Last reviewed · How we verify
Pinorubicin (PIRARUBICIN)
Pinorubicin (generic name: PIRARUBICIN) is a pirarubicin drug. It is currently in Phase 3 development.
Pirarubicin works by intercalating DNA strands, thereby inhibiting the progression of the enzyme topoisomerase II and inducing DNA damage in cancer cells.
Pinorubicin is a small molecule used in the treatment of various conditions, including Hepatocellular Carcinoma and Lymphoma, as per ClinicalTrials.gov. It is also known by other names, including Adriamycin and Pirarubicin, as listed in ChEMBL.
-
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 | PIRARUBICIN |
|---|---|
| Drug class | pirarubicin |
| Modality | Small molecule |
| Therapeutic area | Oncology |
| Phase | Phase 3 |
Mechanism of action
Imagine DNA as a ladder with rungs that need to be opened and closed for the cell to divide. Pirarubicin gets in the way of this process by inserting itself between the rungs, causing the cell to become confused and eventually die. This helps to slow or stop the growth of cancer cells.
Approved indications
Common side effects
- Bone marrow failure
- Myelosuppression
- Renal salt-wasting syndrome
- Febrile neutropenia
- Pleuroparenchymal fibroelastosis
- Cerebral salt-wasting syndrome
Key clinical trials
- A Study of Intravesical SHR-1501 Combination With BCG Versus Investigator-selected Chemotherapy in Subjects With BCG-unresponsive NMIBC (PHASE3)
- Phase II Exploratory Study of Toripalimab Combined With SBRT in HER2-Negative Breast Cancer Patients With Insensitivity to Neoadjuvant Chemotherapy (PHASE2)
- FMD and Neoadjuvant Chemo-immunotherapy in TNBC (PHASE2)
- TACE+RFA Versus TACE Alone for Intermediate-stage Hepatocellular Carcinoma (PHASE3)
- A Study of QL1706 Combined With Short-Cycle Anthracyclines or Taxanes for the Treatment of Early-Stage TNBC (PHASE1)
- TACE Combined With Anti-PD-1 Antibody in Patients With Advanced Hepatocellular Carcinoma: Study on Efficacy and Immune Microenvironment
- TACE Combined With Lenvatinib and PD-1 Inhibitor for Ruptured Hepatocellular Carcinoma (NA)
- Lenvatinib, Sintilimab, and DEB-TACE With/Without HAIC for HCC >7 cm With PVTT (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:
- Pinorubicin CI brief — competitive landscape report
- Pinorubicin updates RSS · CI watch RSS
Frequently asked questions about Pinorubicin
What is Pinorubicin?
How does Pinorubicin work?
What is the generic name of Pinorubicin?
What drug class is Pinorubicin in?
What development phase is Pinorubicin in?
What are the side effects of Pinorubicin?
Related
- Drug class: All pirarubicin drugs
- Therapeutic area: All drugs in Oncology
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing