For the latest QIDP listing, please click HERE
Our latest internet search came up with 37 drugs that garnered QIDP status. They are listed in the Table below (if I missed a compound, please leave a comment!!). The table is searchable so you should be able to massage the data to your liking.
Let’s break down the numbers:
- 34 are antibacterials, 2 are antifungals, and 1 is in the ‘other’ category:
Drug Name Company Action Site Phase Antibiotic Class Cadazolid Actelion Pharmaceuticals GI only Phase 3 other SMT-19969 Summit plc GI only Phase 2 other Surotomycin Cubist Pharmaceuticals GI only Phase 3 glycopeptide Amikacin Inhale Bayer pulmonary Phase 3 aminoglycoside Amikacin + fosfomycin Cardeas Pharma pulmonary Phase 2 combination Arikayce Insmed Pharmaceuticals pulmonary Phase 3 aminoglycoside Ciprofloxacin DPI Bayer HealthCare pulmonary Phase 3 quinolone AeroVanc Savara Pharmaceuticals pulmonary Phase 2 glycopeptide Ciprofloxacin Aradigm Pharmaceuticals pulmonary Phase 3 quinolone Imipenem/cilastatin + MK-7655 Merck systemic Phase 2 B-lactam / BLI Finafloxacin MerLion Pharmaceuticals systemic Phase 2 quinolone Eravacycline Tetraphase Pharmaceuticals systemic Phase 3 tetracycline Delafloxacin Melinta Therapeutics systemic Phase 3 quinolone Nemonoxacin TaiGen Biotechnology systemic Phase 3 quinolone Ceftazidime + avibactam Actavis systemic Approved US B-lactam / BLI Solithromycin Cempra Pharmaceuticals systemic Phase 3 macrolide / ketolide Brilacidin Cellceutix Pharmaceuticals systemic Phase 2 defensin-mimetic Meropenem + RPX7009 The Medicines Company systemic Phase 3 B-lactam / BLI BC-3781 Nabriva Therapeutics systemic Phase 2 pleuromutilin Avarofloxacin Actavis systemic Phase 2 quinolone Ceftolozane + tazobactam Merck systemic Approved US B-lactam / BLI Fusidic Acid Cempra Pharmaceuticals systemic Phase 2 fusidic acid Isavuconazole Basilea Pharmaceutica systemic Approved US azole NikZ Valley Fever Solutions systemic Phase 1 other SCY-078 Scynexis Pharmaceuticals systemic Phase 1 other WCK-2349 Wockhardt Pharmaceuticals systemic Phase 1 quinolone Plazomicin Achaogen systemic Phase 3 aminoglycoside AZD-0914 AstraZeneca systemic Phase 2 quinolone Omadacycline Paratek Pharmaceuticals systemic Phase 3 tetracycline Tedizolid Cubist Pharmaceuticals systemic Approved US oxazolidinone Dalbavancin Durata Therapeutics systemic Approved US glycopeptide Oritavancin The Medicines Company systemic Approved US glycopeptide Radezolid Melinta Therapeutics systemic Phase 2 oxazolidinone Deb-1452 Debiopharm Pharmaceuticals systemic Phase 2 Fabl inhibitor WCK-771 Wockhardt Pharmaceuticals systemic Phase 1 quinolone BisEDT Antimicrobial Gel Microbion Corporation topical Phase 1 other Neutrolin CorMedix topical Phase 2 other - The 34 antibacterials are representatives of 13 antibacterial drug classes,there are 9 compounds not currently used in humans:
- \Most antibacterials have a systemic MoA, fewer were for pulmonary, purely GI, or topical use:
- Most QIDP drugs are currently in Phases 2 and 3 of development, some have already been approved:
Some interesting findings:
- Combination therapy with a potent BLI is making a come-back. The arrival of avibactam (ceftazidime/avibactam = Avycaz®) and other novel late-stage BLI from Merck and TMC will change our approach to ESBL infections.
- Surprising the number of quinolones with MRSA activity as their only claim to fame (i.e., differentiation).
- The 6 pulmonary drugs are inhaled generic antibiotics from well-known drug classes; hence, not truly representing innovation from the antibiotic point-of-view. However, some are addressing novel non-CF indications, like bronchiectasis, NTM infections, and COPD.
I also categorized drugs by degree of differentiation, using the following simple ranking system:
0 = undifferentiated
1 = significant PK OR significant microbiologic differentiation
2 = MDR differentiation
3 = new drug class
4 = new drug class and MDR differentiation
Assigning these categories to all QIDP drugs, I came up with this – admittedly subjective – assessment of the antibacterial development landscape:
I will not disclose which drugs specifically were in Category 0, 1, or 2 (nor those in Category 3 or 4). Suffice it to say that at least 7 (of 24) systemic antibacterials have a significantly differentiated profile and the potential for great innovation addressing significant medical needs.
Not a bad place to be, I’d say.
NOTE: Zavante Therapeutics should be added to the list for ZTI-01 (intravenous fosfomycin disodium), which is being developed for cUTI.
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ABBREVIATIONS USED:
BLI Beta-lactamase inhibitor
COPD chronic obstructive pulmonary disease
MDR multi-drug resistant
NTM non-tuberculous mycobacteria
CF cystic fibrosis
ESBL extended spectrum beta-lactamase
TMC The Medicines Company
MoA mode of action
