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Liporaxel
Liporaxel is a Small molecule drug developed by Asan Medical Center. It is currently in Phase 2 development.
Liporaxel, also known as DHP107, is being studied in clinical trials for the treatment of recurrent or metastatic breast cancer, as well as other advanced solid tumors. It is being evaluated in combination with other medications, including paclitaxel and pertuzumab/trastuzumab, in a phase 2 clinical trial.
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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 | Liporaxel |
|---|---|
| Sponsor | Asan Medical Center |
| Modality | Small molecule |
| Therapeutic area | Other |
| Phase | Phase 2 |
Approved indications
Common side effects
Key clinical trials
- Neoadjuvant Oral Paclitaxel Plus Subcutaneous Pertuzumab/Trastuzumab in Patients With HER2-positive Breast Cancer (NA)
- Oral Paclitaxel Trial In Recurrent and Metastatic Breast Cancer As 1st Line Therapy (PHASE2, PHASE3)
- Food Effect on Pharmacokinetics and Safety of DHP107 (Liporaxel®) FEEL Study (PHASE1)
- GIST Oral Paclitaxel(Liporaxel) (PHASE2)
- Oral Paclitaxel Efficacy Safety and PK in Recurrent and Metastatic Breast Cancer (PHASE2)
- A Study Using Whole-body PET After Oral Microdose of 18F-labeled Liporaxel in Patients With Solid Tumor (EARLY_PHASE1)
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:
- Liporaxel CI brief — competitive landscape report
- Liporaxel updates RSS · CI watch RSS
- Asan Medical Center portfolio CI
Frequently asked questions about Liporaxel
What is Liporaxel?
Who makes Liporaxel?
What development phase is Liporaxel in?
Related
- Manufacturer: Asan Medical Center — full pipeline
- Therapeutic area: All drugs in Other
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing