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RTB101
RTB101 is a Small molecule drug developed by Restorbio Inc.. It is currently in Phase 2 development. Also known as: Dactolisib, BEZ235.
RTB101 is a small molecule inhibitor of the serine/threonine-protein kinase mTOR, which is being studied in a Phase 3 clinical trial to determine its effectiveness in preventing clinically symptomatic respiratory illness in the elderly. RTB101 is also being investigated for its potential to treat respiratory tract infections, COVID-19, and clinically symptomatic respiratory illness.
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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).
| 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 | RTB101 |
|---|---|
| Also known as | Dactolisib, BEZ235 |
| Sponsor | Restorbio Inc. |
| Modality | Small molecule |
| Phase | Phase 2 |
Approved indications
Common side effects
Key clinical trials
- A Phase 3 Study to Determine if RTB101 Prevents Clinically Symptomatic Respiratory Illness in the Elderly (PHASE3)
- Phase 2 Study to Determine if RTB101 Reduces the Severity of COVID-19 in Older Adults Residing in Nursing Homes (PHASE2)
- A Phase 2 Study of RTB101 as COVID-19 Post-Exposure Prophylaxis in Older Adults (PHASE2)
- Effect of RTB101 on Illness Associated With Respiratory Tract Infections in the Elderly (PHASE3)
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:
- RTB101 CI brief — competitive landscape report
- RTB101 updates RSS · CI watch RSS
- Restorbio Inc. portfolio CI
Frequently asked questions about RTB101
What is RTB101?
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Is RTB101 also known as anything else?
What development phase is RTB101 in?
Related
- Manufacturer: Restorbio Inc. — full pipeline
- Also known as: Dactolisib, BEZ235
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing