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

Alnylam Pharmaceuticals

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United States

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Alnylam Submits CTA Application In UK To Start Phase 1 Trial Of ALN-HSD To Treat NASH

Lead Product(s): ALN-HSD

Therapeutic Area: Hepatology (Liver, Pancreatic, Gall Bladder) Product Name: ALN-HSD

Highest Development Status: IND Enabling Product Type: Cell and Gene therapy

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable August 03, 2020

Details:

Company has submitted a clinical trial authorization application to The Medicines and Healthcare Products Regulatory Agency in the U.K to initiate a Phase 1 study of ALN-HSD, an investigational RNAi therapeutic targeting HSD17B13 for the treatment of NASH.

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.

Find

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

IND Enabling

Product Type

Companies

Alnylam Pharmaceuticals

Alnylam Submits CTA Application In UK To Start Phase 1 Trial Of ALN-HSD To Treat NASH

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