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US- sourced Opdivo®
US- sourced Opdivo® is a Small molecule drug developed by mAbxience Research S.L.. It is currently in Phase 3 development.
Opdivo is a PD-1 inhibitor that works by blocking the PD-1 receptor on T cells, allowing them to attack cancer cells.
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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).
| 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 | US- sourced Opdivo® |
|---|---|
| Sponsor | mAbxience Research S.L. |
| Modality | Small molecule |
| Phase | Phase 3 |
Mechanism of action
By blocking the PD-1 receptor, Opdivo allows T cells to recognize and attack cancer cells, which can help to slow or stop the growth of tumors. This mechanism is thought to be effective in a variety of cancers, including melanoma, lung cancer, and kidney cancer.
Approved indications
Common side effects
Key clinical trials
- Phase I Clinical Study To Evaluate Pharmacokinetic Profile, Safety, Efficacy and Immunogenicity Of Ipilimumab Biosimilar HLX13 Vs. YERVOY® (US-Sourced YERVOY®) As A First-Line Treatment For Patients With Unresectable Hepatocellular Carcinoma (PHASE1)
- Study to Compare Pharmacokinetics, Efficacy, Safety, and Immunogenicity of MB11 Versus EU-/US-Opdivo® in Subjects With Previously Untreated Advanced [Unresectable or Metastatic] Melanoma (PHASE3)
- A Study to Compare the Efficacy, Safety, Immunogenicity, and Pharmacokinetic Profile of HLX13 with YERVOY As a First-Line Treatment for Patients with Unresectable Hepatocellular Carcinoma (PHASE3)
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:
- US- sourced Opdivo® CI brief — competitive landscape report
- US- sourced Opdivo® updates RSS · CI watch RSS
- mAbxience Research S.L. portfolio CI
Frequently asked questions about US- sourced Opdivo®
What is US- sourced Opdivo®?
How does US- sourced Opdivo® work?
Who makes US- sourced Opdivo®?
What development phase is US- sourced Opdivo® in?
Related
- Manufacturer: mAbxience Research S.L. — full pipeline
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing