23
Latest approval
2026-07-27
Authorities
FDA
Total events
10
fdaU.S. Food and Drug Administration· 10 events
2026-07-27Approval
Approval: FLUTICASONE PROPIONATE AND SALMETEROL (ANDA213087)
Evidence ↗
2025-12-19Label change
Label change: FLUTICASONE PROPIONATE (NDA205434)
Evidence ↗
2025-01-10Label change
Label change: FLUTICASONE PROPIONATE (NDA205434)
Evidence ↗

Data from the U.S. Food and Drug Administration (U.S. Food and Drug Administration), public domain (CC0).

Clinical trials

164 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
164
registered trials across all phases
LATEST COMPLETION 2024
7
Active studies
3
Recruiting
111
Late-stage (III+)
129
Completed
28
Discontinued
PHASE DISTRIBUTIONn = 164
Early Phase 11Phase 117Phase 235Phase 2 / 35Phase 344Phase 447Phase N / A15

Late-stage studies

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

A Proof-of-Concept Study of a Novel Method for Removal of Residual Oropharyngeal Inhaled Corticosteroid Deposits in Asthma

Not yet recruitingPH IVUniversity of Wisconsin, Madisonn=202027

A Randomized, Open-labelled Bronchoscopy Study to Assess the Effects of Inhaled Corticosteroids (ICS) on Adult Healthy Volunteers

Active, not recruitingPH IVUniversity Hospitals, Leicestern=302026

Effectiveness of Cycling of Topical Steroid Therapy in Maintaining Clinical and Histologic Remission in Eosinophilic Esophagitis

CompletedPH IVUniversity Hospitals Cleveland Medical Centern=232023

Randomized Controlled Trial Comparing Fluticasone Plus Omeprazole With Fluticasone Alone for Eosinophilic Esophagitis

Unknown statusPH IVClaire Danielsn=1002022

A Single-Center, Randomized, Double-Masked, Parallel Study Comparing the Efficacy of Pataday® Once Daily Relief Extra Strength to Flonase® Allergy Relief in Reducing Ocular Itching in Subjects With Allergic Conjunctivitis

CompletedPH IVAndover Research Eye Instituten=612022

Recent completions

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

ACTIV-6: COVID-19 Outpatient Randomized Trial to Evaluate Efficacy of Repurposed Medications

CompletedPH IIIKey trialSusanna Naggie, MDn=10,9562024

Effectiveness of Cycling of Topical Steroid Therapy in Maintaining Clinical and Histologic Remission in Eosinophilic Esophagitis

CompletedPH IVUniversity Hospitals Cleveland Medical Centern=232023

A Single-Center, Randomized, Double-Masked, Parallel Study Comparing the Efficacy of Pataday® Once Daily Relief Extra Strength to Flonase® Allergy Relief in Reducing Ocular Itching in Subjects With Allergic Conjunctivitis

CompletedPH IVAndover Research Eye Instituten=612022

ACTIV-6: COVID-19 Outpatient Randomized Trial to Evaluate Efficacy of Repurposed Medications

CompletedPH IIIKey trialSusanna Naggie, MDn=1,4072022

Prospective, Comparative, Double-blind, Parallel, Multicentric, Randomized Study Between Two Brands of Fluticasone Propionate Nasal Topic in The Control of Perene Allergic Rhinithis Symptoms

CompletedPH IIILibbs Farmacêutica LTDAn=5662020

Evaluating Factors Involved in Dymista's Superior Clinical Efficacy to Fluticasone Propionate in the Treatment of Seasonal Allergic Rhinitis

CompletedPH IVUniversity of Chicagon=222020

Research activity

3 papers

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

Publications over time
20102017
Journals, researchers & institutions
Top journals
  • British journal of clinical pharmacology1
  • Chest1
  • The New England journal of medicine1
Leading researchers
  • Adcock IM1
  • Bacharier LB1
  • Barnes PJ1
  • Boehmer SJ1
  • Chalmers D1
  • Covar RA1
  • Durham AL1
  • Efthimiou J1
Leading institutions
free-text, unnormalised
  • Clinical and Biostatistics1
  • Clinical Programme Management1
  • Clinical Research1
  • National Heart and Lung Institute1
  • Quotient Clinical1
  • University of Wisconsin School of Medicine and Public Health1
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.