{"id":"gp-mdi-pt001","safety":{"commonSideEffects":[{"rate":null,"effect":"Tremor"},{"rate":null,"effect":"Headache"},{"rate":null,"effect":"Palpitations"},{"rate":null,"effect":"Oral candidiasis"},{"rate":null,"effect":"Dysphonia"}]},"_chembl":null,"_dailymed":null,"mechanism":{"_ai_source":"claude-haiku-4.5","explanation":"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.","oneSentence":"PT001 is a combination inhaled corticosteroid and long-acting beta-2 agonist delivered via metered-dose inhaler for maintenance treatment of asthma and COPD.","_ai_confidence":"medium"},"_scrapedAt":"2026-03-28T01:14:21.492Z","_scrapedBy":"cloudflare-swarm","_wikipedia":null,"indications":{"approved":[{"name":"Maintenance treatment of asthma"},{"name":"Maintenance treatment of chronic obstructive pulmonary disease (COPD)"}]},"trialDetails":[{"nctId":"NCT03358147","phase":"PHASE2, PHASE3","title":"Efficacy and Safety of PT001 to Placebo and Open-label Spiriva® Respimat® in Subjects With Persistant Asthma","status":"COMPLETED","sponsor":"Pearl Therapeutics, Inc.","startDate":"2017-12-13","conditions":"Asthma","enrollment":1077},{"nctId":"NCT02937584","phase":"PHASE3","title":"A Study to Assess the Effects of PT001 and PT005 MDI on Specific Image Based Parameters in Subjects With Moderate to Severe COPD","status":"COMPLETED","sponsor":"Pearl Therapeutics, Inc.","startDate":"2016-12-29","conditions":"COPD, Chronic Obstructive Pulmonary Disease","enrollment":23},{"nctId":"NCT02343458","phase":"PHASE3","title":"Study to Assess the Efficacy and Safety of PT003, PT005, and PT001 in Subjects With Moderate to Very Severe COPD","status":"COMPLETED","sponsor":"Pearl Therapeutics, Inc.","startDate":"2015-03-30","conditions":"Chronic Obstructive Pulmonary Disease","enrollment":1756},{"nctId":"NCT03256552","phase":"PHASE2","title":"Study to Assess the Efficacy and Safety of Three Doses of PT001 in Japanese Subjects With Moderate to Severe COPD","status":"COMPLETED","sponsor":"Pearl Therapeutics, Inc.","startDate":"2015-01-28","conditions":"Chronic Obstructive Pulmonary Disease","enrollment":66},{"nctId":"NCT02433834","phase":"PHASE2","title":"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","status":"COMPLETED","sponsor":"Pearl Therapeutics, Inc.","startDate":"2015-05-27","conditions":"Asthma","enrollment":248},{"nctId":"NCT02196714","phase":"PHASE1","title":"PK Study of PT003 and PT001 in Japanese Healthy Subjects","status":"COMPLETED","sponsor":"Pearl Therapeutics, Inc.","startDate":"2014-07","conditions":"COPD","enrollment":24},{"nctId":"NCT01854645","phase":"PHASE3","title":"Efficacy and Safety of PT003, PT005, and PT001 in Subjects With Moderate to Very Severe Chronic Obstructive Pulmonary Disease (COPD); (PINNACLE 1)","status":"COMPLETED","sponsor":"Pearl Therapeutics, Inc.","startDate":"2013-05","conditions":"Chronic Obstructive Pulmonary Disease","enrollment":2103},{"nctId":"NCT01854658","phase":"PHASE3","title":"Multi-Center Study to Assess the Efficacy and Safety of PT003, PT005, and PT001 in Subjects With Moderate to Very Severe COPD (PINNACLE 2)","status":"COMPLETED","sponsor":"Pearl Therapeutics, Inc.","startDate":"2013-07","conditions":"Chronic Obstructive Pulmonary Disease (COPD)","enrollment":1615},{"nctId":"NCT01970878","phase":"PHASE3","title":"Extension Study to Evaluate the Safety and Efficacy of PT003, PT001, and PT005 in Subjects With Moderate to Very Severe COPD, With Spiriva® Handihaler® (PINNACLE 3)","status":"COMPLETED","sponsor":"Pearl Therapeutics, Inc.","startDate":"2013-11","conditions":"Chronic Obstructive Pulmonary Disease (COPD)","enrollment":892}],"_emaApprovals":[],"_faersSignals":[],"_approvalHistory":[],"publicationCount":1,"rwe":[],"genericFilers":[],"relatedDrugs":[],"labelChanges":[],"biosimilarFilings":[],"pricing":[],"formularyStatus":[],"manufacturing":[],"companionDiagnostics":[],"competitors":[],"timeline":[],"patents":[],"ownershipHistory":[],"trials":[],"biosimilars":[],"latestUpdates":[],"references":[],"tags":[],"ecosystem":[],"genericManufacturerList":[],"offLabel":[],"developmentCodes":[],"aliases":["Glycopyrronium Metered Dose Inhaler (GP MDI; PT001); Glycopyrronium Inhalation Aerosol","glycopyrrolate metered dose inhaler (GP MDI)"],"phase":"phase_3","status":"active","brandName":"GP MDI (PT001)","genericName":"GP MDI (PT001)","companyName":"Pearl Therapeutics, Inc.","companyId":"pearl-therapeutics-inc","modality":"Small molecule","firstApprovalDate":"","aiSummary":"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).","enrichmentLevel":3,"visitCount":0,"trialStats":{"total":0,"withResults":0},"verificationStatus":"verified","dataCompleteness":{"mechanism":true,"indications":true,"safety":true,"trials":true,"score":4}}