Suprax
(Cefixime)ApprovedSmall molecule
Suprax is one of 6 small molecule programs targeting Complication. It is currently in Approved.
2
Indications
17
Total Trials
1
Active Trials
5
Competitors
4
FDA Applications
NDA/BLA/ANDA regulatory filings
1
Patents
Pipeline
Status by Indication[3][1]
Competition
Competitive Landscape
8 competitors in Syphilis
#DrugCompanyPhaseTrials
1Vibramycin
PPfizer's Upjohn has merged with Mylan to form Viatris Inc.
Approved
Rocephin
CConrado Roberto Hoffmann Filho
Approved
Amoxil
GGlobal Antibiotics Research and Development Partnership
Phase 3
Suprax
WWyeth-Lederle Vaccines
Approved
Doxycycline for 14 Days
UUniversity of Washington
Phase 2
Ceftriaxone Sodium
PfizerPreclinical
Ranked by pipeline maturity and clinical activity. Current drug highlighted in teal.
Timeline
Expected Milestones
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
Cefixime / Azithromycin pK Study
Completed·NNational Institute of Allergy and Infectious Diseases (NIAID)·Phase 1·NCT02708992·10 enrolled
Experimental2 trials
Syphilis2 trials
Cefixime Versus Benzathine Penicillin G in Treatment of Early Syphilis
Terminated·—·Phase 4·NCT06907316·61 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
8 more indications
Cervicitis1 trial
Empiric Therapy of Mucopurulent Cervicitis (MPC)
Terminated·NNational Institute of Allergy and Infectious Diseases (NIAID)·Phase 3·NCT01072136·87 enrolled
Congenital Abnormalities1 trial
Antibiotic Prophylaxis and Renal Damage In Congenital Abnormalities of the Kidney and Urinary Tract
Unknown status·FFondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico·Phase 3·NCT02021006·292 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
Neuroblastoma1 trial
N2003-01: Irinotecan, Temozolomide, and Cefixime in Treating Young Patients With Recurrent or Resistant Neuroblastoma
Completed·—·Phase 1·NCT00093353·30 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
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]
- [2]
- [3]Open Targets Platform — Drug–disease associations for Cefixime. EMBL-EBI & Wellcome Sanger Institute.
- [4]
- [5]FDA Orange Book — Patent and exclusivity data for Suprax. U.S. Food & Drug Administration.
- [6]
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