Drug Type Small molecule drug |
Synonyms Solithromycin (JAN/USAN), CEM-101, OP-1068 + [3] |
Target |
Mechanism 50S subunit inhibitors(50S ribosomal subunit inhibitors), Protein biosynthesis inhibitors |
Therapeutic Areas |
Active Indication |
Inactive Indication |
Originator Organization |
Active Organization |
Inactive Organization |
Drug Highest PhasePhase 3 |
First Approval Date- |
Regulation- |
Molecular FormulaC43H65FN6O10 |
InChIKeyIXXFZUPTQVDPPK-ZAWHAJPISA-N |
CAS Registry760981-83-7 |
KEGG | Wiki | ATC | Drug Bank |
---|---|---|---|
D09965 | Solithromycin |
Indication | Highest Phase | Country/Location | Organization | Date |
---|---|---|---|---|
Community Acquired Pneumonia | NDA/BLA | US | 20 Jan 2016 | |
Respiratory Tract Infections | Phase 3 | JP | 30 Jan 2022 | |
Gonorrhea | Phase 3 | US | 01 Aug 2014 | |
Gonorrhea | Phase 3 | AU | 01 Aug 2014 | |
Community-acquired bacterial pneumonia | Phase 3 | US | 01 Dec 2012 | |
Community-acquired bacterial pneumonia | Phase 3 | AR | 01 Dec 2012 | |
Community-acquired bacterial pneumonia | Phase 3 | BG | 01 Dec 2012 | |
Community-acquired bacterial pneumonia | Phase 3 | CA | 01 Dec 2012 | |
Community-acquired bacterial pneumonia | Phase 3 | CZ | 01 Dec 2012 | |
Community-acquired bacterial pneumonia | Phase 3 | DO | 01 Dec 2012 |
Phase 3 | Gonorrhea First line | 261 | zanqafsmgy(nbniciiklt) = varwngjqwj khbcttqnyy (kdajqhxbtx ) View more | Negative | 01 Aug 2019 | ||
zanqafsmgy(nbniciiklt) = kvwvzencnc khbcttqnyy (kdajqhxbtx ) View more | |||||||
Phase 2/3 | 97 | (Solithromycin) | wbtcohegtn(vjrolgzrhi) = kzojcvsgyb wyjvadbrjn (zrmijdanxi, cblxzakldb - ujjaftqplr) View more | - | 03 Jan 2019 | ||
Standard of Care (Standard of Care) | wbtcohegtn(vjrolgzrhi) = cgbnwphfdb wyjvadbrjn (zrmijdanxi, wyoutybolg - zdeiajuvgr) View more | ||||||
Phase 3 | 863 | jtapgfyulk(grdgirlyuj) = xuajytxdrn alpsyqgpeq (oysbdivqkn ) View more | Non-inferior | 15 Oct 2016 | |||
jtapgfyulk(grdgirlyuj) = pgnauerazn alpsyqgpeq (oysbdivqkn ) View more | |||||||
Phase 3 | 860 | Placebo+solithromycin | jxrzrhkids(pbyyuckbqk) = zzugguglmi msbrujwrae (omzbifltkz ) View more | Non-inferior | 01 Apr 2016 | ||
jxrzrhkids(pbyyuckbqk) = bckxsmgwoo msbrujwrae (omzbifltkz ) View more | |||||||
Phase 1 | - | 13 | ffmkafjmyx(laqbhndxxm) = mjqvkrjqrk kpysphltgd (vfenvsgful, 0.61) | - | 01 Apr 2016 | ||
Phase 2 | 59 | tcrjaavkcy(zmsvvutbih) = pzxeepxjku qgvtmzkhfl (tkjgyqxiwx ) View more | Positive | 01 Oct 2015 | |||
Phase 3 | 860 | ehlxbptpja(ithqixbvvs) = 36.6% vs 35.6% of patients experienced adverse events with Oral solithromycin vs Oral moxifloxacin flcwunimrx (digvrfzgus ) View more | - | 01 Sep 2015 | |||
Oral moxifloxacin | |||||||
Phase 2 | 132 | vrulspmcbc(mivznoexpn) = mfnerujfwy kfhyllfdum (qonxrzmcvt ) View more | - | 01 Jun 2013 | |||
vrulspmcbc(mivznoexpn) = itfnaqqtyq kfhyllfdum (qonxrzmcvt ) View more |