cefditoren
Trade name: spectracef
Approved
Aug 29, 2001
Cefditoren pivoxil is a semi-synthetic cephalosporin antibiotic for oral administration. It is a 3rd generation cephalosporin that is FDA approved for the treatment of acute bacterial exacerbation of chronic bronchitis, community acquired pneumonia, infection of skin and/or subcutaneous tissue, and pharyngitis/tonsillitis. Cefditoren is a cephalosporin with antibacterial activity against gram-positive and gram-negative pathogens. The bactericidal activity of cefditoren results from the inhibition of cell wall synthesis via affinity for penicillin-binding proteins (PBPs). Common adverse reactions include diarrhea, nausea and candida vaginitis. Co-administration of a single dose of an antacid which contained both magnesium (800 mg) and aluminum (900 mg) hydroxides or co-administration of a single dose of intravenously administered famotidine (20 mg) reduced the oral absorption of a single 400 mg dose of cefditoren pivoxil administered following a meal. Co-administration of probenecid with cefditoren pivoxil resulted in an increase in the plasma exposure of cefditoren. — NCATS
Clinical trial activity
5 trials · 7 clinical orgs · 2 marketing orgs
Earliest trial started Nov 1, 2007 (NCT00598403)
Timeline
2000s
- Aug 29, 2001
TAP Pharmaceuticals — Earliest FDA Approval
- Aug 29, 2001
TAP Pharmaceuticals — NDA Organization
- Aug 29, 2001
Vansen Pharma — NDA Secondary Org
- Jan 1, 2007
Earliest Phase 3 Sponsor(trial)
Indications
Approved for
Mechanism of action
- Bacterial penicillin-binding proteinINHIBITOR
Bacterial penicillin-binding protein inhibitor
- D-alanyl-D-alanine carboxypeptidase DacB (dacB) ↗
- Peptidoglycan D,D-transpeptidase FtsI (ftsI) ↗
- Penicillin-binding protein 1A (mrcA) ↗
- Penicillin-binding protein 1B (mrcB) ↗
- D-alanyl-D-alanine carboxypeptidase DacA (dacA) ↗
- Peptidoglycan D,D-transpeptidase MrdA (mrdA) ↗
- D-alanyl-D-alanine carboxypeptidase DacC (dacC) ↗
Approval history
- approvedAug 29, 2001
Chemistry & pharmacology
SMILES
CO\N=C(/C(=O)N[C@H]1[C@H]2SCC(\C=C/C3=C(C)N=CS3)=C(N2C1=O)C(O)=O)C4=CSC(N)=N4- Mol. weight
- 506.578 g/mol
- Lipinski Ro5
- 2 violation(s)
- Rule of 3
- No
- Chirality
- Single Stereoisomer
- Inorganic
- No
- Polymer
- No
- Availability
- Discontinued
Oral
No
Parenteral
No
Topical
No
Sources
- WikipediaCefditoren ↗
- NCATS81QS09V3YW ↗
- ChEMBLCHEMBL454446 ↗
- ChEMBLCHEMBL1743 ↗
Also known as
- 5-thia-1-azabicyclo(4.2.0)oct-2-ene-2-carboxylic acid, 7-(((2-amino-4-thiazolyl)(methoxyimino)acetyl)amino)-3-(2-(4-methyl-5-thiazolyl)ethenyl)-8-oxo-, (2,2-dimethyl-1-oxopropoxy)methyl ester, (6r-(3(z),6alpha,7beta(z)))-
- (-)-(6r,7r)-2,2-dimethylpropionyloxymethyl 7-((z)-2-(2-aminothiazol-4-yl)-2-methoxyiminoacetamido)-3-((z)-2-(4-methylthiazol-5-yl)ethenyl)-8-oxo-5-thia-1-azabicyclo(4.2.0)oct-2-ene-2-carboxylate
- 7-(2-(2-aminothiazol-4-yl)-2-(methoxyimino)acetamido)-3-(2-(4-methylthiazol-5-yl)ethenyl)cephem-4-carboxylic acid pivaloyloxymethyl ester
- cdtr-pi
- cdtr-pi
- cdtr-pi
- cefditoren
- cefditoren
- cefditoren
- cefditoren
- cefditoren
- cefditoren pivaloyloxymethyl ester
- cefditoren pivoxil
- cefditoren pivoxil
- cefditoren pivoxil
- cefditoren pivoxil
- cefditoren pivoxil
- cefditoren pivoxil
- cefditoren pivoxil
- cefditoren pivoxil
- cefditoren pivoxil
- cefditoren pivoxil
- cefditoren pivoxyl
- cefditoren, sodium salt, (6r-(3(z),6alpha,7beta(z)))-isomer
- ceftidoren
- me 1206
- me-1206
- me1207
- me1207
- me 1207
- me-1207
- meiact
- meiact
- spectracef
- spectracef
- spectracef
- spectracef
Clinical trials
| NCT ID | Phase | Start date | Sponsor(s) |
|---|---|---|---|
| NCT06644105 | N/A | Jan 10, 2024 | Government of China, Sichuan University |
| NCT04709172 | Phase 4 | Jan 5, 2021 | Alcala de Henares University, Meiji Seika Pharma Co., Ltd. |
| NCT01467297 | Phase 4 | Jan 1, 2012 | University of Milan |
| NCT01553006 | Phase 4 | Jan 1, 2012 | Thammasat University |
| NCT00598403 | Phase 3 | Nov 1, 2007 | Tedec-Meiji Farma, S.A. |
Organizations
Research & Development (7)
| Organization | Org type | Trials | As lead sponsor | Phases | Earliest year |
|---|---|---|---|---|---|
| Alcala de Henares University | Academic/Hospital | 1 | 0 | 1 | 2021 |
| Government of China | Government | 1 | 0 | 1 | 2024 |
| Meiji Seika Pharma Co., Ltd. | For profit | 1 | 1 | 1 | 2021 |
| Sichuan University | Academic/Hospital | 1 | 1 | 1 | 2024 |
| Tedec-Meiji Farma, S.A. | For profit | 1 | 1 | 1 | 2007 |
| Thammasat University | Academic/Hospital | 1 | 1 | 1 | 2012 |
| University of Milan | Academic/Hospital | 1 | 1 | 1 | 2012 |
Marketing (2)
| Organization | Org type | Relationship | Date |
|---|---|---|---|
| TAP Pharmaceuticals | For profit | NDA | Aug 29, 2001 |
| Vansen Pharma | For profit | NDA2 | Aug 29, 2001 |