Vibativ

(Telavancin)

ApprovedSmall molecule

AApotex Inc.

Vibativ is one of 100 small molecule programs targeting Chronic Kidney Disease. It is currently in Approved.

Indications

Total Trials

Active Trials

Competitors

FDA Application

NDA/BLA/ANDA regulatory filings

Patents

Pipeline

Status by Indication[3][1]

Indication

Chronic Kidney DiseaseActive, not recruiting

Cystic FibrosisCompleted

ConcentrationRecruiting

Chronic Kidney DiseaseApproved

Active, not recruiting

Cystic FibrosisApproved

Completed

ConcentrationApproved

Recruiting

Competition

Competitive Landscape

172 competitors in Chronic Kidney Disease

#DrugCompanyPhaseTrials

Vibativ

AApotex Inc.

Approved

1 2

Uloric

Takeda

Preclinical

2 3

Vemlidy

Gilead

Preclinical

1 4

Sovaldi

Gilead

Preclinical

1 5

Glucotrol

Pfizer

Preclinical

1 6

Lorelco

Sanofi

Preclinical

1 7

Activase

Flomax

Verquvo

CCidara Therapeutics Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)

Preclinical

1 10

PROCRIT

WWim Janssens

Preclinical

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

Timeline

Expected Milestones

Q4 2026

Post-ApprovalRecruiting

Concentration

NCT06119061

Clinical

Trials by Indication[1]

Pneumonia2 trials

Comparison of Telavancin and Vancomycin for Hospital-acquired Pneumonia Due to Methicillin-resistant Staphylococcus Aureus

Completed·CCumberland Pharmaceuticals·Phase 3·NCT00124020·771 enrolled

Comparison of Telavancin and Vancomycin for Hospital-acquired Pneumonia Due to Methicillin-resistant Staphylococcus Aureus

Completed·CCumberland Pharmaceuticals·Phase 3·NCT00107952·761 enrolled

Infections2 trials

Phase 2 Trial of TD-6424 (Telavancin) Versus Standard Therapy for Complicated Gram Positive Skin and Skin Structure Infections (Gram Positive cSSSI)

Completed·CCumberland Pharmaceuticals·Phase 2·NCT00077675·201 enrolled

Phase 2 Trial of TD 6424 (Telavancin) Versus Standard Therapy for Complicated Gram Positive Skin and Skin Structure Infections (Gram Positive cSSSI)

Completed·CCumberland Pharmaceuticals·Phase 2·NCT00061633·169 enrolled

Methicillin-resistant Staphylococcus Aureus2 trials

Comparison of Telavancin and Vancomycin for Complicated Skin and Skin Structure Infections With a Focus on Methicillin-resistant Staphylococcus Aureus

Completed·CCumberland Pharmaceuticals·Phase 3·NCT00107978·1,035 enrolled

Comparison of Telavancin and Vancomycin for Complicated Skin and Skin Structure Infections With a Focus on Methicillin-resistant Staphylococcus Aureus

Completed·CCumberland Pharmaceuticals·Phase 3·NCT00091819·862 enrolled

Cystic Fibrosis1 trial

Telavancin Pharmacokinetics in Cystic Fibrosis Patients

Completed·JJoseph L. Kuti, PharmD·Phase 4·NCT03172793·18 enrolled

Concentration1 trial

Telavancin Blood and Cerebrospinal Fluid Concentrations in Patients With External Ventricular Drainage

Recruiting·AAaron Cook·Phase 4·NCT06119061·20 enrolled

7 more indications

Obese1 trial

Pharmacokinetics of Telavancin in Normal and Obese Subjects

Completed·UUniversity of Illinois at Chicago·Phase 1·NCT02753855·32 enrolled

Function1 trial

A Study to Evaluate the Effect of Renal Function on the Biological Activity of Telavancin

Completed·CCumberland Pharmaceuticals·Phase 1·NCT01238796·45 enrolled

Staphylococcus Aureus Bacteremia1 trial

Telavancin for Treatment of Uncomplicated Staphylococcus Aureus Bacteremia

Completed·CCumberland Pharmaceuticals·Phase 2·NCT00062647·60 enrolled

Pediatric1 trial

Telavancin Pediatric PK Study (Ages >12 Months to 17 Years)

Terminated·CCumberland Pharmaceuticals·Phase 1·NCT02013141·22 enrolled

Staphylococcus Aureus1 trial

A Phase 3 Telavancin Staphylococcus Aureus (S. Aureus) Bacteremia Trial

Terminated·CCumberland Pharmaceuticals·Phase 3·NCT02208063·121 enrolled

Bloodstream Infection1 trial

Study to Evaluate the Safety and Efficacy of Telavancin in the Treatment of Gram Positive Bloodstream Infections in Cancer Patients

Completed·MM.D. Anderson Cancer Center·Phase 2·NCT01321879·40 enrolled

Chronic Kidney Disease1 trial

Effect of Dialysis on the Pharmacokinetics of Telavancin in Patients With Chronic Kidney Disease Stage 5

Completed·UUniversity of Michigan·Phase 4·NCT02392208·8 enrolled

Regulatory

FDA Approval Timeline[4]

Sep 11, 2009

VIBATIV

NDA NDA022110

Sources

References

[1]
ClinicalTrials.gov — 15 trial records for Telavancin. U.S. National Library of Medicine, National Institutes of Health.
[2]
ChEMBL — Telavancin compound record. European Bioinformatics Institute (EMBL-EBI).
[3]
Open Targets Platform — Drug–disease associations for Telavancin. EMBL-EBI & Wellcome Sanger Institute.
[4]
OpenFDA — FDA approval records (NDA NDA022110). U.S. Food & Drug Administration.
[5]
FDA Orange Book — Patent and exclusivity data for Vibativ. U.S. Food & Drug Administration.
[6]
SEC EDGAR — Apotex Inc. company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Modality: Small molecule[2]
Highest Phase: Approved[1]
Company: AApotex Inc.

Patent Landscape[5]

Patent Cliff

Jan 1, 2027

Earliest patent expiration — generic entry possible after this date

Patent #Expires

7531623Jan 1, 2027

Vibativ

Status by Indication[3][1]

Competitive Landscape

Expected Milestones

Q4 2026

Trials by Indication[1]

Pneumonia2 trials

Infections2 trials

Methicillin-resistant Staphylococcus Aureus2 trials

Cystic Fibrosis1 trial

Concentration1 trial

Obese1 trial

Function1 trial

Staphylococcus Aureus Bacteremia1 trial

Pediatric1 trial

Staphylococcus Aureus1 trial

Bloodstream Infection1 trial

Chronic Kidney Disease1 trial

FDA Approval Timeline[4]

References

Drug Info

Quick Facts

Patent Landscape[5]

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