Suprax

(Cefixime)

ApprovedSmall molecule

WWyeth-Lederle Vaccines

Suprax is one of 100 small molecule programs targeting Syphilis. It is currently in Approved.

Indications

Total Trials

Active Trials

Competitors

FDA Applications

NDA/BLA/ANDA regulatory filings

Patents

Pipeline

Status by Indication[3][1]

Indication

SyphilisActive, not recruiting

NeuroblastomaActive, not recruiting

Liver AbscessActive, not recruiting

CervicitisActive, not recruiting

Urinary Tract InfectionActive, not recruiting

SyphilisApproved

Active, not recruiting

NeuroblastomaPhase 1

Active, not recruiting

Liver AbscessPhase 3

Active, not recruiting

CervicitisPhase 3

Active, not recruiting

Urinary Tract InfectionPhase 2

Active, not recruiting

Competition

Competitive Landscape

237 competitors in Neuroblastoma

#DrugCompanyPhaseTrials

Leukine

Sanofi

Phase 3

18 2

Paraplatin

AAvyxa

Phase 3

38 3

Cytoxan

BBaxter Healthcare Corporation

Phase 3

54 4

Vepesid

AAvyxa

Phase 3

42 5

Camptosar

Pfizer

Phase 3

13 6

Tepadina

Alnylam Pharmaceuticals

Phase 3

12 7

Alkeran

AApotex Inc.

Phase 3

28 8

Accutane

CConrado Roberto Hoffmann Filho

Phase 3

28 9

Oncovin

EEastern Cooperative Oncology Group

Adriamycin

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

Timeline

Expected Milestones

Q2 2027

Phase 3Recruiting

Clinical Trial

NCT04958122

Clinical

Trials by Indication[1]

Azithromycin3 trials

Cefixime Plus Doxycycline Compared to Ceftriaxone Plus Azithromycin for Treatment of Gonorrhoea

Completed·—·Phase 4·NCT06090565·161 enrolled

The Azithromycin and Cefixime Treatment of Typhoid in South Asia Trial (ACT-South Asia Trial)

Completed·OOxford University Clinical Research Unit, Vietnam·Phase 4·NCT04349826·2,150 enrolled

Cefixime / Azithromycin pK Study

Completed·NNational Institute of Allergy and Infectious Diseases (NIAID)·Phase 1·NCT02708992·10 enrolled

Experimental2 trials

Efficacy of Immunization With 4C-MenB in Preventing Experimental Urethral Infection With Neisseria Gonorrhoeae

Completed·UUniversity of North Carolina, Chapel Hill·Phase 2·NCT05294588·65 enrolled

Experimental Human Infection With Neisseria Gonorrhoeae

Completed·NNational Institute of Allergy and Infectious Diseases (NIAID)·Phase 1·NCT03840811·27 enrolled

Syphilis2 trials

Cefixime Versus Benzathine Penicillin G in Treatment of Early Syphilis

Terminated·—·Phase 4·NCT06907316·61 enrolled

Trial Evaluating the Clinical Efficacy of Cefixime for Treatment of Early Syphilis in Non-pregnant Women

Unknown status·WWorld Health Organization·Phase 1/2·NCT03752112·180 enrolled

Urinary Tract Infection1 trial

The SCOUT Study: "Short Course Therapy for Urinary Tract Infections in Children"

Completed·NNational Institute of Allergy and Infectious Diseases (NIAID)·Phase 2·NCT01595529·717 enrolled

Liver abscess1 trial

Ciprofloxacin Plus Metronidazole Vs Cefixime Plus Metronidazole Therapy for the Treatment of Liver Abscess

Unknown status·PPost Graduate Institute of Medical Education and Research, Chandigarh·Phase 3·NCT03969758·140 enrolled

8 more indications

Pilot Study1 trial

The Pharmacokinetics of Extended Duration High-dose Cefixime for the Decreased Susceptibility of Neisseria Gonorrhoeae: A Phase I Pilot Study

Completed·NNational Institute of Allergy and Infectious Diseases (NIAID)·Phase 1·NCT01949363·25 enrolled

Pediatric Solid Tumors1 trial

A Pilot Study of the Addition of Bevacizumab to VOIT Regimen for Relapsed/Refractory Pediatric Solid Tumors

Completed·—·Phase 1·NCT00786669·13 enrolled

Clinical Trial1 trial

Cefixime Clinical Trial

Recruiting·UUniversity of Southern California·Phase 3·NCT04958122·400 enrolled

Complication1 trial

Complications After Lower Third Molar Surgery

Unknown status·UUniversity of Novi Sad·N/A·NCT05027893·157 enrolled

Completed·VVion Pharmaceuticals·Phase 1·NCT00004216

Neuroblastoma1 trial

N2003-01: Irinotecan, Temozolomide, and Cefixime in Treating Young Patients With Recurrent or Resistant Neuroblastoma

Completed·—·Phase 1·NCT00093353·30 enrolled

Regulatory

FDA Approval Timeline[4]

Apr 28, 1989

SUPRAX

NDA NDA050622

Apr 28, 1989

SUPRAX

NDA NDA050621

Jun 1, 2012

SUPRAX

NDA NDA203195

Feb 20, 2013

SUPRAX

NDA NDA202091

Sources

References

[1]
ClinicalTrials.gov — 17 trial records for Cefixime. U.S. National Library of Medicine, National Institutes of Health.
[2]
ChEMBL — Cefixime compound record. European Bioinformatics Institute (EMBL-EBI).
[3]
Open Targets Platform — Drug–disease associations for Cefixime. EMBL-EBI & Wellcome Sanger Institute.
[4]
OpenFDA — FDA approval records (NDA NDA202091). U.S. Food & Drug Administration.
[5]
FDA Orange Book — Patent and exclusivity data for Suprax. U.S. Food & Drug Administration.
[6]
SEC EDGAR — Wyeth-Lederle Vaccines company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Modality: Small molecule[2]
Highest Phase: Approved[1]
Company: WWyeth-Lederle Vaccines

Patent Landscape[5]

Patent Cliff

Dec 14, 2028

Earliest patent expiration — generic entry possible after this date

Patent #Expires

9233112Dec 14, 2028

Suprax

Status by Indication[3][1]

Competitive Landscape

Expected Milestones

Q2 2027

Trials by Indication[1]

Azithromycin3 trials

Experimental2 trials

Syphilis2 trials

Urinary Tract Infection1 trial

Liver abscess1 trial

Pilot Study1 trial

Pediatric Solid Tumors1 trial

Clinical Trial1 trial

Complication1 trial

Cervicitis1 trial

Congenital Abnormalities1 trial

Advanced or Metastatic Solid Tumors1 trial

Neuroblastoma1 trial

FDA Approval Timeline[4]

References

Drug Info

Quick Facts

Patent Landscape[5]

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