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GP MDI (PT001)
PT001 is a combination inhaled corticosteroid and long-acting beta-2 agonist delivered via metered-dose inhaler for maintenance treatment of asthma and COPD.
PT001 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 Maintenance treatment of asthma, Maintenance treatment of chronic obstructive pulmonary disease (COPD).
At a glance
| Generic name | GP MDI (PT001) |
|---|---|
| Also known as | Glycopyrronium Metered Dose Inhaler (GP MDI; PT001); Glycopyrronium Inhalation Aerosol, glycopyrrolate metered dose inhaler (GP MDI) |
| Sponsor | Pearl Therapeutics, Inc. |
| Drug class | Inhaled corticosteroid/long-acting beta-2 agonist combination |
| Target | Glucocorticoid receptor; beta-2 adrenergic receptor |
| Modality | Small molecule |
| Therapeutic area | Respiratory/Pulmonology |
| Phase | Phase 3 |
Mechanism of action
GP MDI combines a corticosteroid (for anti-inflammatory effects) with a long-acting beta-2 agonist (for bronchodilation) in a single inhaler device. This dual mechanism reduces airway inflammation and improves airflow, providing both immediate and sustained symptom relief in obstructive airway diseases.
Approved indications
- Maintenance treatment of asthma
- Maintenance treatment of chronic obstructive pulmonary disease (COPD)
Common side effects
- Tremor
- Headache
- Palpitations
- Oral candidiasis
- Dysphonia
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 (PT001) CI brief — competitive landscape report
- GP MDI (PT001) updates RSS · CI watch RSS
- Pearl Therapeutics, Inc. portfolio CI