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BFF MDI (PT009)
BFF MDI (PT009) is a Triple combination inhaled corticosteroid/long-acting beta-2 agonist/long-acting muscarinic antagonist Small molecule drug developed by Pearl Therapeutics, Inc.. It is currently in Phase 3 development for Chronic obstructive pulmonary disease (COPD) maintenance therapy. Also known as: BFF.
BFF MDI is a combination inhaled therapy containing budesonide, formoterol, and glycopyrronium that reduces airway inflammation and improves bronchodilation in chronic obstructive pulmonary disease.
BFF MDI (PT009) is a small molecule medication used to treat Chronic Obstructive Pulmonary Disease (COPD). It is administered via a metered-dose inhaler (MDI) in various formulations, including BGF MDI 320/14.4/9.6 μg, GFF MDI 14.4/9.6 μg, and BGF MDI 160/14.4/9.6 μg.
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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 | BFF MDI (PT009) |
|---|---|
| Also known as | BFF |
| Sponsor | Pearl Therapeutics, Inc. |
| Drug class | Triple combination inhaled corticosteroid/long-acting beta-2 agonist/long-acting muscarinic antagonist |
| Target | Glucocorticoid receptor, beta-2 adrenergic receptor, muscarinic M3 receptor |
| Modality | Small molecule |
| Therapeutic area | Respiratory/Pulmonology |
| Phase | Phase 3 |
Mechanism of action
PT009 combines an inhaled corticosteroid (budesonide) to reduce inflammation, a long-acting beta-2 agonist (formoterol) for bronchodilation, and a long-acting muscarinic antagonist (glycopyrronium) for additional airway relaxation. This triple-therapy approach addresses multiple pathways in COPD pathophysiology through a single maintenance inhaler device.
Approved indications
- Chronic obstructive pulmonary disease (COPD) maintenance therapy
Common side effects
- Tremor
- Headache
- Palpitations
- Oral candidiasis
- Nasopharyngitis
Key clinical trials
- Study to Assess PT010 in Adult and Adolescent Participants With Inadequately Controlled Asthma (KALOS) (PHASE3)
- Study to Assess PT010 in Adult and Adolescent Participants With Inadequately Controlled Asthma (LOGOS) (PHASE3)
- Study to Assess the Safety and Tolerability of PT010, PT009 and PT003 in Subjects With Moderate to Very Severe Chronic Obstructive Pulmonary Disease (PHASE3)
- Study to Assess the Efficacy and Safety of PT010 Relative to PT003 and PT009 in Subjects With Moderate to Very Severe COPD (Ethos) (PHASE3)
- A Randomized, Double-Blind, Parallel-Group, 24-Week, Chronic-Dosing, Multi-Center Study to Assess the Efficacy and Safety of PT010, PT003, and PT009 Compared With Symbicort® Turbuhaler® (Kronos) (PHASE3)
- Study to Assess the Safety and Efficacy of PT010, PT003, and PT009 in Japanese Subjects With COPD Compared With Symbicort® Turbohaler® (PHASE3)
- A Study to Assess the Efficacy and Safety of PT009 Compared to PT005 on COPD Exacerbations Over a 52-Week Period in Subjects With Moderate to Very Severe COPD (Sophos) (PHASE3)
- Study to Assess Efficacy and Safety of PT009 Compared to PT005, PT008, and Symbicort® Turbuhaler® on Lung Function Over 24-Weeks in Subjects With Moderate to Very Severe COPD (PHASE3)
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:
- BFF MDI (PT009) CI brief — competitive landscape report
- BFF MDI (PT009) updates RSS · CI watch RSS
- Pearl Therapeutics, Inc. portfolio CI
Frequently asked questions about BFF MDI (PT009)
What is BFF MDI (PT009)?
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Related
- Drug class: All Triple combination inhaled corticosteroid/long-acting beta-2 agonist/long-acting muscarinic antagonist drugs
- Target: All drugs targeting Glucocorticoid receptor, beta-2 adrenergic receptor, muscarinic M3 receptor
- Manufacturer: Pearl Therapeutics, Inc. — full pipeline
- Therapeutic area: All drugs in Respiratory/Pulmonology
- Indication: Drugs for Chronic obstructive pulmonary disease (COPD) maintenance therapy
- Also known as: BFF
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing