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liposomal cisplatin
liposomal cisplatin is a Platinum-based chemotherapy Small molecule drug developed by Federation Francophone de Cancerologie Digestive. It is currently in Phase 3 development for Ovarian cancer, Non-small cell lung cancer, Bladder cancer.
Liposomal cisplatin works by releasing cisplatin, a platinum-based chemotherapy drug, in a targeted manner to kill cancer cells.
Liposomal cisplatin is a small molecule modality used in combination with other treatments, such as Sintilimab and chemotherapy, to study its safety and efficacy in various conditions including Esophageal Squamous Cell Carcinoma and Pleural Mesothelioma. It is used in clinical trials, often in combination with other interventions like Liposomal Paclitaxel and Doxorubicin, to investigate its effects in potentially resectable esophageal cancer and other conditions.
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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 | liposomal cisplatin |
|---|---|
| Sponsor | Federation Francophone de Cancerologie Digestive |
| Drug class | Platinum-based chemotherapy |
| Modality | Small molecule |
| Therapeutic area | Oncology |
| Phase | Phase 3 |
Mechanism of action
Cisplatin is a DNA crosslinking agent that interferes with DNA replication and transcription, leading to cell death. The liposomal formulation helps to reduce systemic toxicity and increase the drug's accumulation in tumors.
Approved indications
- Ovarian cancer
- Non-small cell lung cancer
- Bladder cancer
- Stomach cancer
Common side effects
- Nausea and vomiting
- Neutropenia
- Anemia
- Thrombocytopenia
- Renal impairment
- Hearing loss
- Peripheral neuropathy
Key clinical trials
- The Efficacy and Safety of the Combination of PD-1 With Chemotherapy and Adaptive Radiotherapy Strategy in the Treatment of Stage III Non-small Cell Lung Cancer Patients (PHASE2)
- Efficacy & Safety of Olvi-Vec and Platinum-doublet + Bevacizumab Compared to Physician's Choice of Chemotherapy and Bevacizumab in Platinum-Resistant/Refractory Ovarian Cancer (PRROC) (OnPrime, GOG-3076) (PHASE3)
- A Cancer Vaccine (STEMVAC) in Combination With Chemotherapy for the Treatment of PD-L1 Negative Metastatic Triple-Negative Breast Cancer (PHASE2)
- Surgery and Chemotherapy With or Without Chemotherapy After Surgery in Treating Patients With Ovarian, Fallopian Tube, Uterine, or Peritoneal Cancer (PHASE1)
- A Study of ASP3082 in Adults With Advanced Solid Tumors (PHASE1)
- Tislelizumab Monotherapy Versus Salvage Chemotherapy for Relapsed/Refractory Classical Hodgkin Lymphoma (PHASE3)
- Adebrelimab Combined With Chemotherapy for the Esophageal Squamous Cell Carcinoma (NA)
- Prospective, Single-arm, Phase II Clinical Study of Irinotecan Hydrochloride Liposome Injection Combined With Platinum and Immune Checkpoint Inhibitors Combined With Anlotinib for the Maintenance of Extensive Small Cell Lung Cancer After First-line Induction (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:
- liposomal cisplatin CI brief — competitive landscape report
- liposomal cisplatin updates RSS · CI watch RSS
- Federation Francophone de Cancerologie Digestive portfolio CI
Frequently asked questions about liposomal cisplatin
What is liposomal cisplatin?
How does liposomal cisplatin work?
What is liposomal cisplatin used for?
Who makes liposomal cisplatin?
What drug class is liposomal cisplatin in?
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Related
- Drug class: All Platinum-based chemotherapy drugs
- Manufacturer: Federation Francophone de Cancerologie Digestive — full pipeline
- Therapeutic area: All drugs in Oncology
- Indication: Drugs for Ovarian cancer
- Indication: Drugs for Non-small cell lung cancer
- Indication: Drugs for Bladder cancer
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing