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IL-12 DNA
IL-12 DNA is a Biologic drug developed by National Institute of Allergy and Infectious Diseases (NIAID). 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 | IL-12 DNA |
|---|---|
| Sponsor | National Institute of Allergy and Infectious Diseases (NIAID) |
| Modality | Biologic |
| Phase | Phase 1 |
Approved indications
Common side effects
- Any Event in SOC
- Fatigue
- Nausea
- Procedural pain
- Injection site reaction
- Injection site pain
- Anemia
- Headache
- Vomiting
- Myalgia
- Chills
- Arthralgia
Key clinical trials
- DNA Vaccine Therapy in Treating Patients With Chronic Hepatitis C Virus Infection (PHASE1)
- INO-5401 and INO-9012 Delivered by Electroporation (EP) in Combination With Cemiplimab (REGN2810) in Newly-Diagnosed Glioblastoma (GBM) (PHASE1, PHASE2)
- Combinatorial Therapy to Induce an HIV Remission (PHASE1, PHASE2)
- Neoantigen-based Personalized DNA Vaccine in Patients With Newly Diagnosed, Unmethylated Glioblastoma (PHASE1)
- Clinical Trial to Evaluate the Safety and Immunogenicity of Synthetic DNAs Encoding NP-GT8 and IL-12, With or Without a TLR-agonist-Adjuvanted HIV Env Trimer 4571 Boost, in Adults Without HIV (PHASE1)
- Cytokine Alterations and Chronic Post-Surgical Pain
- Safety and Immunogenicity Study of Na-GST-1 With or Without CpG (PHASE1)
- GNOS-PV02 Personalized Neoantigen Vaccine, INO-9012 and Pembrolizumab in Subjects with Advanced HCC (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:
- IL-12 DNA CI brief — competitive landscape report
- IL-12 DNA updates RSS · CI watch RSS
- National Institute of Allergy and Infectious Diseases (NIAID) portfolio CI
Frequently asked questions about IL-12 DNA
What is IL-12 DNA?
Who makes IL-12 DNA?
What development phase is IL-12 DNA in?
What are the side effects of IL-12 DNA?
Related
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing