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Montanide ISA 51 VG
Montanide ISA 51 VG is a adjuvant Small molecule drug developed by National Cancer Institute (NCI). It is currently in Phase 3 development for Cancer immunotherapy. Also known as: Montanide ISA 51, NSC 737063.
Montanide ISA 51 VG is an adjuvant used to enhance the immune response to vaccines.
Montanide ISA 51 VG is an adjuvant used to enhance the immune response to vaccines. Used for Cancer immunotherapy.
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Baseline phase 3 → approval rate
+58.3pp
Industry-wide phase 3 drugs reach approval ~58.3% of the time (BIO/Informa 2023 industry benchmark across all therapeutic areas). -
Oncology Phase 3 boost
+3.0pp
Oncology Phase 3 trials have higher approval rates (~61%) than the cross-industry average due to clearer endpoints and FDA oncology pathway.
| Regulator | Country | Likely year | Lag vs FDA |
|---|---|---|---|
| FDA | US | 2028–2030 | — |
| EMA | EU | 2029–2031 | +0.7 yr |
| MHRA | GB | 2029–2031 | +0.7 yr |
| Health Canada | CA | 2029–2032 | +0.9 yr |
| TGA | AU | 2029–2032 | +1.2 yr |
| PMDA | JP | 2029–2032 | +1.5 yr |
| NMPA | CN | 2030–2033 | +2.3 yr |
| MFDS | KR | 2029–2032 | +1.4 yr |
| CDSCO | IN | 2029–2033 | +1.8 yr |
| ANVISA | BR | 2030–2033 | +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 | Montanide ISA 51 VG |
|---|---|
| Also known as | Montanide ISA 51, NSC 737063 |
| Sponsor | National Cancer Institute (NCI) |
| Drug class | adjuvant |
| Modality | Small molecule |
| Therapeutic area | Oncology |
| Phase | Phase 3 |
Mechanism of action
It works by stimulating the immune system to produce a stronger response to the vaccine antigens, potentially leading to improved protection against diseases.
Approved indications
- Cancer immunotherapy
Common side effects
- Local reaction
Key clinical trials
- Evaluation of a Cancer Lysate Vaccine and Montanide (Registered Trademark) ISA-51 VG With or Without the IL-15 Super-Agonist N-803 as Adjuvant Therapy for PD-L1 Negative Non-Small Cell Lung Cancer (PHASE1, PHASE2)
- Testing the SurVaxM Vaccine for Lung Cancer Prevention (PHASE2)
- A Phase II Trial of Neoadjuvant PD-1 Vaccine PD1-Vaxx in Operable MSI High Colorectal Cancer (PHASE2)
- SurVaxM Vaccine Therapy and Temozolomide in Treating Patients With Newly Diagnosed Glioblastoma (PHASE2)
- Peptide Vaccine for Fibrolamellar Hepatocellular Carcinoma Patients and Other Tumor Entities Carrying the Driver Fusion DNAJB1-PRKACA (PHASE1)
- Phase IIa/b Trial of PvCS/Montanide ISA-51 Malaria Vaccine in Adults in Chocó, Colombia (PHASE2)
- IO102-IO103 in Combination With Pembrolizumab Versus Pembrolizumab Alone in Advanced Melanoma (IOB-013 / KN-D18) (PHASE3)
- PPV-06 Vaccine in Inflammatory Knee Osteoarthritis (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:
- Montanide ISA 51 VG CI brief — competitive landscape report
- Montanide ISA 51 VG updates RSS · CI watch RSS
- National Cancer Institute (NCI) portfolio CI
Frequently asked questions about Montanide ISA 51 VG
What is Montanide ISA 51 VG?
How does Montanide ISA 51 VG work?
What is Montanide ISA 51 VG used for?
Who makes Montanide ISA 51 VG?
Is Montanide ISA 51 VG also known as anything else?
What drug class is Montanide ISA 51 VG in?
What development phase is Montanide ISA 51 VG in?
What are the side effects of Montanide ISA 51 VG?
Related
- Drug class: All adjuvant drugs
- Manufacturer: National Cancer Institute (NCI) — full pipeline
- Therapeutic area: All drugs in Oncology
- Indication: Drugs for Cancer immunotherapy
- Also known as: Montanide ISA 51, NSC 737063
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing