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FP-01.1-Adjuvant
FP-01.1-Adjuvant is a Biologic drug developed by Immune Targeting Systems Ltd. It is currently in Phase 1 development. Also known as: Flunisyn + Adjuvant.
FP-01.1-Adjuvant is a small molecule adjuvant being studied in combination with an influenza A vaccine. It is being investigated in a clinical trial for the treatment of influenza A in older adults.
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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 | FP-01.1-Adjuvant |
|---|---|
| Also known as | Flunisyn + Adjuvant |
| Sponsor | Immune Targeting Systems Ltd |
| Modality | Biologic |
| Phase | Phase 1 |
Approved indications
Common side effects
Key clinical trials
- Influenza A Vaccine (FP-01.1) Formulated With and Without Adjuvant, in the Presence or Absence of a Single Administration of a Trivalent Inactivated Influenza Virus Vaccine in Older Adults (PHASE1)
- Safety, Tolerability and Immunogenicity of Two Different Formulations of an Influenza A Vaccine (FP-01.1) (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:
- FP-01.1-Adjuvant CI brief — competitive landscape report
- FP-01.1-Adjuvant updates RSS · CI watch RSS
- Immune Targeting Systems Ltd portfolio CI
Frequently asked questions about FP-01.1-Adjuvant
What is FP-01.1-Adjuvant?
Who makes FP-01.1-Adjuvant?
Is FP-01.1-Adjuvant also known as anything else?
What development phase is FP-01.1-Adjuvant in?
Related
- Manufacturer: Immune Targeting Systems Ltd — full pipeline
- Also known as: Flunisyn + Adjuvant
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing