Spectracef

(cefditoren pivoxil)

ApprovedSmall molecule

Jazz Pharmaceuticals

Spectracef is one of 89 small molecule programs targeting Sinusitis. It is currently in Approved.

Indications

Total Trials

Active Trials

Competitors

FDA Application

NDA/BLA/ANDA regulatory filings

Pipeline

Status by Indication[3][1]

Indication

SinusitisActive, not recruiting

PneumoniaCompleted

BreastCompleted

SinusitisApproved

Active, not recruiting

PneumoniaApproved

Completed

BreastPreclinical

Completed

Competition

Competitive Landscape

152 competitors in Pneumonia

#DrugCompanyPhaseTrials

Spectracef

Jazz Pharmaceuticals

Approved

1 2

Innohep

Jazz Pharmaceuticals

Preclinical

1 3

Jakafi

Incyte

Preclinical

1 4

Primaquine

Sanofi

Preclinical

1 5

Acanya

Pfizer

Preclinical

1 6

Prevacid

Takeda

Preclinical

1 7

Plaquenil

Jazz Pharmaceuticals

Preclinical

1 8

Avlosulfon

AAlmirall, S.A.

Preclinical

4 9

Virazole

CConrado Roberto Hoffmann Filho

Preclinical

2 10

Advil

KKenvue Brands

Preclinical

Ranked by pipeline maturity and clinical activity. Current drug highlighted in teal.

Clinical

Trials by Indication[1]

Sinusitis1 trial

Study of Cefditoren Pivoxil in Treatment of Childhood With Acute Rhinosinusitis

Unknown status·TThammasat University·Phase 4·NCT01553006·120 enrolled

Pneumonia1 trial

Pilot Study of Cefditoren Pivoxil in COVID-19 Patients With Mild to Moderate Pneumonia

Completed·MMeiji Pharma Spain S.A.·Phase 4·NCT04709172·20 enrolled

Breast1 trial

Pharmacokinetic Study of Cefditoren Pivoxil in Breast Milk and Blood of Lactating Women

Completed·WWest China Second University Hospital·N/A·NCT06644105·12 enrolled

Cystitis1 trial

Efficacy and Safety of Cefditoren Pivoxil Versus Ciprofloxacin in Acute Uncomplicated Cystitis

Completed·TTedec-Meiji Farma, S.A.·Phase 3·NCT00598403·611 enrolled

Regulatory

FDA Approval Timeline[4]

Aug 29, 2001

SPECTRACEF

NDA NDA021222

Sources

References

[1]
ClinicalTrials.gov — 4 trial records for cefditoren pivoxil. U.S. National Library of Medicine, National Institutes of Health.
[2]
ChEMBL — cefditoren pivoxil compound record. European Bioinformatics Institute (EMBL-EBI).
[3]
Open Targets Platform — Drug–disease associations for cefditoren pivoxil. EMBL-EBI & Wellcome Sanger Institute.
[4]
OpenFDA — FDA approval records (NDA NDA021222). U.S. Food & Drug Administration.
[5]
SEC EDGAR — Jazz Pharmaceuticals company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Modality: Small molecule[2]
Highest Phase: Approved[1]
Company: Jazz Pharmaceuticals

Spectracef

Status by Indication[3][1]

Competitive Landscape

Trials by Indication[1]

Sinusitis1 trial

Pneumonia1 trial

Breast1 trial

Cystitis1 trial

FDA Approval Timeline[4]

References

Drug Info

Quick Facts

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