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.
Product Name : Yuvanci
Product 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 FDF
Sponsor : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
EU Approves Yuvanci for Pulmonary Arterial Hypertension Treatment
Details : Yuvanci (macitentan) is a ETA/ETB inhibitor small molecule drug candidate, which is indicated in combination with tadalafil for the treatment of pulmonary arterial hypertension in adult.
Product Name : Yuvanci
Product Type : Other Small Molecule
Upfront Cash : Inapplicable
September 30, 2024
Lead Product(s) : Macitentan,Tadalafil
Therapeutic Area : Cardiology/Vascular Diseases
Highest Development Status : Approved FDF
Sponsor : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
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.
Product Name : Yuvanci
Product 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.
Product Name : Opsynvi
Product 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.
Product Name : ACT-064992D
Product 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.
Product Name : ACT-064992D
Product 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...
Product Name : ACT-064992D
Product 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.
Product Name : Macitentan-Generic
Product 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...
Product Name : Opsynvi
Product 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) : Macitentan,Cabotegravir,Tadalafil,Rilpivirine
Therapeutic Area : Infections and Infectious Diseases
Study Phase : Approved
Sponsor : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
ViiV Healthcare Initiates Rolling Submission for Long-Acting Cabotegravir NDA
Details : CAB LA (cabotegravir) inhibits HIV integrase, which is essential for HIV replication and rilpivirine which inhibits HIV-1 reverse transcriptase.
Product Name : Undisclosed
Product Type : Small molecule
Upfront Cash : Not Applicable
May 04, 2021
Lead Product(s) : Macitentan,Cabotegravir,Tadalafil,Rilpivirine
Therapeutic Area : Infections and Infectious Diseases
Highest Development Status : Approved
Sponsor : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable