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Xtoro

(Finafloxacin)

Small molecule

FFabricio Lopes da Fonseca

0

Indications

7

Total Trials

0

Active Trials

0

Competitors

1

FDA Application

NDA/BLA/ANDA regulatory filings

4

Patents

Clinical

Trials by Indication[1]

Pyelonephritis1 trial

Finafloxacin for the Treatment of cUTI and/or Acute Pyelonephritis

Completed·MMerLion Pharmaceuticals GmbH·Phase 2·NCT01928433·225 enrolled

Age1 trial

Effect of Age and Gender on the PK and Tolerability of Finafloxacin

Completed·MMerLion Pharmaceuticals GmbH·Phase 1·NCT01904162·40 enrolled

Ciprofloxacin1 trial

Finafloxacin 300 mg Twice a Day (b.i.d.) Versus Ciprofloxacin 250 mg Twice a Day (b.i.d) in Patients With Lower Uncomplicated UTI (uUTI)

Completed·MMerLion Pharmaceuticals GmbH·Phase 2·NCT00722735·36 enrolled

SMA1 trial

Pharmacokinetic Profile in Plasma and Epithelial Lining Fluid of Finafloxacin

Completed·MMerLion Pharmaceuticals GmbH·Phase 1·NCT01907867·18 enrolled

Efficacy and Safety1 trial

Efficacy and Safety Study of Finafloxacin Used in Helicobacter Pylori Infected Patients

Completed·MMerLion Pharmaceuticals GmbH·Phase 2·NCT00723502·30 enrolled

2 more indications

Intravenous1 trial

Safety and Tolerability of Single and Multiple Intravenous Doses of Finafloxacin in Healthy Subjects

Completed·MMerLion Pharmaceuticals GmbH·Phase 1·NCT01910883·58 enrolled

Unspecified1 trial

First Time in Man Study of Finafloxacin Hydrochloride

Completed·MMerLion Pharmaceuticals GmbH·Phase 1·NCT00483158·95 enrolled

Regulatory

FDA Approval Timeline[3]

Dec 17, 2014

XTORO

NDA NDA206307

Sources

References

[1]
ClinicalTrials.gov — 7 trial records for Finafloxacin. U.S. National Library of Medicine, National Institutes of Health.
[2]
ChEMBL — Finafloxacin compound record. European Bioinformatics Institute (EMBL-EBI).
[3]
OpenFDA — FDA approval records (NDA NDA206307). U.S. Food & Drug Administration.
[4]
FDA Orange Book — Patent and exclusivity data for Xtoro. U.S. Food & Drug Administration.
[5]
SEC EDGAR — Fabricio Lopes da Fonseca company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Modality: Small molecule[2]
Company: FFabricio Lopes da Fonseca

Patent Landscape[4]

Patent Cliff

Jul 2, 2030

Earliest patent expiration — generic entry possible after this date

Patent #Expires

9119859Jul 2, 2030

9993483Jul 2, 2030

8536167Aug 8, 2031

9504691Nov 21, 2033

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