Drugs / Lefamulin
Lefamulin
Regulatory milestones approvals, filings & regulatory actions · 2 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Approved | EU (EMA) | Xenleta | — | 2020-07-27 | europa.eu ↗ |
| Approved | US (FDA) | XENLETA | — | 2019-08-19 | fda.gov ↗ |
Trials 7
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 13 trials | ||||||
| Phase 1 | NCT05225805 | Mar → Sep 2022 | cystic fibrosis | Nabriva Therapeutics AG | Completed | No outcome recorded |
| Phase 1 | NCT03131141 | Jan → Oct 2017 | — | Nabriva Therapeutics AG | Completed | No outcome recorded |
| Phase 1 | NCT02557789 | Jun 2015 | — | Nabriva Therapeutics AG | Completed | No outcome recorded |
| Phase 1/21 trial | ||||||
| Phase 1/2 | NCT05111002 | Apr 2022 → Nov 2023 | Mycoplasmoides infection | University of Washington | Terminated | No outcome recorded |
| Phase 21 trial | ||||||
| Phase 2 | NCT01119105 | May → Dec 2010 | bacterial infectious disease, skin infection | Nabriva Therapeutics AG | Completed | No outcome recorded |
| Phase 32 trials · 2 met primary | ||||||
| Phase 3 | NCT02813694 | Aug 2016 → Jan 2018 | — | Nabriva Therapeutics AG | Completed | Met primary |
| Phase 3 | NCT02559310 | Sep 2015 → Apr 2017 | — | Nabriva Therapeutics AG | Completed | Met primary |
Press releases naming this drug 2 releases
| Date | Issuer | Release |
|---|---|---|
| 2024-12-11 | Meitheal Pharmaceuticals, Inc. | Meitheal Pharmaceuticals Grows Specialty Biopharmaceuticals Portfolio with Exclusive Commercial Licensing Agreement for XENLETA® (lefamulin acetate) meithealpharma.com ↗ |
| 2023-11-22 | Sumitomo Pharma America, Inc. | Sumitomo Pharma Announces the Approval of XENLETA (lefamulin acetate) for the Treatment of Community-Acquired Pneumonia in China sumitomo-pharma.com ↗ |
Evidence & citations 9 cited values
Every value below carries the sentence it was read from. 9 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Lefamulin | ClinicalTrials.gov intervention name — accepted as the source's own label NCT05225805 ↗ |
| Known as | BC-3781 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT01119105 ↗ |
| Known as | BC-3781.Ac | ChEMBL registry synonym — accepted as the source's own label CHEMBL3291398 ↗ |
| Known as | LEFAMULIN ACETATE | ChEMBL registry synonym — accepted as the source's own label CHEMBL3291398 ↗ |
| Known as | Lefamulina | ChEMBL registry synonym — accepted as the source's own label CHEMBL3291398 ↗ |
| Known as | Lefamuline | ChEMBL registry synonym — accepted as the source's own label CHEMBL3291398 ↗ |
| Known as | Xenleta | ChEMBL registry synonym — accepted as the source's own label CHEMBL3291398 ↗ |
| Modality | Other / unclassified | “BC-3781, a pleuromutilin antimicrobial agent” PMID 25348519 ↗ Oct 2014 |
| Route | Intravenous | “BC-3781 dose 100mg is administered as i.v. infusion every 12 h for 5 to 14 days depending on the clinical response.” NCT01119105 ↗ |