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Nivolumab, fixed dose
Nivolumab, fixed dose is a Small molecule drug developed by Philogen S.p.A.. It is currently in Phase 1 development.
Nivolumab is a programmed cell death protein 1 inhibitor, classified as an antibody inhibitor. It is used to treat conditions such as unresectable or metastatic melanoma, metastatic renal cell carcinoma, and stage III melanoma.
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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 | Nivolumab, fixed dose |
|---|---|
| Sponsor | Philogen S.p.A. |
| Modality | Small molecule |
| Phase | Phase 1 |
Approved indications
Common side effects
Key clinical trials
- ACTengine® IMA203/IMA203CD8 as Monotherapy or in Combination With Nivolumab in Recurrent and/or Refractory Solid Tumors (PHASE1, PHASE2)
- Peri-Operative Immune Checkpoint Inhibition and Cryoablation in Women With Triple-negative Breast Cancer (PHASE2)
- De-intensified Radiation Therapy With Chemotherapy (Cisplatin) or Immunotherapy (Nivolumab) in Treating Patients With Early-Stage, HPV-Positive, Non-Smoking Associated Oropharyngeal Cancer (PHASE2, PHASE3)
- NeoVax + CDX-301 and Nivolumab or Pembrolizumab in Melanoma (PHASE1)
- Hepzato Kit and Opdualag for Metastatic Melanoma and Liver Metastasis (PHASE1, PHASE2)
- Pan Tumor Rollover Study (PHASE2)
- A Multicenter Clinical Study of Combined Therapy for Unresectable Hepatocellular Carcinoma (PHASE1, PHASE2)
- Pomalidomide and Nivolumab in People With Virus-Associated Malignancies With or Without HIV (PHASE1)
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:
- Nivolumab, fixed dose CI brief — competitive landscape report
- Nivolumab, fixed dose updates RSS · CI watch RSS
- Philogen S.p.A. portfolio CI
Frequently asked questions about Nivolumab, fixed dose
What is Nivolumab, fixed dose?
Who makes Nivolumab, fixed dose?
What development phase is Nivolumab, fixed dose in?
Related
- Manufacturer: Philogen S.p.A. — full pipeline
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing