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Yervoy Injectable Product
Yervoy Injectable Product is a Small molecule drug developed by ImmunSYS, LLC. It is currently in Phase 2 development. Also known as: ipilimumab.
Yervoy is a small molecule injectable product used to treat various conditions, including extensive-stage small cell lung cancer (ES-SCLC), stage III/IV melanoma, localized oesogastric adenocarcinoma, microsatellite instability (MSI) and/or deficient mismatch repair (dMMR) cancers, and fibrolamellar hepatocellular carcinoma (FLC). It is administered in combination with chemotherapy and/or other treatments, such as etoposide and cisplatin, and is also used in combination with iparomlimab and tuvonralimab injection.
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Baseline phase 2 → approval rate
+15.3pp
Industry-wide phase 2 drugs reach approval ~15.3% of the time (BIO/Informa 2023 industry benchmark across all therapeutic areas).
| Regulator | Country | Likely year | Lag vs FDA |
|---|---|---|---|
| FDA | US | 2031–2034 | — |
| EMA | EU | 2032–2035 | +0.7 yr |
| MHRA | GB | 2032–2035 | +0.7 yr |
| Health Canada | CA | 2032–2036 | +0.9 yr |
| TGA | AU | 2032–2036 | +1.2 yr |
| PMDA | JP | 2032–2036 | +1.5 yr |
| NMPA | CN | 2033–2037 | +2.3 yr |
| MFDS | KR | 2032–2036 | +1.4 yr |
| CDSCO | IN | 2032–2037 | +1.8 yr |
| ANVISA | BR | 2033–2037 | +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 | Yervoy Injectable Product |
|---|---|
| Also known as | ipilimumab |
| Sponsor | ImmunSYS, LLC |
| Modality | Small molecule |
| Phase | Phase 2 |
Approved indications
Common side effects
Key clinical trials
- Study Evaluating the Benefit of Adding Ipilimumab to the Combination of Atezolizumab and Bevacizumab in Patients With Hepatocellular Carcinoma Receiving First-line Systemic Therapy (PHASE2, PHASE3)
- A DNAJB1-PRKACA Fusion Kinase Peptide Vaccine Combined With Glutamine Antagonist DRP-104, Nivolumab, and Ipilimumab in Patients With Advanced Stage Fibrolamellar Carcinoma (FLC) (PHASE1)
- XH001 Combination With Immunocheckpoint Inhibitor and Chemotherapy for Patients With Resected Pancreatic Cancer (NA)
- Iparomlimab and Tuvonralimab Injection Combined With Chemotherapy and Sequential Thoracic Radiotherapy for Extensive-Stage Small Cell Lung Cancer (PHASE2)
- Interleukin-6 Receptor Inhibitor Sarilumab in Combination With Ipilimumab, Nivolumab and Relatlimab in Patients With Unresectable Stage III or Stage IV Melanoma (PHASE2)
- CAR-DC Vaccine and ICIs in Local Advanced/Metastatic Solid Tumors (PHASE1)
- Ipilimumab and Decitabine in Treating Patients With Relapsed or Refractory Myelodysplastic Syndrome or Acute Myeloid Leukemia (PHASE1)
- iRECIST Evaluation's Relevance for DCR in MMR/MSI Metastatic Colorectal Cancer Patients on Nivolumab and Ipilimumab (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:
- Yervoy Injectable Product CI brief — competitive landscape report
- Yervoy Injectable Product updates RSS · CI watch RSS
- ImmunSYS, LLC portfolio CI
Frequently asked questions about Yervoy Injectable Product
What is Yervoy Injectable Product?
Who makes Yervoy Injectable Product?
Is Yervoy Injectable Product also known as anything else?
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Related
- Manufacturer: ImmunSYS, LLC — full pipeline
- Also known as: ipilimumab
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing