Zemdri

(plazomicin)

Small molecule

Cipla

Indications

Total Trials

Active Trials

Competitors

FDA Application

NDA/BLA/ANDA regulatory filings

Patents

Clinical

Trials by Indication[1]

Urinary Tract Infection2 trials

A Study of Plazomicin Compared With Meropenem for the Treatment of Complicated Urinary Tract Infection (cUTI) Including Acute Pyelonephritis (AP)

Completed·AAchaogen, Inc.·Phase 3·NCT02486627·609 enrolled

A Study of Plazomicin Compared With Levofloxacin for the Treatment of Complicated Urinary Tract Infection (cUTI) and Acute Pyelonephritis (AP)

Completed·AAchaogen, Inc.·Phase 2·NCT01096849·145 enrolled

ESRD1 trial

Plazomicin Study in ESRD Patients Receiving IHD

Completed·CCipla USA Inc.·Phase 1·NCT04699656·6 enrolled

Metformin1 trial

A Study to Assess the Effect of Plazomicin on the Pharmacokinetics of Metformin

Completed·AAchaogen, Inc.·Phase 1·NCT03270553·16 enrolled

Infection1 trial

A Study of Plazomicin Compared With Colistin in Patients With Infection Due to Carbapenem-Resistant Enterobacteriaceae (CRE)

Completed·AAchaogen, Inc.·Phase 3·NCT01970371·69 enrolled

Regulatory

FDA Approval Timeline[3]

Jun 25, 2018

ZEMDRI

NDA NDA210303

Sources

References

[1]
ClinicalTrials.gov — 5 trial records for plazomicin. U.S. National Library of Medicine, National Institutes of Health.
[2]
ChEMBL — plazomicin compound record. European Bioinformatics Institute (EMBL-EBI).
[3]
OpenFDA — FDA approval records (NDA NDA210303). U.S. Food & Drug Administration.
[4]
FDA Orange Book — Patent and exclusivity data for Zemdri. U.S. Food & Drug Administration.
[5]
SEC EDGAR — Cipla company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Modality: Small molecule[2]
Company: Cipla

Patent Landscape[4]

Patent Cliff

Nov 21, 2028

Earliest patent expiration — generic entry possible after this date

Patent #Expires

9688711Nov 21, 2028

9266919Nov 21, 2028

8822424Nov 21, 2028

8383596Jun 25, 2032