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Hipec with Cisplatin
Hipec with Cisplatin is a Regional chemotherapy / Intraperitoneal chemotherapy Small molecule drug developed by Fundacion para la Formacion e Investigacion Sanitarias de la Region de Murcia. It is currently in Phase 3 development for Peritoneal carcinomatosis from colorectal cancer, Peritoneal mesothelioma, Ovarian cancer with peritoneal involvement.
HIPEC (hyperthermic intraperitoneal chemotherapy) with cisplatin delivers heated chemotherapy directly into the peritoneal cavity to treat intra-abdominal malignancies.
HIPEC (hyperthermic intraperitoneal chemotherapy) with cisplatin delivers heated chemotherapy directly into the peritoneal cavity to treat intra-abdominal malignancies. Used for Peritoneal carcinomatosis from colorectal cancer, Peritoneal mesothelioma, Ovarian cancer with peritoneal involvement.
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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 | Hipec with Cisplatin |
|---|---|
| Sponsor | Fundacion para la Formacion e Investigacion Sanitarias de la Region de Murcia |
| Drug class | Regional chemotherapy / Intraperitoneal chemotherapy |
| Target | DNA (cisplatin acts as a platinum-based alkylating agent) |
| Modality | Small molecule |
| Therapeutic area | Oncology |
| Phase | Phase 3 |
Mechanism of action
HIPEC is a regional chemotherapy technique that circulates heated cisplatin solution throughout the peritoneal cavity during surgery, allowing direct contact with peritoneal surfaces and tumor nodules while minimizing systemic exposure. The combination of hyperthermia (elevated temperature) and cisplatin enhances cytotoxic effects against cancer cells. This approach is used as an adjunctive treatment during cytoreductive surgery for peritoneal malignancies.
Approved indications
- Peritoneal carcinomatosis from colorectal cancer
- Peritoneal mesothelioma
- Ovarian cancer with peritoneal involvement
Common side effects
- Myelosuppression
- Nephrotoxicity
- Neurotoxicity
- Gastrointestinal toxicity
- Peritoneal/abdominal complications
Key clinical trials
- Individual Response to Hyperthermic Intraperitoneal Chemotherapy (HIPEC) Treatment of Peritoneal Carcinomatosis From Peritoneal Mesothelioma or Atypical Mesothelial Proliferation or From Ovarian, Colorectal, or Appendiceal Histologies (PHASE1)
- To Evaluate the Feasibility and Safety of Combining Surgery (Pancreatectomy and Cytoreduction) With HIPEC for Treating Pancreatic Cancer With Peritoneal Involvement. (NA)
- Hyperthermic Intraperitoneal Chemotherapy (HIPEC) in Ovarian Cancer (CHIPPI) (PHASE3)
- Combined Systemic and Intraperitoneal Chemotherapy for Synchronous Gastric and/or Gastroesophageal Peritoneal Carcinomatosis (PHASE2)
- The PROOV Study: Exploiting the Synergistic Effect of PARP Inhibition With Cisplatin and Hyperthermia During Interval Cytoreductive Surgery and HIPEC in Ovarian Cancer (PHASE1, PHASE2)
- Surgery and Chemotherapy With or Without Chemotherapy After Surgery in Treating Patients With Ovarian, Fallopian Tube, Uterine, or Peritoneal Cancer (PHASE1)
- Robotic Cytoreduction and Hyperthermic Intraperitoneal Chemotherapy for Treatment of Gastric Cancer With Limited Peritoneal Metastasis, ROBO-CHIP Study (PHASE2)
- Interval Cytoreductive Surgery With or Without HIPEC for Ovarian Cancer (FOCUS / KOV-HIPEC-04) (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:
- Hipec with Cisplatin CI brief — competitive landscape report
- Hipec with Cisplatin updates RSS · CI watch RSS
- Fundacion para la Formacion e Investigacion Sanitarias de la Region de Murcia portfolio CI
Frequently asked questions about Hipec with Cisplatin
What is Hipec with Cisplatin?
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What does Hipec with Cisplatin target?
Related
- Drug class: All Regional chemotherapy / Intraperitoneal chemotherapy drugs
- Target: All drugs targeting DNA (cisplatin acts as a platinum-based alkylating agent)
- Manufacturer: Fundacion para la Formacion e Investigacion Sanitarias de la Region de Murcia — full pipeline
- Therapeutic area: All drugs in Oncology
- Indication: Drugs for Peritoneal carcinomatosis from colorectal cancer
- Indication: Drugs for Peritoneal mesothelioma
- Indication: Drugs for Ovarian cancer with peritoneal involvement
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing