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Immune checkpoint inhibitor
Immune checkpoint inhibitor is a Immune checkpoint inhibitor Small molecule drug developed by John L. Villano, MD, PhD. It is currently in Phase 3 development for Cancer (specific indication not specified in provided information). Also known as: ICI, Chemotherapy, Cadonilimab, AK104.
Immune checkpoint inhibitors block inhibitory signals on T cells, allowing the immune system to recognize and attack cancer cells.
Immune checkpoint inhibitors are a type of cancer immunotherapy that stimulate the immune system to fight cancer. They have been studied in various clinical trials for conditions such as metastatic melanoma, gastric cancer, gastroesophageal cancer, advanced solid tumors, and nasopharyngeal carcinoma, and have been used in combination with other treatments like Nivolumab.
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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 | Immune checkpoint inhibitor |
|---|---|
| Also known as | ICI, Chemotherapy, Cadonilimab, AK104, PD-1/CTLA-4 inhibitor |
| Sponsor | John L. Villano, MD, PhD |
| Drug class | Immune checkpoint inhibitor |
| Modality | Small molecule |
| Therapeutic area | Oncology |
| Phase | Phase 3 |
Mechanism of action
These drugs work by inhibiting checkpoint proteins (such as PD-1, PD-L1, or CTLA-4) that cancer cells exploit to evade immune detection. By removing these 'brakes' on the immune system, checkpoint inhibitors restore T cell activation and proliferation, enabling durable anti-tumor immunity. This mechanism has proven effective across multiple cancer types.
Approved indications
- Cancer (specific indication not specified in provided information)
Common side effects
- Fatigue
- Immune-related colitis
- Pneumonitis
- Hepatotoxicity
- Rash
Key clinical trials
- Testing the Addition of an Anti-cancer Drug, Copanlisib, to the Usual Immunotherapy (Nivolumab With or Without Ipilimumab) in Patients With Advanced Solid Cancers That Have Changes in the Following Genes: PIK3CA and PTEN (PHASE1, PHASE2)
- Testing the Combination of ZEN003694 and Nivolumab With or Without Ipilimumab in Solid Tumors (PHASE1)
- Lenvatinib or Regorafenib for Advanced Hepatocellular Carcinoma After Immunotherapy (REVIVE) (PHASE2)
- Testing the Combination of Copanlisib, Nivolumab and Ipilimumab in Patients With Advanced Cancer and Lymphoma (PHASE1)
- A Clinical Study on the Safety, Tolerability and Efficacy of Neoantigen-based Personalized mRNA Therapy iNeo-Vac-R01 Plus PD-1 Inhibitor in Adjuvant Treatment of Liver Cancer Post Radical Resection (PHASE1, PHASE2)
- Immunotherapy With Nivolumab and Ipilimumab Followed by Nivolumab or Nivolumab With Cabozantinib for Patients With Advanced Kidney Cancer, The PDIGREE Study (PHASE3)
- HAIC Plus Systemic Therapy as De-escalation Therapy Strategy for Biliary Tract Cancer (NA)
- Correlation Vitamin D Level to Endocrine Autoimmune Toxicity Due to Immune Checkpoint Inhibitors
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:
- Immune checkpoint inhibitor CI brief — competitive landscape report
- Immune checkpoint inhibitor updates RSS · CI watch RSS
- John L. Villano, MD, PhD portfolio CI
Frequently asked questions about Immune checkpoint inhibitor
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Related
- Drug class: All Immune checkpoint inhibitor drugs
- Manufacturer: John L. Villano, MD, PhD — full pipeline
- Therapeutic area: All drugs in Oncology
- Indication: Drugs for Cancer (specific indication not specified in provided information)
- Also known as: ICI, Chemotherapy, Cadonilimab, AK104, PD-1/CTLA-4 inhibitor
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing