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IPI3/NIVO1
IPI3/NIVO1 is a ICOS agonist + PD-1 inhibitor combination Small molecule drug developed by Vastra Gotaland Region. It is currently in Phase 3 development for Advanced or metastatic melanoma, Non-small cell lung cancer. Also known as: Ipilimumab 3 mg/kg, Nivolumab 1 mg/kg.
IPI3/NIVO1 is a combination of an inducible T-cell co-stimulator (ICOS) agonist and a PD-1 inhibitor that enhances anti-tumor immune responses by activating T cells while removing inhibitory checkpoint signals.
IPI3/NIVO1 is a combination of an inducible T-cell co-stimulator (ICOS) agonist and a PD-1 inhibitor that enhances anti-tumor immune responses by activating T cells while removing inhibitory checkpoint signals. Used for Advanced or metastatic melanoma, Non-small cell lung cancer.
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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 | IPI3/NIVO1 |
|---|---|
| Also known as | Ipilimumab 3 mg/kg, Nivolumab 1 mg/kg |
| Sponsor | Vastra Gotaland Region |
| Drug class | ICOS agonist + PD-1 inhibitor combination |
| Target | ICOS and PD-1 |
| Modality | Small molecule |
| Therapeutic area | Oncology |
| Phase | Phase 3 |
Mechanism of action
The ICOS agonist component (IPI3) activates CD4+ and CD8+ T cells through the inducible T-cell co-stimulator pathway, promoting T-cell proliferation and effector function. Nivolumab (NIVO1), a PD-1 inhibitor, blocks the PD-1/PD-L1 checkpoint interaction that normally suppresses T-cell activity. Together, this dual mechanism aims to generate a more robust and durable anti-tumor immune response than either agent alone.
Approved indications
- Advanced or metastatic melanoma
- Non-small cell lung cancer
Common side effects
- Immune-related colitis
- Immune-related pneumonitis
- Immune-related hepatitis
- Fatigue
- Rash
Key clinical trials
- PHP in Combination With IPI1/NIVO3 Compared to IPI3/NIVO1 Only in Patients With Uveal Melanoma Liver Metastases (PHASE3)
- Optimal Neo-adjuvant Combination Scheme of Ipilimumab and Nivolumab (PHASE2)
- Tailored ImmunoTherapy Approach With Nivolumab in Subjects With Metastatic or Advanced Transitional Cell Carcinoma (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:
- IPI3/NIVO1 CI brief — competitive landscape report
- IPI3/NIVO1 updates RSS · CI watch RSS
- Vastra Gotaland Region portfolio CI
Frequently asked questions about IPI3/NIVO1
What is IPI3/NIVO1?
How does IPI3/NIVO1 work?
What is IPI3/NIVO1 used for?
Who makes IPI3/NIVO1?
Is IPI3/NIVO1 also known as anything else?
What drug class is IPI3/NIVO1 in?
What development phase is IPI3/NIVO1 in?
What are the side effects of IPI3/NIVO1?
What does IPI3/NIVO1 target?
Related
- Drug class: All ICOS agonist + PD-1 inhibitor combination drugs
- Target: All drugs targeting ICOS and PD-1
- Manufacturer: Vastra Gotaland Region — full pipeline
- Therapeutic area: All drugs in Oncology
- Indication: Drugs for Advanced or metastatic melanoma
- Indication: Drugs for Non-small cell lung cancer
- Also known as: Ipilimumab 3 mg/kg, Nivolumab 1 mg/kg
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing