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
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]
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
---|---|---|---|---|---|
2024/12/13 | Phase 1 | Active, not recruiting | |||
2024/10/30 | Phase 1 | Completed | |||
2024/09/19 | Phase 1 | Completed | |||
2023/12/05 | Phase 1 | Completed | |||
2023/10/12 | Phase 1 | Recruiting | |||
2022/09/26 | Phase 1 | Completed | |||
2022/09/06 | Phase 1 | Completed | |||
2022/08/04 | Phase 1 | Completed | |||
2008/07/29 | Phase 3 | Terminated | IRCCS Burlo Garofolo |
EMA Drug Approvals
Approved Product | Authorization Holder | Status | Issued Date |
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No EMA approvals found for this drug. |
HSA Drug Approvals
Approved Product | Manufacturer | Approval Number | Dosage Form | Strength | Approval Date |
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No HSA approvals found for this drug. |
NMPA Drug Approvals
Approved Product | Company | Approval Number | Drug Type | Dosage Form | Approval Date |
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No NMPA approvals found for this drug. |
PPB Drug Approvals
Approved Product | Registration No. | Company | Licence No. | Strength | Registration Date |
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No PPB approvals found for this drug. |
TGA Drug Approvals
Approved Product | ARTG ID | Sponsor | Registration Type | Status | Registration Date |
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No TGA approvals found for this drug. |
Health Canada Drug Approvals
Approved Product | Company | DIN | Dosage Form | Strength | Market Date |
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No Health Canada approvals found for this drug. |
CIMA AEMPS Drug Approvals
Approved Product | Company | Registration Number | Pharmaceutical Form | Prescription Type | Status |
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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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