CDEK
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cefiderocol

Trade name: Fetroja

Small moleculeapprovedFast Track FDA

Approved

Nov 14, 2019

Cefiderocol, sold under the brand name Fetroja among others, is an antibiotic used to treat complicated urinary tract infections when no other options are available. It is indicated for the treatment of multi-drug-resistant Gram-negative bacteria including Pseudomonas aeruginosa. It is given by injection into a vein. — Wikipedia

Clinical trial activity

23 trials · 18 clinical orgs · 1 marketing orgs

Phase 1
10
Phase 2
10
Phase 3
3
Phase 4
2

Earliest trial started Dec 1, 2014 (NCT02321800)

Timeline

2010s

  1. Jan 1, 2014

    Shionogi — Earliest Phase 2 Sponsor(trial)

  2. Jan 1, 2016

    Shionogi — Earliest Phase 3 Sponsor(trial)

  3. Jan 1, 2019

    Shionogi — Earliest Phase 1 Sponsor(trial)

  4. Nov 14, 2019

    Shionogi — Earliest FDA Approval

  5. Nov 14, 2019

    Shionogi — Marketing Organization

  6. Nov 14, 2019

    Shionogi — NDA Organization

Indications

Approved for

Studied for

Mechanism of action

Approval history

  • approvedPriority reviewFast trackNov 14, 2019

Chemistry & pharmacology

Loading structure…

SMILES

CC(C)(O\N=C(/C(=O)N[C@H]1[C@H]2SCC(C[N+]4(CCNC(=O)C3=C(Cl)C(O)=C(O)C=C3)CCCC4)=C(N2C1=O)C([O-])=O)C5=CSC(N)=N5)C(O)=O
Mol. weight
752.215 g/mol
Lipinski Ro5
3 violation(s)
Rule of 3
No
Chirality
Single Stereoisomer
Inorganic
No
Polymer
No
Delivery
Parenteral
Availability
Prescription Only

Oral

No

Parenteral

Yes

Topical

No

Sources

Also known as

  • s-649266
  • s-649266

Clinical trials

NCT IDPhaseStart dateSponsor(s)
NCT07104162Phase 1Sep 16, 2025Department of Health and Human Services, Orlando Clinical Research Center, Qpex Biopharma, Inc., Shionogi, University of Miami
NCT07049107Phase 1Jul 31, 2025Hengrui Therapeutics, Inc.
NCT07073157Phase 1Jul 15, 2025Hengrui Therapeutics, Inc.
NCT07049562Phase 1May 21, 2025Hengrui Therapeutics, Inc.
NCT06841731Phase 2Mar 31, 2025Hengrui Therapeutics, Inc.
NCT06569056Phase 3Sep 25, 2024Hengrui Therapeutics, Inc.
NCT06547554Phase 1Sep 4, 2024Department of Health and Human Services, Qpex Biopharma, Inc., Shionogi
NCT05922124Phase 4Jan 31, 2024Hebrew University, Monaldi Hospital, Rutgers University, Technion University, Tel Aviv University
NCT06144060Phase 2Dec 31, 2023Hengrui Therapeutics, Inc.
NCT06086626Phase 2Nov 30, 2023Shionogi
NCT07070375Phase 1Apr 19, 2023Hengrui Therapeutics, Inc.
NCT05373615Phase 1Jul 25, 2022Shionogi, University of Connecticut
NCT05314764Phase 4Jun 1, 2022Indiana University, Keystone Bioanalytical, Inc., Shionogi, University of Connecticut, University of Pittsburgh, University of Texas, Galveston
NCT05395104Phase 1May 23, 2022Shionogi
NCT04995835Phase 1Jul 16, 2021Hartford Hospital, Shionogi, University of Connecticut
NCT04335539Phase 2Dec 1, 2020Shionogi
NCT04215991Phase 2Jan 20, 2020Shionogi
NCT03869437Phase 2Apr 11, 2019Shionogi, University of Queensland
NCT03862040Phase 1Feb 20, 2019Shionogi
NCT03032380Phase 3Jul 15, 2017Shionogi
Showing 20 of 23 trials
Page 1 / 2

Organizations

Research & Development (18)

OrganizationOrg typeTrialsAs lead sponsorPhasesEarliest year
ShionogiFor profit15952014
Hengrui Therapeutics, Inc.For profit7732023
University of ConnecticutAcademic/Hospital3222021
Department of Health and Human ServicesGovernment2012024
Qpex Biopharma, Inc.For profit2212024
Hartford HospitalAcademic/Hospital1112021
Hebrew UniversityAcademic/Hospital1012024
Indiana UniversityAcademic/Hospital1012022
Keystone Bioanalytical, Inc.For profit1012022
Monaldi HospitalAcademic/Hospital1012024
Orlando Clinical Research CenterFor profit1012025
Rutgers UniversityAcademic/Hospital1012024
Technion UniversityAcademic/Hospital1112024
Tel Aviv UniversityAcademic/Hospital1012024
University of MiamiAcademic/Hospital1012025
University of PittsburghAcademic/Hospital1012022
University of QueenslandAcademic/Hospital1112019
University of Texas, GalvestonAcademic/Hospital1012022
18 organizations
Page 1 / 1

Marketing (3)

OrganizationOrg typeRelationshipDate
ShionogiFor profitMKTGNov 14, 2019
ShionogiFor profitNDANov 14, 2019
ShionogiFor profitSYNNov 14, 2019