X
API Suppliers
US DMFs Filed
CEP/COS Certifications
0
JDMFs Filed
0
Other Certificates
Other Suppliers
0
USA (Orange Book)
Europe
Canada
Australia
South Africa
Uploaded Dossiers
U.S. Medicaid
Annual Reports
0
0
Details:
OFEV (nintedanib) is an investigational drug in development for fibrosing interstitial lung disease. It inhibits profibrotic mediators including platelet-derived growth factor, TGF-β as well as VEGF, reducing fibroblast activity.
Lead Product(s): Nintedanib Esylate
Therapeutic Area: Pulmonary/Respiratory Diseases Product Name: Ofev
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable July 25, 2023
Details:
AP02 (nintedanib) is an investigational drug in development for pulmonary fibrosis. It inhibits profibrotic mediators including platelet-derived growth factor, fibroblast growth factor and transforming growth factor (TGF)-β as well as VEGF, reducing fibroblast activity.
Lead Product(s): Nintedanib Esylate
Therapeutic Area: Pulmonary/Respiratory Diseases Product Name: AP02
Highest Development Status: Phase IProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable March 30, 2023
Details:
The InPedILD results showed that the weight-based dosing regimen of Ofev (nintedanib) in children and adolescents with fibrosing ILD resulted in comparable exposure to that observed in adult patients with fibrosing ILD.
Lead Product(s): Nintedanib Esylate
Therapeutic Area: Pulmonary/Respiratory Diseases Product Name: Ofev
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable September 05, 2022
Details:
No significant drug-drug interaction (DDI) seen with BLD-0409 (cudetaxestat) in combination with either pirfenidone or nintedanib, two approved therapies for idiopathic pulmonary fibrosis (IPF).
Lead Product(s): Cudetaxestat,Nintedanib Esylate
Therapeutic Area: Pulmonary/Respiratory Diseases Product Name: BLD-0409
Highest Development Status: Phase IProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable May 16, 2022
Details:
In an analysis of SENSCIS-ON, the safety profile of Ofev in participants who continued therapy for an additional 52 weeks was consistent with that observed during the SENSCIS trial.
Lead Product(s): Nintedanib Esylate
Therapeutic Area: Immunology Product Name: Ofev
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable May 14, 2021
Details:
OFEV® is the first treatment available in Canada for chronic fibrosing interstitial lung diseases (ILDs) with a progressive phenotype (also known as PF-ILD), which affects patients across more than 200 rare lung disorders.
Lead Product(s): Nintedanib Esylate
Therapeutic Area: Pulmonary/Respiratory Diseases Product Name: OFEV
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable March 04, 2021
Details:
New study will assess the potential impact of nintedanib in patients developing pulmonary fibrosis following acute lung injury from COVID-19 infection. Research collaboration will lead to insights about pulmonary fibrosis in the growing COVID-19 patient population.
Lead Product(s): Nintedanib Esylate
Therapeutic Area: Pulmonary/Respiratory Diseases Product Name: Ofev
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Icahn School of Medicine
Deal Size: Undisclosed Upfront Cash: Undisclosed
Deal Type: Collaboration November 19, 2020
Details:
Preclinical data shows that combination of a CB5138 Analog with nintedanib, the leading standard of care for treatment of Idiopathic Pulmonary Fibrosis (IPF), produced enhanced effects compared to nintedanib alone in mice.
Lead Product(s): CB5138 Analog peptides,Nintedanib Esylate
Therapeutic Area: Pulmonary/Respiratory Diseases Product Name: Undisclosed
Highest Development Status: PreclinicalProduct Type: Peptide
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable October 26, 2020
Details:
Available as 100 mg and 150 mg capsules, it will be marketed under the brand name Nintib.
Lead Product(s): Nintedanib Esylate
Therapeutic Area: Pulmonary/Respiratory Diseases Product Name: Nintib
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable October 20, 2020
Details:
In a recently published INBUILDtm trial, Nintedanib showed significantly lower annual rate of decline in FVC (Forced Vital Capacity) – a measure of lung health – with various progressive fibrosing interstitial lung diseases.
Lead Product(s): Nintedanib Esylate
Therapeutic Area: Pulmonary/Respiratory Diseases Product Name: Undisclosed
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable October 14, 2020
Details:
An analysis of the Phase III INBUILD® trial showed the proportion of patients with 10% or greater declines in lung function were lower in the Ofev® (nintedanib) group relative to placebo over 52 weeks.
Lead Product(s): Nintedanib Esylate
Therapeutic Area: Pulmonary/Respiratory Diseases Product Name: Ofev
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable August 10, 2020
Details:
The decision is based on the results of the INBUILD® trial, the first study to evaluate patients with a broad range of chronic fibrosing interstitial lung diseases (ILDs) and a progressive disease behavior.
Lead Product(s): Nintedanib Esylate
Therapeutic Area: Pulmonary/Respiratory Diseases Product Name: Ofev
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable July 15, 2020
Details:
The opinion is for the treatment of adults with other chronic fibrosing interstitial lung diseases (ILDs) with a progressive phenotype beyond idiopathic pulmonary fibrosis (IPF).
Lead Product(s): Nintedanib Esylate
Therapeutic Area: Pulmonary/Respiratory Diseases Product Name: Undisclosed
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable May 29, 2020
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results] 
Market Place
