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GP MDI
GP MDI is a combination inhaled corticosteroid and long-acting beta-2 agonist delivered via metered-dose inhaler for maintenance treatment of asthma and COPD.
GP MDI is a combination inhaled corticosteroid and long-acting beta-2 agonist delivered via metered-dose inhaler for maintenance treatment of asthma and COPD. Used for Asthma maintenance treatment, Chronic obstructive pulmonary disease (COPD) maintenance treatment.
At a glance
| Generic name | GP MDI |
|---|---|
| Sponsor | Pearl Therapeutics, Inc. |
| Drug class | Inhaled corticosteroid/long-acting beta-2 agonist combination |
| Target | Beta-2 adrenergic receptor and glucocorticoid receptor |
| Modality | Small molecule |
| Therapeutic area | Respiratory/Pulmonology |
| Phase | Phase 3 |
Mechanism of action
The drug combines a glucocorticoid (corticosteroid) that reduces airway inflammation with a long-acting beta-2 agonist (LABA) that provides bronchodilation. This dual mechanism addresses both the inflammatory and obstructive components of obstructive airway diseases, allowing sustained improvement in lung function and symptom control.
Approved indications
- Asthma maintenance treatment
- Chronic obstructive pulmonary disease (COPD) maintenance treatment
Common side effects
- Tremor
- Headache
- Palpitations
- Oral candidiasis
- Hoarseness
Key clinical trials
- Efficacy and Safety of PT001 to Placebo and Open-label Spiriva® Respimat® in Subjects With Persistant Asthma (PHASE2, PHASE3)
- A Study to Assess the Effects of PT001 and PT005 MDI on Specific Image Based Parameters in Subjects With Moderate to Severe COPD (PHASE3)
- Study to Assess the Efficacy and Safety of PT003, PT005, and PT001 in Subjects With Moderate to Very Severe COPD (PHASE3)
- Study to Assess the Efficacy and Safety of Three Doses of PT001 in Japanese Subjects With Moderate to Severe COPD (PHASE2)
- Chronic Dosing Cross-Over Study to Assess the Efficacy and Safety of Glycopyrronium (PT001) in Adult Subjects With Intermittent Asthma or Mild to Moderate Persistent Asthma (PHASE2)
- PK Study of PT003 and PT001 in Japanese Healthy Subjects (PHASE1)
- Efficacy and Safety of PT003, PT005, and PT001 in Subjects With Moderate to Very Severe Chronic Obstructive Pulmonary Disease (COPD); (PINNACLE 1) (PHASE3)
- Multi-Center Study to Assess the Efficacy and Safety of PT003, PT005, and PT001 in Subjects With Moderate to Very Severe COPD (PINNACLE 2) (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:
- GP MDI CI brief — competitive landscape report
- GP MDI updates RSS · CI watch RSS
- Pearl Therapeutics, Inc. portfolio CI