CDEK
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lefamulin

Trade name: Xenleta

Small moleculeapprovedFast Track FDA

Approved

Aug 19, 2019

LEFAMULIN is a pleuromutilin antibiotic under development for the treatment of community-acquired bacterial pneumonia, as well as acute bacterial skin and skin structure infections. It inhibits bacterial protein synthesis by binding to the peptidyl transferase center of the 50S ribosome, resulting in the cessation of bacterial growth. — NCATS

Clinical trial activity

7 trials · 3 clinical orgs · 2 marketing orgs

Phase 1
4
Phase 2
4
Phase 3
2
Phase 4
0

Earliest trial started May 1, 2010 (NCT01119105)

Timeline

2010s

  1. Jan 1, 2010

    Nabriva Therapeutics AG — Earliest Phase 2 Sponsor(trial)

  2. Jan 1, 2015

    Nabriva Therapeutics AG — Earliest Phase 1 Sponsor(trial)

  3. Jan 1, 2015

    Nabriva Therapeutics AG — Earliest Phase 3 Sponsor(trial)

  4. Aug 19, 2019

    Nabriva Therapeutics AG — Earliest FDA Approval

  5. Aug 19, 2019

    Nabriva Therapeutics AG — Marketing Organization

  6. Aug 19, 2019

    Nabriva Therapeutics AG — NDA Organization

  7. Aug 19, 2019

    Eu Yan Sang — Marketing Organization

Indications

Approved for

Studied for

Mechanism of action

Approval history

  • approvedPriority reviewFast trackAug 19, 2019

Chemistry & pharmacology

Loading structure…

SMILES

C[C@@H]1CC[C@@]23CCC(=O)[C@H]2[C@]1(C)[C@@H](C[C@@](C)(C=C)[C@@H](O)[C@@H]3C)OC(=O)CS[C@@H]4CC[C@@H](N)C[C@H]4O
Mol. weight
507.726 g/mol
Lipinski Ro5
1 violation(s)
Rule of 3
No
Chirality
Single Stereoisomer
Inorganic
No
Polymer
No
Delivery
Oral, Parenteral
Availability
Prescription Only

Oral

Yes

Parenteral

Yes

Topical

No

Sources

Also known as

  • bc-3781
  • bc-3781
  • bc-3781
  • bc-3781
  • lefamulin
  • lefamulin
  • lefamulin
  • lefamulin

Clinical trials

NCT IDPhaseStart dateSponsor(s)
NCT05225805Phase 1Mar 1, 2022Nabriva Therapeutics AG
NCT05111002Phase 1/Phase 2 (Phase 2)Nov 30, 2021Nabriva Therapeutics AG, University of Washington
NCT03131141Phase 1Jan 8, 2017Nabriva Therapeutics AG, Quotient
NCT02813694Phase 3Apr 1, 2016Nabriva Therapeutics AG
NCT02559310Phase 3Sep 1, 2015Nabriva Therapeutics AG
NCT02557789Phase 1Jun 1, 2015Nabriva Therapeutics AG
NCT01119105Phase 2May 1, 2010Nabriva Therapeutics AG
Showing 7 of 7 trials
Page 1 / 1

Organizations

Research & Development (3)

OrganizationOrg typeTrialsAs lead sponsorPhasesEarliest year
Nabriva Therapeutics AGFor profit7632010
QuotientFor profit1012017
University of WashingtonAcademic/Hospital1112021
3 organizations
Page 1 / 1

Marketing (3)

OrganizationOrg typeRelationshipDate
Eu Yan SangFor profitMKTGAug 19, 2019
Nabriva Therapeutics AGFor profitMKTGAug 19, 2019
Nabriva Therapeutics AGFor profitNDAAug 19, 2019