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HIPEC
HIPEC is a Regional chemotherapy delivery system with hyperthermia Small molecule drug developed by UNICANCER. It is currently in Phase 3 development for Peritoneal carcinomatosis from colorectal cancer, Peritoneal carcinomatosis from ovarian cancer, Peritoneal mesothelioma. Also known as: hyperthermic intraperitoneal chemoperfusion, Hyperthermic intraperitoneal chemotherapy, intra-peritoneal chemotherapy, mitomycin c.
HIPEC is a hyperthermic intraperitoneal chemotherapy delivery system that circulates heated chemotherapy drugs directly into the abdominal cavity during surgery to treat peritoneal cancers.
HIPEC is a hyperthermic intraperitoneal chemotherapy delivery system that circulates heated chemotherapy drugs directly into the abdominal cavity during surgery to treat peritoneal cancers. Used for Peritoneal carcinomatosis from colorectal cancer, Peritoneal carcinomatosis from ovarian cancer, Peritoneal mesothelioma.
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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 |
|---|---|
| Also known as | hyperthermic intraperitoneal chemoperfusion, Hyperthermic intraperitoneal chemotherapy, intra-peritoneal chemotherapy, mitomycin c |
| Sponsor | UNICANCER |
| Drug class | Regional chemotherapy delivery system with hyperthermia |
| Modality | Small molecule |
| Therapeutic area | Oncology |
| Phase | Phase 3 |
Mechanism of action
HIPEC combines regional chemotherapy delivery with hyperthermia (heat) to enhance drug penetration and cytotoxicity in peritoneal tumors while minimizing systemic exposure. The heated chemotherapy solution is perfused throughout the peritoneal cavity during cytoreductive surgery, allowing direct contact with cancer cells and peritoneal surfaces. The combination of heat and chemotherapy is intended to improve local control and survival in patients with peritoneal carcinomatosis.
Approved indications
- Peritoneal carcinomatosis from colorectal cancer
- Peritoneal carcinomatosis from ovarian cancer
- Peritoneal mesothelioma
Common side effects
- Abdominal pain
- Infection/peritonitis
- Bowel perforation
- Hematologic toxicity
- Renal toxicity
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)
- Chemotherapy With or Without Immunotherapy for Peritoneal Mesothelioma (PHASE2)
- Enhanced Recovery After Surgery (ERAS) in Patients With Peritoneal Carcinomatosis Undergoing Cytoreductive Surgery With or Without HIPEC (NA)
- To Evaluate the Feasibility and Safety of Combining Surgery (Pancreatectomy and Cytoreduction) With HIPEC for Treating Pancreatic Cancer With Peritoneal Involvement. (NA)
- Perioperative Systemic Therapy for Isolated Resectable Colorectal Peritoneal Metastases (PHASE2, PHASE3)
- Telehealth Intervention for Improving Distress and Financial Toxicity in the Caregivers (NA)
- Trial Evaluating Feasibility and Quality of Life of Second Look Laparoscopy With Hyperthermic Intraperitoneal Chemotherapy (PHASE2)
- Integrating Peritoneal Histological Growth Patterns Into Preoperative Decision-Making for Colorectal Peritoneal Metastses
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 CI brief — competitive landscape report
- HIPEC updates RSS · CI watch RSS
- UNICANCER portfolio CI
Frequently asked questions about HIPEC
What is HIPEC?
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Related
- Drug class: All Regional chemotherapy delivery system with hyperthermia drugs
- Manufacturer: UNICANCER — full pipeline
- Therapeutic area: All drugs in Oncology
- Indication: Drugs for Peritoneal carcinomatosis from colorectal cancer
- Indication: Drugs for Peritoneal carcinomatosis from ovarian cancer
- Indication: Drugs for Peritoneal mesothelioma
- Also known as: hyperthermic intraperitoneal chemoperfusion, Hyperthermic intraperitoneal chemotherapy, intra-peritoneal chemotherapy, mitomycin c
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing