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Vacc-4x
Vacc-4x is a Biologic drug developed by Bionor Immuno AS. It is currently in Phase 2 development. Also known as: A combination of Vacc-10, Vacc-11, Vacc-12 and Vacc-13, Combination of Vacc-10, Vacc-11, Vacc-12 and Vacc-13., Combination of Vacc-10, Vacc-11, Vacc-12 and Vacc-13.
Vacc-4x is a treatment being studied for HIV-1 Infection, HIV Infection, and HIV I Infection. It is being tested in combination with lenalidomide and a placebo in a double-blind, placebo-controlled study.
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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 | Vacc-4x |
|---|---|
| Also known as | A combination of Vacc-10, Vacc-11, Vacc-12 and Vacc-13, Combination of Vacc-10, Vacc-11, Vacc-12 and Vacc-13., Combination of Vacc-10, Vacc-11, Vacc-12 and Vacc-13 |
| Sponsor | Bionor Immuno AS |
| Modality | Biologic |
| Phase | Phase 2 |
Approved indications
Common side effects
Key clinical trials
- Vacc-4x + Lenalidomide vs. Vacc-4x +Placebo in HIV-1-infected Subjects on Antiretroviral Therapy (ART) (PHASE1, PHASE2)
- Re-boosting of HIV-1 Infected Subjects With Vacc-4x (PHASE2)
- Safety and Efficacy of Romidepsin and the Therapeutic Vaccine Vacc-4x for Reduction of the Latent HIV-1 Reservoir (PHASE1, PHASE2)
- Immunogenicity Study of Vacc-4x Versus Placebo in Patients Infected With HIV (PHASE2)
- Intranasal Modified Vacc-4x Gag Peptides With Endocine as Adjuvant (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:
- Vacc-4x CI brief — competitive landscape report
- Vacc-4x updates RSS · CI watch RSS
- Bionor Immuno AS portfolio CI
Frequently asked questions about Vacc-4x
What is Vacc-4x?
Who makes Vacc-4x?
Is Vacc-4x also known as anything else?
What development phase is Vacc-4x in?
Related
- Manufacturer: Bionor Immuno AS — full pipeline
- Also known as: A combination of Vacc-10, Vacc-11, Vacc-12 and Vacc-13, Combination of Vacc-10, Vacc-11, Vacc-12 and Vacc-13., Combination of Vacc-10, Vacc-11, Vacc-12 and Vacc-13
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing