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Antibiotics exposure
Antibiotics exposure is a Small molecule drug developed by Harvard Pilgrim Health Care. It is currently in Phase 2 development for Observational study of antibiotic exposure and health outcomes.
This is an observational study examining the health effects of antibiotic exposure in a patient population, not a drug with a specific molecular mechanism.
Antibiotics, specifically Isoniazid and Rifampicin, are used to treat conditions such as Tuberculosis and Pulmonary Tuberculosis. These antibiotics are small molecule interventions, as classified by ChEMBL, which are used to combat bacterial infections.
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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 | Antibiotics exposure |
|---|---|
| Sponsor | Harvard Pilgrim Health Care |
| Modality | Small molecule |
| Therapeutic area | Infectious Disease / Epidemiology |
| Phase | Phase 2 |
Mechanism of action
Antibiotics exposure refers to a research investigation into how exposure to antibiotics (across various classes and durations) correlates with health outcomes in patients. This is an epidemiological or observational study conducted by Harvard Pilgrim Health Care, likely examining associations between antibiotic use patterns and clinical outcomes, rather than a novel therapeutic agent with a defined mechanism of action.
Approved indications
- Observational study of antibiotic exposure and health outcomes
Common side effects
Key clinical trials
- Quantifying Gram-negative Resistance to Empiric Therapy in the Intensive Care Unit
- Safety and Tolerability of Metformin in People With Tuberculosis (TB) and Human Immunodeficiency Virus (HIV) (PHASE2)
- SHAPE Pilot Trial: Skin Health and Allergy Prevention Exposure (NA)
- A Platform Protocol to Investigate Post-Transplant Cyclophosphamide-Based Graft-Versus-Host Disease Prophylaxis in Patients With Hematologic Malignancies Undergoing Mismatched Unrelated Donor Peripheral Blood Stem Cell Transplantation (PHASE2)
- Fecal Microbiome Transplant to Remodel Intestinal Microbiota for Patients With Relapsed or Refractory Lymphoma With Exposure to High-Risk Antibiotics Who Are Receiving Chimeric Antigen Receptor T Cells (PHASE2)
- Anthrax AV7909 Boost Evaluation Study (PHASE2)
- Flourish: Exploring the Early Infant Gut Microbiome (NA)
- Comparing Impacts of Donor Human Milk to Formula Supplementation on the Gut Microbiome of Full-term Infants (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:
- Antibiotics exposure CI brief — competitive landscape report
- Antibiotics exposure updates RSS · CI watch RSS
- Harvard Pilgrim Health Care portfolio CI
Frequently asked questions about Antibiotics exposure
What is Antibiotics exposure?
How does Antibiotics exposure work?
What is Antibiotics exposure used for?
Who makes Antibiotics exposure?
What development phase is Antibiotics exposure in?
Related
- Manufacturer: Harvard Pilgrim Health Care — full pipeline
- Therapeutic area: All drugs in Infectious Disease / Epidemiology
- Indication: Drugs for Observational study of antibiotic exposure and health outcomes
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing