Last reviewed · How we verify
AP611074 5% gel
AP611074 5% gel is a Small molecule drug developed by Vaxart. It is currently in Phase 2 development for Investigational immunomodulatory indication (specific indication not publicly disclosed).
AP611074 is a topical immunomodulatory agent designed to enhance local immune responses in the skin.
AP611074 is a topical immunomodulatory agent designed to enhance local immune responses in the skin. Used for Investigational immunomodulatory indication (specific indication not publicly disclosed).
-
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). -
Immunology slight uplift
+1.0pp
Mature endpoint landscape (ACR, DAS28, PASI) makes immunology approvals slightly more predictable.
| 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 | AP611074 5% gel |
|---|---|
| Sponsor | Vaxart |
| Modality | Small molecule |
| Therapeutic area | Immunology |
| Phase | Phase 2 |
Mechanism of action
AP611074 is a 5% gel formulation developed by Vaxart for topical application. As a phase 2 candidate, it is intended to modulate immune function at the site of application, potentially enhancing antiviral or anti-tumor immunity through local immune activation.
Approved indications
- Investigational immunomodulatory indication (specific indication not publicly disclosed)
Common side effects
Key clinical trials
- A Study to Assess the Safety, Tolerability, Pharmacokinetics and Efficacy of Twice Daily Topical Applications of AP611074 5% Gel for up to 16 Weeks in Condyloma Patients (PHASE2)
- Safety and Efficacy Study of Topical AP611074 Gel to Treat Genital Warts (PHASE1, PHASE2)
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:
- AP611074 5% gel CI brief — competitive landscape report
- AP611074 5% gel updates RSS · CI watch RSS
- Vaxart portfolio CI
Frequently asked questions about AP611074 5% gel
What is AP611074 5% gel?
How does AP611074 5% gel work?
What is AP611074 5% gel used for?
Who makes AP611074 5% gel?
What development phase is AP611074 5% gel in?
Related
- Manufacturer: Vaxart — full pipeline
- Therapeutic area: All drugs in Immunology
- Indication: Drugs for Investigational immunomodulatory indication (specific indication not publicly disclosed)
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing