Hepatology (Liver, Pancreatic, Gall Bladder) | IND Enabling Drugs

Ascletis Pharma

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CHINA China

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Ascletis' THR- beta Agonist ASC41 Receives Approval for Clinical Trials of NASH Indication

Lead Product(s): ASC41

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

Highest Development Status: IND Enabling Product Type: Undisclosed

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable May 13, 2020

Details:

Ascletis Pharma received IND approval from China's National Medical Products Administration (NMPA) for its in-house developed Category 1 Drug ASC41 to conduct clinical trials for Non-alcoholic Steatohepatitis (NASH) indication.

Lipocine

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United States

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FDA Clears LPCN 1148 IND Application for Phase 2 Cirrhosis Trial

Lead Product(s): LPCN 1148

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

Highest Development Status: IND Enabling Product Type: Large molecule

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable May 05, 2020

Details:

The Phase 2 proof-of-concept study will evaluate the therapeutic potential of LPCN 1148, for the treatment of liver cirrhosis in adult male cirrhotic patients.

Ascletis Pharma

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CHINA China

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Ascletis' IND Filing for Its Non-alcoholic Steatohepatitis (NASH) Drug Accepted by NMPA

Lead Product(s): ASC41,ASC40

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

Highest Development Status: IND Enabling Product Type: Undisclosed

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable February 17, 2020

Details:

ASC41 is expected to be used in combination with ASC40, another innovative drug of the Company, for treatment of NASH.

Theraly Fibrosis

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United States

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Theraly Fibrosis Awarded $3.9 Million SBIR Phase II Grant to Support Development of TLY012 for Chronic Pancreatitis

Lead Product(s): TLY012

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

Highest Development Status: IND Enabling Product Type: Large molecule

Partner/Sponsor/Collaborator: National Institutes of Health

Deal Size: $5.9 million Upfront Cash: Undisclosed

Deal Type: Funding January 30, 2020

Details:

Theraly Fibrosis has been awarded a Small Business Innovation Research Phase II grant by the National Institutes of Health to support development of TLY012 for treatment of chronic pancreatitis.

Enleofen Bio Pte

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Singapore

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Boehringer Ingelheim Partners with Enleofen to Develop First-in-Class Anti-IL-11 Therapies for a Range of Fibrotic Diseases

Lead Product(s): Enx108A

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

Highest Development Status: IND Enabling Product Type: Large molecule

Partner/Sponsor/Collaborator: Boehringer Ingelheim GmbH

Deal Size: $1,000.0 million Upfront Cash: $1,000.0 million

Deal Type: Partnership January 09, 2020

Details:

Acquisition of worldwide exclusive rights adds extensive anti-IL-11 platform to Boehringer Ingelheim pipeline portfolio.

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Find FDA Investigational New Drug (IND) Submissions for Hepatology (Liver, Pancreatic, Gall Bladder)

IND Enabling

Product Type

Companies

Ascletis Pharma

Ascletis' THR- beta Agonist ASC41 Receives Approval for Clinical Trials of NASH Indication

Lipocine

FDA Clears LPCN 1148 IND Application for Phase 2 Cirrhosis Trial

Ascletis Pharma

Ascletis' IND Filing for Its Non-alcoholic Steatohepatitis (NASH) Drug Accepted by NMPA

Theraly Fibrosis

Theraly Fibrosis Awarded $3.9 Million SBIR Phase II Grant to Support Development of TLY012 for Chronic Pancreatitis

Enleofen Bio Pte

Boehringer Ingelheim Partners with Enleofen to Develop First-in-Class Anti-IL-11 Therapies for a Range of Fibrotic Diseases