Vistogard

(uridine triacetate)

PreclinicalSmall molecule

BBTG International Inc.

Vistogard is one of 50 small molecule programs targeting Toxicity. It is currently in Preclinical.

Indications

Total Trials

Active Trials

Competitors

FDA Applications

NDA/BLA/ANDA regulatory filings

Patents

Pipeline

Status by Indication[3][1]

Indication

ToxicityActive, not recruiting

ToxicityPreclinical

Active, not recruiting

Competition

Competitive Landscape

61 competitors in Toxicity

#DrugCompanyPhaseTrials

Aldactone

Pfizer

Approved

1 2

Oncovin

Eli Lilly

Approved

1 3

Zyvox

Pfizer

Approved

1 4

Lipitor

PPfizer's Upjohn has merged with Mylan to form Viatris Inc.

Approved

3 5

Xeloda

EEngelhard Arzneimittel GmbH & Co.KG

Approved

2 6

Ativan

BBausch Health Americas, Inc.

Approved

1 7

Merrem

BB. Braun Medical Inc.

Approved

1 8

Vancocin

HHikma Pharmaceuticals LLC

Approved

1 9

Cubicin

BBaxter Healthcare Corporation

Approved

1 10

Atropen

FFresenius Kabi Taiwan Ltd.

Approved

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

Clinical

Trials by Indication[1]

Pediatric Patients1 trial

Open-Label Study of Uridine Triacetate in Pediatric Patients With Hereditary Orotic Aciduria

Completed·WWellstat Therapeutics·Phase 3·NCT02110147·4 enrolled

Toxicity1 trial

Uridine Triacetate as Antidote for Patients at Excess Risk of 5-FU Toxicity Due to Overdosage or Impaired Elimination

Approved for marketing·WWellstat Therapeutics··NCT01432301

Regulatory

FDA Approval Timeline[4]

Sep 4, 2015

XURIDEN

NDA NDA208169

Dec 11, 2015

VISTOGARD

NDA NDA208159

Sources

References

[1]
ClinicalTrials.gov — 2 trial records for uridine triacetate. U.S. National Library of Medicine, National Institutes of Health.
[2]
ChEMBL — uridine triacetate compound record. European Bioinformatics Institute (EMBL-EBI).
[3]
Open Targets Platform — Drug–disease associations for uridine triacetate. EMBL-EBI & Wellcome Sanger Institute.
[4]
OpenFDA — FDA approval records (NDA NDA208159). U.S. Food & Drug Administration.
[5]
FDA Orange Book — Patent and exclusivity data for Vistogard. U.S. Food & Drug Administration.
[6]
SEC EDGAR — BTG International Inc. company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Modality: Small molecule[2]
Highest Phase: Preclinical[1]
Company: BBTG International Inc.

Patent Landscape[5]

Patent Cliff

Aug 17, 2027

Earliest patent expiration — generic entry possible after this date

Patent #Expires

7776838Aug 17, 2027

Vistogard

Status by Indication[3][1]

Competitive Landscape

Trials by Indication[1]

Pediatric Patients1 trial

Toxicity1 trial

FDA Approval Timeline[4]

References

Drug Info

Quick Facts

Patent Landscape[5]

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