Drugs / Solithromycin
Solithromycin
Trials 11
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 13 trials | ||||||
| Phase 1 | NCT02348424 | May 2015 → Jan 2017 | gonorrhea | National Institute of Allergy and Infectious Diseases (NIAID) | Completed | No outcome recorded |
| Phase 1 | NCT02268279 | Jan 2015 → Oct 2016 | bacterial infectious disease | Melinta Therapeutics, Inc. | Completed | No outcome recorded |
| Phase 1 | NCT01966055 | Dec 2013 → Aug 2014 | bacterial infectious disease | Melinta Therapeutics, Inc. | Completed | No outcome recorded |
| Phase 24 trials | ||||||
| Phase 2 | NCT02510599 | Dec 2015 → Jan 2017 | metabolic dysfunction-associated steatohepatitis | Melinta Therapeutics, Inc. | Completed | No outcome recorded |
| Phase 2 | NCT02628769 | Jul 2015 → Jan 2017 | chronic obstructive pulmonary disease | Imperial College London | Terminated | No outcome recorded |
| Phase 2 | NCT01591447 | May 2012 → Jun 2013 | gonorrhea | Melinta Therapeutics, Inc. | Completed | No outcome recorded |
| Phase 2 | NCT01168713 | Aug 2010 → Jul 2011 | bacterial pneumonia | Melinta Therapeutics, Inc. | Completed | No outcome recorded |
| Phase 2/31 trial | ||||||
| Phase 2/3 | NCT02605122 | Apr 2016 → Mar 2018 | bacterial pneumonia | Melinta Therapeutics, Inc. | Terminated | No outcome recorded |
| Phase 33 trials · 2 met primary · 1 missed | ||||||
| Phase 3 | NCT02210325 | Aug 2014 → Feb 2017 | gonorrhea | Melinta Therapeutics, Inc. | Completed | Missed primary |
| Phase 3 | NCT01968733 | Nov 2013 → Jul 2015 | bacterial pneumonia | Melinta Therapeutics, Inc. | Completed | Met primary |
| Phase 3 | NCT01756339 | Dec 2012 → Oct 2014 | bacterial pneumonia | Melinta Therapeutics, Inc. | Completed | Met primary |
Evidence & citations 7 cited values
Every value below carries the sentence it was read from. 14 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Solithromycin | ClinicalTrials.gov intervention name — accepted as the source's own label NCT02605122 ↗ |
| Known as | CEM-101 | “Solithromycin (CEM-101) is a novel oral fluoroketolide antimicrobial with substantial in vitro activity against Neisseria gonorrhoeae.” PMID 26089222 ↗ Jun 2015 |
| Known as | OP 1068 | ChEMBL registry synonym — accepted as the source's own label CHEMBL1232510 ↗ |
| Known as | Solithromycine | ChEMBL registry synonym — accepted as the source's own label CHEMBL1232510 ↗ |
| Known as | Solitromicina | ChEMBL registry synonym — accepted as the source's own label CHEMBL1232510 ↗ |
| Modality | Other / unclassified | “Solithromycin is a novel fluoroketolide antibiotic” PMID 29891609 ↗ Jul 2018 |
| Route | Oral | “CEM-101 800 mg PO Day 1” NCT01168713 ↗ |