{"id":"fdc-macitentan-tadalafil","safety":{"commonSideEffects":[{"rate":null,"effect":"Headache"},{"rate":null,"effect":"Nasal congestion"},{"rate":null,"effect":"Flushing"},{"rate":null,"effect":"Peripheral edema"},{"rate":null,"effect":"Anemia"}]},"_chembl":null,"_dailymed":null,"mechanism":{"_ai_source":"claude-haiku-4.5","explanation":"Macitentan is an endothelin receptor antagonist that blocks the vasoconstrictive and proliferative effects of endothelin-1 in pulmonary vessels. Tadalafil is a phosphodiesterase-5 inhibitor that increases cyclic GMP, promoting vasodilation and reducing right ventricular afterload. The combination targets complementary pathways in pulmonary hypertension pathophysiology.","oneSentence":"This fixed-dose combination blocks endothelin-1 receptors (via macitentan) and phosphodiesterase-5 (via tadalafil) to reduce pulmonary vascular resistance and improve exercise capacity in pulmonary arterial hypertension.","_ai_confidence":"medium"},"_scrapedAt":"2026-03-28T01:12:20.147Z","_scrapedBy":"cloudflare-swarm","_wikipedia":null,"indications":{"approved":[{"name":"Pulmonary arterial hypertension (PAH)"}]},"trialDetails":[{"nctId":"NCT05179876","phase":"PHASE3","title":"A Study Providing Treatment Access in Participants With Pulmonary Hypertension Completing a Parent Study and Having no Other Option","status":"RECRUITING","sponsor":"Actelion","startDate":"2022-05-04","conditions":"Hypertension, Pulmonary","enrollment":280},{"nctId":"NCT03904693","phase":"PHASE3","title":"Clinical Study to Compare the Efficacy and Safety of Macitentan and Tadalafil Monotherapies With the Corresponding Fixed-dose Combination Therapy in Subjects With Pulmonary Arterial Hypertension (PAH)","status":"COMPLETED","sponsor":"Actelion","startDate":"2019-07-29","conditions":"Pulmonary Arterial Hypertension (PAH) (WHO Group 1 PH)","enrollment":187},{"nctId":"NCT03215966","phase":"PHASE1","title":"A Study to Compare the Macitentan-tadalafil Fixed Dose Combination Tablet Relative to the Concomitant Administration of the Reference Tablets of Macitentan and Tadalafil in Healthy Subjects","status":"COMPLETED","sponsor":"Actelion","startDate":"2017-08-07","conditions":"Healthy Subjects","enrollment":38},{"nctId":"NCT04235270","phase":"PHASE1","title":"A Study of Macitentan and Tadalafil as a Fixed Dose Combination and the Free Combination in Healthy Adult Participants","status":"COMPLETED","sponsor":"Janssen Research & Development, LLC","startDate":"2020-01-17","conditions":"Healthy","enrollment":62},{"nctId":"NCT04540744","phase":"PHASE1","title":"A Study of Macitentan/Tadalafil Combination Administered a Fixed-dose Combination Formulation Compared to the Reference Free Combination of Macitentan and Tadalafil","status":"COMPLETED","sponsor":"Janssen Research & Development, LLC","startDate":"2021-04-30","conditions":"Healthy","enrollment":18},{"nctId":"NCT05236231","phase":"PHASE1","title":"A Study of Fixed Dose Combination of Macitentan/Tadalafil (10 mg/20 mg) Compared to the Reference Free Combination of Macitentan and Tadalafil in Healthy Adult Participants","status":"COMPLETED","sponsor":"Actelion","startDate":"2022-02-04","conditions":"Healthy","enrollment":40}],"_emaApprovals":[],"_faersSignals":[],"_approvalHistory":[],"publicationCount":6,"rwe":[],"genericFilers":[],"relatedDrugs":[],"labelChanges":[],"biosimilarFilings":[],"pricing":[],"formularyStatus":[],"manufacturing":[],"companionDiagnostics":[],"competitors":[],"timeline":[],"patents":[],"ownershipHistory":[],"trials":[],"biosimilars":[],"latestUpdates":[],"references":[],"tags":[],"ecosystem":[],"genericManufacturerList":[],"offLabel":[],"developmentCodes":[],"aliases":["ACT-064992D"],"phase":"phase_3","status":"active","brandName":"FDC macitentan/tadalafil","genericName":"FDC macitentan/tadalafil","companyName":"Actelion","companyId":"actelion","modality":"Small molecule","firstApprovalDate":"","aiSummary":"This fixed-dose combination blocks endothelin-1 receptors (via macitentan) and phosphodiesterase-5 (via tadalafil) to reduce pulmonary vascular resistance and improve exercise capacity in pulmonary arterial hypertension. Used for Pulmonary arterial hypertension (PAH).","enrichmentLevel":3,"visitCount":0,"trialStats":{"total":0,"withResults":0},"verificationStatus":"verified","dataCompleteness":{"mechanism":true,"indications":true,"safety":true,"trials":true,"score":4}}