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Xenleta

(Lefamulin)

Small molecule

TTaizhou Hanzhong biomedical co. LTD

0

Indications

5

Total Trials

0

Active Trials

0

Competitors

2

FDA Applications

NDA/BLA/ANDA regulatory filings

4

Patents

Clinical

Trials by Indication[1]

Pneumonia2 trials

Study to Compare Lefamulin to Moxifloxacin for the Treatment of Adults With Pneumonia

Completed·NNabriva Therapeutics AG·Phase 3·NCT02813694·738 enrolled

Study to Compare Lefamulin to Moxifloxacin (With or Without Linezolid) for the Treatment of Adults With Pneumonia

Completed·NNabriva Therapeutics AG·Phase 3·NCT02559310·551 enrolled

Tics1 trial

Bioavailability and Pharmacokinetics of Lefamulin When Administered to Fed and Fasted Healthy Subjects

Completed·NNabriva Therapeutics AG·Phase 1·NCT02557789·20 enrolled

Treatment Failure1 trial

Lefamulin for M. Genitalium Treatment Failures

Terminated·UUniversity of Washington·Phase 1/2·NCT05111002·12 enrolled

Cystic Fibrosis1 trial

Study to Assess the Safety and PK of Oral and IV Xenleta in Adults With Cystic Fibrosis

Completed·NNabriva Therapeutics AG·Phase 1·NCT05225805·13 enrolled

Regulatory

FDA Approval Timeline[3]

Aug 19, 2019

XENLETA

NDA NDA211673

Aug 19, 2019

XENLETA

NDA NDA211672

Sources

References

[1]
ClinicalTrials.gov — 5 trial records for Lefamulin. U.S. National Library of Medicine, National Institutes of Health.
[2]
ChEMBL — Lefamulin compound record. European Bioinformatics Institute (EMBL-EBI).
[3]
OpenFDA — FDA approval records (NDA NDA211673). U.S. Food & Drug Administration.
[4]
FDA Orange Book — Patent and exclusivity data for Xenleta. U.S. Food & Drug Administration.
[5]
SEC EDGAR — Taizhou Hanzhong biomedical co. LTD company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Modality: Small molecule[2]
Company: TTaizhou Hanzhong biomedical co. LTD

Patent Landscape[4]

Patent Cliff

Mar 19, 2028

Earliest patent expiration — generic entry possible after this date

Patent #Expires

8153689Mar 19, 2028

9120727May 23, 2031

8071643Mar 25, 2033

12121582Jun 14, 2036

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