X
API Suppliers
0
US DMFs Filed
0
CEP/COS Certifications
0
JDMFs Filed
0
Other Certificates
0
Other Suppliers
0
USA (Orange Book)
0
Europe
0
Canada
0
Australia
0
South Africa
0
Uploaded Dossiers
0
U.S. Medicaid
0
Annual Reports
0
0
USFDA Orange Book Patents
0
USFDA Exclusivities
0
Blog #PharmaFlow
0
News
EDQM
0
USP
0
JP
0
Other Listed Suppliers
0
0
Details:
IVA337 (lanifibranor) is an orally-available small molecule that acts by activating all three peroxisome proliferator activated receptor (PPAR) isoforms. It is being evaluated for the treatment of Nonalcoholic Steatohepatitis and Diabetes Mellitus, Type 2.
Lead Product(s): Lanifibranor,Empagliflozin
Therapeutic Area: Hepatology (Liver, Pancreatic, Gall Bladder) Product Name: IVA337
Highest Development Status: Phase IIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable March 18, 2024
Details:
IVA-337 (lanifibranor) is a pan-PPAR (peroxisome proliferator–activated receptor) agonist, which is being evaluated for the treatment of Nonalcoholic Steatohepatitis.
Lead Product(s): Lanifibranor
Therapeutic Area: Hepatology (Liver, Pancreatic, Gall Bladder) Product Name: IVA337
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 March 07, 2024
Details:
Inventiva intends to use the proceeds to fund part of its ongoing pivotal NATiV3 Phase III clinical trial evaluating IVA-337 (lanifibranor), an orally-available small molecule, in patients with NASH.
Lead Product(s): Lanifibranor
Therapeutic Area: Hepatology (Liver, Pancreatic, Gall Bladder) Product Name: IVA337
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: European Investment Bank
Deal Size: Undisclosed Upfront Cash: Undisclosed
Deal Type: Financing January 10, 2024
Details:
IVA337 (lanifibranor) is a PPAR agonist small molecule drug candidate, which is currently being evaluated for the treatment of non-alcoholic steatohepatitis.
Lead Product(s): Lanifibranor
Therapeutic Area: Hepatology (Liver, Pancreatic, Gall Bladder) Product Name: IVA337
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 December 20, 2023
Details:
IVA337 (lanifibranor) is a pan-PPAR (peroxisome proliferator–activated receptor) agonist, which is being evaluated in phase 3 clinical trials for the treatment of Nonalcoholic Steatohepatitis.
Lead Product(s): Lanifibranor
Therapeutic Area: Hepatology (Liver, Pancreatic, Gall Bladder) Product Name: IVA337
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 December 04, 2023
Details:
Under the agreement, Hepalys will develop and commercialize Inventiva’s proprietary drug candidate IVA337 (lanifibranor), an orally-available small molecule, PPAR agonist, for the treatment of non-alcoholic steatohepatitis (NASH) in Japan and South Korea.
Lead Product(s): Lanifibranor
Therapeutic Area: Hepatology (Liver, Pancreatic, Gall Bladder) Product Name: IVA337
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Hepalys Pharma
Deal Size: $241.0 million Upfront Cash: $10.0 million
Deal Type: Licensing Agreement September 20, 2023
Details:
The company will use the proceeds for the Phase III evaluation of IVA337 (lanifibranor), a pan-peroxisome proliferator-activated receptor agonist, in the treatment of patients suffering from NASH and for its other pre-clinical and clinical programs, in particular Yap-Tead.
Lead Product(s): Lanifibranor
Therapeutic Area: Hepatology (Liver, Pancreatic, Gall Bladder) Product Name: IVA337
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Qatar Holding
Deal Size: $38.6 million Upfront Cash: Undisclosed
Deal Type: Financing August 31, 2023
Details:
IVA337 (lanifibranor), is an orally-available small molecule which induces anti-fibrotic, anti-inflammatory and beneficial vascular and metabolic changes in the body by activating all three PPAR isoforms, regulating gene expression and evaluating in patients with T2D and NAFLD.
Lead Product(s): Lanifibranor
Therapeutic Area: Hepatology (Liver, Pancreatic, Gall Bladder) Product Name: IVA337
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 June 13, 2023
Details:
IVA337 (Lanifibranor), is an orally-available small molecule which induces anti-fibrotic, anti-inflammatory and beneficial vascular and metabolic changes in the body by activating all three PPAR isoforms, regulating gene expression.
Lead Product(s): Lanifibranor
Therapeutic Area: Hepatology (Liver, Pancreatic, Gall Bladder) Product Name: IVA337
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Sino Biopharmaceutical
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable May 25, 2023
Details:
IVA337 (Lanifibranor), is an orally-available small molecule which induces anti-fibrotic, anti-inflammatory and beneficial vascular and metabolic changes in the body by activating all three PPAR isoforms, regulating gene expression.
Lead Product(s): Lanifibranor
Therapeutic Area: Hepatology (Liver, Pancreatic, Gall Bladder) Product Name: IVA337
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 January 04, 2023
Details:
IVA337 (lanifibranor) is a next generation pan-PPAR (peroxisome proliferator-activated receptors) agonist addressing the pathophysiology of NASH. Inventiva intends to use the proceeds to fund the pivotal Phase III clinical trial evaluating lanifibranor in patients with NASH.
Lead Product(s): Lanifibranor
Therapeutic Area: Hepatology (Liver, Pancreatic, Gall Bladder) Product Name: IVA337
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: European Investment Bank
Deal Size: $26.4 million Upfront Cash: Undisclosed
Deal Type: Agreement December 12, 2022
Details:
Lanifibranor is orally-available small molecule that acts to induce anti-fibrotic, anti-inflammatory and beneficial vascular and metabolic changes in body by activating all three PPAR isoforms.
Lead Product(s): Lanifibranor
Therapeutic Area: Hepatology (Liver, Pancreatic, Gall Bladder) Product Name: IVA337
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 November 28, 2022
Details:
Lanifibranor (IVA337), is an orally-available small molecule with breakthrough therapy designation from the U.S. Food and Drug Administration (FDA) following a positive Phase IIb trial in patients with non-alcoholic steatohepatitis (NASH).
Lead Product(s): Lanifibranor
Therapeutic Area: Hepatology (Liver, Pancreatic, Gall Bladder) Product Name: IVA337
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Sino Biopharm
Deal Size: $307.0 million Upfront Cash: $12.0 million
Deal Type: Licensing Agreement September 21, 2022
Details:
IVA337 (lanifibranor), orally-available small molecule that acts to induce anti-fibrotic, anti-inflammatory, beneficial vascular and metabolic changes in body by activating all PPAR isoforms, which are well‑characterized nuclear receptor proteins that regulate gene expression.
Lead Product(s): Lanifibranor,Empagliflozin
Therapeutic Area: Hepatology (Liver, Pancreatic, Gall Bladder) Product Name: IVA337
Highest Development Status: Phase IIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable July 07, 2022
Details:
In addition, improvement of glycemic control in patients who received lanifibranor (IVA337) correlated with the improvement of metabolic-immune markers of NASH insulin resistance, lipid metabolism, inflammation, liver enzymes and with hepatic steatosis.
Lead Product(s): Lanifibranor
Therapeutic Area: Hepatology (Liver, Pancreatic, Gall Bladder) Product Name: IVA337
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 June 03, 2022
Details:
The Company plans to use the facility toward its preclinical and clinical pipeline, including to help fund a portion of its Phase III clinical trial of IVA337 (lanifibranor), in patients with NASH.
Lead Product(s): Lanifibranor
Therapeutic Area: Hepatology (Liver, Pancreatic, Gall Bladder) Product Name: IVA337
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: European Investment Bank
Deal Size: Undisclosed Upfront Cash: Undisclosed
Deal Type: Financing May 16, 2022
Details:
Lanifibranor, a pan-PPAR agonist, improves markers of cardiometabolic health in patients with NASH, has demonstrated beneficial effects on liver histology, NASH resolution and fibrosis improvement in patients.
Lead Product(s): Lanifibranor,Empagliflozin
Therapeutic Area: Hepatology (Liver, Pancreatic, Gall Bladder) Product Name: IVA337
Highest Development Status: Phase IIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable April 07, 2022
Details:
Phase IIb has demonstrated that IVA337 (lanifibranor) as a monotherapy could not only resolve NASH and improve fibrosis but also improve lipids and glycemic profiles, in combination with empagliflozin provide additional benefits and further improve cardiometabolic risk profile.
Lead Product(s): Lanifibranor,Empagliflozin
Therapeutic Area: Hepatology (Liver, Pancreatic, Gall Bladder) Product Name: IVA337
Highest Development Status: Phase IIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable March 08, 2022
Details:
IVA337 (lanifibranor) is next generation pan-PPAR (peroxisome proliferator-activated receptors) agonist addressing pathophysiology of NASH (Non-alcoholic steatohepatitis) or in the treatment of, liver steatosis and moderate to severe necroinflammation without cirrhosis.
Lead Product(s): Lanifibranor
Therapeutic Area: Hepatology (Liver, Pancreatic, Gall Bladder) Product Name: IVA 337
Highest Development Status: Phase IIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable October 20, 2021
Details:
FDA confirms that a single Phase III clinical trial may be adequate for submitting U.S. marketing authorization application for lanifibranor.
Lead Product(s): Lanifibranor
Therapeutic Area: Hepatology (Liver, Pancreatic, Gall Bladder) Product Name: IVA 337
Highest Development Status: Phase IIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable November 10, 2020
Details:
Two late-breaking abstracts covering new data from Inventiva’s NATIVE Phase IIb clinical trial evaluating lanifibranor for the treatment of NASH have been selected for poster presentations during the congress.
Lead Product(s): Lanifibranor
Therapeutic Area: Hepatology (Liver, Pancreatic, Gall Bladder) Product Name: IVA 337
Highest Development Status: Phase IIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable November 02, 2020
Details:
Designation based on positive topline results from NATIVE Phase IIb clinical trial evaluating lanifibranor in non-alcoholic steatohepatitis (NASH).
Lead Product(s): Lanifibranor
Therapeutic Area: Hepatology (Liver, Pancreatic, Gall Bladder) Product Name: IVA 337
Highest Development Status: Phase IIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable October 12, 2020
Details:
Lanifibranor met primary endpoint with significant reduction of the Steatosis Activity Fibrosis score, which combines assessments of hepatocellular inflammation and ballooning, with no worsening of fibrosis in the Intention To Treat and Per Protocol populations.
Lead Product(s): Lanifibranor
Therapeutic Area: Hepatology (Liver, Pancreatic, Gall Bladder) Product Name: IVA 337
Highest Development Status: Phase IIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable October 05, 2020
Details:
Following higher than expected effects on steatosis reduction during the Phase IIb NATIVE trial in NASH, the number of patients to be recruited in the trial evaluating lanifibranor in patients with T2DM and NAFLD has been reduced to 34 (vs. 64 initially).
Lead Product(s): Lanifibranor
Therapeutic Area: Hepatology (Liver, Pancreatic, Gall Bladder) Product Name: IVA 337
Highest Development Status: Phase IIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable July 06, 2020
Details:
Lanifibranor met the primary endpoint in the ITT population at the dose of 1200mg/day with a statistically significant (p = 0.004) decrease of at least two points in the SAF activity score6, compared to baseline, with no worsening of fibrosis.
Lead Product(s): Lanifibranor
Therapeutic Area: Hepatology (Liver, Pancreatic, Gall Bladder) Product Name: Undisclosed
Highest Development Status: Phase IIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable June 15, 2020
Details:
Last patient last visit took place in the United States on March 16, 2020. Publication of study head-line results expected for June 2020.
Lead Product(s): Lanifibranor
Therapeutic Area: Hepatology (Liver, Pancreatic, Gall Bladder) Product Name: Undisclosed
Highest Development Status: Phase IIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable March 17, 2020
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results] 
Market Place
