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Efruxifermin

Not yet reviewed: Listed from FDA or ClinicalTrials.gov records; an editor has not checked it yetListed from FDA or ClinicalTrials.gov records; an editor has not checked it yet.

Akero Therapeutics, Inc. · MASH - Metabolic Dysfunction-Associated Steatohepatitis; MASH With Fibrosis; NAFLD/MASLD; NASH - Nonalcoholic Steatohepatitis; NASH With Fibrosis

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Key figures

  • Next catalyst

    None scheduled

    Only dates with a source are listed

  • Phase

    Phase 3

    Not recorded

  • Linked trials

    3

    From ClinicalTrials.gov

  • Latest FDA action

    None on record

    From Drugs@FDA

Recalls, shortages, patents and EU status at a glance

Key information

Sponsor
Akero Therapeutics, Inc. Source: Company record for Akero Therapeutics, Inc. (opens in a new tab)
Indications
MASH - Metabolic Dysfunction-Associated Steatohepatitis; MASH With Fibrosis; NAFLD/MASLD; NASH - Nonalcoholic Steatohepatitis; NASH With Fibrosis Source: Conditions from ClinicalTrials.gov (opens in a new tab)
Designations
None recorded
Next catalyst
None scheduled

Development timeline

  1. Preclinical Completed
  2. Phase 1 Completed
  3. Phase 2 Completed
  4. Phase 3 Current stageFirst trial start 10 Nov 20233 linked trials
  5. Filed Not yet
  6. Approved Not yet

Overview

Mechanism
Not recorded
Route
Not recorded
Modality
Not recorded
Specialties
Not recorded

Overview text is written by HealthTrade editors.

Key dates

No catalysts yet. Editors add each date together with its source.

FDA designations

No FDA designations are on record for Efruxifermin. Editors add each one with its source.

Filed application

No filed application is on record for Efruxifermin. Approvals are listed under FDA actions.

FDA advisory committees

No FDA advisory committee meetings are on record for Efruxifermin.

Clinical trials

Trials linked to Efruxifermin
TrialTitlePhaseStatusEnrollmentPrimary completionResults posted
NCT06528314ClinicalTrials.gov record for NCT06528314 (opens in a new tab)A Study Evaluating Efruxifermin in Subjects With Compensated Cirrhosis Due to NASH/MASHPhase 3Recruiting2,150 (estimated)Feb 2030 (estimated) No
NCT06215716ClinicalTrials.gov record for NCT06215716 (opens in a new tab)A Study Evaluating Efruxifermin in Subjects With Non-Cirrhotic Nonalcoholic Steatohepatitis (NASH)/Metabolic Dysfunction-Associated Steatohepatitis (MASH) and FibrosisPhase 3Recruiting1,650 (estimated)Feb 2033 (estimated) No
NCT06161571ClinicalTrials.gov record for NCT06161571 (opens in a new tab)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)Phase 3Active, not recruiting700 (estimated)3 Mar 2026 (actual) No

Source: ClinicalTrials.gov, U.S. National Library of Medicine. Posted results are shown as ClinicalTrials.gov prints them; results from company and journal sources are entered by editors and listed separately. Full result tables are on ClinicalTrials.gov.

Trial quality

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FDA actions

No FDA approvals on record for this drug.

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FDA drug shortages load here.

Orange Book patents load here.

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Community discussion loads here.

EU status (EMA)

EMA's medicines data lists no human medicine with the same active substance as Efruxifermin.

Source: European Medicines Agency (EMA), medicines data download.

Related news

No recent headlines mention this drug.

Sources

Record updated .

Dates come from company and FDA disclosures and can change. Nothing on this page is investment advice.