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Flutiform 250/10 micrograms
Flutiform 250/10 micrograms is a Inhaled corticosteroid/long-acting beta-2 agonist combination (ICS/LABA) Small molecule drug developed by Mundipharma Research Limited. It is currently in Phase 3 development for Asthma maintenance therapy in patients requiring combination inhaled corticosteroid and long-acting beta-2 agonist.
Flutiform combines fluticasone propionate (an inhaled corticosteroid) and formoterol (a long-acting beta-2 agonist) to reduce airway inflammation and improve bronchial smooth muscle relaxation in asthma.
Flutiform combines fluticasone propionate (an inhaled corticosteroid) and formoterol (a long-acting beta-2 agonist) to reduce airway inflammation and improve bronchial smooth muscle relaxation in asthma. Used for Asthma maintenance therapy in patients requiring combination inhaled corticosteroid and long-acting beta-2 agonist.
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Baseline phase 3 → approval rate
+58.3pp
Industry-wide phase 3 drugs reach approval ~58.3% of the time (BIO/Informa 2023 industry benchmark across all therapeutic areas).
| Regulator | Country | Likely year | Lag vs FDA |
|---|---|---|---|
| FDA | US | 2028–2030 | — |
| EMA | EU | 2029–2031 | +0.7 yr |
| MHRA | GB | 2029–2031 | +0.7 yr |
| Health Canada | CA | 2029–2032 | +0.9 yr |
| TGA | AU | 2029–2032 | +1.2 yr |
| PMDA | JP | 2029–2032 | +1.5 yr |
| NMPA | CN | 2030–2033 | +2.3 yr |
| MFDS | KR | 2029–2032 | +1.4 yr |
| CDSCO | IN | 2029–2033 | +1.8 yr |
| ANVISA | BR | 2030–2033 | +2.3 yr |
Hover any row for the lag rationale. Lag estimates are reduced when the drug has FDA Breakthrough or EMA PRIME designation (sponsors file globally in parallel).
Estimate based on the BIO/Informa industry phase transition rates plus per-drug modifiers for therapeutic area, sponsor type, FDA designations, mechanism, and trial design. Per-jurisdiction lags from Tufts CSDD international approval studies. Not investment, clinical or regulatory advice. Methodology: /methodology#likelihood.
At a glance
| Generic name | Flutiform 250/10 micrograms |
|---|---|
| Sponsor | Mundipharma Research Limited |
| Drug class | Inhaled corticosteroid/long-acting beta-2 agonist combination (ICS/LABA) |
| Target | Glucocorticoid receptor; beta-2 adrenergic receptor |
| Modality | Small molecule |
| Therapeutic area | Respiratory/Pulmonology |
| Phase | Phase 3 |
Mechanism of action
Fluticasone propionate binds to glucocorticoid receptors in the airways, suppressing inflammatory mediator release and reducing airway edema and mucus production. Formoterol activates beta-2 adrenergic receptors on bronchial smooth muscle, causing relaxation and bronchodilation. Together, they provide both anti-inflammatory and bronchodilator effects for maintenance asthma control.
Approved indications
- Asthma maintenance therapy in patients requiring combination inhaled corticosteroid and long-acting beta-2 agonist
Common side effects
- Tremor
- Headache
- Palpitations
- Oral candidiasis
- Nervousness/anxiety
Key clinical trials
- Study of FlutiForm® Versus Fluticasone Plus Formoterol in Adult Subjects With Severe Asthma (PHASE3)
- A Study to Show That Flutiform is Well Tolerated and Effective in the Treatment of COPD (PHASE3)
- A Guideline Approach to Therapy Step-down Utilising Flutiform Change and Step-down (PHASE4)
- A Phase 3, Multicenter, Open-label Continuation Study in Moderate to Severe Asthmatic Subjects Who Completed FlutiForm HFA pMDI Study SKY2028-3-005 (PHASE3)
- A Phase I Study in Asthma Patients Evaluating the Effect of Doses of FlutiForm™ on the Amount, if Any, of Cortisol Produced by the Adrenal Glands (PHASE1)
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 |
|---|---|
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- Flutiform 250/10 micrograms CI brief — competitive landscape report
- Flutiform 250/10 micrograms updates RSS · CI watch RSS
- Mundipharma Research Limited portfolio CI
Frequently asked questions about Flutiform 250/10 micrograms
What is Flutiform 250/10 micrograms?
How does Flutiform 250/10 micrograms work?
What is Flutiform 250/10 micrograms used for?
Who makes Flutiform 250/10 micrograms?
What drug class is Flutiform 250/10 micrograms in?
What development phase is Flutiform 250/10 micrograms in?
What are the side effects of Flutiform 250/10 micrograms?
What does Flutiform 250/10 micrograms target?
Related
- Drug class: All Inhaled corticosteroid/long-acting beta-2 agonist combination (ICS/LABA) drugs
- Target: All drugs targeting Glucocorticoid receptor; beta-2 adrenergic receptor
- Manufacturer: Mundipharma Research Limited — full pipeline
- Therapeutic area: All drugs in Respiratory/Pulmonology
- Indication: Drugs for Asthma maintenance therapy in patients requiring combination inhaled corticosteroid and long-acting beta-2 agonist
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing