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Antiinfectives
Antiinfectives is a Small molecule drug developed by University Hospital of Cologne. It is currently in Phase 2 development. Also known as: Antifungals, Antibacterials, Antivirals.
Antiinfectives are a class of drugs that inhibit bacterial DNA gyrase, a mechanism that targets bacterial DNA replication. They are used to treat various conditions, including HIV-1-infection, Surgical Site Infection, Pressure Ulcer, Effective Intracanal Medicaments Against Enterococcus Faecalis, and Chronic Pulmonary Aspergillosis.
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Baseline phase 2 → approval rate
+15.3pp
Industry-wide phase 2 drugs reach approval ~15.3% of the time (BIO/Informa 2023 industry benchmark across all therapeutic areas). -
Anti-infectives pathway favourability
+2.0pp
Microbiological endpoints + non-inferiority designs raise approval rates above baseline.
| Regulator | Country | Likely year | Lag vs FDA |
|---|---|---|---|
| FDA | US | 2031–2034 | — |
| EMA | EU | 2032–2035 | +0.7 yr |
| MHRA | GB | 2032–2035 | +0.7 yr |
| Health Canada | CA | 2032–2036 | +0.9 yr |
| TGA | AU | 2032–2036 | +1.2 yr |
| PMDA | JP | 2032–2036 | +1.5 yr |
| NMPA | CN | 2033–2037 | +2.3 yr |
| MFDS | KR | 2032–2036 | +1.4 yr |
| CDSCO | IN | 2032–2037 | +1.8 yr |
| ANVISA | BR | 2033–2037 | +2.3 yr |
Hover any row for the lag rationale. Lag estimates are reduced when the drug has FDA Breakthrough or EMA PRIME designation (sponsors file globally in parallel).
Estimate based on the BIO/Informa industry phase transition rates plus per-drug modifiers for therapeutic area, sponsor type, FDA designations, mechanism, and trial design. Per-jurisdiction lags from Tufts CSDD international approval studies. Not investment, clinical or regulatory advice. Methodology: /methodology#likelihood.
At a glance
| Generic name | Antiinfectives |
|---|---|
| Also known as | Antifungals, Antibacterials, Antivirals |
| Sponsor | University Hospital of Cologne |
| Modality | Small molecule |
| Therapeutic area | Infectious Disease |
| Phase | Phase 2 |
Approved indications
Common side effects
Key clinical trials
- Topical Methylene Blue-Photodynamic Therapy (MB-PDT) for Burn Wound Infection (PHASE1, PHASE2)
- A Study of Doxycycline to Treat Chlamydial Infection (PHASE4)
- Immediate Versus Substantiated Antibiotic Therapy in Suspected Non-Severe Ventilator-Associated Pneumonia (NA)
- Safety and Immunogenicity Trial of PepGNP-COVID19 Vaccine in Adults (PHASE1)
- Optimization of Beta-lactam Dosing in Critically Ill Patients With Cystatin C (OPTIMIZE-GNI) (PHASE4)
- Quantifying Gram-negative Resistance to Empiric Therapy in the Intensive Care Unit
- A Study to Learn About a Study Medicine Called Ibuzatrelvir in Adult and Adolescent Patients With COVID-19 Who Are Not Hospitalized But Are at Risk For Severe Disease (PHASE3)
- MP101 in Adults With Acute Pseudomonas Aeruginosa Pneumonia (PHASE1)
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- Antiinfectives CI brief — competitive landscape report
- Antiinfectives updates RSS · CI watch RSS
- University Hospital of Cologne portfolio CI
Frequently asked questions about Antiinfectives
What is Antiinfectives?
Who makes Antiinfectives?
Is Antiinfectives also known as anything else?
What development phase is Antiinfectives in?
Related
- Manufacturer: University Hospital of Cologne — full pipeline
- Therapeutic area: All drugs in Infectious Disease
- Also known as: Antifungals, Antibacterials, Antivirals
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing