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Low dose Penicillin
Low dose Penicillin is a Small molecule drug developed by Northern Ontario School of Medicine. It is currently in Phase 1 development.
Low-dose penicillin is used in clinical trials to study and potentially treat penicillin allergy, with interventions including single dose low-risk penicillin challenge. Penicillin is a small molecule antibiotic with the synonyms benzyl penicillin, classified under the modality of small molecule.
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Baseline phase 1 → approval rate
+9.6pp
Industry-wide phase 1 drugs reach approval ~9.6% of the time (BIO/Informa 2023 industry benchmark across all therapeutic areas).
| Regulator | Country | Likely year | Lag vs FDA |
|---|---|---|---|
| FDA | US | 2033–2036 | — |
| EMA | EU | 2034–2037 | +0.7 yr |
| MHRA | GB | 2034–2037 | +0.7 yr |
| Health Canada | CA | 2034–2038 | +0.9 yr |
| TGA | AU | 2034–2038 | +1.2 yr |
| PMDA | JP | 2034–2038 | +1.5 yr |
| NMPA | CN | 2035–2039 | +2.3 yr |
| MFDS | KR | 2034–2038 | +1.4 yr |
| CDSCO | IN | 2034–2039 | +1.8 yr |
| ANVISA | BR | 2035–2039 | +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 | Low dose Penicillin |
|---|---|
| Sponsor | Northern Ontario School of Medicine |
| Modality | Small molecule |
| Phase | Phase 1 |
Approved indications
Common side effects
- Minor adverse events
- Gastrointestinal Intolerance During Subsequent Penicillin Treatment at VUMC
- Vomiting
Key clinical trials
- Testing a Novel Combination Treatment (Arm D) Versus Standard of Care for Intensive Phase Treatment for Mycobacterium Abscessus Pulmonary Disease in People With or Without Cystic Fibrosis in the Finding the Optimal Regimen for Mycobacterium Abscessus Treatment (FORMaT) Adaptive Platform Trial (PHASE2)
- Intravenous Immunoglobulin for the Treatment of Acute Exacerbations of Idiopathic Pulmonary Fibrosis (PHASE3)
- Effectiveness of the Eradication of Helicobacter Pylori and an Inhibitor of Pump With Proton Versus Control (PHASE4)
- Comparative Efficacy of Antibiotics for Small Intestine Bacterial Overgrowth in Bangladeshi Children (PHASE2)
- Optimization of Keverprazan-amoxicillin Dual Therapy for Eradicating Helicobacter Pylori Infection (PHASE3)
- The Implementation and Impact of an Allergy De-Labeling Program in the Emergency Department (PHASE1)
- Role of Antibiotic Therapy or Immunoglobulin On iNfections in hAematoLogy Platform Trial (RATIONAL-PT) (PHASE2, PHASE3)
- Geisinger Antibiotic Allergy Pilot Program: Assess and Address (EARLY_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:
- Low dose Penicillin CI brief — competitive landscape report
- Low dose Penicillin updates RSS · CI watch RSS
- Northern Ontario School of Medicine portfolio CI
Frequently asked questions about Low dose Penicillin
What is Low dose Penicillin?
Who makes Low dose Penicillin?
What development phase is Low dose Penicillin in?
What are the side effects of Low dose Penicillin?
Related
- Manufacturer: Northern Ontario School of Medicine — full pipeline
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing