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89bio (ETNB)
NASDAQ:ETNB
Pegozafermin
Metabolic Dysfunction-Associated Steatohepatitis (Mash) / Nonalcoholic Steatohepatitis (Nash) With Compensated Cirrhosis
Phase III
Recruiting
A Study to Evaluate the Efficacy and Safety of Pegozafermin in Participants With Compensated Cirrhosis Due to MASH
May 14, 2024
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Pegozafermin
Metabolic Dysfunction-Associated Steatotic Liver Disease (Mash) / Nonalcoholic Steatohepatitis (Nash) With Fibrosis
Phase III
Recruiting
A Study Evaluating the Efficacy and Safety of Pegozafermin in Participants With MASH and Fibrosis (ENLIGHTEN-Fibrosis)
Mar 13, 2024
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Pegozafermin
Severe Hypertriglyceridemia
Phase III
Active Not Recruiting
To Evaluate the Efficacy and Safety of Pegozafermin in Subjects With Severe Hypertriglyceridemia
May 02, 2023
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Bio89-100
Nash - Nonalcoholic Steatohepatitis
Phase I
Completed
PK Study of Liquid Formulation of BIO89-100 in Subjects With NASH With Compensation Cirrhosis
Aug 20, 2021
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Bio89-100
Nash - Nonalcoholic Steatohepatitis
Phase II
Completed
Study Evaluating the Safety, Efficacy and Tolerability of BIO89-100 in Subjects With Biopsy-confirmed Nonalcoholic Steatohepatitis (NASH)
Jun 10, 2021
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Pegozafermin
Severe Hypertriglyceridemia
Phase II
Completed
Study to Explore the Efficacy and Safety of BIO89-100 (Pegozafermin) in Participants With Severe Hypertriglyceridemia
Aug 14, 2020
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Pegozafermin
Nash
Phase I/II
Completed
A Multiple Ascending Dose Study of Pegozafermin in Participants With Biopsy Confirmed Nonalcoholic Steatohepatitis (NASH) or Nonalcoholic Fatty Liver Disease (NAFLD) and at High Risk of NASH
Aug 04, 2019
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FAQ
What are the FDA phases for drug approval?
The FDA approval process for new drugs is divided into several phases:
a. Preclinical testing
b. Phase 1 – Safety and dosage
c. Phase 2 – Effectiveness and side effects
d. Phase 3 – Confirmation of effectiveness, monitoring of adverse reactions, and comparison with existing treatments
e. Phase 4 – Post-marketing studies to track long-term safety and effectiveness
a. Preclinical testing
b. Phase 1 – Safety and dosage
c. Phase 2 – Effectiveness and side effects
d. Phase 3 – Confirmation of effectiveness, monitoring of adverse reactions, and comparison with existing treatments
e. Phase 4 – Post-marketing studies to track long-term safety and effectiveness
What is a clinical trial?
A clinical trial is a carefully designed study in which researchers test a drug, treatment, or medical device in people to evaluate its safety, effectiveness, and potential side effects. These trials are essential for determining whether a new treatment should be approved for widespread use.
What drugs does 89bio (ETNB) have in its pipeline
ETNB is currently developing the following drugs: Pegozafermin, Pegozafermin, Pegozafermin. These drug candidates are in various stages of clinical development as the company works toward FDA approval.