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Flonase (fluticasone propionate)
Fluticasone (Flonase/Flovent) is one of the most prescribed corticosteroids, developed by GSK and approved in 1994. Available OTC as a nasal spray for allergies and as a prescription inhaler for asthma. Available generically.
At a glance
| Generic name | fluticasone propionate |
|---|---|
| Also known as | Flonase, Flovent, Cutivate, Arnuity |
| Sponsor | GSK (GlaxoSmithKline) |
| Drug class | Inhaled/intranasal corticosteroid |
| Target | Cytosolic phospholipase A2, Glucocorticoid receptor, Mineralocorticoid receptor |
| Modality | Small molecule |
| Therapeutic area | Oncology |
| Phase | FDA-approved |
| First approval | 1994-11-04 (United States) |
Approved indications
- Allergic asthma
- Allergic rhinitis
- Asthma management
- Atopic dermatitis
- Bronchospasm Prevention with COPD
- COPD Associated with Chronic Bronchitis
- Chronic Non-Allergic Rhinitis
- Contact dermatitis
- Discoid lupus erythematosus
- Eruption of skin
- Granuloma annulare
- Lichen simplex chronicus
- Non-allergic asthma
- Plaque psoriasis
- Primary cutaneous T-cell lymphoma
- Pruritus ani
- Pruritus of genital organs
- Pulmonary emphysema
- Scalp psoriasis
- Seborrheic dermatitis
Common side effects
- Ear, nose, and throat adverse events
- Tremor
- Nervousness
- Palpitations
- Muscle cramps
- Headache
- Tachycardia
- Gastrointestinal upset
- Hypokalemia
- Arrhythmias
- Muscle stiffness and rigidity
- Lower respiratory symptoms
Serious adverse events
- Pneumonia
- Bacterial infections
- Hepatic enzyme elevation
- Keratitis and conjunctivitis
- Fractures
- Compressed nerve syndromes
- Bone and cartilage disorders
- Wounds and lacerations
- Contusions and hematomas
- Throat irritation
Key clinical trials
- Erdosteine Effect on Oxidative Stress, Inflammatory Response and Immune Modulation in Patients With COPD. A Single Center, Open Label, Double Arm, Controlled, 4-week, Explorative, ex Vivo Study." (NA)
- Phase 3, Multicenter, Randomized, Parallel-group, Open-label, Non-inferiority Study of N0783 Versus Comparator (Formoterol 6 mcg / Budesonide 200 mcg) in the Treatment of Moderate Asthma (Phase 3)
- A 26-Week Open-Label Study to Assess the Long-Term Safety of Fluticasone Propionate Multidose Dry Powder Inhaler and Fluticasone Propionate/Salmeterol Multidose Dry Powder Inhaler in Patients 12 Years (Phase 3)
- An Exploratory Study to Evaluate the Response of Salmeterol Plus Fluticasone vs Fluticasone Alone to Experimental Nasal Inoculation With Rhinovirus (Phase 4)
- A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Multicenter Study to Evaluate the Efficacy and Safety of Once-Daily Intranasal Administration of Fluticasone Furoate Nasal Spray 110mcg (Phase 4)
- Effects of Treated and Untreated Allergic Rhinitis on Mood, Cognitive Functions and Actual Driving Performance (NA)
- A Six-Week, Randomized, Double-Blind, Quadruple-Dummy Parallel Group Multiple Dose Study Comparing the Efficacy and Safety of Tiotropium Inhalation Capsules Plus Formoterol Inhalation Capsules to Salm (Phase 4)
- An Open-Label, Crossover Study to Determine the Pharmacokinetic Profile and Tolerability of Single Doses of High Strength Fluticasone Propionate Multidose Dry Powder Inhaler and Fluticasone Propionate (Phase 1)
Patents
| Patent | Expiry | Type |
|---|---|---|
| 11554229 | 2036-02-23 | Method of Use |
| 12083270 | 2031-04-04 | Method of Use |
| 11344685 | 2039-09-26 | Formulation |
| 10195375 | 2031-02-14 | Formulation |
| 7500444 | 2026-02-26 | Formulation |
| 11969544 | 2039-08-20 | Formulation |
| 10918816 | 2035-12-14 | Formulation |
| 11173259 | 2040-07-06 | Formulation |
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| FDA label | Mechanism, indications, dosing, boxed warnings, drug interactions |
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
| FDA Orange Book | Patents + exclusivity |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- Flonase CI brief — competitive landscape report
- Flonase updates RSS · CI watch RSS
- GSK (GlaxoSmithKline) portfolio CI