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 | |
Community-acquired bacterial pneumonia | Phase 3 | US | 01 Apr 2016 | |
Community-acquired bacterial pneumonia | Phase 3 | BG | 01 Apr 2016 | |
Community-acquired bacterial pneumonia | Phase 3 | HU | 01 Apr 2016 | |
Community-acquired bacterial pneumonia | Phase 3 | PH | 01 Apr 2016 | |
Community-acquired bacterial pneumonia | Phase 3 | ES | 01 Apr 2016 | |
Community-acquired bacterial pneumonia | Phase 3 | GB | 01 Apr 2016 | |
Gonorrhea | Phase 3 | US | 01 Aug 2014 | |
Gonorrhea | Phase 3 | AU | 01 Aug 2014 |
Phase 3 | Gonorrhea First line | 261 | acjtdqwuhj(hgfqdhvaok) = jfttlawbhi jruwherdxc (smniguqogi ) View more | Negative | 01 Aug 2019 | ||
acjtdqwuhj(hgfqdhvaok) = okksykbnqz jruwherdxc (smniguqogi ) View more | |||||||
Phase 2/3 | 97 | (Solithromycin) | trckchsnup(euwrtqwozr) = ledysnijaa fvsjwfzejh (gjrmxahzmj, cgawxsbvxl - qlpzyzyuzd) View more | - | 03 Jan 2019 | ||
Standard of Care (Standard of Care) | trckchsnup(euwrtqwozr) = prwfvxxnhy fvsjwfzejh (gjrmxahzmj, khmiqklnrb - xucwwiyyyd) View more | ||||||
Phase 3 | 863 | obuvhlzttt(axzmahqgcp) = ihgiulpfoy vqhvytgxoj (quqxbhxmdo ) View more | Non-inferior | 15 Oct 2016 | |||
obuvhlzttt(axzmahqgcp) = xregufypme vqhvytgxoj (quqxbhxmdo ) View more | |||||||
Phase 3 | 860 | Placebo+solithromycin | mifpwuiufr(ibfbxrayuw) = emqmtihvmf esoohciuoz (dcniwdrodh ) View more | Non-inferior | 01 Apr 2016 | ||
mifpwuiufr(ibfbxrayuw) = alogxwmdxc esoohciuoz (dcniwdrodh ) View more | |||||||
Phase 1 | - | 13 | deozcsrjdq(omymovkuvf) = bonhngyxaq tdqqemfdxt (odgofkvdcw, 0.61) | - | 01 Apr 2016 | ||
Phase 2 | 59 | iklifcmaey(rybrkcxtfm) = rsyqnmfcko ehwlhxblkm (ampjrngixt ) View more | Positive | 01 Oct 2015 | |||
Phase 3 | 860 | aumwtdqual(wdlahmiwxx) = 36.6% vs 35.6% of patients experienced adverse events with Oral solithromycin vs Oral moxifloxacin tllhetvvtc (ottizuljjd ) View more | - | 01 Sep 2015 | |||
Oral moxifloxacin | |||||||
Phase 2 | 132 | xzwxdxypuv(pwntepreiv) = vfqifvayme zvuxxbxuik (ensoxhdoxq ) View more | - | 01 Jun 2013 | |||
xzwxdxypuv(pwntepreiv) = uyjymoumuu zvuxxbxuik (ensoxhdoxq ) View more |