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Bludigo

(Indigotindisulfonate sodium 0.8% injection)

PProvepharm SAS

0

Indications

1

Total Trials

1

Active Trials

0

Competitors

1

FDA Application

NDA/BLA/ANDA regulatory filings

Timeline

Expected Milestones

Q4 2026

Phase 3Not yet recruiting

Ureter Injury

NCT06448143

Clinical

Trials by Indication[1]

Ureter Injury1 trial

An Open-Label, Multicenter Study to Evaluate the Safety, Pharmacokinetics and Conspicuity of Bludigo® When Used as an Aid in the Determination of Ureteral Patency in Pediatric Patients

Not yet recruiting·PProve pharm·Phase 3·NCT06448143·18 enrolled

Regulatory

FDA Approval Timeline[3]

Jul 8, 2022

BLUDIGO

NDA NDA216264

Sources

References

[1]
ClinicalTrials.gov — 1 trial record for Indigotindisulfonate sodium 0.8% injection. U.S. National Library of Medicine, National Institutes of Health.
[2]
ChEMBL — Indigotindisulfonate sodium 0.8% injection compound record. European Bioinformatics Institute (EMBL-EBI).
[3]
OpenFDA — FDA approval records (NDA NDA216264). U.S. Food & Drug Administration.
[4]
SEC EDGAR — Provepharm SAS company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Company: PProvepharm SAS

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