{"id":"macitentan-tadalafil-fdc","safety":{"commonSideEffects":[{"rate":null,"effect":"Headache"},{"rate":null,"effect":"Flushing"},{"rate":null,"effect":"Nasal congestion"},{"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 hypertension. Tadalafil is a phosphodiesterase-5 inhibitor that increases cyclic GMP levels, promoting smooth muscle relaxation and vasodilation. Together, these complementary mechanisms address multiple pathways in pulmonary arterial hypertension pathophysiology.","oneSentence":"This fixed-dose combination blocks endothelin-1 receptors (via macitentan) to reduce pulmonary vascular resistance while simultaneously inhibiting phosphodiesterase-5 (via tadalafil) to promote vasodilation in the pulmonary circulation.","_ai_confidence":"medium"},"_scrapedAt":"2026-03-28T00:49:43.012Z","_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":0,"rwe":[],"genericFilers":[],"relatedDrugs":[],"labelChanges":[],"biosimilarFilings":[],"pricing":[],"formularyStatus":[],"manufacturing":[],"companionDiagnostics":[],"competitors":[],"timeline":[],"patents":[],"ownershipHistory":[],"trials":[],"biosimilars":[],"latestUpdates":[],"references":[],"tags":[],"ecosystem":[],"genericManufacturerList":[],"offLabel":[],"developmentCodes":[],"aliases":["JNJ-68150420"],"phase":"phase_3","status":"active","brandName":"Macitentan/Tadalafil FDC","genericName":"Macitentan/Tadalafil FDC","companyName":"Actelion","companyId":"actelion","modality":"Small molecule","firstApprovalDate":"","aiSummary":"Macitentan/Tadalafil FDC is a fixed-dose combination of two drugs, macitentan and tadalafil, which are used to treat Pulmonary Arterial Hypertension (PAH). Macitentan works as an endothelin receptor antagonist, specifically targeting the ET-A/ET-B receptors, while tadalafil's mechanism is not specified in the provided facts.","enrichmentLevel":3,"visitCount":0,"trialStats":{"total":0,"withResults":0},"verificationStatus":"verified","dataCompleteness":{"mechanism":true,"indications":true,"safety":true,"trials":true,"score":4}}