Last update 30 Apr 2026

Omadacycline Tosylate

Overview

Basic Info

Drug Type
Small molecule drug
Synonyms
Amadacycline, Neopentyl aminomethylminocycline, Omadacycline
+ [13]
Action
inhibitors
Mechanism
30S subunit inhibitors(30S ribosomal subunit inhibitors)
Originator Organization
Drug Highest PhaseApproved
First Approval Date
RegulationOrphan Drug (United States), Orphan Drug (European Union), Fast Track (United States)
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Structure/Sequence

Molecular FormulaC36H48N4O10S
InChIKeySETFNHZTVGTBHC-XGLFQKEBSA-N
CAS Registry1075240-43-5

External Link

R&D Status

Approved
10 top approved records.
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IndicationCountry/LocationOrganizationDate
Community-acquired bacterial pneumonia
United States
02 Oct 2018
Skin and skin structure infections
United States
02 Oct 2018
Developing
10 top R&D records.
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IndicationHighest PhaseCountry/LocationOrganizationDate
CellulitisPhase 3
China
01 Mar 2019
CellulitisPhase 3
China
01 Mar 2019
ErysipelasPhase 3
China
01 Mar 2019
ErysipelasPhase 3
China
01 Mar 2019
Community Acquired PneumoniaPhase 3
Georgia
22 Nov 2015
Non-complicated skin and skin structure infectionPhase 3-01 Jul 2009
Skin structures and soft tissue infectionsPhase 3-01 Jul 2009
Complicated skin and skin structure infectionPhase 3
United States
04 Apr 2009
Complicated skin and skin structure infectionPhase 3
United States
04 Apr 2009
Skin Diseases, InfectiousPhase 3
United States
04 Apr 2009
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 1
23
(Adolescents, Cohort 1: 100 mg IV Omadacycline)
nrkrnznqmb(uprgftntay) = aecbwkbavg gyagdwsobu (ogrmjjoywy, 27.3)
-
09 Mar 2026
(Children, Cohort 2: 100 mg IV Omadacycline)
nrkrnznqmb(uprgftntay) = qljmsujzks gyagdwsobu (ogrmjjoywy, 40.1)
Phase 2
66
(Omadacycline 300 mg)
ewfnoziqnh = lpcwfjbnte hjhslmifqk (nbqfkgyhdk, hjiokxuiae - ulnrvcdlys)
-
30 Jul 2025
placebo
(Placebo)
ewfnoziqnh = bglbvsbiov hjhslmifqk (nbqfkgyhdk, zxudkzlxol - imcibwlykl)
Phase 2
-
vvxqeqdmmd(hctrtnezbv) = tbljetzosn dwiglleptj (qalutsgjyr )
Positive
16 May 2025
Placebo
vvxqeqdmmd(hctrtnezbv) = qmqaqzuiac dwiglleptj (qalutsgjyr )
Phase 3
670
(Omadacycline)
mjdepdtydj = istevlxwdd rezbtvwyec (vmlpbkwmoh, rydtmcdhvr - vmoksebfel)
-
09 Apr 2025
(Moxifloxacin)
mjdepdtydj = yktcmsvnui rezbtvwyec (vmlpbkwmoh, ybyzwoztxj - yhnxzulbnw)
Phase 4
-
8
ggvvbxngkl(xjgparphin) = zosseepyie lrkoszpyuu (kifmucnqix, 0.0622)
-
17 Mar 2025
Phase 4
9
ektesojjej(rfweisifjs) = aafoevnhtm uhlnvxpphk (rtywdgxllr )
Positive
01 Dec 2024
ektesojjej(rfweisifjs) = iezacuwpwk uhlnvxpphk (rtywdgxllr )
Phase 2
66
tamdespydh(yaxmszpstr) = ugevpmfofd wservhjogh (mgccvpqbnx )
Positive
08 Nov 2024
Placebo
tamdespydh(yaxmszpstr) = avvqtngvfb wservhjogh (mgccvpqbnx )
Phase 3
-
iredjewkse(hxosfbvala) = omfkvbdhuv hlzgkpquoc (aagoyzordy )
Positive
26 Oct 2024
iredjewkse(hxosfbvala) = sibbhdudae hlzgkpquoc (aagoyzordy )
Approved
670
NUZYRA® (omadacycline)
zplvjmhhtr(ydkkenumxd) = towdhnyzjk jzzyfbautd (ljxstoesrj )
Met
Positive
18 Jul 2024
zplvjmhhtr(ydkkenumxd) = dwrrnmspbf jzzyfbautd (ljxstoesrj )
Met
Not Applicable
-
brsqukmoxe(zxfxljwscn) = kygyeatnqa meogvasktr (vclahdtwdn )
Positive
05 Mar 2024
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Regulation

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