Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as Macitentan
macitentan/tadalafil · 1 trial · 1 indication
Change in PVR expressed as the ratio of geometric means of EDBT to baseline were reported.
| Arm | Type | Description |
|---|---|---|
| FDC therapy + Placebo macitentan + Placebo tadalafil | EXPERIMENTAL | Subjects to receive FDC macitentan/tadalafil (macitentan 10 mg and tadalafil 40 mg) plus matching placebos for the two other study treatments. |
| Macitentan mono-therapy + Placebo tadalafil + Placebo FDC | ACTIVE_COMPARATOR | Subjects to receive macitentan 10 mg plus matching placebos for the two other study treatments. |
| Tadalafil mono-therapy + Placebo macitentan + Placebo FDC | ACTIVE_COMPARATOR | Subjects to receive tadalafil 40 mg (2 x 20 mg) plus matching placebos for the two other study treatments. |
| Name | Type | Description |
|---|---|---|
| FDC macitentan/tadalafil | DRUG | Film-coated tablet with 10 mg macitentan and 40 mg tadalafil, to be administered orally once daily. |
| Macitentan 10 mg | DRUG | Film-coated tablet with 10 mg macitentan, to be administered orally once daily. |
| Tadalafil 40 mg | DRUG | Film-coated tablet with 40 mg tadalafil (2 x 20 mg tablets), to be administered orally once daily. |
| Placebo FDC | DRUG | Matching placebo not containing any active substance but otherwise identical in appearance to the respective active drug tablet, to be administered orally once daily. |
| Placebo macitentan | DRUG | Matching placebo not containing any active substance but otherwise identical in appearance to the respective active drug tablet, to be administered orally once daily. |
| Placebo tadalafil | DRUG | Matching placebo not containing any active substance but otherwise identical in appearance to the respective active drug tablet, to be administered orally once daily. |
Inclusion Criteria: * Signed and dated informed consent form (ICF) * Confirmed diagnosis of symptomatic PAH in WHO FC II or III * Symptomatic PAH belonging to one of the following subgroups of WHO Group 1 pulmonary hypertension: * Idiopathic * Heritable * Drug- or toxin-induced * Associate...
Macitentan is an investigational small molecule being studied for systemic sclerosis, pulmonary arterial hypertension (PAH, WHO Group 1 PH), congenital heart disease, and heart failure with preserved ejection fraction. It is also used in clinical trials involving healthy subjects. The drug is in Phase 2 development for these indications.
Macitentan is a small molecule being developed for cardiovascular conditions. It is being studied in patients with pulmonary arterial hypertension and heart failure with preserved ejection fraction. The drug's specific molecular target is not disclosed in the available information.
Macitentan is developed by Johnson & Johnson, a company traded on the New York Stock Exchange under the ticker JNJ. The drug is currently in Phase 2 clinical development for cardiovascular indications.
Macitentan is in Phase 2 clinical development. It is an investigational drug and has not been approved by regulatory authorities. The drug is being studied for systemic sclerosis, pulmonary arterial hypertension, congenital heart disease, and heart failure with preserved ejection fraction.
Macitentan has been studied in 10 clinical trials with a total enrollment of 3,395 participants. One trial is active, and nine are completed. Notable trials include NCT04273945, a Phase 3 study of a 75 mg dose in pulmonary arterial hypertension, and NCT03153111, a Phase 2 study in heart failure with preserved ejection fraction.
Yes, Macitentan is also known as Macitentan 10 mg. This alternative name refers to the 10 mg dosage form of the drug. The drug is being developed by Johnson & Johnson under the ticker JNJ.