Bludigo

(Indigotindisulfonate sodium 0.8%)

Small molecule

PProvepharm SAS

Indications

Total Trials

Active Trials

Competitors

FDA Application

NDA/BLA/ANDA regulatory filings

Patents

Timeline

Expected Milestones

Q3 2026

Post-ApprovalRecruiting

Renal Impairment

NCT06085183

Q4 2026

Phase 3Not yet recruiting

Pediatric Patients

NCT06448143

Clinical

Trials by Indication[1]

Renal Impairment1 trial

Indigotindisulfonate Sodium as an Aid in Determination of Ureteral Patency in Patient's With Renal Impairment

Recruiting·PProve pharm·Phase 4·NCT06085183·48 enrolled

Pediatric Patients1 trial

Indigotindisulfonate Sodium Injection, USP as an Aid in the Determination of Ureteral Patency in Pediatric Patients

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

Unspecified1 trial

Indigotindisulfonate Sodium Injection, USP as an Aid in the Determination of Ureteral Patency

Recruiting·PProve pharm·Phase 4·NCT06054880·116 enrolled

Regulatory

FDA Approval Timeline[3]

Jul 8, 2022

BLUDIGO

NDA NDA216264

Sources

References

[1]
ClinicalTrials.gov — 3 trial records for Indigotindisulfonate sodium 0.8%. U.S. National Library of Medicine, National Institutes of Health.
[2]
ChEMBL — Indigotindisulfonate sodium 0.8% compound record. European Bioinformatics Institute (EMBL-EBI).
[3]
OpenFDA — FDA approval records (NDA NDA216264). U.S. Food & Drug Administration.
[4]
FDA Orange Book — Patent and exclusivity data for Bludigo. U.S. Food & Drug Administration.
[5]
SEC EDGAR — Provepharm SAS company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Modality: Small molecule[2]
Company: PProvepharm SAS

Patent Landscape[4]

Patent Cliff

Nov 25, 2036

Earliest patent expiration — generic entry possible after this date

Patent #Expires

11845867Nov 25, 2036

10927258Dec 23, 2037

11499050Dec 23, 2037