Hepatology (Liver, Pancreatic, Gall Bladder) | Phase III Developments

Madrigal Pharmaceuticals

Upgrade this company profile, update & customize all content// Ask PharmaCompass, click HERE

United States

Post An Enquiry

Virtual Booth

BE PHARMA 2020

Participation Not Confirmed

Update your events

Madrigal Pharmaceuticals Exceeds Target Enrollment in Phase 3 MAESTRO NAFLD-1 Trial

Lead Product(s): Resmetirom

Therapeutic Area: Hepatology (Liver, Pancreatic, Gall Bladder) Product Name: MGL-3196

Highest Development Status: Phase III Product Type: Small molecule

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable September 03, 2020

Details:

Recent presentations at EASL Digital ILC of secondary analysis of Ph2 data demonstrated that reduction in MRI-PDFF can predict improvement in all components of histologic response in NASH, including steatosis, ballooning, inflammation and fibrosis.

CymaBay Therapeutics

Upgrade this company profile, update & customize all content// Ask PharmaCompass, click HERE

United States

Post An Enquiry

Virtual Booth

BE PHARMA 2020

Participation Not Confirmed

Update your events

CymaBay Therapeutics Presents Positive Final Results From 52-Week Phase 2 Study in Primary Biliary Cholangitis at The Digital ILC 2020

Lead Product(s): Seladelpar

Therapeutic Area: Hepatology (Liver, Pancreatic, Gall Bladder) Product Name: MBX-8025

Highest Development Status: Phase III Product Type: Small molecule

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable August 27, 2020

Details:

This electronic presentation highlights the efficacy, safety, and tolerability of seladelpar over 1 year of open-label treatment.

Intercept Pharma

Upgrade this company profile, update & customize all content// Ask PharmaCompass, click HERE

United States

Post An Enquiry

Virtual Booth

BE PHARMA 2020

Participation Not Confirmed

Update your events

Intercept Present New Data from the Interim Analysis of Regenerate Show that Oca Helped Patients with Liver Fibrosis Due to NASH

Lead Product(s): Obeticholic Acid

Therapeutic Area: Hepatology (Liver, Pancreatic, Gall Bladder) Product Name: Undisclosed

Highest Development Status: Phase III Product Type: Small molecule

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable August 27, 2020

Details:

Additional data indicate that obeticholic acid (OCA) helped patients with nonalcoholic steatohepatitis (NASH) achieve sustained improvements in liver biochemistry and noninvasive markers of liver fibrosis over two years of treatment.

Madrigal Pharmaceuticals

Upgrade this company profile, update & customize all content// Ask PharmaCompass, click HERE

United States

Post An Enquiry

Virtual Booth

BE PHARMA 2020

Participation Not Confirmed

Update your events

Madrigal Pharmaceuticals to Present Secondary Analyses of Data from Phase 2 NASH Study of Resmetirom and Symposium at the Digital ILC 2020

Lead Product(s): Resmetirom

Therapeutic Area: Hepatology (Liver, Pancreatic, Gall Bladder) Product Name: MGL-3196

Highest Development Status: Phase III Product Type: Small molecule

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable August 26, 2020

Details:

MRI-PDFF reduction has been shown to be associated with improvement in NASH components as assessed on liver biopsy. These secondary analyses of Madrigal’s Phase 2 NASH clinical trial add significant additional insight into the potential of PDFF to predict NASH response.

CymaBay Therapeutics

Upgrade this company profile, update & customize all content// Ask PharmaCompass, click HERE

United States

Post An Enquiry

Virtual Booth

BE PHARMA 2020

Participation Not Confirmed

Update your events

CymaBay Announces Positive Topline Results from ENHANCE for Seladelpar in Patients with Primary Biliary Cholangitis

Lead Product(s): Seladelpar

Therapeutic Area: Hepatology (Liver, Pancreatic, Gall Bladder) Product Name: MBX-8025

Highest Development Status: Phase III Product Type: Small molecule

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable August 03, 2020

Details:

The study demonstrated seladelpar to be efficacious, safe and well-tolerated . 78.2% of patients on seladelpar 10 mg versus 12.5% on placebo achieved the primary composite outcome after only 3 months.

CymaBay Therapeutics

Upgrade this company profile, update & customize all content// Ask PharmaCompass, click HERE

United States

Post An Enquiry

Virtual Booth

BE PHARMA 2020

Participation Not Confirmed

Update your events

FDA Lifts All Clinical Holds on CymaBay Therapeutics' Seladelpar

Lead Product(s): Seladelpar

Therapeutic Area: Hepatology (Liver, Pancreatic, Gall Bladder) Product Name: MBX-8025

Highest Development Status: Phase III Product Type: Small molecule

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable July 23, 2020

Details:

CymaBay had halted all studies of seladelpar after liver biopsies showed some patients in a phase 2b NASH trial had inflamed and destroyed liver cells, a condition known as interface hepatitis.

Intercept Pharma

Upgrade this company profile, update & customize all content// Ask PharmaCompass, click HERE

United States

Post An Enquiry

Virtual Booth

BE PHARMA 2020

Participation Not Confirmed

Update your events

ICER Publishes Evidence Report on Obeticholic Acid for the Treatment of Nonalcoholic Steatohepatitis

Lead Product(s): Obeticholic Acid

Therapeutic Area: Hepatology (Liver, Pancreatic, Gall Bladder) Product Name: OCA

Highest Development Status: Phase III Product Type: Small molecule

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable July 21, 2020

Details:

Viewing the evidence from the study as a whole, ICMR feels that the long-term net effects of OCA on quality of life and health of patients with NASH and F2/F3 fibrosis are uncertain.

Intercept Pharma

Upgrade this company profile, update & customize all content// Ask PharmaCompass, click HERE

United States

Post An Enquiry

Virtual Booth

BE PHARMA 2020

Participation Not Confirmed

Update your events

USFDA Postponds Intercept's NDA Application Meeting for Obeticholic Acid

Lead Product(s): Obeticholic Acid

Therapeutic Area: Hepatology (Liver, Pancreatic, Gall Bladder) Product Name: Undisclosed

Highest Development Status: Phase III Product Type: Small molecule

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable May 22, 2020

Details:

U.S.FDA has notified Intercept that its advisory committee meeting (AdCom) relating to the company’s new drug application (NDA) for obeticholic acid (OCA) for the treatment of liver fibrosis due to nonalcoholic steatohepatitis (NASH) has been postponed.

Genfit

Upgrade this company profile, update & customize all content// Ask PharmaCompass, click HERE

FRANCE France

Post An Enquiry

Virtual Booth

BE PHARMA 2020

Participation Not Confirmed

Update your events

Genfit Delivers Latest NASH Drug Failure

Lead Product(s): Elafibranor

Therapeutic Area: Hepatology (Liver, Pancreatic, Gall Bladder) Product Name: Undisclosed

Highest Development Status: Phase III Product Type: Small molecule

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable May 11, 2020

Details:

Elafibranor did not demonstrate a statistically significant effect on the primary endpoint of NASH resolution without worsening of fibrosis.

Madrigal Pharmaceuticals

Upgrade this company profile, update & customize all content// Ask PharmaCompass, click HERE

United States

Post An Enquiry

Virtual Booth

BE PHARMA 2020

Participation Not Confirmed

Update your events

Madrigal MAESTRO Phase 3 NASH Trials Continue without Protocol Modifications

Lead Product(s): Resmetirom

Therapeutic Area: Hepatology (Liver, Pancreatic, Gall Bladder) Product Name: Undisclosed

Highest Development Status: Phase III Product Type: Small molecule

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable April 14, 2020

Details:

Once daily oral 80 mg and 100 mg Phase 3 doses of resmetirom deliver at least 50% to more than 60% reductions in liver fat, respectively.

Find

Find Drugs for Hepatology (Liver, Pancreatic, Gall Bladder) in Phase III Clinical Development

Phase III

Product Type

Companies

Madrigal Pharmaceuticals

Madrigal Pharmaceuticals Exceeds Target Enrollment in Phase 3 MAESTRO NAFLD-1 Trial

CymaBay Therapeutics

CymaBay Therapeutics Presents Positive Final Results From 52-Week Phase 2 Study in Primary Biliary Cholangitis at The Digital ILC 2020

Intercept Pharma

Intercept Present New Data from the Interim Analysis of Regenerate Show that Oca Helped Patients with Liver Fibrosis Due to NASH

Madrigal Pharmaceuticals

Madrigal Pharmaceuticals to Present Secondary Analyses of Data from Phase 2 NASH Study of Resmetirom and Symposium at the Digital ILC 2020

CymaBay Therapeutics

CymaBay Announces Positive Topline Results from ENHANCE for Seladelpar in Patients with Primary Biliary Cholangitis

CymaBay Therapeutics

FDA Lifts All Clinical Holds on CymaBay Therapeutics' Seladelpar

Intercept Pharma

ICER Publishes Evidence Report on Obeticholic Acid for the Treatment of Nonalcoholic Steatohepatitis

Intercept Pharma

USFDA Postponds Intercept's NDA Application Meeting for Obeticholic Acid

Genfit

Genfit Delivers Latest NASH Drug Failure

Madrigal Pharmaceuticals

Madrigal MAESTRO Phase 3 NASH Trials Continue without Protocol Modifications