Pipeline

  PRODUCT/INDICATION PRE CLINICAL PHASE 1 PHASE 2 PHASE 3 NDA Submitted FDA Approved
Baxdela™ (delafloxacin)
Serious Community-Acquired Bacterial Pneumonia (CABP)
IV-ORAL (QIDP)
(QIDP)
Complicated Urinary Tract Infections (cUTI)
IV-ORAL
(QIDP ELIGIBLE)
Solithromycin
Community acquired bacterial pneumonia (CABP)
Oral (QIDP)
IV-to-oral (QIDP)
Pediatric (QIDP)
Urethritis / gonorrhea
Oral
Conjunctivitis / blepharitis /dry eye
Ophthalmic
Fusidic Acid
Skin infections (ABSSSI)
Oral (QIDP)
Chronic bone and joint infections
Oral
Proprietary Discovery Platform
Radezolid: 2nd generation oxazolidinone
Topical for Acne Vulgaris
Topical
Topical for Bacterial Vaginosis
Topical (QIDP)
ESKAPE* Program: novel pyrrolocytosine
“SUPER-BUGS”
Macrolide Program
NEXT-GEN
PRODUCT/INDICATION DELIVERY/PHASE
Baxdela™ (delafloxacin)
Serious Community-Acquired Bacterial Pneumonia (CABP)
IV-ORAL (QIDP)
(QIDP) / Phase 3
Complicated Urinary Tract Infections (cUTI)
IV-ORAL
(QIDP ELIGIBLE) / Phase 1
Solithromycin
Community acquired bacterial pneumonia (CABP)
Oral (QIDP) / NDA Submitted
IV-to-oral (QIDP) / NDA Submitted
Pediatric (QIDP) / Phase 3
Urethritis / gonorrhea
Oral / Phase 3
Conjunctivitis / blepharitis /dry eye
Ophthalmic / Preclinical
Fusidic Acid
Skin infections (ABSSSI)
Oral (QIDP) / Phase 3
Chronic bone and joint infections
Oral / Phase 2
Proprietary Discovery Platform
Radezolid: 2nd generation oxazolidinone
Topical for Acne Vulgaris Topical / Phase 2
Topical for Bacterial Vaginosis Topical / Preclinical
ESKAPE* Program: novel pyrrolocytosine
“SUPER-BUGS” / Preclinical
Macrolide Program
NEXT-GEN / Preclinical
  • ABSSSI: Acute bacterial skin and skin structure infections || CABP: Community-acquired bacterial pneumonia || cUTI: Complicated urinary tract infections || ESKAPE: The ESKAPE pathogen program includes a focus on multidrug- and extremely-drug-resistant versions of the following pathogens: Enterococcus faecium, Staphylococcus aureus, Klebsiella pneumoniae, Acinetobacter baumannii, Pseudomonas aeruginosa, Enterobacter species and Escherichia coli || QIDP: Qualified Infectious Disease Product || SPA: Special Protocol Assessment