Xenleta

(Lefamulin)

Phase 3Small molecule

TTaizhou Hanzhong biomedical co. LTD

Xenleta is one of 58 small molecule programs targeting Pneumonia. It is currently in Phase 3.

Indications

Total Trials

Active Trials

Competitors

FDA Applications

NDA/BLA/ANDA regulatory filings

Patents

Pipeline

Status by Indication[3][1]

Indication

PneumoniaActive, not recruiting

Cystic FibrosisActive, not recruiting

PneumoniaPhase 3

Active, not recruiting

Cystic FibrosisPhase 1

Active, not recruiting

Competition

Competitive Landscape

547 competitors in Pneumonia

#DrugCompanyPhaseTrials

Xenleta

TTaizhou Hanzhong biomedical co. LTD

Phase 3

2 2

Primaquine

Sanofi

Preclinical

1 3

Avlosulfon

AAlmirall, S.A.

Preclinical

4 4

Virazole

CConrado Roberto Hoffmann Filho

Preclinical

2 5

Advil

KKenvue Brands

Preclinical

2 6

Gantanol

CConrado Roberto Hoffmann Filho

Preclinical

2 7

Retrovir

BBp Consulting, Inc

Preclinical

2 8

Primsol

CConrado Roberto Hoffmann Filho

Preclinical

2 9

Prograf

VVeloxis Pharmaceuticals

Preclinical

1 10

Nexium

DDexcel Pharma Technologies Ltd.

Preclinical

Ranked by pipeline maturity and clinical activity. Current drug highlighted in teal.

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

Treatment Failure1 trial

Lefamulin for M. Genitalium Treatment Failures

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

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[4]

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]
Open Targets Platform — Drug–disease associations for Lefamulin. EMBL-EBI & Wellcome Sanger Institute.
[4]
OpenFDA — FDA approval records (NDA NDA211673). U.S. Food & Drug Administration.
[5]
FDA Orange Book — Patent and exclusivity data for Xenleta. U.S. Food & Drug Administration.
[6]
SEC EDGAR — Taizhou Hanzhong biomedical co. LTD company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Modality: Small molecule[2]
Highest Phase: Phase 3[1]
Company: TTaizhou Hanzhong biomedical co. LTD

Patent Landscape[5]

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

Xenleta

Status by Indication[3][1]

Competitive Landscape

Trials by Indication[1]

Pneumonia2 trials

Treatment Failure1 trial

Tics1 trial

Cystic Fibrosis1 trial

FDA Approval Timeline[4]

References

Drug Info

Quick Facts

Patent Landscape[5]

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