Last update 04 Oct 2024

Solithromycin

Overview

Basic Info

Drug Type
Small molecule drug
Synonyms
Solithromycin (JAN/USAN), CEM-101, OP-1068
+ [3]
Mechanism
50S subunit inhibitors(50S ribosomal subunit inhibitors), Protein biosynthesis inhibitors
Originator Organization
Drug Highest PhasePhase 3
First Approval Date-
Regulation-

Structure

Molecular FormulaC43H65FN6O10
InChIKeyIXXFZUPTQVDPPK-ZAWHAJPISA-N
CAS Registry760981-83-7

External Link

R&D Status

10 top R&D records.
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IndicationHighest PhaseCountry/LocationOrganizationDate
Community Acquired PneumoniaNDA/BLA
US
20 Jan 2016
Respiratory Tract InfectionsPhase 3
JP
30 Jan 2022
GonorrheaPhase 3
US
01 Aug 2014
GonorrheaPhase 3
AU
01 Aug 2014
Community-acquired bacterial pneumoniaPhase 3
US
01 Dec 2012
Community-acquired bacterial pneumoniaPhase 3
AR
01 Dec 2012
Community-acquired bacterial pneumoniaPhase 3
BG
01 Dec 2012
Community-acquired bacterial pneumoniaPhase 3
CA
01 Dec 2012
Community-acquired bacterial pneumoniaPhase 3
CZ
01 Dec 2012
Community-acquired bacterial pneumoniaPhase 3
DO
01 Dec 2012
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Clinical Result

Indication
Phase
Evaluation
View All Results
Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 3
Gonorrhea
First line
261
zanqafsmgy(nbniciiklt) = varwngjqwj khbcttqnyy (kdajqhxbtx )
Negative
01 Aug 2019
zanqafsmgy(nbniciiklt) = kvwvzencnc khbcttqnyy (kdajqhxbtx )
Phase 2/3
97
(Solithromycin)
wbtcohegtn(vjrolgzrhi) = kzojcvsgyb wyjvadbrjn (zrmijdanxi, cblxzakldb - ujjaftqplr)
-
03 Jan 2019
Standard of Care
(Standard of Care)
wbtcohegtn(vjrolgzrhi) = cgbnwphfdb wyjvadbrjn (zrmijdanxi, wyoutybolg - zdeiajuvgr)
Phase 3
863
jtapgfyulk(grdgirlyuj) = xuajytxdrn alpsyqgpeq (oysbdivqkn )
Non-inferior
15 Oct 2016
jtapgfyulk(grdgirlyuj) = pgnauerazn alpsyqgpeq (oysbdivqkn )
Phase 3
860
jxrzrhkids(pbyyuckbqk) = zzugguglmi msbrujwrae (omzbifltkz )
Non-inferior
01 Apr 2016
jxrzrhkids(pbyyuckbqk) = bckxsmgwoo msbrujwrae (omzbifltkz )
Phase 1
-
13
ffmkafjmyx(laqbhndxxm) = mjqvkrjqrk kpysphltgd (vfenvsgful, 0.61)
-
01 Apr 2016
Phase 2
59
tcrjaavkcy(zmsvvutbih) = pzxeepxjku qgvtmzkhfl (tkjgyqxiwx )
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 )
-
01 Sep 2015
Oral moxifloxacin
Phase 2
132
vrulspmcbc(mivznoexpn) = mfnerujfwy kfhyllfdum (qonxrzmcvt )
-
01 Jun 2013
vrulspmcbc(mivznoexpn) = itfnaqqtyq kfhyllfdum (qonxrzmcvt )
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Regulation

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