Dificlir

(Fidaxomicin)

ApprovedSmall molecule

Fidaxomicin is used to treat serious bacterial infections in the colon caused by Clostridioides difficile, which can cause severe diarrhea and inflammation of the intestines.[2] Dificlir is currently approved and in use across 5 indications[4].[1]

Dificlir is one of 66 small molecule programs targeting Clostridium Difficile Infection. It is currently in Approved.

Indications

Total Trials

Active Trials

Competitors

FDA Applications

NDA/BLA/ANDA regulatory filings

Patents

Pipeline

Status by Indication[4][1]

Indication

Clostridium Difficile InfectionTerminated

Commensal Clostridium Infectious DiseaseActive, not recruiting

Clostridioides Difficile InfectionActive, not recruiting

Inflammatory Bowel DiseaseActive, not recruiting

ClostridiumTerminated

Clostridium Difficile InfectionApproved

Terminated

Commensal Clostridium Infectious DiseaseApproved

Active, not recruiting

Clostridioides Difficile InfectionPreclinical

Active, not recruiting

Inflammatory Bowel DiseaseApproved

Active, not recruiting

ClostridiumApproved

Terminated

Competition

Competitive Landscape

61 competitors in Inflammatory Bowel Disease

#DrugCompanyPhaseTrials

Remicade

Johnson & Johnson

Approved

17 2

Humira

Novartis

Approved

7 3

Skyrizi

AbbVie

Approved

3 4

Mounjaro

Eli Lilly

Approved

1 5

Elavil

Calciferol

Avandia

Zyloprim

Dificlir

1 10

Vancocin

HHikma Pharmaceuticals LLC

Approved

Ranked by pipeline maturity and clinical activity. Current drug highlighted in teal.

Timeline

Expected Milestones

Q2 2027

N/ANot yet recruiting

Clostridioides Difficile Infection

NCT07120490

Q4 2030

Phase 3Recruiting

Colitis

NCT07328971

Q3 2031

Post-ApprovalNot yet recruiting

Inflammatory Bowel Disease

NCT06794944

Clinical

Trials by Indication[1]

Clostridium Difficile Infection10 trials

Use Of Oral Fidaxomicin Vs. Oral Vancomycin For Clostridium Difficile Infection In Patients With Spinal Cord Injury

Terminated·—·Phase 4·NCT02355938·12 enrolled

Fecal Microbiota Transplant (FMT) Plus Fidaxomicin for Severe or Fulminant Clostridium Difficile Infection

Terminated·UUniversity of Alberta·Phase 2·NCT03760484·4 enrolled

A Post-marketing, Blinded Study to Investigate How Effective Fidaxomicin is Compared to Vancomycin in the Sustained Cure of Clostridium Difficile Infection in Adults That Are Receiving Therapy to Suppress the Immune System

Terminated· Astellas logo

Astellas·Phase 4·NCT01775397·12 enrolled

Show 7 more trials

A Phase IIIB/IV Study to Compare the Efficacy of Vancomycin Therapy to Extended Duration of Fidaxomicin Therapy in the Clinical Cure of Clostridium Difficile Infection (CDI) in an Older Population

Completed· Astellas logo

Astellas·Phase 4·NCT02254967·364 enrolled

Evaluation of Fidaxomicin in the Treatment of Clostridium Difficile Infection (CDI)

Withdrawn·UUniversity of Pittsburgh··NCT04070352

Study to Evaluate the Pharmacokinetics of Fidaxomicin in Inflammatory Bowel Disease (IBD) Subjects With Clostridium Difficile Infection (CDI)

Completed· Astellas logo

Astellas·Phase 4·NCT02437591·25 enrolled

A Study of Ridinilazole (SMT19969) Compared With Fidaxomicin for the Treatment of Clostridium Difficile Infection (CDI)

Completed·SSummit Therapeutics·Phase 2·NCT02784002·27 enrolled

Fidaxomicin Versus Standard of Care Therapy in Solid Organ Transplant Recipients With Clostridium Difficile Infection

Withdrawn·UUniversity of Colorado, Denver·Phase 4·NCT02464306

Description of the Use of fidAxomicin in Hospitalized Patients With Documented Clostridium diFficile iNfection and of the managEment of These Patients

Completed· Astellas logo

Astellas··NCT02214771·296 enrolled

Fecal Microbiota Transplantation for Relapsing Clostridium Difficile Infection

Completed·UUniversity of Aarhus·Phase 3·NCT02743234·64 enrolled

Diarrhea4 trials

Fidaxomicin Versus Vancomycin for the Treatment of Clostridium Difficile-Associated Diarrhea (CDAD) (MK-5119-018)

Completed· Merck & Co. logo

Merck & Co.·Phase 3·NCT00314951·629 enrolled

Safety, Tolerability, and Pharmacokinetics of Fidaxomicin in Pediatric Subjects With Clostridium Difficile-associated Diarrhea (CDAD)

Completed· Merck & Co. logo

Merck & Co.·Phase 2·NCT01591863·38 enrolled

A Study to Investigate the Safety and Efficacy of Fidaxomicin (Oral Suspension or Tablets) and Vancomycin (Oral Liquid or Capsules) in Pediatric Subjects With Clostridium Difficile-associated Diarrhea (CDAD)

Completed· Astellas logo

Astellas·Phase 3·NCT02218372·148 enrolled

Show 1 more trial

Safety and Efficacy of Fidaxomicin Versus Placebo for Prophylaxis Against Clostridium Difficile-Associated Diarrhea in Adults Undergoing Hematopoietic Stem Cell Transplantation (MK-5119-001)

Completed· Merck & Co. logo

Merck & Co.·Phase 3·NCT01691248·611 enrolled

Fidaxomicin4 trials

A Study to Assess the Effects of Multiple Doses of Fidaxomicin on a Single Dose of Rosuvastatin in Healthy Male Subjects

Completed· Astellas logo

Astellas·Phase 1·NCT02083627·25 enrolled

Study to Assess Inhibition of Spore Production in Patients With C. Difficile Infections: Fidaxomicin Versus Vancomycin

Completed·HHartford Hospital·Phase 4·NCT01818141·34 enrolled

A Study to Assess the Safety, Tolerability and Pharmacokinetics of Single and Multiple Ascending Doses of Fidaxomicin in Healthy Male Japanese and Caucasian Subjects

Completed· Astellas logo

Astellas·Phase 1·NCT01813448·36 enrolled

Show 1 more trial

Efficacy of 30-day Duration of Fidaxomicin for Recurrent C. Difficile Infection

Terminated·MMcMaster University·Phase 3·NCT02395848·31 enrolled

Clostridioides difficile Infection2 trials

Primary or Recurrent Clostridioides Difficile Infection Treatment With Capsules of Lyophilised Faecal Microbiota vs Fidaxomicin

Completed·MMikrobiomik Healthcare Company S.L.·Phase 3·NCT05201079·93 enrolled

STOP-CDI: Efficacy of Fecal Microbiota Transplantation vs Fidaxomicin vs Vancomycin in Treating and Preventing Relapse of Clostridioides Difficile Infection

Not yet recruiting·MMedical University of Warsaw·N/A·NCT07120490·424 enrolled

Inflammatory Bowel Disease1 trial

Use of Fidaxomicin Compared to Vancomycin for Decolonization of C. Difficile in Patients With Inflammatory Bowel Disease

Not yet recruiting·—·Phase 4·NCT06794944·60 enrolled

5 more indications

Antibiotics1 trial

A Comparison of Fidaxomicin and Vancomycin in Patients With CDI Receiving Antibiotics for Concurrent Infections

Completed·UUniversity of Michigan·Phase 4·NCT02692651·144 enrolled

Clostridium Difficile1 trial

Fidaxomicin to Prevent Clostridium Difficile Colonization

Withdrawn·WWashington University School of Medicine·Phase 4·NCT01552668

Antibiotic1 trial

Impact of Oral Antibiotic Treatment on C. Difficile

Completed·—·Phase 4·NCT02057198·33 enrolled

Clostridium1 trial

CSP #596 - Optimal Treatment for Recurrent Clostridium Difficile Infection

Terminated·VVA Office of Research and Development·Approved·NCT02667418·308 enrolled

Colitis1 trial

Initial Vancomycin Taper for the Prevention of Recurrent Clostridioides Difficile Infection 2: A Randomized Controlled Trial

Recruiting·MMcGill University Health Centre/Research Institute of the McGill University Health Centre·Phase 3·NCT07328971·500 enrolled

Regulatory

FDA Approval Timeline[5]

May 27, 2011

DIFICID

NDA NDA201699

Jan 24, 2020

DIFICID

NDA NDA213138

Sources

References

[1]
ClinicalTrials.gov — 26 trial records for Fidaxomicin. U.S. National Library of Medicine, National Institutes of Health.
[2]
MedlinePlus Drug Information — Dificlir drug information. U.S. National Library of Medicine, National Institutes of Health.
[3]
ChEMBL — Fidaxomicin compound record. European Bioinformatics Institute (EMBL-EBI).
[4]
Open Targets Platform — Drug–disease associations for Fidaxomicin. EMBL-EBI & Wellcome Sanger Institute.
[5]
OpenFDA — FDA approval records (NDA NDA213138). U.S. Food & Drug Administration.
[6]
FDA Orange Book — Patent and exclusivity data for Dificlir. U.S. Food & Drug Administration.
[7]
SEC EDGAR — Merck & Co. company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Mechanism of Action: DNA-Directed RNA Polymerase Inhibitor[3]
Modality: Small molecule[3]
Highest Phase: Approved[1]
Company: Merck & Co.

Patent Landscape[6]

Patent Cliff

Mar 4, 2027

Earliest patent expiration — generic entry possible after this date

Patent #Expires

7906489Mar 4, 2027

8859510Jul 31, 2027

7378508Jul 31, 2027

7863249Jul 31, 2027

7906489*PEDSep 4, 2027

5 more patents

7378508*PEDJan 31, 2028

7863249*PEDJan 31, 2028

8859510*PEDJan 31, 2028

9808530May 28, 2034

9808530*PEDNov 28, 2034

Dificlir

Status by Indication[4][1]

Competitive Landscape

Expected Milestones

Q2 2027

Q4 2030

Q3 2031

Trials by Indication[1]

Clostridium Difficile Infection10 trials

Diarrhea4 trials

Fidaxomicin4 trials

Clostridioides difficile Infection2 trials

Inflammatory Bowel Disease1 trial

Antibiotics1 trial

Clostridium Difficile1 trial

Antibiotic1 trial

Clostridium1 trial

Colitis1 trial

FDA Approval Timeline[5]

References

Drug Info

Quick Facts

Patent Landscape[6]

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