Year
DEALS // DEV.
Country
Therapeutic Area
Study Phase
Deal Type
Product Type
Dosage Form
Lead Product
Target
Lead Product(s) : Macitentan,Tadalafil
Therapeutic Area : Cardiology/Vascular Diseases
Study Phase : Approved
Sponsor : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
European Commission Approves Yuvanci® for Patients with Pulmonary Arterial Hypertension
Details : Yuvanci (macitentan, tadalafil) is an FDC available as a film coated tablet, for the treatment of pulmonary arterial hypertension in adults, works by inhibiting endothelin receptor & PDE5 inhibitor.
Brand Name : Yuvanci
Molecule Type : Small molecule
Upfront Cash : Not Applicable
September 30, 2024
Lead Product(s) : Macitentan,Tadalafil
Therapeutic Area : Cardiology/Vascular Diseases
Highest Development Status : Approved
Sponsor : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
Lead Product(s) : Macitentan,Tadalafil
Therapeutic Area : Cardiology/Vascular Diseases
Study Phase : Approved
Sponsor : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
J&J Receives Positive CHMP Opinion for Yuvanci® in Pulmonary Arterial Hypertension
Details : Yuvanci (macitentan, tadalafil) is an FDC available as a film coated tablet, for the treatment of pulmonary arterial hypertension in adults, works by inhibiting endothelin receptor & PDE5 inhibitor.
Brand Name : Yuvanci
Molecule Type : Small molecule
Upfront Cash : Not Applicable
July 26, 2024
Lead Product(s) : Macitentan,Tadalafil
Therapeutic Area : Cardiology/Vascular Diseases
Highest Development Status : Approved
Sponsor : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
Lead Product(s) : Macitentan,Tadalafil
Therapeutic Area : Cardiology/Vascular Diseases
Study Phase : Approved
Sponsor : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
FDA Approves OPSYNVI® As First Once-Daily Combination Therapy for PAH
Details : Opsynvi is a combination of macitentan (an endothelin receptor antagonist) and tadalafil (a phosphodiesterase 5 inhibitor), approved for adults with pulmonary arterial hypertension.
Brand Name : Opsynvi
Molecule Type : Small molecule
Upfront Cash : Not Applicable
March 22, 2024
Lead Product(s) : Macitentan,Tadalafil
Therapeutic Area : Cardiology/Vascular Diseases
Highest Development Status : Approved
Sponsor : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
Lead Product(s) : Macitentan,Tadalafil
Therapeutic Area : Cardiology/Vascular Diseases
Study Phase : Phase III
Sponsor : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
Details : ACT-064992D (macitentan/tadalafil ) Tablet act Endothelin A receptor antagonists, macitentan, and the PDE5 inhibitor, tadalafil, used for long-term treatment of PAH in adult patients of WHO Functional Class (FC) II to III.
Brand Name : ACT-064992D
Molecule Type : Small molecule
Upfront Cash : Not Applicable
June 26, 2023
Lead Product(s) : Macitentan,Tadalafil
Therapeutic Area : Cardiology/Vascular Diseases
Highest Development Status : Phase III
Sponsor : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
Lead Product(s) : Macitentan,Tadalafil
Therapeutic Area : Cardiology/Vascular Diseases
Study Phase : Phase III
Sponsor : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
Details : The investigational single tablet combination therapy of ACT-064992D (macitentan) Endothelin A receptor 10mg and tadalafil PDE5 inhibitor 40mg (M/T STCT) for the long-term treatment of pulmonary arterial hypertension.
Brand Name : ACT-064992D
Molecule Type : Small molecule
Upfront Cash : Not Applicable
May 30, 2023
Lead Product(s) : Macitentan,Tadalafil
Therapeutic Area : Cardiology/Vascular Diseases
Highest Development Status : Phase III
Sponsor : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
Lead Product(s) : Macitentan,Tadalafil
Therapeutic Area : Cardiology/Vascular Diseases
Study Phase : Phase III
Sponsor : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
Details : A combination of opsumit (macitentan) and tadalafil is being investigated to improve pulmonary hemodynamics, where opsumit is an ERA antagonist and tadalafil relaxes blood vessels and lowers the blood pressure in lungs, to allow blood to flow more easily...
Brand Name : ACT-064992D
Molecule Type : Small molecule
Upfront Cash : Not Applicable
March 06, 2023
Lead Product(s) : Macitentan,Tadalafil
Therapeutic Area : Cardiology/Vascular Diseases
Highest Development Status : Phase III
Sponsor : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
Lead Product(s) : Macitentan
Therapeutic Area : Cardiology/Vascular Diseases
Study Phase : Approved
Sponsor : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
Alembic Gets US FDA Tentative Nod for Macitentan Tablets
Details : Macitentan tablets are an endothelin receptor antagonist (ERA) indicated for the treatment of pulmonary arterial hypertension (PAH, WHO Group I) to delay disease progression.
Brand Name : Macitentan-Generic
Molecule Type : Small molecule
Upfront Cash : Not Applicable
March 14, 2022
Lead Product(s) : Macitentan
Therapeutic Area : Cardiology/Vascular Diseases
Highest Development Status : Approved
Sponsor : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
Lead Product(s) : Macitentan,Tadalafil
Therapeutic Area : Cardiology/Vascular Diseases
Study Phase : Approved
Sponsor : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
Details : Health Canada approved OPSYNVI® (macitentan 10mg and tadalafil 40mg) for long-term treatment of pulmonary arterial hypertension. Macitentan is antagonist/blocker of endothelin receptors on blood vessels and smooth muscle, and tadalafil is a selective in...
Brand Name : Opsynvi
Molecule Type : Small molecule
Upfront Cash : Not Applicable
October 15, 2021
Lead Product(s) : Macitentan,Tadalafil
Therapeutic Area : Cardiology/Vascular Diseases
Highest Development Status : Approved
Sponsor : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
Lead Product(s) : Selexipag,Macitentan,Tadalafil
Therapeutic Area : Cardiology/Vascular Diseases
Study Phase : Phase III
Sponsor : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
TRITON Phase 3b Study Results Presented at the European Society of Cardiology Congress
Details : While the primary endpoint was not met, exploratory analysis suggests a signal of reduced risk of disease progression of initial triple oral combination therapy vs initial double oral therapy for Pulmonary Arterial Hypertension (PAH) patients .
Brand Name : Uptravi
Molecule Type : Small molecule
Upfront Cash : Not Applicable
August 29, 2020
Lead Product(s) : Selexipag,Macitentan,Tadalafil
Therapeutic Area : Cardiology/Vascular Diseases
Highest Development Status : Phase III
Sponsor : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
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