Sivextro

(Tedizolid)

ApprovedSmall molecule

Merck & Co.

Sivextro is one of 21 small molecule programs targeting Infective Endocarditis. It is currently in Approved.

Indications

Total Trials

Active Trials

Competitors

FDA Applications

NDA/BLA/ANDA regulatory filings

Patents

Pipeline

Status by Indication[3][1]

Indication

Infective EndocarditisActive, not recruiting

Infective EndocarditisApproved

Active, not recruiting

Competition

Competitive Landscape

28 competitors in Infective Endocarditis

#DrugCompanyPhaseTrials

Acanya

Zyvox

Avelox

Rifadin

Cipro

Cubicin

BBaxter Healthcare Corporation

Approved

2 7

Vancocin

HHikma Pharmaceuticals LLC

Approved

2 8

Alka-Seltzer

AAbbott

Approved

1 9

Levaquin

WWim Janssens

Approved

—10

Amoxil

GGlobal Antibiotics Research and Development Partnership

Approved

—

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

Timeline

Expected Milestones

Q4 2027

ApprovedRecruiting

Endocarditis

NCT05398679

Clinical

Trials by Indication[1]

Hospitalized Patients1 trial

Sivextro in Acute Bacterial Skin and Skin Structure Infection (ABSSSI) in Hospitalized Patients. A Global Observational Study

Terminated· Bayer logo

Bayer··NCT02991131·108 enrolled

Efficacy and Safety1 trial

Efficacy and Safety of Intravenous to Oral 6-Day Tedizolid Phosphate vs. Intravenous to Oral 10-Day Linezolid in Patients With Acute Bacterial Skin and Skin Structure Infection (ABSSSI)

Completed· Bayer logo

Bayer·Phase 3·NCT02066402·598 enrolled

Wound Infection1 trial

Tedizolid Tissue Penetration in Diabetic Patients With Wound Infections and Healthy Volunteers Via In Vivo Microdialysis

Completed·HHartford Hospital·Phase 1·NCT02620787·18 enrolled

Bone and Joint Infection1 trial

Tolerability, Safety, and Efficacy of Tedizolid as Oral Treatment for Bone and Joint Infections (OTTER)

Completed·LLundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center·Phase 2·NCT03009045·44 enrolled

Endocarditis1 trial

Oral Antimicrobial Treatment vs. Outpatient Parenteral for Infective Endocarditis

Recruiting·FFundacion Clinic per a la Recerca Biomédica·Approved·NCT05398679·360 enrolled

Regulatory

FDA Approval Timeline[4]

Jun 20, 2014

SIVEXTRO

NDA NDA205436

Jun 20, 2014

SIVEXTRO

NDA NDA205435

Sources

References

[1]
ClinicalTrials.gov — 5 trial records for Tedizolid. U.S. National Library of Medicine, National Institutes of Health.
[2]
ChEMBL — Tedizolid compound record. European Bioinformatics Institute (EMBL-EBI).
[3]
Open Targets Platform — Drug–disease associations for Tedizolid. EMBL-EBI & Wellcome Sanger Institute.
[4]
OpenFDA — FDA approval records (NDA NDA205436). U.S. Food & Drug Administration.
[5]
FDA Orange Book — Patent and exclusivity data for Sivextro. U.S. Food & Drug Administration.
[6]
SEC EDGAR — Merck & Co. company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Modality: Small molecule[2]
Highest Phase: Approved[1]
Company: Merck & Co.

Patent Landscape[5]

Patent Cliff

Feb 23, 2028

Earliest patent expiration — generic entry possible after this date

Patent #Expires

8420676Feb 23, 2028

7816379Jun 20, 2028

9624250Feb 3, 2030

10065947Feb 3, 2030

9988406Feb 3, 2030

2 more patents

10442829Feb 3, 2030

8426389Dec 31, 2030

Sivextro

Status by Indication[3][1]

Competitive Landscape

Expected Milestones

Q4 2027

Trials by Indication[1]

Hospitalized Patients1 trial

Efficacy and Safety1 trial

Wound Infection1 trial

Bone and Joint Infection1 trial

Endocarditis1 trial

FDA Approval Timeline[4]

References

Drug Info

Quick Facts

Patent Landscape[5]

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