MedPath

Ceftibuten

Generic Name
Ceftibuten
Brand Names
Cedax
Drug Type
Small Molecule
Chemical Formula
C15H14N4O6S2
CAS Number
97519-39-6
Unique Ingredient Identifier
IW71N46B4Y

Overview

Ceftibuten is a third-generation cephalosporin antibiotic that is orally-administered. It is typically used to treat acute bacterial exacerbations of chronic bronchitis (ABECB), acute bacterial otitis media, pharyngitis, and tonsilitis.

Indication

Indicated for the treatment of acute bacterial exacerbations of chronic bronchitis (ABECB), acute bacterial otitis media, pharyngitis, and tonsilitis.

Associated Conditions

  • Acute Bacterial Exacerbation of Chronic Bronchitis (ABECB)
  • Acute Otitis Media (AOM)
  • Acute Sinusitis
  • Acute Tracheobronchitis
  • Bacterial Infections
  • Bacterial Pneumonia
  • Lower Respiratory Tract Infection (LRTI)
  • Lower Respiratory Tract Infection (LRTI) caused by susceptible bacteria
  • Pharyngitis
  • Skin and Soft Tissue Infections (SSTIs)
  • Streptococcal Pharyngitis
  • Superinfection bacterial
  • Tonsillitis
  • Tonsillitis streptococcal
  • Upper Respiratory Tract Infection
  • Upper Respiratory Tract Infection caused by susceptible bacteria
  • Urinary Tract Infection caused by susceptible bacteria
  • Bacterial otitis media
  • Uncomplicated Lower Respiratory Tract Infection (LRTI)
  • Uncomplicated Upper Respiratory Tract Infection
  • Uncomplicated Urethritis gonococcal

Research Report

Published: Oct 15, 2025

A Comprehensive Monograph on Lobeglitazone (DB09198): Pharmacology, Clinical Profile, and Comparative Analysis

Section 1: Drug Identification and Physicochemical Properties

1.1. Nomenclature and Identifiers

Lobeglitazone is a small molecule antidiabetic agent identified by a comprehensive set of chemical, commercial, and regulatory identifiers to ensure unambiguous reference across scientific literature, clinical practice, and regulatory documentation.

Its non-proprietary, or generic, name is Lobeglitazone.[1] The compound is systematically named according to the International Union of Pure and Applied Chemistry (IUPAC) nomenclature as 5-[[2-[[6-(4-methoxyphenoxy)pyrimidin-4-yl]-methylamino]ethoxy]phenyl]methyl]-1,3-thiazolidine-2,4-dione.[2]

During its development by Chong Kun Dang Pharmaceutical Corp., it was referred to by the code CKD-501 (also documented as CKD 501 and CKD501).[1] Upon receiving marketing authorization, it has been commercialized under distinct brand names in approved regions: Duvie in South Korea and LOBG in India.[3]

To facilitate its identification in global databases and regulatory systems, Lobeglitazone is assigned several standard identifiers. These include its DrugBank accession number DB09198 and its Chemical Abstracts Service (CAS) Registry Number, which is 607723-33-1 for the free base form of the molecule.[2] The commonly used sulfate salt is identified by CAS number 763108-62-9.[5] Other key identifiers are summarized in the table below.

1.2. Chemical Structure and Properties

Lobeglitazone is an aromatic ether belonging to the thiazolidinedione (TZD) class of compounds.[7] Its molecular structure is defined by the chemical formula , corresponding to a molecular weight of approximately 480.54 g/mol for the free base.[1] The sulfate salt has the formula  and a molecular weight of 578.62 g/mol.[6]

Continue reading the full research report

FDA Drug Approvals

Approved Product
Manufacturer
NDC Code
Route
Strength
Effective Date
Sciele Pharma, Inc.
59630-820
ORAL
400 mg in 1 1
1/12/2010
Sciele Pharma, Inc.
59630-821
ORAL
18 mg in 1 mL
1/12/2010

EMA Drug Approvals

Approved Product
Authorization Holder
Status
Issued Date
No EMA approvals found for this drug.

HSA Drug Approvals

Approved Product
Manufacturer
Approval Number
Dosage Form
Strength
Approval Date
No HSA approvals found for this drug.

NMPA Drug Approvals

Approved Product
Company
Approval Number
Drug Type
Dosage Form
Approval Date
No NMPA approvals found for this drug.

PPB Drug Approvals

Approved Product
Registration No.
Company
Licence No.
Strength
Registration Date
No PPB approvals found for this drug.

TGA Drug Approvals

Approved Product
ARTG ID
Sponsor
Registration Type
Status
Registration Date
No TGA approvals found for this drug.

Health Canada Drug Approvals

Approved Product
Company
DIN
Dosage Form
Strength
Market Date
No Health Canada approvals found for this drug.

CIMA AEMPS Drug Approvals

Approved Product
Company
Registration Number
Pharmaceutical Form
Prescription Type
Status
No CIMA AEMPS (Spain) approvals found for this drug.

Philippines FDA Drug Approvals

Approved Product
Company
License Number
Dosage Form
Strength
Approval Date
No Philippines FDA approvals found for this drug.

Saudi SFDA Drug Approvals

Approved Product
Company
License Number
Dosage Form
Strength
Approval Date
No Saudi SFDA approvals found for this drug.

Malaysia NPRA Drug Approvals

Approved Product
Company
Registration Number
Dosage Form
Strength
Approval Date
No Malaysia NPRA approvals found for this drug.

UK EMC Drug Information

Medicine Name
MA Holder
MA Number
Pharmaceutical Form
Active Ingredient
Authorization Date
No UK EMC drug information found for this drug.

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