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tobramycin / TOBI
tobramycin / TOBI is a Small molecule drug developed by Chiesi Farmaceutici S.p.A.. It is currently in Phase 3 development. Also known as: TOBI.
Tobramycin, also known as TOBI, is a small molecule inhibitor of the 70S ribosome. It is used to treat various conditions, including Cystic Fibrosis Lung, Respiratory Infections, and Pseudomonas Aeruginosa infections.
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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).
| 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 | tobramycin / TOBI |
|---|---|
| Also known as | TOBI |
| Sponsor | Chiesi Farmaceutici S.p.A. |
| Modality | Small molecule |
| Phase | Phase 3 |
Approved indications
Common side effects
Key clinical trials
- Real-component vs All-cement Articulating Spacers for Periprosthetic Knee Infection (NA)
- Microbiome-guided Prophylaxis to Reduce Ventilator-Associated Pneumonia in Intensive Care Units: A Pilot Randomized Controlled Trial (PHASE2)
- Antibiotic Cement Bead Pouch Versus Negative Pressure Wound Therapy (PHASE3)
- Acute Application of Antibiotic Powder in Open Fracture Wounds (PHASE4)
- Topical Antibiotic Therapy to Reduce Infection After Operative Treatment of Fractures at High Risk of Infection: TOBRA (PHASE3)
- Fluorometholone Study (PHASE2)
- Local Antibiotic Concentrations With Tissue Expanders in Breast Reconstruction (NA)
- Tobradex as Intracanal Medicament (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:
- tobramycin / TOBI CI brief — competitive landscape report
- tobramycin / TOBI updates RSS · CI watch RSS
- Chiesi Farmaceutici S.p.A. portfolio CI
Frequently asked questions about tobramycin / TOBI
What is tobramycin / TOBI?
Who makes tobramycin / TOBI?
Is tobramycin / TOBI also known as anything else?
What development phase is tobramycin / TOBI in?
Related
- Manufacturer: Chiesi Farmaceutici S.p.A. — full pipeline
- Also known as: TOBI
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing