Cefdinir

Summary

Cefdinir (CHEMBL927) is an approved small-molecule antibacterial drug (ATC J01DD15); indicated across 11 conditions including otitis media and chronic bronchitis.

At a glance

• Status: Approved (max clinical phase 4)
• Modality: Small molecule
• ATC class: J01DD15
• Indications: 11 conditions
• Clinical trials: 18
• Chemistry: 395.4 Da · C14H13N5O5S2

Identifiers

Drug identity and classification

Field	Value
ChEMBL ID	CHEMBL927
Name	Cefdinir
Type	Small molecule
Max phase	4
FDA approved	yes
PubChem CID	6915944
ChEBI	CHEBI:3485
ATC	J01DD15
Molecular formula	C14H13N5O5S2
Molecular weight	395.4
InChIKey	RTXOFQZKPXMALH-GHXIOONMSA-N

SMILES: C=CC1=C(N2[C@@H]([C@@H](C2=O)NC(=O)/C(=N\O)/C3=CSC(=N3)N)SC1)C(=O)O

IUPAC name: (6R,7R)-7-[[(2Z)-2-(2-amino-1,3-thiazol-4-yl)-2-hydroxyiminoacetyl]amino]-3-ethenyl-8-oxo-5-thia-1-azabicyclo[4.2.0]oct-2-ene-2-carboxylic acid

ChEBI definition: A cephalosporin compound having 7β-2-(2-amino-thiazol-4-yl)-2-[(Z)-hydroxyimino]-acetylamino- and 3-vinyl side groups.

Pharmacological roles (ChEBI): antibacterial drug.

Also known as: BMY-28488, Cefdinir, Cefdinir anhydrous, Cefzon, CI-983, FK 482, FK-482, NSC-758926, Omnicef, cefdinir, SID49679095, CEFDINIR

Patent coverage: 5,026 distinct patent families (19,403 SureChEMBL compound mentions), from 2 matched compound structure(s). One matched structure accounts for 19,402 (100%) of the total. Mentions count patents naming the compound (not distinct inventions), so promiscuous / reference molecules inflate the mention figure — families are the dedup metric.

Targets

Targets

Broader ChEMBL bioactivity targets: 5 (assay-derived). Sample: RNA-binding protein pos-1, Zinc finger protein mex-5, ATP-binding cassette sub-family C member 4, Carboxy-terminal domain RNA polymerase II polypeptide A small phosphatase 1, Cannabinoid receptor 1.

Bioactivity

ChEMBL activities: 1 potent at pChembl ≥ 5 of 5 total. Top 30 by potency (10 = 0.1 nM, 6 = 1 µM):

Target	pChembl	Type	Value	Unit	Activity ID
CTDSP1	5.35	IC50	4480	nM	CHEMBL_ACT_6959789

Target pathways

No target-pathway data for this drug (no mapped target genes).

Indications & clinical

Indications

11 indications (8 at ChEMBL trial phase 4). Phase below is the highest clinical-trial phase recorded for this drug against each disease — not the molecule’s overall approval status (that is in the Summary).

Indication	Trial phase	MONDO	EFO
otitis media	4	MONDO:0005441	EFO:0004992
chronic bronchitis	4	MONDO:0005607	EFO:0006505
pneumonia	4	MONDO:0005249	EFO:0003106
tonsillitis	4	MONDO:0001039	HP:0011110
bacterial infectious disease	4	MONDO:0005113	EFO:0000771
pharyngitis	4	MONDO:0002258	MONDO:0002258
mastitis	2	MONDO:0006849	EFO:1001034
osteomyelitis	0	MONDO:0005246	EFO:0003102
appendicitis	0	MONDO:0005649	EFO:0007149

2 further indication records had no mapped disease name (EFO/MeSH-only) or were duplicates, and are omitted.

Clinical trials

Total trials: 18.

Phase distribution

Phase	Trials
PHASE4	10
PHASE1	4
PHASE2/PHASE3	2
PHASE2	1
Not specified	1

Top trials by phase / activity

NCT	Phase	Status	Title
NCT00147914	PHASE4	COMPLETED	Comparison Study Between Cefdinir & Amoxicilline/Clavulanate in Acute Sinusitis and Assessment of Quality of Life
NCT00234949	PHASE4	COMPLETED	A Study to Compare Cefdinir and Cephalexin for the Treatment of Mild to Moderate Uncomplicated Skin Infections
NCT00644774	PHASE4	COMPLETED	A Pediatric Taste Test Study of Omnicef Versus Zithromax Antibiotic Suspension Medications
NCT00644891	PHASE4	COMPLETED	Pediatric Taste Test Study of Cefdinir (Omnicef) Versus Amoxicillin Antibiotic Suspension Medications
NCT00644943	PHASE4	COMPLETED	A Comparison of the Safety and Efficacy of Cefdinir Oral Suspension Versus Amoxicillin/Clavulanate in Pediatric Subjects With Acute Otitis Media
NCT00645073	PHASE4	COMPLETED	Study of the Safety and Efficacy of Cefdinir and Levofloxacin for the Treatment of Subjects With Acute Bacterial Sinusitis
NCT00645112	PHASE4	COMPLETED	A Comparison of Safety and Efficacy of Cefdinir Oral Suspension Versus Azithromycin in Pediatric Subjects With Acute Otitis Media
NCT00645125	PHASE4	COMPLETED	A Comparative, Single-Center, Pediatric Taste Test Study of Omnicef Versus Amoxicillin Antibiotic Suspension Medications
NCT02891915	PHASE4	COMPLETED	Trial to Evaluate Beta-Lactam Antimicrobial Therapy of Community Acquired Pneumonia in Children
NCT04664803	PHASE4	TERMINATED	Safety and Efficacy of Cefecin Tab. in Patients With Acute Sinusitis
NCT00645203	PHASE2/PHASE3	COMPLETED	Safety and Efficacy Study of Cefdinir Oral Suspension, in Pediatric Subjects to Treat Acute Otitis Media
NCT03756324	PHASE2/PHASE3	UNKNOWN	The Effect of Chinese Herbal Medicine for Reducing the Application of Antibiotics in the Treatment of Acute Mastitis
NCT06406114	PHASE2	RECRUITING	Optimizing the Diagnostic Approach to Cephalosporin Allergy Testing
NCT00834535	PHASE1	COMPLETED	Cefdinir Capsules 300 mg, Non-fasting
NCT00835484	PHASE1	COMPLETED	Cefdinir Capsules 300 mg, Fasting
NCT00882570	PHASE1	COMPLETED	To Demonstrate the Relative Bioequivalence of Cefdinir and Omnicel 250mg/5 ml Oral Suspension Fasting Conditions
NCT00883883	PHASE1	COMPLETED	To Demonstrate the Relative Bioequivalence of Cefdinir and Omnicel 250 mg/5 ml Oral Suspension Fed Conditions
NCT01000298	Not specified	COMPLETED	Effectiveness of Oral Antibiotics in the Treatment of Severe Acute Malnutrition

Clinical evidence (CIViC)

No CIViC predictive evidence (expected for non-precision-medicine drugs).

Pharmacology

Pharmacogenomics

No CPIC/DPWG dosing guideline, but PharmGKB curates 0 clinical and 1 variant annotation(s) for this drug (gene-keyed; see PharmGKB).

Related molecules

Related molecules

No competitor molecules sharing a primary target (ChEMBL phase ≥2 or PubChem drug-class).