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procalcitonin-guided antibiotic therapy
procalcitonin-guided antibiotic therapy is a Small molecule drug developed by Capital Medical University. It is currently in Phase 3 development for Community-acquired pneumonia, Hospital-acquired pneumonia, Ventilator-associated pneumonia.
Procalcitonin-guided antibiotic therapy involves using procalcitonin levels to guide the initiation and discontinuation of antibiotic therapy in patients with suspected bacterial infections.
Procalcitonin-guided antibiotic therapy involves using procalcitonin levels to guide the initiation and discontinuation of antibiotic therapy in patients with suspected bacterial infections. Used for Community-acquired pneumonia, Hospital-acquired pneumonia, Ventilator-associated pneumonia.
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Baseline phase 3 → approval rate
+58.3pp
Industry-wide phase 3 drugs reach approval ~58.3% 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 | 2028–2030 | — |
| EMA | EU | 2029–2031 | +0.7 yr |
| MHRA | GB | 2029–2031 | +0.7 yr |
| Health Canada | CA | 2029–2032 | +0.9 yr |
| TGA | AU | 2029–2032 | +1.2 yr |
| PMDA | JP | 2029–2032 | +1.5 yr |
| NMPA | CN | 2030–2033 | +2.3 yr |
| MFDS | KR | 2029–2032 | +1.4 yr |
| CDSCO | IN | 2029–2033 | +1.8 yr |
| ANVISA | BR | 2030–2033 | +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 | procalcitonin-guided antibiotic therapy |
|---|---|
| Sponsor | Capital Medical University |
| Modality | Small molecule |
| Therapeutic area | Infectious Diseases |
| Phase | Phase 3 |
Mechanism of action
Procalcitonin is a peptide hormone that is produced in response to bacterial infections. By measuring procalcitonin levels, healthcare providers can determine the likelihood of a bacterial infection and make informed decisions about antibiotic therapy. This approach aims to reduce unnecessary antibiotic use and minimize the development of antibiotic resistance.
Approved indications
- Community-acquired pneumonia
- Hospital-acquired pneumonia
- Ventilator-associated pneumonia
Common side effects
- Increased risk of antibiotic resistance
- Potential for delayed diagnosis and treatment of bacterial infections
Key clinical trials
- Impact of Rapid Pathogen Detection in ICU Patients With Suspected Pneumonia on Antimicrobial Therapy (PHASE2)
- AI-assisted Subtyping-directed Precision Treatment in Acute Aortic Dissection (NA)
- Assessing the Procalcitonin-guidance and Molecular-guided Diagnosis for Therapy of Severe Infections (the MODIFY Trial) (PHASE3)
- KInetics of Procalcitonin to Reduce Unnecessary aNtibiotic Use - Comparing Procalcitonin Kinetics-guided and Absolute Procalcitonin Value-guided Antibiotic Initiation in Reducing Unnecessary Antibiotic Use in Critically Ill Patients (NA)
- Procalcitonin and Duration of AntiBiotherapy In Late Onset Sepsis of Neonate (NA)
- An Antibiotic Protocol Guided by a Multimodal Approach in AECOPD With Pneumonia in Intensive Care (NA)
- Procalcitonin Aided Antimicrobial Therapy vs Standard of Care (NA)
- PROcalcitonin Impact on Antibiotic Reduction, adverSe Events and AVoidable healthcarE Costs (ProSAVE): A RCT (NA)
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:
- procalcitonin-guided antibiotic therapy CI brief — competitive landscape report
- procalcitonin-guided antibiotic therapy updates RSS · CI watch RSS
- Capital Medical University portfolio CI
Frequently asked questions about procalcitonin-guided antibiotic therapy
What is procalcitonin-guided antibiotic therapy?
How does procalcitonin-guided antibiotic therapy work?
What is procalcitonin-guided antibiotic therapy used for?
Who makes procalcitonin-guided antibiotic therapy?
What development phase is procalcitonin-guided antibiotic therapy in?
What are the side effects of procalcitonin-guided antibiotic therapy?
Related
- Manufacturer: Capital Medical University — full pipeline
- Therapeutic area: All drugs in Infectious Diseases
- Indication: Drugs for Community-acquired pneumonia
- Indication: Drugs for Hospital-acquired pneumonia
- Indication: Drugs for Ventilator-associated pneumonia
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing