Wednesday, July 8, 2026

Drug profile · INN

fidaxomicin

fidaxomicin (DIFICLIR) is a dna-directed rna polymerase inhibitor. Route of administration: oral. Current US regulatory status: approved.

FDA: approved EMA: approved Alimentary tract and metabolism (A07) A07AA12
US status approved
Patents linked 0
Pipeline programs 0
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Drug details — fidaxomicin
US status
approved
Class
Alimentary tract and metabolism (A07)
Route
ORAL
Patents
0
Programs
0
Data quality
0.84

Quick answer

fidaxomicin (DIFICLIR) is a dna-directed rna polymerase inhibitor. Route of administration: oral. Current US regulatory status: approved.

Key facts

INN fidaxomicin
Brand DIFICLIR
Mechanism DNA-directed RNA polymerase inhibitor
Target DNA-directed RNA polymerase
Therapeutic class Alimentary tract and metabolism (A07)
Route ORAL
Formulation TABLET
ATC code A07AA12

Mechanism of action

DNA-directed RNA polymerase inhibitor

Primary target: DNA-directed RNA polymerase

Approval history

Authority Status Date
FDA approved
EMA approved

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  4. aprepitant Alimentary tract and metabolism (A04)
  5. budesonide Alimentary tract and metabolism (A07)
  6. canagliflozin Alimentary tract and metabolism (A10)

Frequently asked questions

What is fidaxomicin?

fidaxomicin (DIFICLIR) is a dna-directed rna polymerase inhibitor. Route of administration: oral. Current US regulatory status: approved.

What is the brand name for fidaxomicin?

DIFICLIR is a marketed brand name for fidaxomicin. Check FDA Drugs@FDA for the current US label holder and prescribing information.

What is the US approval status of fidaxomicin?

fidaxomicin has approved status in the United States according to our Drugs@FDA-derived records. Verify on the official FDA label before clinical or commercial decisions.