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Akero Therapeutics Inc (AKRO)
NASDAQ:AKRO
efruxifermin
Nash - Nonalcoholic Steatohepatitis, Mash - Metabolic Dysfunction-Associated Steatohepatitis
Phase III
Recruiting
A Study Evaluating Efruxifermin in Subjects With Compensated Cirrhosis Due to NASH/MASH
Jun 28, 2024
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efruxifermin
Nash With Fibrosis, Mash With Fibrosis
Phase III
Recruiting
A Study Evaluating Efruxifermin in Subjects With Non-Cirrhotic Nonalcoholic Steatohepatitis (NASH)/Metabolic Dysfunction-Associated Steatohepatitis (MASH) and Fibrosis
Dec 06, 2023
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efruxifermin
Nash/Mash, Nafld/Masld
Phase III
Active Not Recruiting
A Study Evaluating Efruxifermin in Subjects With Non-invasively Diagnosed Nonalcoholic Steatohepatitis (NASH)/Metabolic Dysfunction-Associated Steatohepatitis (MASH) and Nonalcoholic Fatty Liver Disease (NAFLD)/Metabolic Dysfunction-Associated Steatotic Liver Disease (MASLD)
Nov 22, 2023
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Efx
Nash - Nonalcoholic Steatohepatitis
Phase II
Active Not Recruiting
A Study of Efruxifermin in Subjects With Compensated Cirrhosis Due to Nonalcoholic Steatohepatitis (NASH) (Symmetry)
Jul 29, 2021
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efruxifermin
Nash - Nonalcoholic Steatohepatitis
Phase II
Completed
A Study of Efruxifermin in Non-Cirrhotic Subjects With Histologically Confirmed Nonalcoholic Steatohepatitis (NASH)
Feb 16, 2021
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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 Akero Therapeutics Inc (AKRO) have in its pipeline
AKRO is currently developing the following drugs: efruxifermin, efruxifermin, efruxifermin. These drug candidates are in various stages of clinical development as the company works toward FDA approval.