Last reviewed · How we verify
AdCh3NSmut1
AdCh3NSmut1 is a Biologic drug developed by ReiThera Srl. It is currently in Phase 1 development.
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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 | AdCh3NSmut1 |
|---|---|
| Sponsor | ReiThera Srl |
| Modality | Biologic |
| Phase | Phase 1 |
Approved indications
Common side effects
Key clinical trials
- Staged Phase I/II Hepatitis C Prophylactic Vaccine (PHASE1, PHASE2)
- A Study to Assess the Safety of HIV and Hep C Vaccine Candidates When Given Separately or in Combination (PHASE1)
- A Study to Assess the Safety of Hep C Vaccine Candidates in HIV Seropositive Individuals (PHASE1)
- Study of a New MVA Vaccine for Hepatitis C Virus (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:
- AdCh3NSmut1 CI brief — competitive landscape report
- AdCh3NSmut1 updates RSS · CI watch RSS
- ReiThera Srl portfolio CI
Frequently asked questions about AdCh3NSmut1
What is AdCh3NSmut1?
Who makes AdCh3NSmut1?
What development phase is AdCh3NSmut1 in?
Related
- Manufacturer: ReiThera Srl — full pipeline
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing