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Triplizumab
Triplizumab is a Small molecule drug developed by The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School. It is currently in Phase 2 development.
Triplizumab is being studied in combination with the TIP regimen (Paclitaxel + Ifosfamide + Cisplatin) as a neoadjuvant therapy for locally advanced penile cancer. Triplizumab is also being investigated in clinical trials for other conditions, including esophageal squamous cell carcinoma, adrenocortical carcinoma, nasopharyngeal carcinoma, and bladder cancer.
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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 | Triplizumab |
|---|---|
| Sponsor | The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School |
| Modality | Small molecule |
| Therapeutic area | Other |
| Phase | Phase 2 |
Approved indications
Common side effects
Key clinical trials
- TN Induction and Adjuvant Therapy for Resectable Local Recurrent Nasopharyngeal Carcinoma (PHASE2)
- Phase II Study of PD-1 Antibody Combined With Radiotherapy in Recurrent or Metastatic Adrenal Cortical Carcinoma (PHASE2)
- TIP Regimen Combined With Triplizumab Neoadjuvant Therapy for Locally Advanced Penile Cancer (PHASE2)
- BTLA Inhibitor (JS004) Combined with Toripalimab and Chemotherapy in the Perioperative Treatment of Resectable Locally Advanced Thoracic Esophageal Squamous Cell Carcinoma (PHASE2)
- An Open-label, Single-arm, Multicenter Phase II Clinical Study： Evaluating RC48-ADC Combined With Triplizumab in the Neoadjuvant Treatment of Her2-positive Muscle-invasive Bladder Cancer (PHASE2)
- A Clinical Study of RC48-ADC Combined With Triplizumab For Treatment of Myometrial Invasive Bladder Cancer (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:
- Triplizumab CI brief — competitive landscape report
- Triplizumab updates RSS · CI watch RSS
- The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School portfolio CI
Frequently asked questions about Triplizumab
What is Triplizumab?
Who makes Triplizumab?
What development phase is Triplizumab in?
Related
- Manufacturer: The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School — full pipeline
- Therapeutic area: All drugs in Other
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing