CDEK
← All drugs Report issue

omadacycline

Trade name: nuzyra

Small moleculeapprovedFast Track FDA

Approved

Oct 2, 2018

Omadacycline is a tetracyclin-derivative antibiotic, originated in Tufts University, and later co-developed by Merck and Paratek Pharmaceuticals. The drug was approved for treatment of community-acquired pneumonia, and for treatment of acute bacterial skin and skin structure infections. Omadacycline tosylate is available as tablets and in injectable form. — NCATS

Clinical trial activity

19 trials · 13 clinical orgs · 1 marketing orgs

Phase 1
5
Phase 2
12
Phase 3
7
Phase 4
2

Earliest trial started Jul 18, 2007 (NCT03716024)

Timeline

2000s

  1. Jan 1, 2007

    Paratek Pharmaceuticals Inc — Earliest Phase 2 Sponsor(trial)

  2. Jan 1, 2009

    Paratek Pharmaceuticals Inc — Earliest Phase 3 Sponsor(trial)

2010s

  1. Oct 2, 2018

    Paratek Pharmaceuticals Inc — Earliest FDA Approval

  2. Oct 2, 2018

    Paratek Pharmaceuticals Inc — NDA Secondary Org

  3. Oct 2, 2018

    Paratek Pharmaceuticals Inc — NDA Organization

  4. Jan 1, 2019

    Paratek Pharmaceuticals Inc — Earliest Phase 1 Sponsor(trial)

Indications

Approved for

Studied for

Mechanism of action

Approval history

  • approvedPriority reviewFast trackOct 2, 2018

Chemistry & pharmacology

Loading structure…

SMILES

CN(C)c1cc(CNCC(C)(C)C)c(O)c2c1C[C@H]1C[C@H]3[C@H](N(C)C)C(O)=C(C(N)=O)C(=O)[C@@]3(O)C(O)=C1C2=O
Mol. weight
556.66 g/mol
Lipinski Ro5
2 violation(s)
Rule of 3
No
Chirality
Single Stereoisomer
Inorganic
No
Polymer
No
Delivery
Oral, Parenteral
Availability
Prescription Only

Oral

Yes

Parenteral

Yes

Topical

No

Sources

Also known as

  • 7-dimethylamino-9-(2,2-dimethylpropyl)aminomethylcycline
  • amadacyclin
  • amadacycline
  • amadacycline
  • omadacycline
  • omadacycline
  • omadacycline
  • omadacycline
  • omadacycline tosylate
  • omadacycline tosylate
  • omadacycline tosylate
  • ptk0796
  • ptk 0796
  • ptk 0796
  • ptk 0796
  • ptk-0796
  • ptk-0796
  • ptk-0796

Clinical trials

NCT IDPhaseStart dateSponsor(s)
NCT06462326Phase 1Apr 16, 2024Zai Lab Pty. Ltd., Zhejiang University
NCT06162286Phase 3Nov 17, 2023Fudan University, Zai Lab Pty. Ltd.
NCT05753215Phase 2May 9, 2023Paratek Pharmaceuticals Inc, University of California, Los Angeles
NCT05515562Phase 4Jan 31, 2023High Point University, Paratek Pharmaceuticals Inc, University of Houston, Wake Forest University
NCT05217537Phase 1Apr 6, 2022Paratek Pharmaceuticals Inc
NCT04922554Phase 2Oct 15, 2021Paratek Pharmaceuticals Inc
NCT04779242Phase 3Feb 25, 2021Paratek Pharmaceuticals Inc
NCT06030219Phase 1Oct 12, 2020Ohio State University, Paratek Pharmaceuticals Inc, University of Houston
NCT04460586Phase 4Sep 1, 2020Paratek Pharmaceuticals Inc, University of Southern California
NCT04144374Phase 1Dec 31, 2019Hartford Hospital, Paratek Pharmaceuticals Inc, University of Connecticut
NCT04160260Phase 1Nov 30, 2019Paratek Pharmaceuticals Inc
NCT03757234Phase 2Nov 19, 2018Paratek Pharmaceuticals Inc
NCT03425396Phase 2Dec 28, 2017Paratek Pharmaceuticals Inc
NCT02877927Phase 3Aug 1, 2016Paratek Pharmaceuticals Inc
NCT02531438Phase 3Nov 1, 2015Paratek Pharmaceuticals Inc
NCT02378480Phase 3Jun 1, 2015Paratek Pharmaceuticals Inc
NCT00876850Phase 3Jul 1, 2009Paratek Pharmaceuticals Inc
NCT00865280Phase 3Mar 1, 2009Novartis, Paratek Pharmaceuticals Inc
NCT03716024Phase 2Jul 18, 2007Paratek Pharmaceuticals Inc
Showing 19 of 19 trials
Page 1 / 1

Organizations

Research & Development (13)

OrganizationOrg typeTrialsAs lead sponsorPhasesEarliest year
Paratek Pharmaceuticals IncFor profit171242007
University of HoustonAcademic/Hospital2122020
Zai Lab Pty. Ltd.For profit2222023
Fudan UniversityAcademic/Hospital1012023
Hartford HospitalAcademic/Hospital1012019
High Point UniversityAcademic/Hospital1012023
NovartisFor profit1012009
Ohio State UniversityAcademic/Hospital1012020
University of California, Los AngelesAcademic/Hospital1112023
University of ConnecticutAcademic/Hospital1112019
University of Southern CaliforniaAcademic/Hospital1112020
Wake Forest UniversityAcademic/Hospital1112023
Zhejiang UniversityAcademic/Hospital1012024
13 organizations
Page 1 / 1

Marketing (2)

OrganizationOrg typeRelationshipDate
Paratek Pharmaceuticals IncFor profitNDA2Oct 2, 2018
Paratek Pharmaceuticals IncFor profitNDAOct 2, 2018