ethionamide

Trade name: trecator

Small moleculeapproved

Approved

Apr 30, 1965

Ethionamide is a second-line agent, structurally similar to isoniazid, used as a second-line therapy for the treatment of multidrug-resistant tuberculosis or active tuberculosis in case of patient intolerance to other drugs. Depending on its the concentration at the infected site and the susceptibility of the infecting organism it may be bacteriostatic or bactericidal. When used alone rapidly develops bacterial resistance. Ethionamide was approved by FDA in 1965 as TRECATOR manufactured by Wyeth Pharmaceuticals Inc. (purchased by Pfizer in 2009). Ethionamide is specific for Mycobacteria and is thought to exert a toxic effect on mycolic acid components of the bacterial cell wall when activated through intermediate S-oxidation by EtaA. Mycolic acid synthesis was shown to be inhibited by ethionamide in the EthA protein-overexpressing mycobacteria, — NCATS

Clinical trial activity

7 trials · 12 clinical orgs · 2 marketing orgs

Phase 1
0
Phase 2
4
Phase 3
2
Phase 4
1

Earliest trial started Nov 2, 1999 (NCT00000796)

Timeline

1960s

  1. Apr 30, 1965

    American Home Products — Earliest FDA Approval

  2. Apr 30, 1965

    American Home Products — NDA Organization

  3. Apr 30, 1965

    Wyeth — NDA Secondary Org

2010s

  1. Jan 1, 2015

    Earliest Phase 2 Sponsor(trial)

  2. Jan 1, 2017

    Earliest Phase 3 Sponsor(trial)

Indications

Mechanism of action

Approval history

  • approvedPriority reviewApr 30, 1965

Chemistry & pharmacology

Loading structure…

SMILES

CCC1=CC(=CC=N1)C(N)=S
Mol. weight
166.243 g/mol
Lipinski Ro5
Pass
Rule of 3
Yes
Chirality
Achiral Molecule
Inorganic
No
Polymer
No
Delivery
Oral
Availability
Prescription Only

Oral

Yes

Parenteral

No

Topical

No

Prodrug

Sources

Also known as

  • 1314 th
  • 1314 th
  • 2-ethyl-4-thiopyridylamide
  • 2-ethyl-4-thiopyridylamide
  • 2-ethylthioisonicotinamide
  • 2-ethylthioisonicotinamide
  • amidazine
  • ehionamide
  • eth
  • eth
  • ethinamide
  • ethinamide
  • ethionamide
  • ethionamide
  • ethionamide
  • ethionamide
  • ethionamide
  • ethionamide
  • ethionamide
  • ethionamide
  • ethionamide
  • ethionamidum
  • ethionamidum
  • ethioniamide
  • ethioniamide
  • ethioniamide
  • ethioniamide
  • ethioniamide
  • ethioniamide
  • ethylisothiamide
  • ethylisothiamide
  • ethyonomide
  • ethyonomide
  • etionamid
  • etionamid
  • etionamida
  • etionamida
  • etionamide
  • etionamide
  • etioniamid
  • etioniamid
  • etp
  • etp
  • trecator
  • trecator
  • trecator
  • trecator-sc
  • trecator-sc

Clinical trials

NCT IDPhaseStart dateSponsor(s)
NCT05473195Phase 2Oct 31, 2022TASK Applied Science
NCT02975570Phase 3Aug 1, 2017Boston University, University of Florida, Westat
NCT02354014Phase 2May 3, 2016Johnson and Johnson
NCT02454205Phase 2/Phase 3 (Phase 3)Oct 1, 2015Stellenbosch University, University of Cape Town, University of Limpopo, Walter Sisulu University
NCT02365623Phase 2Feb 18, 2015Janssen Pharmaceutica NV, Johnson and Johnson
NCT00042289Phase 4Mar 1, 2003Boston University, National Institute of Allergy and Infectious Diseases (NIAID), National Institutes of Health (NIH)
NCT00000796N/ANov 2, 1999National Institute of Allergy and Infectious Diseases (NIAID)
Showing 7 of 7 trials
Page 1 / 1

Organizations

Research & Development (12)

OrganizationOrg typeTrialsAs lead sponsorPhasesEarliest year
Boston UniversityAcademic/Hospital2122003
Johnson and JohnsonFor profit2212015
National Institute of Allergy and Infectious Diseases (NIAID)Government2221999
Janssen Pharmaceutica NVFor profit1012015
National Institutes of Health (NIH)Government1012003
Stellenbosch UniversityAcademic/Hospital1012015
TASK Applied ScienceFor profit1112022
University of Cape TownAcademic/Hospital1112015
University of FloridaAcademic/Hospital1012017
University of LimpopoAcademic/Hospital1012015
Walter Sisulu UniversityAcademic/Hospital1012015
WestatFor profit1012017
12 organizations
Page 1 / 1

Marketing (2)

OrganizationOrg typeRelationshipDate
American Home ProductsFor profitNDAApr 30, 1965
WyethFor profitNDA2Apr 30, 1965